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Abstract Background We describe the study design, procedures, and development of the risk counseling protocol used in a randomized controlled trial to evaluate the impact of genetic testing for diabetes mellitus (DM) on psychological, health behavior, and clinical outcomes. Methods/Design Eligible patients are aged 21 to 65 years with body mass index (BMI) ≥27 kg/m2 and no prior diagnosis of DM. At baseline, conventional DM risk factors are assessed, and blood is drawn for possible genetic testing. Participants are randomized to receive conventional risk counseling for DM with eye disease counseling or with genetic test results. The counseling protocol was pilot tested to identify an acceptable graphical format for conveying risk estimates and match the length of the eye disease to genetic counseling. Risk estimates are presented with a vertical bar graph denoting risk level with colors and descriptors. After receiving either genetic counseling regarding risk for DM or control counseling on eye disease, brief lifestyle counseling for prevention of DM is provided to all participants. Discussion A standardized risk counseling protocol is being used in a randomized trial of 600 participants. Results of this trial will inform policy about whether risk counseling should include genetic counseling. Trial registration ClinicalTrials.gov Identifier NCT01060540

Abstract Background Osteoarthritis (OA) of the hip and knee are among the most common chronic conditions, resulting in substantial pain and functional limitations. Adequate management of OA requires a combination of medical and behavioral strategies. However, some recommended therapies are under-utilized in clinical settings, and the majority of patients with hip and knee OA are overweight and physically inactive. Consequently, interventions at the provider-level and patient-level both have potential for improving outcomes. This manuscript describes two ongoing randomized clinical trials being conducted in two different health care systems, examining patient-based and provider-based interventions for managing hip and knee OA in primary care. Methods / Design One study is being conducted within the Department of Veterans Affairs (VA) health care system and will compare a Combined Patient and Provider intervention relative to usual care among n = 300 patients (10 from each of 30 primary care providers). Another study is being conducted within the Duke Primary Care Research Consortium and will compare Patient Only, Provider Only, and Combined (Patient + Provider) interventions relative to usual care among n = 560 patients across 10 clinics. Participants in these studies have clinical and / or radiographic evidence of hip or knee osteoarthritis, are overweight, and do not meet current physical activity guidelines. The 12-month, telephone-based patient intervention focuses on physical activity, weight management, and cognitive behavioral pain management. The provider intervention involves provision of patient-specific recommendations for care (e.g., referral to physical therapy, knee brace, joint injection), based on evidence-based guidelines. Outcomes are collected at baseline, 6-months, and 12-months. The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (self-reported pain, stiffness, and function), and secondary outcomes are the Short Physical Performance Test Protocol (objective physical function) and the Patient Health Questionnaire-8 (depressive symptoms). Cost effectiveness of the interventions will also be assessed. Discussion Results of these two studies will further our understanding of the most effective strategies for improving hip and knee OA outcomes in primary care settings. Trial registration NCT01130740 (VA); NCT 01435109 (NIH)

Abstract Background Almost 50% of Americans have elevated low-density lipoprotein cholesterol (LDL-C). The behaviors required to lower LDL-C levels may be difficult to adhere to if they are inconsistent with spouses' health practices, and, alternatively, may be enhanced by enlisting support from the spouse. This trial extends previous trials by requiring spouse enrollment, teaching spouses how to provide emotional and instrumental support, allowing patients to decide which component of the intervention they would like to receive, and having patients determine their own goals and action plans. Methods Veteran outpatients with above-goal LDL-C (N = 250) and their spouses are randomized, as a couple, to receive printed education materials only or the materials plus an 11-month, nurse-delivered, telephone-based intervention. The intervention contains four modules: medication adherence, diet, exercise, and patient-physician communication. Patients decide which modules they complete and in which order; modules may be repeated or omitted. Telephone calls are to patients and spouses separately and occur monthly. During each patient telephone call, patients' progress is reviewed, and patients create goals and action plans for the upcoming month. During spouse telephone calls, which occur within one week of patient calls, spouses are informed of patients' goals and action plans and devise strategies to increase emotional and instrumental support. The primary outcome is patients' LDL-C, measured at baseline, 6 months, and 11 months. Linear mixed models will be used to test the primary hypothesis that an 11-month, telephone-based patient-spouse intervention will result in a greater reduction in LDL-C as compared to printed education materials. Various process measures, including social support, self-efficacy, medication adherence, dietary behavior, and exercise, are also assessed to explain any change, or lack thereof, in LDL-C. Discussion Given the social context in which self-management occurs, interventions that teach spouses to provide instrumental and emotional support may help patients initiate and adhere to behaviors that lower their LDL-C levels. Moreover, allowing patients to retain autonomy by deciding which behaviors they would like to change and how may improve adherence and clinical outcomes. Trial Registration The ClinicalTrials.gov registration number is NCT00321789.

