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The purpose of this study was to explore health-related quality of life (HRQL) and family impact in the context of an advanced practice registered nurse–delivered telehealth care coordination intervention for children with medical complexity (CMC). This was a secondary outcomes analysis of a randomized controlled trial with 163 families of CMC in an existing medical home. HRQL and family impact were measured using the PedsQL measurement model. Bivariate and analysis of covariance analyses were conducted to explore associations at baseline and the intervention effect over 2 years. Significant predictors of Year 2 child HRQL were baseline HRQL and the presence of both neurologic impairment and technology dependence. There was no significant intervention effect on child HRQL or family impact after 24 months. Care coordination interventions for CMC may need to incorporate family system interventions for optimal outcomes in a range of quality of life domains.

Introduction The purpose of this study was to evaluate the effect of advanced practice registered nurse (APRN) telehealth care coordination for children with medical complexity (CMC) on family caregiver perceptions of health care. Method Families with CMC ages 2 to 15 years (N = 148) were enrolled in a three-armed, 30-month randomized controlled trial to test the effects of adding an APRN telehealth care coordination intervention to an existing specialized medical home for CMC. Satisfaction with health care was measured using items from the Consumer Assessment of Healthcare Providers and Systems survey at baseline and after 1 and 2 years. Results The intervention was associated with higher ratings on measures of the child's provider, provider communication, overall health care, and care coordination adequacy, compared with control subjects. Higher levels of condition complexity were associated with higher ratings of overall health care in some analyses. Discussion APRN telehealth care coordination for CMC was effective in improving ratings of caregiver experiences with health care and providers. Additional research with CMC is needed to determine which children benefit most from high-intensity care coordination.

Care coordination is an essential component of the pediatric health care home. This study investigated the attributes of relationship-based advanced practice registered nurse care coordination for children with medical complexity enrolled in a tertiary hospital-based health care home. Retrospective review of 2,628 care coordination episodes conducted by telehealth over a consecutive 3-year time period for 27 children indicated that parents initiated the majority of episodes and the most frequent reason was acute and chronic condition management. During this period, care coordination episodes tripled, with a significant increase (p.001) between years 1 and 2. The increased episodes could explain previously reported reductions in hospitalizations for this group of children. Descriptive analysis of a program-specific survey showed that parents valued having a single place to call and assistance in managing their child's complex needs. The advanced practice registered nurse care coordination model has potential for changing the health management processes for children with medical complexity.

Background: Incorporating telehealth into outpatient care delivery supports management of consumer health between clinic visits. Task–technology fit is a framework for understanding how technology helps and/or hinders a person during work processes. Evaluating the task–technology fit of video telehealth for personnel working in a pediatric outpatient clinic and providing care between clinic visits ensures the information provided matches the information needed to support work processes. Materials and Methods: The workflow of advanced practice registered nurse (APRN) care coordination provided via telephone and video telehealth was described and measured using a mixed-methods workflow analysis protocol that incorporated cognitive ethnography and time–motion study. Qualitative and quantitative results were merged and analyzed within the task–technology fit framework to determine the workflow fit of video telehealth for APRN care coordination. Results: Incorporating video telehealth into APRN care coordination workflow provided visual information unavailable during telephone interactions. Despite additional tasks and interactions needed to obtain the visual information, APRN workflow efficiency, as measured by time, was not significantly changed. Analyzed within the task–technology fit framework, the increased visual information afforded by video telehealth supported the assessment and diagnostic information needs of the APRN. Conclusions: Telehealth must provide the right information to the right clinician at the right time. Evaluating task–technology fit using a mixed-methods protocol ensured rigorous analysis of fit within work processes and identified workflows that benefit most from the technology.

Introduction The purpose of this analysis was to evaluate the effects of an advanced practice nurse–delivered telehealth intervention on health care use by children with medical complexity (CMC). Because CMC account for a large share of health care use costs, finding effective ways to care for them is an important challenge requiring exploration. Method This was a secondary analysis of data from a randomized clinical trial with a control group and two intervention groups. The focus of the analysis was planned and unplanned clinical and therapy visits by CMC over a 30-month data collection period. Nonparametric tests were used to compare visit counts among and within the three groups. Results The number of unplanned visits decreased over time across all groups, with the greatest decrease in the video telehealth intervention group. Planned visits were higher in the video telehealth group across all time periods. Discussion Advanced practice registered nurse–delivered telehealth care coordination may support a shift from unplanned to planned health care service use among CMC.

