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A team's cognitions of interpersonally coordinated actions are a crucial component for successful team performance. Here, we present an approach to practice team action by way of imagery and examine its impact on team cognitions in long-term memory. We investigated the impact of a 4-week team action imagery intervention on futsal players' mental representations of team-level tactics. Skilled futsal players were assigned to either an imagery training group or a no imagery training control group. Participants in the imagery training group practiced four team-level tactics by imagining team actions in specific game situations for three times a week. Results revealed that the imagery training group's representations were more similar to that of an expert representation after the intervention compared with the control group. This study indicates that team action imagery training can have a significant impact on players' tactical skill representations and thus order formation in long-term memory. [ABSTRACT FROM AUTHOR]

Background: The African Surgical OutcomeS-2 (ASOS-2) trial tested an enhanced postoperative surveillance intervention to reduce postoperative mortality in Africa. We undertook a concurrent evaluation to understand the process of intervention delivery.Methods: Mixed-methods process evaluation, including field notes, interviews, and post-trial questionnaire responses. Qualitative analysis used the framework method with subsequent creation of comparative case studies, grouping hospitals by intervention fidelity. A post-trial questionnaire was developed using initial qualitative analyses. Categorical variables were summarised as count (%) and continuous variables as median (inter-quartile range [IQR]). Odds ratios (OR) were used to rank influences by impact on fidelity.Results: The dataset included eight in-depth case studies, and 96 questionnaire responses (response rate 67%) plus intervention fidelity data for each trial site. Overall, 57% (n=55/96) of hospitals achieved intervention delivery using an inclusive definition of fidelity. Delivery of the ASOS-2 interventions and data collection presented a significant burden to the investigators, outstripping limited resources. The influences most associated with fidelity were: surgical staff enthusiasm for the trial (OR=3.0; 95% confidence interval [CI], 1.3-7.0); nursing management support of the trial (OR=2.6; 95% CI, 1.1-6.5); performance of a dummy run (OR=2.6; 95% CI, 1.1-6.1); nursing colleagues seeing the value of the intervention(s) (OR=2.1; 95% CI, 0.9-5.7); and site investigators' belief in the effectiveness of the intervention (OR=3.2; 95% CI, 1.2-9.4).Conclusions: ASOS-2 has proved that coordinated interventional research across Africa is possible, but delivering the ASOS-2 interventions was a major challenge for many investigators. Future improvement science efforts must include better planning for intervention delivery, additional support to investigators, and promotion of strong inter-professional teamwork.Clinical Trial Registration: ClinicalTrials gov NCT03853824. [ABSTRACT FROM AUTHOR]

Affective response to exercise may mediate the effects of self-paced exercise on exercise adherence. Fiftynine low-active (exercise <60 min/week), overweight (body mass index: 25.0-39.9) adults (ages 18-65) were randomly assigned to self-paced (but not to exceed 76% maximum heart rate) or prescribed moderate intensity exercise (64-76% maximum heart rate) in the context of otherwise identical 6-month print-based exercise promotion programs. Frequency and duration of exercise sessions and affective responses (good/bad) to exercise were assessed via ecological momentary assessment throughout the 6-month program. A regression-based mediation model was used to estimate (a) effects of experimental condition on affective response to exercise (path a = 0.20, SE = 0.28, f2 = 0.02); (b) effects of affective response on duration/latency of the next exercise session (path b = 0.47, SE = 0.25, f2 = 0.04); and (c) indirect effects of experimental condition on exercise outcomes via affective response (path ab = 0.11, SE = 0.06, f2 = 0.10). Results provide modest preliminary support for a mediational pathway linking self-paced exercise, affective response, and exercise adherence. [ABSTRACT FROM AUTHOR]

Importance: Mental health comorbidities are increasing worldwide and worsen outcomes for people with diabetes, especially when care is fragmented.Objective: To assess whether collaborative care vs usual care lowers depressive symptoms and improves cardiometabolic indices among adults with diabetes and depression.Design, Setting, and Participants: Parallel, open-label, pragmatic randomized clinical trial conducted at 4 socioeconomically diverse clinics in India that recruited patients with type 2 diabetes; a Patient Health Questionnaire-9 score of at least 10 (range, 0-27); and hemoglobin A1c (HbA1c) of at least 8%, systolic blood pressure (SBP) of at least 140 mm Hg, or low-density lipoprotein (LDL) cholesterol of at least 130 mg/dL. The first patient was enrolled on March 9, 2015, and the last was enrolled on May 31, 2016; the final follow-up visit was July 14, 2018.Interventions: Patients randomized to the intervention group (n = 196) received 12 months of self-management support from nonphysician care coordinators, decision support electronic health records facilitating physician treatment adjustments, and specialist case reviews; they were followed up for an additional 12 months without intervention. Patients in the control group (n = 208) received usual care over 24 months.Main Outcomes and Measures: The primary outcome was the between-group difference in the percentage of patients at 24 months who had at least a 50% reduction in Symptom Checklist Depression Scale (SCL-20) scores (range, 0-4; higher scores indicate worse symptoms) and a reduction of at least 0.5 percentage points in HbA1c, 5 mm Hg in SBP, or 10 mg/dL in LDL cholesterol. Prespecified secondary outcomes were percentage of patients at 12 and 24 months who met treatment targets (HbA1c <7.0%, SBP <130 mm Hg, LDL cholesterol <100 mg/dL [<70 mg/dL if prior cardiovascular disease]) or had improvements in individual outcomes (≥50% reduction in SCL-20 score, ≥0.5-percentage point reduction in HbA1c, ≥5-mm Hg reduction in SBP, ≥10-mg/dL reduction in LDL cholesterol); percentage of patients who met all HbA1c, SBP, and LDL cholesterol targets; and mean reductions in SCL-20 score, Patient Health Questionnaire-9 score, HbA1c, SBP, and LDL cholesterol.Results: Among 404 patients randomized (mean [SD] age, 53 [8.6] years; 165 [40.8%] men), 378 (93.5%) completed the trial. A significantly greater percentage of patients in the intervention group vs the usual care group met the primary outcome (71.6% vs 57.4%; risk difference, 16.9% [95% CI, 8.5%-25.2%]). Of 16 prespecified secondary outcomes, there were no statistically significant between-group differences in improvements in 10 outcomes at 12 months and in 13 outcomes at 24 months. Serious adverse events in the intervention and usual care groups included cardiovascular events or hospitalizations (4 [2.0%] vs 7 [3.4%]), stroke (0 vs 3 [1.4%]), death (2 [1.0%] vs 7 [3.4%]), and severe hypoglycemia (8 [4.1%] vs 0).Conclusions and Relevance: Among patients with diabetes and depression in India, a 12-month collaborative care intervention, compared with usual care, resulted in statistically significant improvements in a composite measure of depressive symptoms and cardiometabolic indices at 24 months. Further research is needed to understand the generalizability of the findings to other low- and middle-income health care settings.Trial Registration: ClinicalTrials.gov Identifier: NCT02022111. [ABSTRACT FROM AUTHOR]

This article reports on a cluster randomized trial of cooperative learning (CL) as a way to prevent escalation in alcohol use during middle school (N = 1,460 seventh-grade students, age 12-13, seven intervention and eight control schools). We hypothesized that CL, by bringing students together in group-based learning activities using positive interdependence, would interrupt the process of deviant peer clustering, provide at-risk youth with prosocial influences, and in turn, reduce escalations in alcohol use. Results indicated that CL significantly reduced growth in deviant peer affiliation and actual alcohol use, and effects for willingness to use alcohol were at the threshold of significance (p = .05). CL also attenuated the link between willingness to use alcohol and later alcohol use. [ABSTRACT FROM AUTHOR]

