Short-Term VA Health Care Expenditures Following a Health Risk Assessment and Coaching Trial.

BACKGROUND: Short-term health care costs following completion of health risk assessments and coaching programs in the VA have not been assessed. OBJECTIVE: To compare VA health care expenditures among veterans who participated in a behavioral intervention trial that randomized patients to complete a HRA followed by health coaching (HRA + coaching) or to complete the HRA without coaching (HRA-alone). DESIGN: Four-hundred seventeen veterans at three Veterans Affairs (VA) Medical Centers or Clinics were randomized to HRA + coaching or HRA-alone. Veterans randomized to HRA-alone (n = 209) were encouraged to discuss HRA results with their primary care team, while veterans randomized to HRA + coaching (n = 208) received two brief telephone-delivered health coaching calls. PARTICIPANTS: We included 411 veterans with available cost data. MAIN MEASURES: Total VA health expenditures 6 months following trial enrollment were estimated using a generalized linear model with a gamma distribution and log link function. In exploratory analysis, model-based recursive partitioning was used to determine whether the intervention effect on short-term costs differed among any patient subgroups. KEY RESULTS: Most participants were male (85%); mean age was 56, and mean body mass index was 34. From the generalized linear model, 6-month estimated mean total VA expenditures were similar ($8665 for HRA + coaching vs $9900 for HRA-alone, p = 0.25). In exploratory subgroup analysis, among unemployed veterans with good sleep and fair or poor perceived health, mean observed expenditures in the HRA + coaching group were higher than in the HRA-alone group ($12,814 vs $7971). Among unemployed veterans with good sleep and good general health, mean observed expenditures in the HRA + coaching group were lower than in the HRA-alone group ($5082 vs $11,612). CONCLUSIONS: Compared to completing and receiving HRA results, working with health coaches to set actionable health behavior change goals following HRA completion did not reduce short-term health expenditures. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01828567.

Discharge Information and Support for Patients Discharged from the Emergency Department: Results from a Randomized Controlled Trial.

BACKGROUND: Little research has been done on primary care-based models to improve health care use after an emergency department (ED) visit. OBJECTIVE: To examine the effectiveness of a primary care-based, nurse telephone support intervention for Veterans treated and released from the ED. DESIGN: Randomized controlled trial with 1:1 assignment to telephone support intervention or usual care arms (ClinicalTrials.gov: NCT01717976). SETTING: Department of Veterans Affairs Health Care System (VAHCS) in Durham, NC. PARTICIPANTS: Five hundred thirteen Veterans who were at high risk for repeat ED visits. INTERVENTION: The telephone support intervention consisted of two core calls in the week following an ED visit. Call content focused on improving the ED to primary care transition, enhancing chronic disease management, and educating Veterans and family members about VHA and community services. MAIN MEASURES: The primary outcome was repeat ED use within 30 days. KEY RESULTS: Observed rates of repeat ED use at 30 days in usual care and intervention groups were 23.1% and 24.9%, respectively (OR = 1.1; 95% CI = 0.7, 1.7; P = 0.6). The intervention group had a higher rate of having at least 1 primary care visit at 30 days (OR = 1.6, 95% CI = 1.1-2.3). At 180 days, the intervention group had a higher rate of usage of a weight management program (OR = 3.5, 95% CI = 1.6-7.5), diabetes/nutrition (OR = 1.8, 95% CI = 1.0-3.0), and home telehealth services (OR = 1.7, 95% CI = 1.0-2.9) compared with usual care. CONCLUSIONS: A brief primary care-based nurse telephone support program after an ED visit did not reduce repeat ED visits within 30 days, despite intervention participants' increased engagement with primary care and some chronic disease management services. TRIALS REGISTRATION: ClinicalTrials.gov NCT01717976.

Acceptability of telephone-based pain coping skills training among African Americans with osteoarthritis enrolled in a randomized controlled trial: a mixed methods analysis.