Efficiency and effectiveness of care coordination depends on a match between the needs of the population and the skills, scope of practice, and intensity of services provided by the care coordinator. There is limited existing literature that addresses the relevance of the APN role as a fit for coordination of care for children with SHCN. The objective of this paper is to describe the value of the advanced practice nurse’s (APN’s) enhanced scope of knowledge and practice for relationship-based care coordination in healthcare homes that serve children with complex special health care needs (SHCN). The TeleFamilies project is provided as an example of the integration of an APN care coordinator in a healthcare home for children with SHCN.

Collaboration across disciplines is vital in clinical practice. It is also needed to generate high-quality actionable research, yet few frameworks for interdisciplinary collaboration exit to promote effective communications among researchers with common boals, but varied backgrounds. A review of that has been learned about collaboration was undertaken to determine attributes of effective interdisciplinary collaboration and barriers to its realization in patients undergoing lung transplantation.

Background—The emergence and subsequent integration of new technologies precipitate changes in roles and work lives of nurses. The nurses' work with home monitoring technologies within a spirometry-based program that transmits pulmonary function data after lung transplantation has characteristics that are distinct from other types of direct patient care. Nurses' changing roles in such programs after transplantation have not been well described.Objective—To describe a time-motion study of 2 research nurses in the context of a home-spirometry study to monitor patients' pulmonary status after lung transplantation.Method—A detailed list of research nurses' 67 routine work-related activities was developed and validated to monitor and record activities of research home monitoring nurses. Two weeks of observations were completed; recordings of a second observer established reliability of observations.Results—In 48.8 hours of observation, 610 tasks related to monitoring of 45 patients were recorded. Task time ran...

Clinicians face an increasing volume of biomedical data. Assessing the efficacy of systems that enable accurate and timely clinical decision making merits corresponding attention. This paper discusses the multiple-reader multiple-case (MRMC) experimental design and linear mixed models as means of assessing and comparing decision accuracy and latency (time) for decision tasks in which clinician readers must interpret visual displays of data. These tools can assess and compare decision accuracy and latency (time). These experimental and statistical techniques, used extensively in radiology imaging studies, offer a number of practical and analytic advantages over more traditional quantitative methods such as percent-correct measurements and ANOVAs, and are recommended for their statistical efficiency and generalizability. An example analysis using readily available, free, and commercial statistical software is provided as an appendix. While these techniques are not appropriate for all evaluation questions, they can provide a valuable addition to the evaluative toolkit of medical informatics research.

Background Lung transplant recipients use a telemedicine device known as the electronic home spirometer to gauge the function of their lungs when they are away from the hospital or clinic setting. Health care providers review transmitted spirometry tests and user's symptom responses to detect early signs of infection and or rejection. Current home spirometry users have questions, concerns, and preferences about spirometry that may influence their daily adherence. A spirometer with two-way electronic messaging has the capability to deliver feedback messages to potentially address these questions and concerns. Objectives The purpose of this study was to identify the type of messaging content users prefer to receive and recognize as positively influencing their spirometry use. Methods The study design followed a qualitative approach investigating the experiences, perceptions, preferences, and realities of home spirometry. Three focus group sessions were used to generate opinions and interests about automatic messaging content. Results The focus group approach revealed the nature of six categories and five subcategories for feedback messaging content. These include education (general, lifestyle, and infection), goals, timing, technique, monitoring, and reminders (time sensitive, positive). Messages were created according to length, feasibility, past experience, and neutrality for electronic implementation. Conclusion The narrative content served as the primary source of electronic feedback messages. Actual quotes were used when applicable. It is believed that pertinent automated electronic feedback messages will enhance home spirometry connection, raise confidence in spirometry use, and influence daily adherence to the spirometry protocol. The content also serves as a foundation for establishing a plan of care individualized to each home spirometry user.

Introduction: Obtaining complete and timely subject data is key to the success of clinical trials, particularly for studies requiring data collected from subjects at home or other remote sites. A multifaceted strategy for data collection in a randomized controlled trial (RCT) focused on care coordination for children with medical complexity is described. The influences of data collection mode, incentives, and study group membership on subject response patterns are analyzed. Data collection included monthly healthcare service utilization (HCSU) calendars and annual surveys focused on care coordination outcomes. Materials and Methods: One hundred sixty-three families were enrolled in the 30-month TeleFamilies RCT. Subjects were 2–15 years of age at enrollment. HCSU data were collected by parent/guardian self-report using mail, e-mail, telephone, or texting. Surveys were collected by mail. Incentives were provided for completed surveys after 8 months to improve collection returns. Outcome measures were the number of HCSU calendars and surveys returned, the return interval, data collection mode, and incentive impact. Results: Return rates of 90% for HCSU calendars and 82% for annual surveys were achieved. Mean return intervals were 72 and 65 days for HCSU and surveys, respectively. Survey response increased from 55% to 95% after introduction of a gift card and added research staff. Conclusions: High return rates for HCSU calendars and health-related surveys are attainable but required a flexible and personnel-intensive approach to collection methods. Family preference for data collection approach should be obtained at enrollment, should be modified as needed, and requires flexible options, training, intensive staff/family interaction, and patience.