Background: The benefit of early integration of palliative care into oncological care is suggested to be due to increased psychosocial support. In Belgium, psychosocial care is part of standard oncological care. The aim of this randomised controlled trial is to examine whether early and systematic integration of palliative care alongside standard psychosocial oncological care provides added benefit compared with usual care.Methods: In this randomised controlled trial, eligible patients were 18 years or older, and had advanced cancer due to a solid tumour, an European Cooperative Oncology Group performance status of 0-2, an estimated life expectancy of 12 months, and were within the first 12 weeks of a new primary tumour or had a diagnosis of progression. Patients were randomly assigned (1:1), by block design using a computer-generated sequence, either to early and systematic integration of palliative care into oncological care, or standard oncological care alone in a setting where all patients are offered multidisciplinary oncology care by medical specialists, psychologists, social workers, dieticians, and specialist nurses. The primary endpoint was change in global health status/quality of life scale assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ C30) at 12 weeks. The McGill Quality of Life Questionnaire (MQOL), which includes the additional existential wellbeing dimension, was also used. Analysis was by intention to treat. This trial is ongoing, but closed for accrual, and is registered with ClinicalTrials.gov, number NCT01865396.Findings: From April 29, 2013, to Feb 29, 2016, we screened 468 patients for eligibility, of whom 186 were enrolled and randomly assigned to the early and systematic palliative care group (92 patients) or the standard oncological care group (94). Compliance at 12 weeks was 71% (65 patients) in the intervention group versus 72% (68) in the control group. The overall quality of life score at 12 weeks, by the EORTC QLQ C30, was 54·39 (95% CI 49·23-59·56) in the standard oncological care group versus 61·98 (57·02-66·95) in the early and systematic palliative care group (difference 7·60 [95% CI 0·59-14·60]; p=0·03); and by the MQOL Single Item Scale, 5·94 (95% CI 5·50-6·39) in the standard oncological care group versus 7·05 (6·59-7·50) in the early and systematic palliative care group (difference 1·11 [95% CI 0·49-1·73]; p=0.0006).Interpretation: The findings of this study show that a model of early and systematic integration of palliative care in oncological care increases the quality of life of patients with advanced cancer. Our findings also show that early and systematic integration of palliative care is more beneficial for patients with advanced cancer than palliative care consultations offered on demand, even when psychosocial support has already been offered. Through integration of care, oncologists and specialised palliative care teams should work together to enhance the quality of life of patients with advanced cancer.Funding: Research Foundation Flanders, Flemish Cancer Society (Kom Op Tegen Kanker). [ABSTRACT FROM AUTHOR]

Background: A considerable proportion of patients with mild to moderate traumatic brain injury (TBI) experience long-lasting somatic, cognitive, and emotional symptoms that may hamper their capacity to return to work (RTW). Although several studies have described medical, psychological, and work-related factors that predict RTW after TBI, well-controlled intervention studies regarding RTW are scarce. Furthermore, there has traditionally been weak collaboration among health-related rehabilitation services, the labor and welfare sector, and workplaces.Methods/design: This study protocol describes an innovative randomized controlled trial in which we will explore the effect of combining manualized cognitive rehabilitation (Compensatory Cognitive Training [CCT]) and supported employment (SE) on RTW and related outcomes for patients with mild to moderate TBI in real-life competitive work settings. The study will be carried out in the southeastern region of Norway and thereby be performed within the Norwegian welfare system. Patients aged 18-60 years with mild to moderate TBI who are employed in a minimum 50% position at the time of injury and sick-listed 50% or more for postconcussive symptoms 2 months postinjury will be included in the study. A comprehensive assessment of neurocognitive function, self-reported symptoms, emotional distress, coping style, and quality of life will be performed at baseline, immediately after CCT (3 months after inclusion), following the end of SE (6 months after inclusion), and 12 months following study inclusion. The primary outcome measures are the proportion of participants who have returned to work at 12-month follow-up and length of time until RTW, in addition to work stability as well as work productivity over the first year following the intervention. Secondary outcomes include changes in self-reported symptoms, emotional and cognitive function, and quality of life. Additionally, a qualitative RTW process evaluation focused on organizational challenges at the workplace will be performed.Discussion: The proposed study will combine cognitive and vocational rehabilitation and explore the efficacy of increased cross-sectoral collaboration between specialized health care services and the labor and welfare system. If the intervention proves effective, the project will describe the cost-effectiveness and utility of the program and thereby provide important information for policy makers. In addition, knowledge about the RTW process for persons with TBI and their workplaces will be provided.Trial Registration: ClinicalTrials.gov, NCT03092713 . Registered on 10 March 2017. [ABSTRACT FROM AUTHOR]

Objective: To determine the effect of a decision support technology on teamwork and associated non-technical (NTS) and technical skills when teams manage post-partum haemorrhage (PPH) in the simulated environment.Methods: Multidisciplinary (MDT) maternity teams were taught how to manage post partum haemorrhage. They were randomised to the intervention: using a decision support mobile digital platform or a control group. Each team managed a post-partum simulation, which was recorded and reviewed by assessors. Primary outcome measures to assess teams NTS were the validated Global Assessment of Obstetric Team Performance (GAOTP) and Clinical Teamwork Scale (CTS). Secondary outcome measures were the 'friends and family test', technical skills, and the System Usability Scale (SUS). Sample size estimation was calculated by using 80% power 5% significance two tailed test (p1=85% p2=40%) n=34.Results: 38 teams from August 2014-February 2016, were recruited, technical issues with failure of recording equipment meant 4 teams were excluded from teamwork analysis (1 intervention 3 control). Teamwork improved across all domains with the intervention (using a decision support mobile digital platform) p <0.01. CTS improved between 6.7-16.8% (average 14.2%) and GAOTP between 8.6-17.1% (average 13.5%) for all domains. Using the control group as baseline, the intervention improved teamwork by 25% using CTS and 22% using GAOTP. Fewer technical skills were missed with the intervention (p<0.01). There was no statistical difference in the time technical skills were achieved. Assessors were more likely to recommend intervention teams 87.5% (77/88) than control teams 63.6% (56/88) p<0.01 to their friends or family. The SUS was 'Good' (69) becoming excellently 'Usable' (81.6) over the study period.Conclusion: We report a decision support system, which improved NTS when managing PPH. Lack of teamwork is often cited as the cause of failures in care and we report a usable technology that assists with and improves teamwork during an emergency. [ABSTRACT FROM AUTHOR]

Background: Randomised clinical trials are key to advancing medical knowledge and to enhancing patient care, but major barriers to their conduct exist. The present paper presents some of these barriers.Methods: We performed systematic literature searches and internal European Clinical Research Infrastructure Network (ECRIN) communications during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project.Results: The following barriers to randomised clinical trials were identified: inadequate knowledge of clinical research and trial methodology; lack of funding; excessive monitoring; restrictive privacy law and lack of transparency; complex regulatory requirements; and inadequate infrastructures. There is a need for more pragmatic randomised clinical trials conducted with low risks of systematic and random errors, and multinational cooperation is essential.Conclusions: The present paper presents major barriers to randomised clinical trials. It also underlines the value of using a pan-European-distributed infrastructure to help investigators overcome barriers for multi-country trials in any disease area. [ABSTRACT FROM AUTHOR]