BACKGROUND: Osteoarthritis (OA) disproportionately impacts African Americans compared to Caucasians, including greater pain severity. The Pain Coping Skills Training for African Americans with Osteoarthritis (STAART) study examined a culturally enhanced Pain Coping Skills Training (CST) program among African Americans with OA. This mixed methods study evaluated the acceptability of the Pain CST program among STAART participants. METHODS: STAART was a randomized controlled trial evaluating the effectiveness of an 11-session, telephone-based pain CST program, compared to a usual care control group. Participants were from the University of North Carolina and Durham Veterans Affairs Healthcare Systems. The present analyses included 93 participants in the CST group who completed a questionnaire about experiences with the program. Descriptive statistics of the questionnaire responses were calculated using SAS software. Thematic analysis was applied to open-response data using Dedoose software. RESULTS: Participants' mean rating of overall helpfulness of the pain CST program for managing arthritis symptoms was 8.0 (SD = 2.2) on a scale of 0-10. A majority of participants reported the program made a positive difference in their experience with arthritis (83.1%). Mean ratings of helpfulness of the specific skills ranged from 7.7 to 8.8 (all scales 0-10). Qualitative analysis of the open-response data identified four prominent themes: Improved Pain Coping, Mood and Emotional Benefits, Improved Physical Functioning, and experiences related to Intervention Delivery. CONCLUSIONS: The high ratings of helpfulness demonstrate acceptability of this culturally enhanced pain CST program by African Americans with OA. Increasing access to cognitive-behavioral therapy-based programs may be a promising strategy to address racial disparities in OA-related pain and associated outcomes. TRIAL REGISTRATION: NCT02560922 , registered September 25, 2015.

Implementation of a group physical therapy program for Veterans with knee osteoarthritis.

BACKGROUND: A previous randomized clinical trial found that a Group Physical Therapy (PT) program for knee osteoarthritis yielded similar improvements in pain and function compared with traditional individual PT. Based on these findings the Group PT program was implemented in a Department of Veterans Affairs Health Care System. The objective of this study was to evaluate implementation metrics and changes in patient-level measures following implementation of the Group PT program. METHODS: This was a one-year prospective observational study. The Group PT program involved 6 weekly sessions. Implementation metrics included numbers of referrals and completed sessions. Patient-level measures were collected at the first and last PT sessions and included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; self-report of pain, stiffness and function (range 0-96)) and a 30-s chair rise test. RESULTS: During the evaluation period, 152 patients were referred, 80 had an initial session scheduled, 71 completed at least one session and 49 completed at least 5 sessions. The mean number of completed appointments per patient was 4.1. Among patients completing baseline and follow-up measures, WOMAC scores (n = 33) improved from 56.8 (SD = 15.8) to 46.9 (SD = 14.0); number of chair rises (n = 38) completed in 30 s increased from 10.4 (SD = 5.1) to 11.9 (SD = 5.0). CONCLUSIONS: Patients completing the Group PT program in this implementation phase showed clinically relevant improvements comparable to those observed in the previous clinical trial that compared group and individual PT for knee osteoarthritis. These results are important because Group PT can improve efficiency and access compared with individual PT. However, there were some limitations with respect to attendance and completion rates, and program adaptations may be needed to optimize these implementation metrics. Larger, longer-term studies are required to more fully evaluate the effectiveness of this program.

Effect of Adding Telephone-Based Brief Coaching to an mHealth App (Stay Strong) for Promoting Physical Activity Among Veterans: Randomized Controlled Trial.