Effective care coordination is a key quality and safety strategy for populations with chronic conditions, including children with medical complexity (CMC). However, gaps remain in parent report of the need for care coordination help and receipt of care coordination help. New models must close this gap while maintaining family-centered focus. A three-armed randomized controlled trial conducted in an established medical home utilized an advanced practice registered nurse intervention based on Presler’s model of clinic-based care coordination. The model supported families of CMC across settings using telephone only or telephone and video telehealth care coordination. Effectiveness was evaluated from many perspectives and this paper reports on a subset of outcomes that includes family-centered care (FCC), need for care coordination help and adequacy of care coordination help received. FCC at baseline and end of study showed no significant difference between groups. Median FCC scores of 18.0–20.0 across all groups indicated high FCC within the medical home. No significant differences were found in the need for care coordination help within or between groups and over time. No significant difference was found in the adequacy of help received between groups at baseline. However, this indicator increased significantly over time for both intervention groups. These findings suggest that in an established medical home with high levels of FCC, families of CMC have unmet needs for care coordination help that are addressed by the APRN telehealth care coordination model.

Patient outcomes and cost were compared when home healthcare was delivered by telemedicine or by traditional means for patients receiving skilled nursing care at home. A randomized controlled trial was established using three groups. The first group, control group C, received traditional skilled nursing care at home. The second group, video intervention group V, received traditional skilled nursing care at home and virtual visits using videoconferencing technology. The third group, monitoring intervention group M, received traditional skilled nursing care at home, virtual visits using videoconferencing technology, and physiologic monitoring for their underlying chronic condition. Discharge to a higher level of care (hospital, nursing home) within 6 months of study participation was 42% for C subjects, 21% for V subjects, and 15% for M subjects. There was no difference in mortality between the groups. Morbidity, as evaluated by changes in the knowledge, behavior and status scales of the Omaha Assessment Tool, showed no differences between groups except for increased scores for activities of daily living at study discharge in the V and M groups. The average visit costs were $48.27 for face-to-face home visits, $22.11 for average virtual visits (video group), and $32.06 and $38.62 for average monitoring group visits for congestive heart failure and chronic obstructive pulmonary disease subjects, respectively. This study has demonstrated that virtual visits between a skilled home healthcare nurse and chronically ill patients at home can improve patient outcome at lower cost than traditional skilled face-to-face home healthcare visits.

Context The medical record is frequently used in clinical studies as a source of information on illness events experienced by patients; however, it may be incomplete. Objective To estimate the extent of incompletely documented acute bronchopulmonary events in a transplant clinic medical record at a single university medical center, using home monitoring data. Design, Setting, and Subjects Trends in daily home monitoring data were compared to contemporaneous medical record documentation at 150 different times in 30 lung transplant recipients over 45 subject-years. Outcome Measure Proportion of acute bronchopulmonary illness events documented in clinic medical record. Results By using home monitoring data in a new way, we found that 40% of events actually suffered by lung recipients could not be ascertained to have occurred from the clinic medical record alone. All missed encounters occurred away from the transplant clinic, and involved hospitalizations and telephone prescriptions. Conclusions Using the clinic medical record alone to identify acute bronchopulmonary events in lung transplant recipients may result in missing 40% of events. This has important ramifications for studies relying on the medical record for acute event ascertainment in lung transplantation and possibly other chronic diseases.

Purpose The objective of this study was to develop and evaluate a computerized rule-based decision support algorithm for nursing triage of potential acute bronchopulmonary events in lung transplant recipients on the basis of home monitoring of spirometry and symptoms. Methods The algorithm automatically separates recipients into 2 groups: those who are stable or improving and those who should be “watched” further because of their potential for developing bronchopulmonary events according to their weekly home-monitoring measurements. A total of 155 recipients (82 females and 73 males) contributed 1944 weekly records for the training (420), testing (786), and prospective evaluation (738) data sets. Weekly records contained daily values of forced expiratory volume at 1 second and respiratory symptoms, which were the inputs for the triage rules. Results Sensitivity and specificity were greater than 90% for the prospective evaluation comparing the computer decision support system with the manual nurse review of the same home-monitoring reports. Conclusions Algorithm performance in identifying lung recipients who should be placed on a “watch” list for the potential to develop acute bronchopulmonary events is comparable to the standard human clinical review of the same weekly home-monitoring data