Background: Care provided in the emergency department (ED) can cost up to five times as much as care received for comparable diagnoses in alternative settings. Small groups of patients, many of whom suffer from an opioid use disorder, often account for a large proportion of total ED visits. We recently conducted, and demonstrated the effectiveness of, the first randomized controlled trial of a citywide ED care-coordination program intending to reduce prescription-opioid-related ED visits. All EDs in the metropolitan study area were connected to a Web-based information exchange system.Objective: The objective of this article was to perform an economic evaluation of the 12-month trial from a third-party-payer perspective.Methods: We modeled the person-period monthly for the 12-month observation period, and estimated total treatment costs and return on investment (ROI) with regard to cost offsets, over time, for all visits where the patient was admitted to and discharged from the ED.Results: By the end of month 4, the mean cumulative cost differential was significantly lower for intervention relative to treatment-as-usual participants (-$1370; p = 0.03); this figure climbed to -$3200 (p = 0.02) by the end of month 12. The ROI trended upward throughout the observation period, but failed to reach statistical significance by the end of month 12 (ROI = 3.39, p = 0.07).Conclusion: The intervention produced significant cost offsets by the end of month 4, which continued to accumulate throughout the trial; however, ROI was not significant. Because the per-patient administrative costs of the program are incurred at the time of enrollment, our results highlight the importance of future studies that are able to follow participants for a period beyond 12 months to more accurately estimate the program's ROI. [ABSTRACT FROM AUTHOR]

Background: Depression is a common illness with great human costs and a significant burden on the public economy. Previous studies have indicated that collaborative care (CC) has a positive effect on symptoms when provided to people with depression, but CC has not yet been applied in a Danish context. We therefore developed a model for CC (the Collabri model) to treat people with depression in general practice in Denmark. Since systematic identification of patients is an "active ingredient" in CC and some literature suggests case finding as the best alternative to standard detection, the two detection methods are examined as part of the study. The aim is to investigate if treatment according to the Collabri model has an effect on depression symptoms when provided to people with depression in general practice in Denmark, and to examine if case finding is a better method to detect depression in general practice than standard detection.Methods/design: The trial is a cluster-randomised, clinical superiority trial investigating the effect of treatment according to the Collabri model for CC, compared to treatment as usual for 480 participants diagnosed with depression in general practice in the Capital Region of Denmark. The primary outcome is depression symptoms (Beck's Depression Inventory (BDI-II)) after 6 months. Secondary outcomes include depression symptoms (BDI-II) after 15 months, anxiety symptoms (Beck's Anxiety Inventory (BAI)), level of functioning (Global Assessment of Function (GAF)) and psychological stress (Symptom Checklist-90-Revised (SCL-90-R)). In addition, case finding (with the recommended screening tool Major Depression Inventory (MDI)) and standard detection of depression is examined in a cluster-randomized controlled design. Here, the primary outcome is the positive predictive value of referral diagnosis.Discussion: If the Collabri model is shown to be superior to treatment as usual, the study will contribute with important knowledge on how to improve treatment of depression in general practice, with major benefit to patients and society. If case finding is shown to be superior to standard detection, it will be recommended as the detection method in future treatment according to the Collabri model.Trial Registration: ClinicalTrials.gov. NCT02678845 . Retrospectively registered on 7 February 2016. [ABSTRACT FROM AUTHOR]

Background: Polypharmacy and inappropriate drug use is associated with negative health outcomes among older people. Various interventions for improving drug treatment have been evaluated, but the majority of studies are limited by the use of surrogate outcomes or suboptimal design. Thus, the potential for clinically significant improvements from different interventions is still unclear. The main objective of this study is therefore to evaluate the effect upon patient-relevant endpoints of a cooperation between geriatricians and general practitioners on complex drug regimens in home-dwelling elderly people.Methods: This is a cluster randomised, single-blind, controlled trial where general practitioners are invited to participate with patients from their lists. The patients must be 70 years or older, use at least seven different medications and have their medications administered by the home nursing service. We plan to recruit 200 patients, with randomisation at physician level. The intervention consists of three main parts: (1) clinical geriatric assessment of the patient, combined with a thorough review of their medications; (2) a meeting between the geriatrician and general practitioner, where the two physicians combine their competence and knowledge and discuss the drug list systematically; (3) clinical follow-up, depending on the medication changes that have been done. The study period is 24 weeks, and the patients are assessed at baseline, 16 and 24 weeks. The primary outcome measure is health-related quality of life according to the 15D instrument. Secondary outcome measures include physical and cognitive functioning, medication appropriateness, falls, carer burden, use of health services (hospital or nursing home admissions, use of home nursing services) and mortality.Discussion: Our choice of patient-relevant outcome measures will hopefully provide new knowledge on the potential for clinical improvements after performing comprehensive medication reviews in home-dwelling elderly people receiving polypharmacy.Trial Registration: ClinicalTrials.gov, NCT02379455 . Registered on 27 February 2015. [ABSTRACT FROM AUTHOR]

Objective: Growing interest in collaborative goal-setting has raised questions. First, are patients making the 'right choices' from a biomedical perspective? Second, are patients and providers setting goals of appropriate difficulty? Finally, what types of support will patients need to accomplish their goals? We analyzed goals and action plans from a trial of collaborative goal-setting among 302 residents of a high-poverty urban region who had multiple chronic conditions.Methods: Patients used a low-literacy aid to prioritize one of their chronic conditions and then set a goal for that condition with their primary care provider. Patients created patient-driven action plans for reaching these goals.Results: Patients chose to focus on conditions that were in poor control and set ambitious chronic disease management goals. The mean goal weight loss -16.8lbs (SD 19.5), goal HbA1C reduction was -1.3% (SD 1.7%) and goal blood pressure reduction was -9.8mmHg (SD 19.2mmHg). Patient-driven action plans spanned domains including health behavior (58.9%) and psychosocial (23.5%).Conclusions: High-risk, low-SES patients identified high priority conditions, set ambitious goals and generate individualized action plans for chronic disease management.Practice Implications: Practices may require flexible personnel who can support patients using a blend of coaching, social support and navigation. [ABSTRACT FROM AUTHOR]

Background: Comparative assessment of treatment results in paediatric hepatoblastoma trials has been hampered by small patient numbers and the use of multiple disparate staging systems by the four major trial groups. To address this challenge, we formed a global coalition, the Children's Hepatic tumors International Collaboration (CHIC), with the aim of creating a common approach to staging and risk stratification in this rare cancer.Methods: The CHIC steering committee-consisting of leadership from the four major cooperative trial groups (the International Childhood Liver Tumours Strategy Group, Children's Oncology Group, the German Society for Paediatric Oncology and Haematology, and the Japanese Study Group for Paediatric Liver Tumours)-created a shared international database that includes comprehensive data from 1605 children treated in eight multicentre hepatoblastoma trials over 25 years. Diagnostic factors found to be most prognostic on initial analysis were PRETreatment EXTent of disease (PRETEXT) group; age younger than 3 years, 3-7 years, and 8 years or older; α fetoprotein (AFP) concentration of 100 ng/mL or lower and 101-1000 ng/mL; and the PRETEXT annotation factors metastatic disease (M), macrovascular involvement of all hepatic veins (V) or portal bifurcation (P), contiguous extrahepatic tumour (E), multifocal tumour (F), and spontaneous rupture (R). We defined five clinically relevant backbone groups on the basis of established prognostic factors: PRETEXT I/II, PRETEXT III, PRETEXT IV, metastatic disease, and AFP concentration of 100 ng/mL or lower at diagnosis. We then carried the additional factors into a hierarchical backwards elimination multivariable analysis and used the results to create a new international staging system.Results: Within each backbone group, we identified constellations of factors that were most predictive of outcome in that group. The robustness of candidate models was then interrogated using the bootstrapping procedure. Using the clinically established PRETEXT groups I, II, III, and IV as our stems, we created risk stratification trees based on 5 year event-free survival and clinical applicability. We defined and adopted four risk groups: very low, low, intermediate, and high.Interpretation: We have created a unified global approach to risk stratification in children with hepatoblastoma on the basis of rigorous statistical interrogation of what is, to the best of our knowledge, the largest dataset ever assembled for this rare paediatric tumour. This achievement provides the structural framework for further collaboration and prospective international cooperative study, such as the Paediatric Hepatic International Tumour Trial (PHITT).Funding: European Network for Cancer Research in Children and Adolescents, funded through the Framework Program 7 of the European Commission (grant number 261474); Children's Oncology Group CureSearch grant contributed by the Hepatoblastoma Foundation; Practical Research for Innovative Cancer Control and Project Promoting Clinical Trials for Development of New Drugs and Medical Devices, Japan Agency for Medical Research; and Swiss Cancer Research grant. [ABSTRACT FROM AUTHOR]