BACKGROUND: Though maintaining physical conditioning and a healthy weight are requirements of active military duty, many US veterans lose conditioning and rapidly gain weight after discharge from active duty service. Mobile health (mHealth) interventions using wearable devices are appealing to users and can be effective especially with personalized coaching support. We developed Stay Strong, a mobile app tailored to US veterans, to promote physical activity using a wrist-worn physical activity tracker, a Bluetooth-enabled scale, and an app-based dashboard. We tested whether adding personalized coaching components (Stay Strong+Coaching) would improve physical activity compared to Stay Strong alone. OBJECTIVE: The goal of this study is to compare 12-month outcomes from Stay Strong alone versus Stay Strong+Coaching. METHODS: Participants (n=357) were recruited from a national random sample of US veterans of recent wars and randomly assigned to the Stay Strong app alone (n=179) or Stay Strong+Coaching (n=178); both programs lasted 12 months. Personalized coaching components for Stay Strong+Coaching comprised of automated in-app motivational messages (3 per week), telephone-based human health coaching (up to 3 calls), and personalized weekly goal setting. All aspects of the enrollment process and program delivery were accomplished virtually for both groups, except for the telephone-based coaching. The primary outcome was change in physical activity at 12 months postbaseline, measured by average weekly Active Minutes, captured by the Fitbit Charge 2 device. Secondary outcomes included changes in step counts, weight, and patient activation. RESULTS: The average age of participants was 39.8 (SD 8.7) years, and 25.2% (90/357) were female. Active Minutes decreased from baseline to 12 months for both groups (P<.001) with no between-group differences at 6 months (P=.82) or 12 months (P=.98). However, at 12 months, many participants in both groups did not record Active Minutes, leading to missing data in 67.0% (120/179) for Stay Strong and 61.8% (110/178) for Stay Strong+Coaching. Average baseline weight for participants in Stay Strong and Stay Strong+Coaching was 214 lbs and 198 lbs, respectively, with no difference at baseline (P=.54) or at 6 months (P=.28) or 12 months (P=.18) postbaseline based on administrative weights, which had lower rates of missing data. Changes in the number of steps recorded and patient activation also did not differ by arm. CONCLUSIONS: Adding personalized health coaching comprised of in-app automated messages, up to 3 coaching calls, plus automated weekly personalized goals, did not improve levels of physical activity compared to using a smartphone app alone. Physical activity in both groups decreased over time. Sustaining long-term adherence and engagement in this mHealth intervention proved difficult; approximately two-thirds of the trial's 357 participants failed to sync their Fitbit device at 12 months and, thus, were lost to follow-up. TRIAL REGISTRATION: ClinicalTrials.gov NCT02360293; https://clinicaltrials.gov/ct2/show/NCT02360293. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/12526.

Family Caregiver Skills Training to Improve Experiences of Care: a Randomized Clinical Trial.

OBJECTIVE: To evaluate the effectiveness of Helping Invested Families Improve Veterans' Experiences Study (HI-FIVES), a skills training program for caregivers of persons with functional or cognitive impairments. DESIGN: A two-arm RCT. SETTING: Single Veterans Affairs Medical Center. PARTICIPANTS: Patients and their primary caregivers referred in the past 6 months to home and community-based services or geriatrics clinic. INTERVENTION: All caregivers received usual care. Caregivers in HI-FIVES also received five training calls and four group training sessions. MAIN MEASURES: Cumulative patient days at home 12 months post-randomization, defined as days not in an emergency department, inpatient hospital, or post-acute facility. Secondary outcomes included patients' total VA health care costs, caregiver and patient rating of the patient's experience of VA health care, and caregiver depressive symptoms. RESULTS: Of 241 dyads, caregivers' (patients') mean age was 61 (73) years, 54% (53%) Black and 89% (4%) female. HI-FIVES was associated with a not statistically significant 9% increase in the rate of days at home (95% CI 0.72, 1.65; mean difference 1 day over 12 months). No significant differences were observed in health care costs or caregiver depressive symptoms. Model-estimated mean baseline patient experience of VA care (scale of 0-10) was 8.43 (95% CI 8.16, 8.70); the modeled mean difference between HI-FIVES and controls at 3 months was 0.29 (p = .27), 0.31 (p = 0.26) at 6 months, and 0.48 (p = 0.03) at 12 months. For caregivers, it was 8.34 (95% CI 8.10, 8.57); the modeled mean difference at 3 months was 0.28 (p = .18), 0.53 (p < .01) at 6 months, and 0.46 (p = 0.054) at 12 months. CONCLUSIONS: HI-FIVES did not increase patients' days at home; it showed sustained improvements in caregivers' and patients' experience of VA care at clinically significant levels, nearly 0.5 points. The training holds promise in increasing an important metric of care quality-reported experience with care.

