A problem-solving intervention for cardiovascular disease risk reduction in veterans: Protocol for a randomized controlled trial.

BACKGROUND: Health behaviors related to diet, tobacco usage, physical activity, medication adherence, and alcohol use are highly determinative of risk for developing cardiovascular disease. This paper describes a study protocol to evaluate a problem-solving intervention that aims to help patients at risk for developing cardiovascular disease address barriers to adopting positive health behaviors in order to reduce cardiovascular risk. METHODS: Eligible patients are adults enrolled in Veterans Affairs (VA) health care who have not experienced a cardiovascular event but are at elevated risk based on their Framingham Risk Score (FRS). Participants in this two-site study are randomized to either the intervention or care as usual, with a target of 400 participants. The study intervention, Healthy Living Problem-Solving (HELPS), consists of six group sessions conducted approximately monthly interspersed with individualized coaching calls to help participants apply problem-solving principles. The primary outcome is FRS, analyzed at the beginning and end of the study intervention (6months). Participants also complete measures of physical activity, caloric intake, self-efficacy, group cohesion, problem-solving capacities, and demographic characteristics. CONCLUSION: Results of this trial will inform behavioral interventions to change health behaviors in those at risk for cardiovascular disease and other health conditions. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01838226.

A Coaching by Telephone Intervention for Veterans and Care Team Engagement (ACTIVATE): A study protocol for a Hybrid Type I effectiveness-implementation randomized controlled trial.

INTRODUCTION: A large proportion of deaths and many illnesses can be attributed to three modifiable risk factors: tobacco use, overweight/obesity, and physical inactivity. Health risk assessments (HRAs) are widely available online but have not been consistently used in healthcare systems to activate patients to participate in prevention programs aimed at improving lifestyle behaviors. OBJECTIVES: The goal of this study is to test whether adding telephone-based coaching to use of a comprehensive HRA increases at-risk patients' activation and enrollment into a prevention program compared to HRA use alone. METHODS: Participants were randomized to either complete an HRA alone or in conjunction with a telephone coaching intervention. To be eligible Veterans had to have at least one modifiable risk factor (current smoker, overweight/obese, or physically inactive). The primary outcome is enrollment and participation in a prevention program by 6months. Secondary outcomes include change in a Patient Activation Measure and Framingham Risk Score. DISCUSSION: This study is the first to test a web-based health risk assessment coupled with a health coaching intervention within a large healthcare system. Results from this study will help the Veterans Health Administration (VHA) implement its national plan to include comprehensive health risk assessments as a tool to engage Veterans in prevention. The results will also inform health systems outside VHA who seek to implement Medicare's advisement that health risk assessment become a mandatory component of care under the Affordable Care Act.

Patient and provider interventions for managing osteoarthritis in primary care: protocols for two randomized controlled trials.

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).

Participant evaluation of a telephone-based osteoarthritis self-management program, 2006-2009.

INTRODUCTION: Self-management support interventions can help improve osteoarthritis outcomes but are underused. Little is known about how participants evaluate the helpfulness of these programs. We describe participants' evaluations of a telephone-based, osteoarthritis self-management support intervention that yielded improved outcomes in a clinical trial. METHODS: Participants were 140 people in the intervention arm of the trial who completed an end-of-trial survey. We used mixed methods to describe participants' perceived helpfulness of the program and its components. We compared ratings of helpfulness according to participant characteristics and analyzed themes from open-ended responses with a constant comparison approach. We calculated Pearson correlation coefficients between perceived helpfulness and changes in pain, function, affect, and self-efficacy. RESULTS: The average rating of overall helpfulness on a scale from 1 to 10 was 7.6 (standard deviation, 2.3), and more than 80% of participants agreed that each component (phone calls, educational material, setting goals and action plans) was helpful. Participants had better perceived helpfulness ratings than their counterparts if they were nonwhite, had limited health literacy, had no college education, had perceived inadequate income, were older, had a spouse or were living together in a committed relationship, and had greater symptom duration and less pain. Ratings of helpfulness increased with greater improvement in outcomes. Participants frequently mentioned the health educator's calls as being helpful for staying on task with self-management behaviors. CONCLUSION: Participants viewed this intervention and each of its components as helpful for improving osteoarthritis symptoms. In addition to the improvements in objective outcomes seen in the clinical trial, these results provide further support for the dissemination of self-management support interventions.