The aim of this study was to demonstrate that telehomecare linking homebound patients with their home health-care nurses over the plain old telephone system (POTS) provides high-quality, clinically useful, and patient satisfactory interactions. Congestive heart failure, chronic obstructive pulmonary disease, and chronic wound-care patients receiving skilled home nursing care were randomized into control (standard home health care, HHC) and two intervention (standard care plus video conferencing/Internet access; the above plus physiological monitoring) groups. Virtual visits (VVs), consisting of two-way audio and video interactions between the central site HHC nurse and the subject at home, were compared for technical quality and clinical usefulness by the HHC nurses who performed the VVs. Subject perception of telehomecare and satisfaction with their HHC were assessed over the course of the project. There were a total of 567 virtual and 1,057 actual visits conducted for the 53 subjects completing the study. The technical quality of VVs were rated at 94.7%. They were considered to be as useful as actual visits in 90.7% of cases. Subject telehomecare perception increased after experiencing the process. All subjects were satisfied with their HHC; satisfaction increased with an increasing level of telehomecare intervention. Subjects receiving physiological monitoring and video conferencing/Internet access in addition to standard care were most satisfied with their care. VVs can be conducted over POTS. Patients can use telehomecare with moderate levels of training. These programs can provide timely and quality home health nursing care with VVs augmenting traditional home visits.

Home monitoring by lung transplant recipients has been effective for early detection of clinical problems. This study used an electronic diary for home monitoring by lung transplant candidates to improve communication between candidates and the transplant team. Candidates were randomized into control (52 subjects following standard telephone reporting procedures) and intervention (67 subjects using an electronic diary to record and transmit a range of health-related measures) groups. Outcome measures were monitoring adherence and level of communication (for monitor acceptability and utilization), hospital length of stay after transplantation and survival at 4 months (for clinical effectiveness). Subjects used the diary without difficulty and with good adherence. Subjects and coordinator contacts were similar between groups; intervention group subjects were positive regarding contact based on diary use. There were no significant differences in clinical outcomes between groups. Changing diary questions might improve the effectiveness of electronic monitoring for lung transplant candidates.

Ten patients in a home care study received virtual visits from nurses via analogue video-phones in their homes. They received standard home care services and two virtual visits per week. The visits were video-recorded and then reviewed. The study involved 10 patients and 10 nurses from one urban and three rural home care agencies. Six of the patients had congestive heart failure, three had chronic obstructive pulmonary disease and one required diabetes-related wound care. The average age of the patients was 78 years (SD 12). All but one lived in rural areas. One hundred and twenty-two virtual visits were reviewed for technical quality. Their mean duration was 21 min (range 5-60). The technical quality was given an average rating of 95% (range 57-100%). There were no technical problems in 78 visits (64%); in 10 cases (8%) there was difficulty establishing a connection. A content analysis of 30 of the visits identified 13 themes, such as assessing the patient's clinical status, promotion of compliance with medication and treatment, psychosocial issues, general informal talk and patient education. In general, the technical problems were minor and did not appear to interfere with care.

Background Atherosclerosis begins in the arterial wall, with endothelial dysfunction accompanied by functional and structural changes that influence arterial stiffness. Pulse contour analysis provides an assessment of compliance or elasticity of the large conduit arteries (C 1 ) and small microcirculatory arteries (C 2 ). In this study, the predictive value of reduced elasticity of these arteries was evaluated by follow-up of subjects who underwent pulse contour analysis at the University of Minnesota. Methods Questionnaires were sent to 870 subjects who had radial artery pulse wave analysis performed between 1993 and 1999 using a noninvasive sensor, parameter estimating algorithm and modified Windkessel model of the circulation. Responses from 419 subjects >19 years of age reported on any cardiovascular events including death, myocardial infarction, stroke, transient ischemic attacks, angina, or coronary or peripheral vascular interventional procedures. Results Of the subjects, 168 (41%) reported one or more cardiovascular events. Events were more common in those with elevated blood pressure, elevated cholesterol, diabetes, and family history of events. Age, reduced C 1 , and reduced C 2 were univariate predictors of events. After adjusting for age, a 2-unit decrease in C 2 remained a significant predictor (odds ratio 1.50, P 1 was no longer predictive. Conclusion Reduced small artery elasticity, which is a measure of endothelial dysfunction, is significantly associated with cardiovascular events independent of age.