Background Previous observational studies have shown that telemedicine is feasible and safe to deliver intravenous (IV) recombinant tissue plasminogen activator (rt-PA). However, implementation of telemedicine may be challenging. To illustrate this fact, we report a study showing that telemedicine failed to improve clinical outcome and analyze the reasons for this shortcoming. Methods We established a tele-stroke network of 10 emergency rooms (ERs) of community hospitals connected to a stroke center to perform a randomized, open-label clinical trial with blinded outcome evaluation. Eligible patients were randomly assigned to either a usual care arm (i.e. immediate transfer to the stroke center and administration of IV rt-PA if indication was confirmed upon stroke arrival) or tele-thrombolysis arm (i.e. immediate administration of IV rt-PA in ER and transfer to the stroke center). The primary efficacy outcome was an excellent outcome (modified Rankin scale (mRS) 0-1 at 90 days). Secondary endpoints included favorable outcome (90-day mRS 0-2) and early neurological improvement (NIHSS score 0-1 at 24 hours or a decrease of ≥ 4 points within 24 hours). Safety outcomes included symptomatic intracerebral hemorrhage (ICH) per ECASS II definition, any ICH and all-cause mortality. Results During an accrual time of 48 months, because of a slow enrollment rate, only 49 of 270 patients initially planned for inclusion were randomized into usual care ( n = 23) and tele-thrombolysis ( n = 26). Despite random assignment, patients allocated to tele-thrombolysis were older and had more severe stroke than patients allocated to usual care. The median duration of video-conference was 23 minutes in the usual care arm and 73 minutes in the tele-thrombolysis arm. Eighty-four percent of patients in the tele-thrombolysis arm were treated by IV rt-PA in comparison to 18% in the usual care arm. In univariate analysis but not after adjustment for age and baseline NIHSS, patients allocated in the usual care arm had a higher rate of excellent or favorable outcome. There were no differences in safety outcomes, with only one symptomatic ICH occurring in the tele-thrombolysis arm. Conclusions Stroke patients included in the telemedicine arm of the TRUST-tPA trial increased their rt-PA eligibility five-fold. However, the efficacy and safety remains to be determined (ClinicalTrials.org, NCT00279149). [ABSTRACT FROM AUTHOR]

Background: Increasing prescription overdose deaths have demonstrated the need for safer emergency department (ED) prescribing practices for patients who are frequent ED users.Objectives: We hypothesized that the care of frequent ED users would improve using a citywide care coordination program combined with an ED care coordination information system, as measured by fewer ED visits by and decreased controlled substance prescribing to these patients.Methods: We conducted a multisite randomized controlled trial (RCT) across all EDs in a metropolitan area; 165 patients with the most ED visits for complaints of pain were randomized. For the treatment arm, drivers of ED use were identified by medical record review. Patients and their primary care providers were contacted by phone. Each patient was discussed at a community multidisciplinary meeting where recommendations for ED care were formed. The ED care recommendations were stored in an ED information exchange system that faxed them to the treating ED provider when the patient presented to the ED. The control arm was subjected to treatment as usual.Results: The intervention arm experienced a 34% decrease (incident rate ratios = 0.66, p < 0.001; 95% confidence interval 0.57-0.78) in ED visits and an 80% decrease (odds ratio = 0.21, p = 0.001) in the odds of receiving an opioid prescription from the ED relative to the control group. Declines of 43.7%, 53.1%, 52.9%, and 53.1% were observed in the treatment group for morphine milligram equivalents, controlled substance pills, prescriptions, and prescribers, respectively.Conclusion: This RCT showed the effectiveness of a citywide ED care coordination program in reducing ED visits and controlled substance prescribing. [ABSTRACT FROM AUTHOR]

Background: The effectiveness of collaborative care of mental health problems is clear for depression and growing but mixed for anxiety disorders, including posttraumatic stress disorder (PTSD). We know little about whether collaborative care can be effective in settings that serve low-income patients such as Federally Qualified Health Centers (FQHCs).Objective: We compared the effectiveness of minimally enhanced usual care (MEU) versus collaborative care for PTSD with a care manager (PCM).Design: This was a multi-site patient randomized controlled trial of PTSD care improvement over 1 year.Participants: We recruited and enrolled 404 patients in six FQHCs from June 2010 to October 2012. Patients were eligible if they had a primary care appointment, no obvious physical or cognitive obstacles to participation, were age 18-65 years, planned to continue care at the study location for 1 year, and met criteria for a past month diagnosis of PTSD.Main Measures: The main outcomes were PTSD diagnosis and symptom severity (range, 0-136) based on the Clinician-Administered PTSD Scale (CAPS). Secondary outcomes were medication and counseling for mental health problems, and health-related quality of life assessed at baseline, 6 months, and 12 months.Key Results: Patients in both conditions improved similarly over the 1-year evaluation period. At 12 months, PTSD diagnoses had an absolute decrease of 56.7% for PCM patients and 60.6% for MEU patients. PTSD symptoms decreased by 26.8 and 24.2 points, respectively. MEU and PCM patients also did not differ in process of care outcomes or health-related quality of life. Patients who actually engaged in care management had mental health care visits that were 14% higher (p < 0.01) and mental health medication prescription rates that were 15.2% higher (p < 0.01) than patients with no engagement.Conclusions: A minimally enhanced usual care intervention was similarly effective as collaborative care for patients in FQHCs. [ABSTRACT FROM AUTHOR]