Abstract Background It has been reported in the quantitative trait locus (QTL) literature that when testing for QTL location and effect, the statistical power supporting methodologies based on two markers and their estimated genetic map is higher than for the genetic map independent methodologies known as single marker analyses. Close examination of these reports reveals that the two marker approaches are more powerful than single marker analyses only in certain cases. Simulation studies are a commonly used tool to determine the behavior of test statistics under known conditions. We conducted a simulation study to assess the general behavior of an intersection test and a two marker test under a variety of conditions. The study was designed to reveal whether two marker tests are always more powerful than intersection tests, or whether there are cases when an intersection test may outperform the two marker approach. We present a reanalysis of a data set from a QTL study of ovariole number in Drosophila melanogaster. Results Our simulation study results show that there are situations where the single marker intersection test equals or outperforms the two marker test. The intersection test and the two marker test identify overlapping regions in the reanalysis of the Drosophila melanogaster data. The region identified is consistent with a regression based interval mapping analysis. Conclusion We find that the intersection test is appropriate for analysis of QTL data. This approach has the advantage of simplicity and for certain situations supplies equivalent or more powerful results than a comparable two marker test.

BackgroundColorectal cancer is the fourth most commonly diagnosed cancer in the United States. Approximately 3-10% of the population has an increased risk for colorectal cancer due to family history and warrants more frequent or intensive screening. Yet,

Objective: To examine the relationship between site‐level adaptation and early adoption of Caregivers Finding Important Resources, Support, and Training (FIRST) training during national implementation across diverse Veteran Health Administration (VA) medical centers. Data Sources and Study Setting: We enrolled and evaluated 25 VA medical centers (VAMCs). Along with administrative data on site characteristics, we examined site‐reported data on adaptations and intervention adoption, defined as ≥4 training classes delivered to ≥5 caregivers at 6 months from April through October 2022. Study Design: A type III hybrid implementation‐effectiveness cluster randomized controlled trial, randomized VAMCs 1:1 to receive foundational (low‐touch) implementation support (n = 12) or the addition of enhanced (high‐touch) implementation support (n = 13). Data Collection/Extraction Methods: At key implementation phases, VAMCs were asked to report adaptations including content, contextual modifications (format, setting, personnel, and population), and training of providers. We describe site‐level adaptations by arm and by organizational characteristics that included VAMC complexity level, staffing, rurality, and organizational readiness to change. We used qualitative comparative analysis to identify unique adaptations that contributed to intervention adoption at 6 months. Principal Finding s : VAMCs randomized to receive enhanced support reported slightly more adaptations than those randomized to foundational support. At 6 months, VAMCs with two or more adaptations adopted Caregivers FIRST at a higher rate than those with fewer adaptations (90% vs. 44%). Staffing adaptations (e.g., who delivered the intervention), format and content (e.g., modified delivery pace), and referring provider training were unique adaptations to adopting sites. Conclusions: Site‐level adaptations were diverse and occurred more frequently in sites with early adoption of Caregivers FIRST. Future research should identify best practices of supporting and monitoring intervention adaptation. Understanding the role of adaptation in early adoption success could assist other healthcare systems in implementing interventions for caregivers. [ABSTRACT FROM AUTHOR]