Telephone-based self-management of osteoarthritis: A randomized trial.

BACKGROUND: Osteoarthritis is a leading cause of pain and disability, and self-management behaviors for osteoarthritis are underutilized. OBJECTIVE: To examine the effectiveness of a telephone-based self-management intervention for hip or knee osteoarthritis in a primary care setting. DESIGN: Randomized clinical trial with equal assignment to osteoarthritis self-management, health education (attention control), and usual care control groups. (ClinicalTrials.gov registration number: NCT00288912) SETTING: Primary care clinics in a Veterans Affairs Medical Center. PATIENTS: 515 patients with symptomatic hip or knee osteoarthritis. INTERVENTION: The osteoarthritis self-management intervention involved educational materials and 12 monthly telephone calls to support individualized goals and action plans. The health education intervention involved nonosteoarthritis educational materials and 12 monthly telephone calls related to general health screening topics. MEASUREMENTS: The primary outcome was score on the Arthritis Impact Measurement Scales-2 pain subscale (range, 0 to 10). Pain was also assessed with a 10-cm visual analog scale. Measurements were collected at baseline and 12 months. RESULTS: 461 participants (90%) completed the 12-month assessment. The mean Arthritis Impact Measurement Scales-2 pain score in the osteoarthritis self-management group was 0.4 point lower (95% CI, -0.8 to 0.1 point; P = 0.105) than in the usual care group and 0.6 point lower (CI, -1.0 to -0.2 point; P = 0.007) than in the health education group at 12 months. The mean visual analog scale pain score in the osteoarthritis self-management group was 1.1 points lower (CI, -1.6 to -0.6 point; P < 0.001) than in the usual care group and 1.0 point lower (CI, -1.5 to -0.5 point; P < 0.001) than in the health education group. Health care use did not differ across the groups. LIMITATION: The study was conducted at 1 Veterans Affairs Medical Center, and the sample consisted primarily of men. CONCLUSION: A telephone-based osteoarthritis self-management program produced moderate improvements in pain, particularly compared with a health education control group. PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs Health Services Research and Development Service.

The Self-Management of OsteoArthritis in Veterans (SeMOA) Study: design and methodology.

BACKGROUND: Osteoarthritis (OA) is a leading cause of disability among adults. Although self-management behaviors such as exercise and weight management can improve pain and function, these behaviors are vastly underutilized. There is a need to implement effective self-management programs among the growing number of adults with OA. OBJECTIVES: The Self-Management of OsteoArthritis (SeMOA) in Veterans Study examines a 12-month telephone-based OA self-management program in the primary care setting. This manuscript details the design, methodology, and advances of the SeMOA trial. METHODS: Participants (N=519) with hip or knee OA are randomly assigned to one of three groups: OA self-management, health education (attention control), or usual care. The OA self-management group receives written and audio materials regarding OA care (including health behaviors, medical care, and interacting with health care providers). A health educator calls participants monthly to review these materials and provide support for developing individualized goals and action plans related to OA management. The health education group receives written and audio materials and monthly calls from a health educator discussing health issues unrelated to OA. Usual care involves no additional materials or phone calls. The primary outcome is change in the Arthritis Impact Measurement Scales-2 pain subscale from baseline to 12 months. Analysis of covariance models will compare changes in pain across study groups. The cost-effectiveness of the OA self-management program will also be assessed. CONCLUSION: SeMOA is one of the first to examine telephone-based delivery of OA self-management and one of few trials to target the primary care setting. This program has the potential for broad dissemination because it reduces both the costs and barriers that accompany in-person programs. This study will provide important information about its feasibility and effectiveness in a real-world clinical setting.