Background: Each year in the USA, 1.5-2.5 million Americans are so severely injured that they require inpatient hospitalization. Multiple conditions including posttraumatic stress disorder (PTSD), alcohol and drug use problems, depression, and chronic medical conditions are endemic among physical trauma survivors with and without traumatic brain injuries.Methods/design: The trauma survivors outcomes and support (TSOS) effectiveness-implementation hybrid trial is designed to test the delivery of high-quality screening and intervention for PTSD and comorbidities across 24 US level I trauma center sites. The pragmatic trial aims to recruit 960 patients. The TSOS investigation employs a stepped wedge cluster randomized design in which sites are randomized sequentially to initiate the intervention. Patients identified by a 10-domain electronic health record screen as high risk for PTSD are formally assessed with the PTSD Checklist for study entry. Patients randomized to the intervention condition will receive stepped collaborative care, while patients randomized to the control condition will receive enhanced usual care. The intervention training begins with a 1-day on-site workshop in the collaborative care intervention core elements that include care management, medication, cognitive behavioral therapy, and motivational-interviewing elements targeting PTSD and comorbidity. The training is followed by site supervision from the study team. The investigation aims to determine if intervention patients demonstrate significant reductions in PTSD and depressive symptoms, suicidal ideation, alcohol consumption, and improvements in physical function when compared to control patients. The study uses implementation science conceptual frameworks to evaluate the uptake of the intervention model. At the completion of the pragmatic trial, results will be presented at an American College of Surgeons' policy summit. Twenty-four representative US level I trauma centers have been selected for the study, and the protocol is being rolled out nationally.Discussion: The TSOS pragmatic trial simultaneously aims to establish the effectiveness of the collaborative care intervention targeting PTSD and comorbidity while also addressing sustainable implementation through American College of Surgeons' regulatory policy. The TSOS effectiveness-implementation hybrid design highlights the importance of partnerships with professional societies that can provide regulatory mandates targeting enhanced health care system sustainability of pragmatic trial results.Trial Registration: ClinicalTrials.gov NCT02655354 . Registered 27 July 2015. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to examine the efficacy of a collaborative care intervention in reducing depression, pain, and fatigue and improve quality of life.Methods: A total of 261 patients with advanced cancer and 179 family caregivers were randomized to a web-based collaborative care intervention or enhanced usual care. The intervention included the following: 1) a web site with written and audiovisual self-management strategies, a bulletin board, and other resources; 2) visits with a care coordinator during a physician's appointment every 2 months; and 3) telephone follow-up every 2 weeks. Primary patient outcomes included measures of depression, pain, fatigue, and health-related quality of life. Secondary outcomes included Interleukin (IL)-1α, IL-1β, IL-6, and IL-8 levels, Natural Killer (NK) cell numbers, and caregiver stress and depression.Results: At the baseline, 51% of the patients reported 1 or more symptoms in the clinical range. For patients who presented with clinical levels of symptoms and were randomized to the intervention, reductions in depression (Cohen's d = 0.71), pain (Cohen's d = 0.62), and fatigue (Cohen's d = 0.26) and improvements in quality of life (Cohen's d = 0.99) were observed when compared to those in the enhanced usual car arm at 6 months. Reductions in IL-6 (φ = 0.18), IL-1β (φ = 0.35), IL-1α (φ = 0.19), and IL-8 (φ = 0.15) and increases in NK cell numbers (φ = 0.23) were observed in comparison with enhanced usual care arm at 6 months. Reductions in caregiver stress (Cohen's d = 0.75) and depression (Cohen's d = 0.37) were observed at 6 months for caregivers whose loved ones were randomized to the intervention arm.Conclusions: The integration of screening and symptom management into cancer care is recommended. [ABSTRACT FROM AUTHOR]

Background: Ageing has become a worldwide reality and presents new challenges for the health-care system. Research has shown that potentially inappropriate prescribing, both potentially inappropriate medications and potentially prescribing omissions, is highly prevalent in older people, especially in the nursing home setting. The presence of potentially inappropriate medications/potentially prescribing omissions is associated with adverse drug events, hospitalisations, mortality and health-care costs. The Collaborative approach to Optimise MEdication use for Older people in Nursing homes (COME-ON) study aims to evaluate the effect of a complex, multifaceted intervention, including interdisciplinary case conferences, on the appropriateness of prescribing of medicines for older people in Belgian nursing homes.Methods/design: A multicentre cluster-controlled trial is set up in 63 Belgian nursing homes (30 intervention; 33 control). In each of these nursing homes, 35 residents (≥65 years) are selected for participation. The complex, multifaceted intervention comprises (i) health-care professional education and training, (ii) local concertation (discussion on the appropriate use of at least one medication class at the level of the nursing home) and (iii) repeated interdisciplinary case conferences between general practitioner, nurse and pharmacist to perform medication review for each included nursing home resident. The control group works as usual. The study period lasts 15 months. The primary outcome measures relate to the appropriateness of prescribing and are defined as (1) among residents who had at least one potentially inappropriate medication/potentially prescribing omission at baseline, the proportion of them for whom there is a decrease of at least one of these potentially inappropriate medications/potentially prescribing omissions at the end of study, and (2) among all residents, the proportion of them for whom at least one new potentially inappropriate medication/potentially prescribing omission is present at the end of the study, compared to baseline. The secondary outcome measures include individual components of appropriateness of prescribing, medication use, outcomes of the case conferences, clinical outcomes and costs. A process evaluation (focusing on implementation, causal mechanisms and contextual factors) will be conducted alongside the study.Discussion: The COME-ON study will contribute to a growing body of knowledge concerning the effect of complex interventions on the use of medicines in the nursing home setting, and on factors influencing their effect. The results will inform policymakers on strategies to implement in the near future.Trial Registration: Current Controlled Trials ISRCTN66138978. [ABSTRACT FROM AUTHOR]

Objective: To use data from a randomized trial to determine the cost-effectiveness of a collaborative care (CC) depression and anxiety treatment program and to assess effects of the CC program on health care utilization.Methods: The CC intervention's impact on health-related quality of life, depression-free days (DFDs), and anxiety-free days (AFDs) over the 24-week postdischarge period was calculated and compared with the enhanced usual care (EUC) condition using independent samples t tests and random-effects regression models. Costs for both the CC and EUC conditions were calculated on the basis of staff time, overhead expenses, and treatment materials. Using this information, incremental cost-effectiveness ratios were calculated. A cost-effectiveness acceptability plot was created using nonparametric bootstrapping with 10,000 replications, and the likelihood of the CC intervention's cost-effectiveness was assessed using standard cutoffs. As a secondary analysis, we determined whether the CC intervention led to reductions in postdischarge health care utilization and costs.Results: The CC intervention was more costly than the EUC intervention ($209.86 vs. $34.59; z = -11.71; P < 0.001), but was associated with significantly greater increases in quality-adjusted life-years (t = -2.49; P = 0.01) and DFDs (t = -2.13; P = 0.03), but not AFDs (t = -1.92; P = 0.057). This translated into an incremental cost-effectiveness ratio of $3337.06 per quality-adjusted life-year saved, $13.36 per DFD, and $13.74 per AFD. Compared with the EUC intervention, the CC intervention was also associated with fewer emergency department visits but no differences in overall costs.Conclusions: This CC intervention was associated with clinically relevant improvements, was cost-effective, and was associated with fewer emergency department visits in the 24 weeks after discharge. [ABSTRACT FROM AUTHOR]

The study was a randomized controlled trial evaluating the efficacy of a brief and preventatively-focused parenting discussion group for dealing with disobedient behavior in preschool-aged children. Eighty-five parents with children aged between 3 and 5 years who were concerned about the noncompliant behavior of their child were recruited from Auckland, New Zealand and Brisbane, Australia. Compared to the waitlist control group (n = 40), parents in the intervention group (n = 45) reported greater improvements in disruptive child behavior, ineffective parenting practices and parenting confidence, as well as clinically significant improvements in child behavior and parenting. All of these effects were maintained at 6-month follow up. No group differences were found for parental wellbeing, inter-parental conflict and general relationship quality, although intervention parents reported improvements in parental wellbeing and inter-parental conflict at 6-month follow-up. The findings are discussed in terms of the implications for making brief and effective parenting support available to parents. [ABSTRACT FROM AUTHOR]