Health Coaching Has Differential Effects on Veterans with Limited Health Literacy and Numeracy: a Secondary Analysis of ACTIVATE.

BACKGROUND: Health coaching is an effective behavior change strategy. Understanding if there is a differential impact of health coaching on patients with low health literacy has not been well investigated. OBJECTIVE: To determine whether a telephone coaching intervention would result in similar improvements in enrollment in prevention programs and patient activation among Veterans with low versus high health literacy (specifically, reading literacy and numeracy). DESIGN: Secondary analysis of a randomized controlled trial. PARTICIPANTS: Four hundred seventeen Veterans with at least one modifiable risk factor: current smoker, BMI ≥ 30, or < 150 min of moderate physical activity weekly. METHODS: A single-item assessment of health literacy and a subjective numeracy scale were assessed at baseline. A logistic regression and general linear longitudinal models were used to examine the differential impact of the intervention compared to control on enrollment in prevention programs and changes in patient activation measures (PAM) scores among patients with low versus high health literacy. RESULTS: The coaching intervention resulted in higher enrollment in prevention programs and improvements in PAM scores compared to usual care regardless of baseline health literacy. The coaching intervention had a greater effect on the probability of enrollment in prevention programs for patients with low numeracy (intervention vs control difference of 0.31, 95% CI 0.18, 0.45) as compared to those with high numeracy (0.13, 95% CI - 0.01, 0.27); the low compared to high differential effect was clinically, but not statistically significant (0.18, 95% CI - 0.01, 0.38; p = 0.07). Among patients with high numeracy, the intervention group had greater increases in PAM as compared to the control group at 6 months (mean difference in improvement 4.8; 95% CI 1.7, 7.9; p = 0.003). This led to a clinically and statistically significant differential intervention effect for low vs high numeracy (- 4.6; 95% CI - 9.1, - 0.15; p = 0.04). CONCLUSIONS: We suggest that health coaching may be particularly beneficial in behavior change strategies in populations with low numeracy when interpretation of health risk information is part of the intervention. CLINICALTRIALS. GOV IDENTIFIER: NCT01828567.

Telemedicine cardiovascular risk reduction in veterans: The CITIES trial.

BACKGROUND: Comprehensive programs addressing tailored patient self-management and pharmacotherapy may reduce barriers to cardiovascular disease (CVD) risk reduction. METHODS: This is a 2-arm (clinical pharmacist specialist-delivered, telehealth intervention and education control) randomized controlled trial including Veterans with poorly controlled hypertension and/or hypercholesterolemia. Primary outcome was Framingham CVD risk score at 6 and 12 months, with systolic blood pressure; diastolic blood pressure; total cholesterol; low-density lipoprotein; high-density lipoprotein; body mass index; and, for those with diabetes, HbA1c as secondary outcomes. RESULTS: Among 428 Veterans, 50% were African American, 85% were men, and 33% had limited health literacy. Relative to the education control group, the clinical pharmacist specialist-delivered intervention did not show a reduction in CVD risk score at 6 months (-1.8, 95% CI -3.9 to 0.3; P = .10) or 12 months (-0.3, 95% CI -2.4 to 1.7; P = .74). No differences were seen in systolic blood pressure, diastolic blood pressure, or low-density lipoprotein at 6 or 12 months. We did observe a significant decline in total cholesterol at 6 months (-7.0, 95% CI -13.4 to -0.6; P = .03) in the intervention relative to education control group. Among patients in the intervention group, 34% received at least 5 of the 12 planned intervention calls and were considered "compliers." A sensitivity analysis of the "complier average causal effect" of intervention compared to control showed a mean difference in CVD risk score reduction of 5.7 (95% CI -12.0 to 0.7) at 6 months and -1.7 (95% CI -7.6 to 4.8) at 12 months. CONCLUSIONS: Despite increased access to pharmacist resources, we did not observe significant improvements in CVD risk for patients randomized to the intervention compared to education control over 12 months. However, the intervention may have positive impact among those who actively participate, particularly in the short term.