Tele HomeCare is a demonstration telemedicine project focused on the delivery of home health care to elderly homebound patients who are receiving care for either congestive heart failure, chronic obstructive pulmonary disease, or chronic wound healing. The telemedicine components of the study involve low-cost, standards-based videoconferencing and Internet access delivered over regular voice-grade telephone service and the patient’s television as well as physiological monitoring. This technology links the patient at home with a home care nurse at the home health agency. This is a randomized clinical trial with control and telemedicine intervention groups. Study design, technology details, and focus group and pilot study results are reported. Outcome measures, including quality of care, access, patient satisfaction, and cost factors, will be reported at the conclusion of the study.

Home telecare is a promising method of improving access to care for rural and urban populations. It requires, however, that patients accept the installation and use of equipment in their home. How patients perceive home telecare may influence its acceptability and diffusion. We developed a questionnaire to assess patients' impressions of the risks and benefits of home telecare. A preliminary 20-item questionnaire was developed and tested on 32 subjects. It proved to be of acceptable reliability (Cronbach's alpha of 0.8) and validity, but three items appeared to be redundant. The final 17-item version was tested twice on 10 more subjects and was found to have high test-retest reliability. Most subjects showed an overall positive attitude towards home telecare and agreed it could improve their health. Many were concerned about being able to trust the equipment. The questionnaire can be used to investigate the acceptance of telemedicine and to improve the design of applications.

A non-invasive technique is implemented to measure a peripheral vascular compliance index Cindex, using an infrared photoplethysmographic waveform as an indicator of intravascular volume change and a continuous blood pressure monitor to measure the blood pressure during each heart-beat. The non-linear behaviour of Cindex with pressure and the effect of age on Cindex are studied in 62 males (15–73 years). Repeatability tests and the effect of ice-water exposure of a portion of a limb are studied in 10 and 14 subjects, respectively. For each individual, Cindex measurements are taken at discrete values of local mean arterial pressure (Pmean), and a Cindex against Pmean plot is obtained. There is a statistically significant difference (p

Summary Adherence with any long-term treatment or research protocol is a challenge; this has been found to be the case with lung transplant recipients participating in an electronic home spirometry research program. Because the purpose of the current study is to develop a system for detecting early infection and rejection in lung transplant recipients, regular transmission of data by subjects to the research data center is imperative to the success of the study. Various adherence-promoting strategies have been developed by the research team to increase subject adherence with the program. An increased adherence rate has been reported after implementation of these various strategies, yet work remains to promote continually regular participation in the program by all subjects. It remains a challenge for the research team to devise creative and effective strategies for increasing adherence to regular spirometer use to provide data to develop a computerized system for detecting early infection and rejection of transplanted lung tissue.

Electronic spirometry units were used to monitor lung transplantation recipients upon their return home. The data from 77 participants were used to develop methods to verify that the pulmonary function measurements, forced vital capacity (FVC) and forced expiratory volume in 1 s (FEV1), were reliable and valid. The standard deviation was calculated for the best daily effort on consecutive days of home spirometry. An acceptable upper limit for the standard deviation, as the measure of day-to-day reliability, was 0.20 for FVC and 0.15 for FEV1. Validity was determined by examining the mean difference (bias) between the spirometry done in the pulmonary function laboratory and the home monitoring results. The clinic values were slightly higher, with an average difference of 0.15 for FVC and 0.12 for FEV1. Therefore, the home spirometry measurements have a high degree of reliability and validity and can now be used for early detection of serious complications.

Background: Lung transplantation is now a standard intervention for patients with advanced lung disease. Home monitoring of pulmonary function and symptoms has been used to follow the progress of lung transplant recipients in an effort to improve care and clinical status. The study objective was to determine the relative performance of a computer-based Bayesian algorithm compared with a manual nurse decision process for triaging clinical intervention in lung transplant recipients participating in a home monitoring program. Materials and Methods: This randomized controlled trial had 65 lung transplant recipients assigned to either the Bayesian or nurse triage study arm. Subjects monitored and transmitted spirometry and respiratory symptoms daily to the data center using an electronic spirometer/diary device. Subjects completed the Short Form-36 (SF-36) survey at baseline and after 1 year. End points were change from baseline after 1 year in forced expiratory volume at 1 s (FEV1) and quality of life (SF-36 scales) within and between each study arm. Results: There were no statistically significant differences between groups in FEV1 or SF-36 scales at baseline or after 1 year.: Results were comparable between nurse and Bayesian system for detecting changes in spirometry and symptoms, providing support for using computer-based triage support systems as remote monitoring triage programs become more widely available. Conclusions: The feasibility of monitoring critical patient data with a computer-based decision system is especially important given the likely economic constraints on the growth in the nurse workforce capable of providing these early detection triage services.