Background: Few evidence-based, on-line resources exist to support home-based care of childhood long-term conditions.Methods: In a feasibility study, children with stages 3, 4, or 5 chronic kidney disease, parents and professionals collaboratively developed a novel Online Parent Information and Support (OPIS) application. Parents were randomized to an intervention arm with access to OPIS or a control arm without access. OPIS usage was assessed using Google Analytics. Parents in the intervention arm completed the Suitability Assessment of Materials (SAM) and User Interface Satisfaction (USE) questionnaires and participated in qualitative interviews.Results: Twenty parents accessed OPIS with a mean of 23.3 (SD 20.8, range 2-64) visits per user. Responses from the SAM and USE questionnaires were positive, most respondents rating OPIS highly and finding it easy to use. Qualitative suggestions include refinement of OPIS components, enabling personalization of OPIS functionalities and proactive endorsements of OPIS by professionals.Conclusions: Implementation of OPIS into standard practice is feasible in the centre where it was developed. Suggested developments will augment reported strengths to inform ongoing testing in the wider UK network of units. Our design and methods are transferrable to developing and evaluating web-applications to support home-based clinical care-giving for other long-term conditions. [ABSTRACT FROM AUTHOR]

In 2007, the first trainee-led surgical research network was founded in the United Kingdom (UK). The West Midlands Research Collaborative was started by a group of enthusiastic adult surgical trainees who saw the benefits of altruistic collaboration to generate high quality, multicenter research. Seeing the success of their research projects, including randomized controlled trials, trainees in other regions and specialties were spurred on to founding their own research collaboratives. The Pediatric Surgical Trainee Research Network was started in 2011 by a group of UK trainees with the aim to promote, facilitate, and encourage trainee-led research in pediatric surgery. This article summarizes the history and evolution of the trainee collaborative surgical research. It examines the challenges which multicenter research entails and the steps the collaboratives have taken to overcome them. We describe some of the projects which have been successfully completed and the benefits that the trainee networks have for patients and surgeons alike. [ABSTRACT FROM AUTHOR]

Background: Both antenatal and postpartum depression have adverse, lasting effects on maternal and child well-being. Socioeconomically disadvantaged women are at increased risk for perinatal depression and have experienced difficulty accessing evidence-based depression care. The authors evaluated whether "MOMCare,"a culturally relevant, collaborative care intervention, providing a choice of brief interpersonal psychotherapy and/or antidepressants, is associated with improved quality of care and depressive outcomes compared to intensive public health Maternity Support Services (MSS-Plus).Methods: A randomized multisite controlled trial with blinded outcome assessment was conducted in the Seattle-King County Public Health System. From January 2010 to July 2012, pregnant women were recruited who met criteria for probable major depression and/or dysthymia, English-speaking, had telephone access, and ≥18 years old. The primary outcome was depression severity at 3-, 6-, 12-, 18-month postbaseline assessments; secondary outcomes included functional improvement, PTSD severity, depression response and remission, and quality of depression care.Results: All participants were on Medicaid and 27 years old on average; 58% were non-White; 71% were unmarried; and 65% had probable PTSD. From before birth to 18 months postbaseline, MOMCare (n = 83) compared to MSS-Plus participants (n = 85) attained significantly lower levels of depression severity (Wald's χ(2) = 6.09, df = 1, P = .01) and PTSD severity (Wald's χ(2) = 4.61, df = 1, P = .04), higher rates of depression remission (Wald's χ(2) = 3.67, df = 1, P = .05), and had a greater likelihood of receiving ≥4 mental health visits (Wald's χ(2) = 58.23, df = 1, P < .0001) and of adhering to antidepressants in the prior month (Wald's χ(2) = 10.00, df = 1, P < .01).Conclusion: Compared to MSS-Plus, MOMCare showed significant improvement in quality of care, depression severity, and remission rates from before birth to 18 months postbaseline for socioeconomically disadvantaged women. Findings suggest that evidence-based perinatal depression care can be integrated into the services of a county public health system in the United States.Clinical Trial Registration: ClinicalTrials.govNCT01045655. [ABSTRACT FROM AUTHOR]

Background: Effective communication is critical for health care professionals, particularly in the Emergency Department (ED). However, currently, there is no standardized consultation model that is consistently practiced by physicians or used for training medical graduates. Recently, the 5Cs of Consultation model (Contact, Communicate, Core Question, Collaborate, and Close the Loop) has been studied in Emergency Medicine residents using simulated consultation scenarios.Objective: Using an experimental design, we aimed to evaluate the efficacy of the 5Cs consultation model in a novel learner population (medical students) and in a "real time and real world" clinical setting.Methods: A prospective, randomized, controlled study was conducted at eight large, academic, urban, tertiary-care medical centers (U.S. and Canada). Intervention involved two experimental groups (asynchronous and live training) compared to a baseline control group. All participants placed up to four consult phone calls. A senior physician observed and assessed each call using a preapproved 5Cs checklist and a Global Rating Scale (GRS).Results: Participants who received training (asynchronous or live) scored significantly higher on the 5Cs checklist total and GRS than the control group. Both training methods (asynchronous and live) were equally effective. Importantly, learning gains were sustained as students' 5Cs checklist total and GRS scores remained consistently higher at their second, third, and fourth consult (relative to their first consult). At posttest, all participants reported feeling more confident and competent in relaying patient information.Conclusion: Medical students can be trained to use the 5Cs model in a timely, inexpensive, and convenient manner and increase effectiveness of physician consultations originating from the ED. [ABSTRACT FROM AUTHOR]

Background: Tobacco consumption is a preventable risk factor for chronic disease and complicates the treatment of medical conditions. Therefore, the German health insurance company AOK NORDWEST has developed a collaborative smoking cessation intervention for individuals with cardiovascular disease, chronic obstructive pulmonary disease and heavy smokers, with the aim of reducing tobacco consumption. The objective of the study ENTER is to evaluate the effectiveness of the collaborative smoking cessation intervention and determine its cost-effectiveness.Methods/design: This study is a cluster-randomized controlled trial conducted with 40 medical practices that are being selected from different geographic regions in Germany. Participating medical practices will be randomly allocated to either the intervention or control group. Within the medical practices, a total of 800 patients will be recruited for participation in the study and blinded to group assignment. Patients are included in the study if they are 18 years or older, insured by AOK, heavy smokers (smoke at least 20 cigarettes per day) and/or suffer from chronic obstructive pulmonary disease or cardiovascular disease. Exclusion criteria are patients who are nonsmokers, who have cognitive impairments or who are illiterate. Physicians from medical practices in the intervention group will motivate patients to participate in a smoking cessation program offered by the health insurance, refer them to the program and ask about their program participation. Physicians from medical practices in the control group will provide usual care. Data collection will take place on the date of study inclusion and after 6 and 12 months. The primary outcome is the amount of cigarettes consumed during the past 30 days, 12 months after the initial medical consultation. Secondary outcomes are abstinence from smoking, health-related quality of life and respiratory complaints. Moreover, a process evaluation and health economic analysis will be performed.Discussion: The results of this study will help to determine whether the collaborative smoking cessation intervention is an effective and feasible way to promote smoking cessation in the primary care setting and provide evidence regarding its cost-effectiveness.Trial Registration: German Clinical Trials Register DRKS00006079 . Registered 4 June 2014. [ABSTRACT FROM AUTHOR]