A Coaching by Telephone Intervention on Engaging Patients to Address Modifiable Cardiovascular Risk Factors: a Randomized Controlled Trial.

BACKGROUND: A large proportion of deaths and chronic illnesses can be attributed to three modifiable risk factors: tobacco use, overweight/obesity, and physical inactivity. OBJECTIVE: To test whether telephone-based health coaching after completion of a comprehensive health risk assessment (HRA) increases patient activation and enrollment in a prevention program compared to HRA completion alone. DESIGN: Two-arm randomized trial at three sites. SETTING: Primary care clinics at Veterans Affairs facilities. PARTICIPANTS: Four hundred seventeen veterans with at least one modifiable risk factor (BMI ≥ 30, < 150 min of at least moderate physically activity per week, or current smoker). INTERVENTION: Participants completed an online HRA. Intervention participants received two telephone-delivered health coaching calls at 1 and 4 weeks to collaboratively set goals to enroll in, and attend structured prevention programs designed to reduce modifiable risk factors. MEASUREMENTS: Primary outcome was enrollment in a structured prevention program by 6 months. Secondary outcomes were Patient Activation Measure (PAM) and Framingham Risk Score (FRS). RESULTS: Most participants were male (85%), white (50%), with a mean age of 56. Participants were eligible, because their BMI was ≥ 30 (80%), they were physically inactive (50%), and/or they were current smokers (39%). When compared to HLA only at 6 months, health coaching intervention participants reported higher rates of enrollment in a prevention program, 51 vs 29% (OR = 2.5; 95% CI: 1.7, 3.9; p < 0.0001), higher rates of program participation, 40 vs 23% (OR = 2.3; 95% CI: 1.5, 3.6; p = 0.0004), and greater improvement in PAM scores, mean difference 2.5 (95% CI: 0.2, 4.7; p = 0.03), but no change in FRS scores, mean difference 0.7 (95% CI - 0.7, 2.2; p = 0.33). CONCLUSIONS: Brief telephone health coaching after completing an online HRA increased patient activation and increased enrollment in structured prevention programs to improve health behaviors. CLINICALTRIALS. GOV IDENTIFIER: NCT01828567.

Cognitive Mediators of Change in Physical Functioning in Response to a Multifaceted Intervention for Managing Osteoarthritis.

PURPOSE: Although non-pharmacological interventions have been shown to improve physical functioning in individuals with osteoarthritis (OA), the mechanisms by which this occurs are often unclear. This study assessed whether changes in arthritis self-efficacy, perceived pain control, and pain catastrophizing mediated changes in physical functioning following an osteoarthritis intervention involving weight management, physical activity, and cognitive-behavioral pain management. METHOD: Three hundred Veteran patients of 30 primary care providers with knee and/or hip OA were cluster randomized to an OA intervention group or usual care. The OA intervention included a 12-month phone-based patient behavioral protocol (weight management, physical activity, and cognitive-behavioral pain management) plus patient-specific OA treatment recommendations delivered to primary care providers. RESULTS: Using linear mixed models adjusted for provider clustering, we observed that baseline to 6-month changes in arthritis self-efficacy and pain control partially mediated baseline to 12-month physical functioning improvements for the intervention group; catastrophizing did not. CONCLUSION: Findings of a mediating role of arthritis self-efficacy and pain control in intervention-related functional changes are consistent with hypotheses and align with theoretical assertions of the role of cognitions in cognitive and behavioral interventions for chronic pain. However, contrary to hypotheses, catastrophizing was not found to be a mediator of these changes.