Objective: To assess the effects of an evidence‐based family caregiver training program (implementation of Helping Invested Families Improve Veteran Experiences Study [iHI‐FIVES]) in the Veterans Affairs healthcare system on Veteran days not at home and family caregiver well‐being. Data Sources and Study Setting: Participants included Veterans referred to home‐ and community‐based services with an identified caregiver across 8 medical centers and confirmed family caregivers of eligible Veterans. Study Design: In a stepped wedge cluster randomized trial, sites were randomized to a 6‐month time interval for starting iHI‐FIVES and received standardized implementation support. The primary outcome, number of Veteran "days not at home," and secondary outcomes, changes over 3 months in measures of caregiver well‐being, were compared between pre‐ and post‐iHI‐FIVES intervals using generalized linear models including covariates. Data Collection/Extraction Methods: Patient data were extracted from the electronic health record. Caregiver data were collected from 2 telephone‐based surveys. Principal Findings: Overall, n = 898 eligible Veterans were identified across pre‐iHI‐FIVES (n = 327) and post‐iHI‐FIVES intervals (n = 571). Just under one fifth (17%) of Veterans in post‐iHI‐FIVES intervals had a caregiver enroll in iHI‐FIVES. Veteran and caregiver demographics in pre‐iHI‐FIVES intervals were similar to those in post‐iHI‐FIVES intervals. In adjusted models, the estimated rate of days not at home over 6‐months was 42% lower (rate ratio = 0.58 [95% confidence interval: 0.31–1.09; p = 0.09]) post‐iHI‐FIVES compared with pre‐iHI‐FIVES. The estimated mean days not at home over a 6‐month period was 13.0 days pre‐iHI‐FIVES and 7.5 post‐iHI‐FIVES. There were no differences between pre‐ and post‐iHI‐FIVES in change over 3 months in caregiver well‐being measures. Conclusions: Reducing days not at home is consistent with effectiveness because more time at home increases quality of life. In this study, after adjusting for Veteran characteristics, we did not find evidence that implementation of a caregiver training program yielded a reduction in Veteran's days not at home. [ABSTRACT FROM AUTHOR]

Objective: To assess whether a team collaboration strategy (CONNECT) improves implementation outcomes of a family caregiver skills training program (iHI‐FIVES). Data Sources and Study Setting: iHI‐FIVES was delivered to caregivers at eight Veterans Affairs (VA) medical centers. Data sources were electronic health records, staff surveys, and interviews. Study Design: In a stepped wedge cluster randomized trial, sites were randomized to a 6‐month time interval start date for iHI‐FIVES launch. Sites were then randomized 1:1 to either (i) CONNECT, a team collaboration training strategy plus Replicating Effective Programs (REP), brief technical support training for staff, or (ii) REP only (non‐CONNECT arm). Implementation outcomes included reach (proportion of eligible caregivers enrolled) and fidelity (proportion of expected trainings delivered). Staff interviews and surveys assessed team function including communication, implementation experience, and their relation to CONNECT and iHI‐FIVES implementation outcomes. Data Collection/Extraction Methods: The sample for assessing implementation outcomes included 571 Veterans referred to VA home‐ and community‐based services and their family caregivers eligible for iHI‐FIVES. Prior to iHI‐FIVES launch, staff completed 65 surveys and 62 interviews. After the start of iHI‐FIVES, staff completed 52 surveys and 38 interviews. Mixed methods evaluated reach and fidelity by arm. Principal Findings: Fidelity was high overall with 88% of expected iHI‐FIVES trainings delivered, and higher among REP only (non‐CONNECT) compared with CONNECT sites (95% vs. 80%). Reach was 18% (average proportion of reach across eight sites) and higher among non‐CONNECT compared with CONNECT sites (22% vs. 14%). Qualitative interviews revealed strong leadership support at high‐reach sites. CONNECT did not influence self‐reported team function. Conclusions: A team collaboration strategy (CONNECT), added to REP, required more resources to implement iHI‐FIVES than REP only and did not substantially enhance reach or fidelity. Leadership support was a key condition of implementation success and may be an important factor for improving iHI‐FIVES reach with national expansion. [ABSTRACT FROM AUTHOR]

Diabetes distress (DD) is a negative psychosocial response to living with type 2 diabetes mellitus (T2DM). We sought insight into Veterans' experiences with DD in the context of T2DM self-management. The four domains in the Diabetes Distress Scale (i.e. regimen, emotional, interpersonal, healthcare provider) informed the interview guide and analysis (structural coding using thematic analysis). The mean age of the cohort (n = 36) was 59.1 years (SD 10.4); 8.3% of patients were female and 63.9% were Black or Mixed Race; mean A1C was 8.8% (SD 2.0); and mean DDS score was 2.4 (SD 1.1), indicating moderate distress. Veterans described DD and challenges to T2DM self-management across the four domains in the Diabetes Distress Scale. We found that (1) Veterans' challenges with their T2DM self-management routines influenced DD and (2) Veterans experienced DD across a wide range of domains, indicating that clinical interventions should take a "whole-person" approach. Trial Registration: NCT04587336 [ABSTRACT FROM AUTHOR]