Posttraumatic stress disorder (PTSD) and its comorbidities are endemic among injured trauma survivors. Previous collaborative care trials targeting PTSD after injury have been effective, but they have required intensive clinical resources. The present pragmatic clinical trial randomized acutely injured trauma survivors who screened positive on an automated electronic medical record PTSD assessment to collaborative care intervention (n = 60) and usual care control (n = 61) conditions. The stepped measurement-based intervention included care management, psychopharmacology, and psychotherapy elements. Embedded within the intervention were a series of information technology (IT) components. PTSD symptoms were assessed with the PTSD Checklist at baseline prerandomization and again, 1-, 3-, and 6-months postinjury. IT utilization was also assessed. The technology-assisted intervention required a median of 2.25 hours (interquartile range = 1.57 hours) per patient. The intervention was associated with modest symptom reductions, but beyond the margin of statistical significance in the unadjusted model: F(2, 204) = 2.95, p = .055. The covariate adjusted regression was significant: F(2, 204) = 3.06, p = .049. The PTSD intervention effect was greatest at the 3-month (Cohen's effect size d = 0.35, F(1, 204) = 4.11, p = .044) and 6-month (d = 0.38, F(1, 204) = 4.10, p = .044) time points. IT-enhanced collaborative care was associated with modest PTSD symptom reductions and reduced delivery times; the intervention model could potentially facilitate efficient PTSD treatment after injury. [ABSTRACT FROM AUTHOR]

Purpose: Scale-up and spread of evidence-based practices is one of the most important challenges facing health care. We tested whether a statewide initiative, Depression Improvement Across Minnesota-Offering a New Direction (DIAMOND), to implement the collaborative care model for depression in 75 primary care clinics resulted in patient outcome improvements corresponding to those reported in randomized controlled trials.Methods: Health plans provided a new monthly payment to participating clinics after a 6-month intensive training program with ongoing data submission, networking, and consultation. Implementation was staggered, with 5 sequences of 10 to 40 clinics every 6 months. Payers provided weekly contact information for members from participating clinics who were filling antidepressant prescriptions, and we conducted baseline and 6-month surveys of 1,578 patients about their care and outcomes.Results: There were 466 patients in DIAMOND clinics who received usual care before implementation (UCB), 559 who received usual care in DIAMOND clinics after implementation (UCA), 245 who received DIAMOND care after implementation (DCA), and 308 who received usual care in comparison clinics (UC). Patients who received DIAMOND care after implementation reported more collaborative care depression services than the 3 comparison groups (10.9 vs 6.4-6.7, on a scale of 0 of 14, where higher numbers indicate more services; P <.001) and more satisfaction with their care (4.0 vs 3.4 on a scale 1 to 5, in which higher scores indicate higher satisfaction; P ≤.001). Depression remission rates, however, were not significantly different among the 4 groups (36.4% DCA vs 35.8% UCB, 35.0% UCA, 33.9% UC; P = .94).Conclusions: Despite the incentive of a supporting payment change and intensive training and support for clinics volunteering to participate, no difference in depression outcomes was documented. Specific unmeasured actions present in trials but not present in these clinics may be critical for successful outcome improvement. [ABSTRACT FROM AUTHOR]

Background: Health services research is expected to involve service users as active partners in the research process, but few examples report how this has been achieved in practice in trials. We implemented a model to involve service users in a multi-centre randomised controlled trial in pre-hospital emergency care. We used the generic Standard Operating Procedure (SOP) from our Clinical Trials Unit (CTU) as the basis for creating a model to fit the context and population of the SAFER 2 trial.Methods: In our model, we planned to involve service users at all stages in the trial through decision-making forums at 3 levels: 1) strategic; 2) site (e.g. Wales; London; East Midlands); 3) local. We linked with charities and community groups to recruit people with experience of our study population. We collected notes of meetings alongside other documentary evidence such as attendance records and study documentation to track how we implemented our model.Results: We involved service users at strategic, site and local level. We also added additional strategic level forums (Task and Finish Groups and Writing Days) where we included service users. Service user involvement varied in frequency and type across meetings, research stages and locations but stabilised and increased as the trial progressed.Conclusion: Involving service users in the SAFER 2 trial showed how it is feasible and achievable for patients, carers and potential patients sharing the demographic characteristics of our study population to collaborate in a multi-centre trial at the level which suited their health, location, skills and expertise. A standard model of involvement can be tailored by adopting a flexible approach to take account of the context and complexities of a multi-site trial.Trial Registration: Current Controlled Trials ISRCTN60481756. Registered: 13 March 2009. [ABSTRACT FROM AUTHOR]

Background: Competing health concerns present real obstacles to people living with diabetes and other chronic diseases as well as to their primary care providers. Guideline implementation interventions rarely acknowledge this, leaving both patients and providers feeling overwhelmed by the volume of recommended actions. Interprofessional (IP) shared decision-making (SDM) with the use of decision aids may help to set treatment priorities. We developed an evidence-based SDM intervention for patients with diabetes and other conditions that was framed by the IP-SDM model and followed a user-centered approach. Our objective in the present study is to pilot an IP-SDM and goal-setting toolkit following the Knowledge-to-Action Framework to assess (1) intervention fidelity and the feasibility of conducting a larger trial and (2) impact on decisional conflict, diabetes distress, health-related quality of life and patient assessment of chronic illness care.Methods/design: A two-step, parallel-group, clustered randomized controlled trial (RCT) will be conducted, with the primary goal being to assess intervention fidelity and the feasibility of conducting a larger RCT. The first step is a provider-directed implementation only; the second (after a 6-month delay) involves both provider- and patient-directed implementation. Half of the clusters will be assigned to receive the IP-SDM toolkit, and the other will be assigned to be mailed a diabetes guidelines summary. Individual interviews with patients, their family members and health care providers will be conducted upon trial completion to explore toolkit use. A secondary purpose of this trial is to gather estimates of the toolkit's impact on decisional conflict. Secondary outcomes include diabetes distress, quality of life and chronic illness care, which will be assessed on the basis of patient-completed questionnaires of validated scales at baseline and at 6 and 12 months. Multilevel hierarchical regression models will be used to account for the clustered nature of the data.Discussion: An individualized approach to patients with multiple chronic conditions using SDM and goal setting is a desirable strategy for achieving guideline-concordant treatment in a patient-centered fashion. Our pilot trial will provide insights regarding strategies for the routine implementation of such interventions in clinical practice, and it will offer an assessment of the impact of this approach.Trial Registration: Clinicaltrials.gov Identifier: NCT02379078. Date of Registration: 11 February 2015. [ABSTRACT FROM AUTHOR]

Abstract: Well-controlled, randomized studies of correctional interventions examining gender effects are rare. This study examined gender main effects and gender × treatment interactions in a multisite randomized trial (N = 431) comparing a new form of correctional supervision for drug-involved offenders (collaborative behavioral management [CBM]) to standard parole. Outcomes included repeated measures of yes/no use of primary drug, alcohol use, and recidivism during 9 months postrelease. Generalized estimating equation analyses indicated that despite using harder drugs at baseline, women were less likely than men to use their primary drug and to use alcohol during the follow-up period. No gender-related differences in recidivism were found. Treatment interacted with gender to predict alcohol use, with women in CBM reporting the best alcohol outcomes (only 5% of women used alcohol during the follow-up period). The clear expectations, positive reinforcement, recognition of successes, fairness, and support present in CBM may be particularly important for women parolees. [Copyright &y& Elsevier]

Background: We aimed to make individual patient data from the International Stroke Trial (IST), one of the largest randomised trials ever conducted in acute stroke, available for public use, to facilitate the planning of future trials and to permit additional secondary analyses.Methods: For each randomised patient, we have extracted data on the variables assessed at randomisation, at the early outcome point (14-days after randomisation or prior discharge) and at 6-months and provide them as an analysable database.Results: The IST dataset includes data on 19 435 patients with acute stroke, with 99% complete follow-up. Over 26.4% patients were aged over 80 years at study entry. Background stroke care was limited and none of the patients received thrombolytic therapy.Conclusions: The IST dataset provides a source of primary data which could be used for planning further trials, for sample size calculations and for novel secondary analyses. Given the age distribution and nature of the background treatment given, the data may be of value in planning trials in older patients and in resource-poor settings. [ABSTRACT FROM AUTHOR]