Prevalence of and characteristics associated with insomnia and obstructive sleep apnea among veterans with knee and hip osteoarthritis.

BACKGROUND: Few studies have examined patterns of specific sleep problems among individuals with osteoarthritis (OA). The primary objective of this study was to examine prevalence of symptoms of insomnia and obstructive sleep apnea (OSA) among Veterans with OA. Secondary objectives were to assess proportions of individuals with insomnia and OSA symptoms who may have been undiagnosed and to examine Veterans' characteristics associated with insomnia and OSA symptoms. METHODS: Veterans (n = 300) enrolled in a clinical trial completed the Insomnia Severity Index (ISI) and the Berlin Questionnaire (BQ) at baseline; proportions of participants with symptoms consistent with insomnia and OSA were calculated, using standard cut-offs for ISI and BQ. For Veterans with insomnia and OSA symptoms, electronic medical records were searched to identify whether there was a diagnosis code for these conditions. Multivariable linear (ISI) and logistic (BQ) regression models examined associations of the following characteristics with symptoms of insomnia and OSA: age, gender, race, self-reported general health, body mass index (BMI), diagnosis of post-traumatic stress disorder (PTSD), pain severity, depressive symptoms, number of joints with arthritis symptoms and opioid use. RESULTS: Symptoms consistent with insomnia and OSA were found in 53 and 66% of this sample, respectively. Among participants screening positive for insomnia and OSA, diagnosis codes for these disorders were present in the electronic medical record for 22 and 51%, respectively. Characteristics associated with insomnia were lower age (ß (SE) = - 0.09 (0.04), 95% confidence interval [CI] = - 0.16, - 0.02), having a PTSD diagnosis (ß (SE) = 1.68 (0.73), CI = 0.25, 3.11), greater pain severity (ß (SE) = 0.36 (0.09), CI = 0.17, 0.55), and greater depressive symptoms (ß (SE) = 0.84 (0.07), CI = 0.70, 0.98). Characteristics associated with OSA were higher BMI (odds ratio [OR] = 1.13, CI = 1.06, 1.21), greater depressive symptoms (OR = 1.12, CI = 1.05, 1.20), and opioid use (OR = 0.51, CI = 0.26, 0.99). CONCLUSIONS: Insomnia and OSA symptoms were very common in Veterans with OA, and a substantial proportion of individuals with symptoms may have been undiagnosed. Characteristics associated with insomnia and OSA symptoms were consistent with prior studies. TRIAL REGISTRATION: NCT01130740 .

Pain coping skills training for African Americans with osteoarthritis study: baseline participant characteristics and comparison to prior studies.