Objective: The goal of this study was to develop, implement, and test an automated decision system to provide early detection of clinically important bronchopulmonary events in a population of lung transplant recipients following a home monitoring protocol. Subjects and Methods: Spirometry and other clinical data were collected daily at home by lung transplant recipients and transmitted weekly to the study data center. Decision rules were developed using wavelet analysis of declines in spirometry and increases in respiratory symptoms from a learning set of patient home data and validated with an independent patient set. Results: Using forced expiratory volume in 1 s or symptoms, the detection captured the majority of events (sensitivity, 80–90%) at an acceptable level of false alarms. On average, detections occurred 6.6–10.8 days earlier than the known event records. Conclusions: This approach is useful for early discovery of pulmonary events and has the potential to decrease the time required for humans to review large amount of home monitoring data to discover relatively infrequent but clinically important events.

Two strategies for teaching lung and heart-lung transplant subjects to use an electronic sptrometer/diary instrument at home to input and transmit daily respiratory, vital sign, and symptom measurements were compared. The first strategy integrated teaching into subjects' postoperative clinic visits, whereas the second strategy involved referral to a Patient Learning Center (PLC) for instruction Adherence was increased by 30% when the teaching was transferred from the clinic setting to the PLC. These findings suggest that the PLC is an effective resource for preparing patients to manage their care after discharge from a hospital or clinic.

Meaningful use of electronic health records to coordinate care requires skillful synthesis and integration of subjective and objective data by practitioners to provide context for information. This is particularly relevant in the coordination of care for children with complex special health care needs. The purpose of this paper is to present a conceptual framework and example of meaningful use within an innovative telenursing intervention to coordinate care for children with complex special health care needs. The TeleFamilies intervention engages an advanced practice nurse in a full-time care coordinator role within an existing hospital-based medical home for children with complex special health care needs. Care coordination is facilitated by the synthesis and integration of internal and external data using an enhanced electronic health record and telehealth encounters via telephone and videoconferencing between the advanced practice nurse and the family at home. The advanced practice nurse’s ability to maintain an updated plan of care that is shared across providers and systems and build a relationship over time with the patient and family supports meaningful use of these data.

In a double-blind, placebo-controlled study we investigated the effects of dietary fish oil supplementation on arterial wall characteristics in 20 patients with non-insulin-dependent diabetes mellitus. Estimates reflecting compliance values in the large arteries and more peripheral vasculature, as measured by pulse-contour analysis, improved significantly after 6 weeks of fish oil therapy compared with values recorded at baseline and after 6 weeks' administration of olive oil. The large-artery compliance estimate increased from 1.50 (confidence interval [CI], 1.31 to 1.69) mL/mm Hg at baseline to 1.68 (CI, 1.52 to 1.84) mL/mm Hg after fish oil administration (P < .01). The oscillatory compliance value increased from 0.015 (CI, 0.011 to 0.019) mL/mm Hg at baseline to 0.022 (CI, 0.016 to 0.028) mL/mm Hg after fish oil ingestion (P < .05). No changes occurred in arterial blood pressure, cardiac output, stroke volume, or systemic vascular resistance with either intervention. The improved compliance estimates with fish oil ingestion occurred without altering fasting blood glucose and cholesterol concentrations. These results support the hypothesis that fish oils alter vascular reactivity and favorably influence arterial wall characteristics in patients with non-insulin-dependent diabetes mellitus. These direct vascular effects, expressed at the level of the vessel wall, may contribute to the cardioprotective actions of fish oil in humans.

We developed an instrument to measure the satisfaction of lung transplant recipients with home monitoring. The survey comprised 15 items, each scored on a five-point Likert-type scale (from strongly disagree to strongly agree). Three additional free-text items enabled subjects to provide comments. The survey had a scoring range of 15–75. In a test group of 43 patients, the internal consistency (Cronbach's alpha) was 0.93 overall for all questions. The intra-class correlation for scores from the same 27 patients approximately 2.5 months apart was 0.77 for the total score. The survey was used to evaluate subject satisfaction in a randomized controlled trial of a computerized algorithm for triaging lung transplant recipients. Surveys were mailed to 50 study subjects and were returned by 32 (64% return rate). Ninety percent of respondents were satisfied with the home monitoring programme and would recommend it to other patients.