Objective: To investigate the effect of font size and paper thickness on the response to, and completion of, a self-completion postal questionnaire among older people with joint pain.Study Design and Setting: Randomized trial. People aged 50 years and older with joint pain who consulted a general practitioner at one of five general practices in Central Cheshire were sent a postal questionnaire. Questionnaire format (large or small font size, thick or thin paper) was randomly allocated using a 2 x 2 factorial design.Results: Questionnaires were received from 502 out of 650 participants (crude response 77%). Response was significantly higher for participants receiving questionnaires with a larger font size (79.3% vs. 75.2%; hazard ratio 1.26, 95% confidence interval: 1.02, 1.56). Paper thickness had no significant effect on response. Completion (measure by assessing double-page turnover error) was increased in participants receiving questionnaires printed on thicker paper (3.2% vs. 7.1%; P=0.049) but was not affected by font size.Conclusion: This study demonstrates that questionnaires in larger font and on thicker paper may produce higher and more complete responses than surveys using standard size font and standard thickness paper, and should therefore be considered in studies among older people. [ABSTRACT FROM AUTHOR]

Background: Depression is common in patients with diabetes, but it is often inadequately treated within primary care. Competing clinical demands and treatment resistance may make it especially difficult to improve depressive symptoms in patients with diabetes who have multiple complications.Objective: To determine whether a collaborative care intervention for depression would be as effective in patients with diabetes who had 2 or more complications as in patients with diabetes who had fewer complications.Design: The Pathways Study was a randomized control trial comparing collaborative care case management for depression and usual primary care. This secondary analysis compared outcomes in patients with 2 or more complications to patients with fewer complications.Patients: Three hundred and twenty-nine patients with diabetes and comorbid depression were recruited through primary care clinics of a large prepaid health plan.Measurements: Depression was assessed at baseline, 3, 6, and 12 months with the 20-item depression scale from the Hopkins Symptom Checklist. Diabetes complications were determined from automated patient records.Results: The Pathways collaborative care intervention was significantly more successful at reducing depressive symptoms than usual primary care in patients with diabetes who had 2 or more complications. Patients with fewer than 2 complications experienced similar reductions in depressive symptoms in both intervention and usual care.Conclusion: Patients with depression and diabetes who have multiple complications may benefit most from collaborative care for depression. These findings suggest that with appropriate intervention depression can be successfully treated in patients with diabetes who have the highest severity of medical problems. [ABSTRACT FROM AUTHOR]

Background: This study evaluates the ability of a model of collaborative primary care practice to reduce mortality and hospital use in community-dwelling elderly persons.Methods: Four rural and four urban clinic sites in east central Illinois were randomized to form treatment and comparison clinics from which patients were enrolled and followed prospectively for 2 years. Patients from the practices of participating physicians were eligible if they were aged 65 and older, were living in the community, and had at least one risk factor as determined prior to the study. Medicare hospital data were obtained from the Health Care Financing Administration. Demographic and health status measures were obtained by telephone interview every 12 months throughout the study.Results: The treatment group experienced a 49% reduction in all-cause mortality during the second year of the study (odds ratio, 0.51, 95% confidence interval, 0.29-0.91, p = .02). There were no significant differences between treatment and comparison patients in percentage of persons hospitalized, hospital length of stay, or Medicare payments. Although measures of health status indicated that the treatment group was significantly sicker at baseline at the end of 1 year, these differences disappeared by the end of 2 years.Conclusions: The collaborative primary care model evaluated in this study significantly reduced mortality in the second year, without increasing hospital use. These findings suggest that a collaborative primary care team that enhances primary care practice can result in better patient outcomes. [ABSTRACT FROM AUTHOR]

Background: Service delivery innovation is at the heart of efforts to combat the growing burden of chronic disease and escalating healthcare expenditure. Small-scale, locally-led service delivery innovation is a valuable source of learning about the complexities of change and the actions of local change agents. This exploratory qualitative study captures the perspectives of clinicians and managers involved in a general practitioner-led integrated diabetes care innovation.Methods: Data on these change agents' perspectives on the local innovation and how it works in the local context were collected through focus groups and semi-structured interviews at two primary health care sites. Transcribed data were analysed thematically. Normalization Process Theory provided a framework to explore perspectives on the individual and collective work involved in putting the innovation into practice in local service delivery contexts.Results: Twelve primary health care clinicians, hospital-based medical specialists and practice managers participated in the study, which represented the majority involved in the innovation at the two sites. The thematic analysis highlighted three main themes of local innovation work: 1) trusting and embedding new professional relationships; 2) synchronizing services and resources; and 3) reconciling realities of innovation work. As a whole, the findings show that while locally-led service delivery innovation is designed to respond to local problems, convincing others to trust change and managing the boundary tensions is core to local work, particularly when it challenges taken-for-granted practices and relationships. Despite this, the findings also show that local innovators can and do act in both discretionary and creative ways to progress the innovation.Conclusions: The use of Normalization Process Theory uncovered some critical professional, organizational and structural factors early in the progression of the innovation. The key to local service delivery innovation lies in building coalitions of trust at the point of service delivery and persuading organizational and institutional mindsets to consider the opportunities of locally-led innovation. [ABSTRACT FROM AUTHOR]

Background: The objective of Heart Health NOW (HHN) is to determine if primary care practice support-a comprehensive evidence-based quality improvement strategy involving practice facilitation, academic detailing, technology support, and regional learning collaboratives-accelerates widespread dissemination and implementation of evidence-based guidelines for cardiovascular disease (CVD) prevention in small- to medium-sized primary care practices and, additionally, increases practices' capacity to incorporate other evidence-based clinical guidelines in the future.Methods/design: HHN is a stepped wedge, stratified, cluster randomized trial to evaluate the effect of primary care practice support on evidence-based CVD prevention, organizational change process measures, and patient outcomes. Each practice will start the trial as a control, receive the intervention at a randomized time point, and then enter a maintenance period 12 months after the start of the intervention. The intervention will be randomized to practices in one of four strata defined by region of the state (east or west) and degree of practice readiness for change. Seventy-five practices in each region with a high degree of readiness will be randomized 1:1:1 in blocks of 3 sometime prior to month 8 to receive the intervention at month 9, 11, or 12. An additional 75 practices within each region that have a low degree of readiness or are recruited later will be randomized 1:1 in blocks of 2 prior to month 13 to receive the intervention at month 14 or 16. The sites will be ordered within each strata based on time of enrollment with the blocking based on this ordering. Evaluation will examine the effect of primary care practice support on (1) practice-level delivery of evidence-based CVD prevention, (2) patient-level health outcomes, (3) practice-level implementation of clinical and organizational changes that support delivery of evidence-based CVD prevention, and (4) practice-level capacity to implement future evidence-based clinical guidelines.Discussion: Results will indicate whether primary care practice support is an effective strategy for widespread dissemination and implementation of evidence-based clinical guidelines in primary care practices. Discernible reductions in cardiovascular risk in 300 practices covering over an estimated 900,000 adult patients would likely lead to prevention of thousands of cardiovascular events within 10 years.Trial Registration: ClinicalTrials.gov NCT02585557. [ABSTRACT FROM AUTHOR]