Objective Most pragmatic trials follow the PRagmatic Explanatory Continuum Indicator Summary (PRECIS-2) criteria. The criteria specify unobtrusive measurement of participants' protocol adherence and practitioners' intervention fidelity but suggest no special monitoring strategies to assure trial integrity. We present experience with adherence/fidelity monitoring in the Pain Management Collaboratory (PMC) and provide recommendations for their monitoring in pragmatic trials to preserve inferences of treatment comparisons. Methods In November 2021, we surveyed 10 of 11 originally funded PMC pragmatic trials to determine the extent to which adherence and fidelity data were being monitored. Results Of the 10 PMC trials, 8 track adherence/fidelity. The electronic health record is the most frequent source for monitoring adherence (7/10) and fidelity (5/10). Most adherence data are used to monitor participant engagement with the trial intervention (4/10) and are reviewed by study teams (8/10) and often with a data and safety monitoring board (DSMB) (5/10). Half of the trials (5/10) reported using fidelity data for feedback/training; such data are not shared with a DSMB (0/10). Only 2 of 10 trials reported having prespecified guidance or rules around adherence/fidelity (eg, stopping rules or thresholds for corrective action, such as retraining). Conclusions As a best practice for pragmatic trials, we recommend early and regular adherence/fidelity monitoring to determine whether intervention delivery is as intended. We propose a 2-stage process with thresholds for intervening and triggers for conducting a formal futility analysis if adherence and fidelity are not maintained. The level of monitoring should be unobtrusive for both participants and those delivering the intervention; resulting data should be reviewed by an independent DSMB. [ABSTRACT FROM AUTHOR]

Objective This manuscript describes the uptake of the AIM-Back Pain Navigator Pathway (PNP) designed to encourage use of non-pharmacologic care options within the Veterans Health Administration (VHA). Design This manuscript describes the implementation of a telehealth intervention from one arm of a multisite, embedded, cluster-randomized pragmatic trial comparing the effectiveness of two novel clinical care pathways that provide access to non-pharmacologic care for Veterans with low back pain (LBP). Setting Ten VHA clinics Subjects 19 pain navigators, >200 primary care physicians, and over 1000 Veterans were involved in the PNP implementation Methods Data were generated within the VHA electronic health record (EHR) for the ongoing AIM-Back trial to describe PNP implementation for system-level findings in terms of number of visits, and type of care received Results Over a 3-year period, 9 of 10 clinics implemented the PNP within the context of the AIM-Back trial. The most frequent care recommended in the PNP included physical therapy, chiropractic, acupuncture, and yoga/tai chi. During follow-up at six-weeks, ∼50% of Veterans elected to receive a different care choice than what was initially prescribed. Notable variation across clinics was documented for PNP based on time to initiation of care and follow-up rates. Conclusions Implementation of the telehealth delivered PNP provides a nuanced understanding of the introduction of novel care programs within diverse clinical settings. These findings are most applicable to care programs that are delivered remotely and involve facilitation of existing care options. [ABSTRACT FROM AUTHOR]

Background: Family caregivers are family members or friends of care recipients who assist with activities of daily living, medication management, transportation, and help with finances among other activities. As a result of their caregiving, family caregivers are often considered a population at risk of experiencing increased stress, isolation, and loneliness. During the COVID-19 pandemic in the US, social isolation and decrease in social activities were a top concern among older adults and their family caregivers. Using secondary analysis of survey data as part of a multi-site implementation trial of a caregiver skills training program, we describe differences in caregiver experiences of loneliness before and during the COVID-19 pandemic. Methods: Health and wellbeing surveys of family caregivers were collected on 422 family caregivers of veterans before and during COVID-19. Logistic regression modeling examined whether the loneliness differed between caregiver groups pre vs during COVID-19, using the UCLA 3-item loneliness measure. Rapid directed qualitative content analysis of open-ended survey questions was used to explore the context of how survey responses were affected by the COVID-19 pandemic. Results: There were no significant differences in loneliness between caregivers pre vs during COVID-19. In open-ended responses regarding effects of COVID-19, caregivers described experiencing loneliness and social isolation; why they were unaffected by the pandemic; and how caregiving equipped them with coping strategies to manage negative pandemic-related effects. Conclusion: Loneliness did not differ significantly between pre vs during COVID-19 caregivers. Future research could assess what specific characteristics are associated with caregivers who have resiliency, and identify caregivers who are more susceptible to experiencing loneliness. Understanding caregiver loneliness could assist other healthcare systems in developing and implementing caregiver support interventions. [ABSTRACT FROM AUTHOR]