We conducted a randomized controlled trial to evaluate the perception, satisfaction and utilization of a home telehealth service for frail elderly people living independently in their home communities. Control group subjects continued with their usual care and intervention group subjects were able to supplement their usual care with the use of a web portal. The web portal allowed videoconferencing and electronic messaging between home care nurses and clients, ordering health-related and home care services, access to health-related information and general access to the Internet. A total of 99 eligible people (59 female, 40 male) from one urban and one rural study site agreed to participate in the study. Eighty-four subjects were active participants for nine months. There were no significant differences in perception of technology between the two groups at baseline. At 60-day follow-up, the intervention group was significantly more positive towards technology compared to their own baseline ( P < 0.001) and compared to the 60-day scores for the controls ( P < 0.001). The intervention group indicated that overall the telehealth service met their expectations (mean score 9 out of 10) and they would recommend it to others (mean score 9.5 out of 10). All subjects were able to use the portal without difficulty after brief instructions from the nurses. A total of 1054 videoconferences were conducted with the intervention subjects. Fifty-six of these (5%) had to be discontinued after successful connection because of technical problems. Intervention subjects made fewer emergency department visits than control subjects, more visits to the eye doctor, fewer visits in all categories of home care utilization, and lower use of transportation services. Frail elderly people are able to adopt home telehealth technologies which may enable them to maintain independent living arrangements.

Context Newsletters are a common intervention for patients in clinical trials. However, it is not clear whether newsletters are associated with increased adherence to the health regimen, and if so, which aspects of the newsletter are reported as most helpful to patients. Objective To examine the association between patients' ratings of worthwhileness of a quarterly newsletter and adherence with a home spirometry regimen. Design Patients (n=48) were in a research-based spirometry program after lung transplant and had received at least 1 newsletter; 24 (50%) returned completed surveys via postal mail. Main Outcome Measures Adherence for forced vital pulmonary function tests for respondents versus nonrespondents, number of weeks they were adherent, ratings they gave the newsletter, and which components of the newsletters were helpful to the respondents. Results Respondents had more forced vital capacity pulmonary function tests (“blows”) overall, blew more times weekly, and blew more consistently from week to week than did nonrespondents. Although it was not statistically significant, a mild correlation was found between the number of weeks that the respondents were adherent and their ratings of the newsletter ( r = 0.36, P = .08). Most respondents reported that newsletter length was “about right,” and 86% reported that newsletters helped encourage regular spirometer use, maintain interest in the study, educate about general health, and alert readers to seasonal health risks. Implications for Practice High ratings for newsletters used to encourage participation among adults in our home spirometry study were associated with higher adherence.

When designing a clinical trial or study, the value of the following interrelated parameters should be determined prior to collecting data: clinical significance, statistical significance, power, and sample size. Too often, clinical importance and the other design issues are ignored and only statistical significance dictates the conclusions of the study. In order to evaluate the frequency that each of these design parameters is addressed in the published literature, the topic of pulmonary function tests (specifically forced vital capacity) was chosen, and all relevant articles for one year (1990) were identified using Minnesota MEDLINE. A total of 121 articles met the selection criteria and were reviewed. Of all the articles, 13.2% discussed clinical significance, 21.5% discussed sample size, and only 5.0% addressed statistical power. As expected, the majority of the articles (92.6%) discussed statistical significance (P values). None of the articles mentioned all four factors. When choosing the level of clinical significance several methods may be used. Such might be well established in certain clinical areas or available from previous publications and references or they may be attainable from pilot study data and, in the absence of any prior information, a clinician may use personal experience. To minimize subjectivity, the clinical effect-size can be based on the population distribution of the measurement of interest. Pediatr Pulmonol. 1993; 16:336–340. © 1993 Wiley-Liss, Inc.

Traditionally, hypertension has been defined in terms of an elevated resistance to flow confined predominantly to the precapillary vasculature. More recently, changes in arterial compliance have been used to estimate vascular adaptations in the larger conduit arteries. This review outlines and updates the many varied techniques employed to estimate arterial compliance changes during hypertension. Most measures of compliance assess changes in small segments of the arterial vasculature. Because hypertension is a disease that influences structure and reactivity in all parts of the systemic circulation, it is desirable that clinical techniques for monitoring vascular adaptations with disease should address the generalized changes in the systemic vasculature.

Objective: Home telemonitoring improves clinical outcomes but can generate large amounts of data. Automating data surveillance with clinical decision support could reduce the impact of translating these systems to clinical settings. We utilized time-motion methodology to measure the time spent on activities monitoring subjects in the two groups of a home spirometry telemonitoring randomized controlled trial: the manual nurse review (control) group and the automated review (intervention) group. These results are examined for potential workflow effects that could occur when the intervention translates to a clinical setting. Materials and Methods: Time motion is an established industrial engineering technique used to evaluate workflow by measuring the time of predefined, discrete tasks. Data were collected via direct observation of two research nurses by a single observer using the repetitive or snap-back timing method. All observed tasks were coded using a list of work activities defined and validated in an earlier study. Reliability data were collected during a 2-h session with a secondary observer. Results: Reliability of the primary observer was established. During 35 h of data collection, a sample of 938 task observations were recorded and coded using 46 previously defined and 5 newly defined work activities. Between-group comparisons of activity time for subjects in the two study groups showed significantly more time spent on data review activities for the automated review group. Reclassification of the 51 observed activities identified 15 activities that would translate to a clinical setting, of which 5 represent potentially new activities. Conclusions: Implementing an intervention into a clinical setting could add work activities to the clinical workflow. Time-motion study of research personnel working with new clinical interventions provides a template for evaluating the workflow impact of these interventions prior to translation from a research to a clinical setting.

Noninvasive evaluation of the health of the vasculature is an increasingly important approach to identifying individuals at risk for cardiovascular morbid events. Vascular health assessment involves functional and structural examination of the large and small arteries. Endothelial dysfunction, which alters small artery function, is a key contributor to progressive structural vascular changes. Ultrasonography of conduit arteries and aortic pulse-wave velocity provide information limited to structural changes in large arteries. Comprehensive assessment of the large and small arteries is best carried out by pulse-contour analysis. This can provide insight into functional and structural abnormalities in the small as well as the large arteries, and may be useful in monitoring response to therapy.

The U Special Kids Program (USK) at the University of Minnesota provides care coordination and case management services by telephone to children with special health-care needs. We measured the effect of the USK programme on hospital resource utilization using a retrospective record review. Information on hospitalizations was collected for children enrolled in the programme for at least two years and validated for accuracy against inpatient claims data. Hospitalizations were classified as planned, unplanned or due to lack of home care. A total of 43 children enrolled in the USK programme between July 1996 and December 2006 met the study criteria. The children had multiple, complex conditions. During the period of the study, there were 61 planned hospitalizations, 184 unplanned hospitalizations and 3 hospitalizations due to lack of home care. The number of unplanned hospitalizations decreased from 74 in the first year of enrolment to 35 in the second; this reduction was significant ( P < 0.007). In the subsequent years, the rate of unplanned admissions stabilized. In contrast, the rate of planned hospitalizations was relatively constant over the five-year enrolment period. Telephone-based care coordination and case management is a promising approach for children with multiple, complex health conditions.

Summary The U Special Kids (USK) programme at the University of Minnesota provides intensive care coordination and case management services to children with complex special health-care needs. We conducted a one-year pilot study to evaluate the feasibility of videoconferencing between the USK office and family homes. To ensure easy installation, families were provided with prepackaged equipment and software. However, the families had different Internet providers, different modems and/or routers and different firewall software, which required case-by-case resolution during home visits by the project coordinator. Five families participated in 3–5 videoconferencing sessions with a USK nurse. All connections with urban families had clear audio and video, whereas connections with rural families had clear audio, but unclear video. All of the scheduled virtual visits were rated by nurses as providing information that was similar to a telephone call. However, the unscheduled virtual visits were rated by the nurses as providing more information than a telephone call, suggesting that home-based videoconferencing may be useful in the management of children with complex special health-care needs.

VALUE is a randomized controlled trial to evaluate the impact of a home telehealth program on the ability of frail elderly individuals to remain living independently in their own home as their self-care abilities decline. VALUE uses broadband access to provide virtual visits with a home care nurse, a Web portal for ordering assisted living services, physiological monitoring, and access to the Internet. Subjects were able to use the VALUE program technology without difficulty after a brief instruction session with the nurse.

Objectives: The University of Minnesota has maintained a home monitoring program for over 10 years for lung and heart–lung transplant patients. A cost analysis was completed to assess the impact of home monitoring on the cost of post-transplant medical care.Methods: Clinical information gathered with the monitoring system includes spirometry, vital signs, and symptom data. To estimate the impact of this system on medical costs, we completed a retrospective analysis of the effects of home monitoring on the cost of post-lung transplant medical care. The cost analysis used multivariate linear regression with inpatient, outpatient, and total medical care costs as the dependent variables. The independent variables for the regression include home monitoring adherence, underlying disease, ambulatory diagnostic group mapping variables, transplant type, and patient demographics.Results: The multivariate regression of the overall cost results predicts a 52.4 percent reduction in total costs with 100 percent patient adherence; this rate includes a 72.24 percent reduction in inpatient costs and a 46.6 percent increase in outpatient costs. The actual first year average patient adherence was 74 percent.Conclusions: Adherence to home monitoring increases outpatient costs and reduces inpatient costs and provides an overall cost savings. The break-even point for patient adherence was 25.28 percent, where the net savings covered the cost of home monitoring. This is well within the actual first year adherence rates (74 percent) for subjects in the lung transplant home monitoring program, providing a net savings with adherence to home monitoring.