BACKGROUND: The Pain Coping Skills Training for African Americans with OsteoaRTthritis (STAART) trial is examining the effectiveness of a culturally enhanced pain coping skills training (CST) program for African Americans with osteoarthritis (OA). This disparities-focused trial aimed to reach a population with greater symptom severity and risk factors for poor pain-related outcomes than previous studies. This paper compares characteristics of STAART participants with prior studies of CST or cognitive behavioral therapy (CBT)-informed training in pain coping strategies for OA. METHODS: A literature search identified 10 prior trials of pain CST or CBT-informed pain coping training among individuals with OA. We descriptively compared characteristics of STAART participants with other studies, in 3 domains of the National Institutes of Minority Health and Health Disparities' Research Framework: Sociocultural Environment (e.g., age, education, marital status), Biological Vulnerability and Mechanisms (e.g, pain and function, body mass index), and Health Behaviors and Coping (e.g., pain catastrophizing). Means and standard deviations (SDs) or proportions were calculated for STAART participants and extracted from published manuscripts for comparator studies. RESULTS: The mean age of STAART participants, 59 years (SD = 10.3), was lower than 9 of 10 comparator studies; the proportion of individuals with some education beyond high school, 75%, was comparable to comparator studies (61-86%); and the proportion of individuals who are married or living with a partner, 42%, was lower than comparator studies (62-66%). Comparator studies had less than about 1/3 African American participants. Mean scores on the Western Ontario and McMaster Universities Osteoarthritis Index pain and function scales were higher (worse) for STAART participants than for other studies, and mean body mass index of STAART participants, 35.2 kg/m2 (SD = 8.2), was higher than all other studies (30-34 kg/m2). STAART participants' mean score on the Pain Catastrophizing scale, 19.8 (SD = 12.3), was higher (worse) than other studies reporting this measure (7-17). CONCLUSIONS: Compared with prior studies with predominantly white samples, STAART participants have worse pain and function and more risk factors for negative pain-related outcomes across several domains. Given STAART participants' high mean pain catastrophizing scores, this sample may particularly benefit from the CST intervention approach. TRIAL REGISTRATION: NCT02560922.

Patient, Provider, and Combined Interventions for Managing Osteoarthritis in Primary Care: A Cluster Randomized Trial.

BACKGROUND: A single-site study showed that a combined patient and provider intervention improved outcomes for patients with knee osteoarthritis, but it did not assess separate effects of the interventions. OBJECTIVE: To examine whether patient-based, provider-based, and patient-provider interventions improve osteoarthritis outcomes. DESIGN: Cluster randomized trial with assignment to patient, provider, and patient-provider interventions or usual care. (ClinicalTrials.gov: NCT01435109). SETTING: 10 Duke University Health System community-based primary care clinics. PARTICIPANTS: 537 outpatients with symptomatic hip or knee osteoarthritis. INTERVENTION: The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved electronic delivery of patient-specific osteoarthritis treatment recommendations to providers. MEASUREMENTS: The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12 months. Secondary outcomes were objective physical function (Short Physical Performance Battery) and depressive symptoms (Patient Health Questionnaire). Linear mixed models assessed the difference in improvement among groups. RESULTS: No difference was observed in WOMAC score changes from baseline to 12 months in the patient (-1.5 [95% CI, -5.1 to 2.0]; P = 0.40), provider (2.5 [CI, -0.9 to 5.9]; P = 0.152), or patient-provider (-0.7 [CI, -4.2 to 2.8]; P = 0.69) intervention groups compared with usual care. All groups had improvements in WOMAC scores at 12 months (range, -3.7 to -7.7). In addition, no differences were seen in objective physical function or depressive symptoms at 12 months in any of the intervention groups compared with usual care. LIMITATIONS: The study involved 1 health care network. Data on provider referrals were not collected. CONCLUSION: Contrary to a previous study of a combined patient and provider intervention for osteoarthritis in a Department of Veterans Affairs medical center, this study found no statistically significant improvements in the osteoarthritis intervention groups compared with usual care. PRIMARY FUNDING SOURCE: National Institute of Arthritis and Musculoskeletal and Skin Diseases.

A Combined Patient and Provider Intervention for Management of Osteoarthritis in Veterans: A Randomized Clinical Trial.

BACKGROUND: Management of osteoarthritis requires both medical and behavioral strategies, but some recommended therapies are underused. OBJECTIVE: To examine the effectiveness of a combined patient and provider intervention for improving osteoarthritis outcomes. DESIGN: Cluster randomized clinical trial with assignment to osteoarthritis intervention and usual care groups. (ClinicalTrials.gov: NCT01130740). SETTING: Department of Veterans Affairs Medical Center in Durham, North Carolina. PARTICIPANTS: 30 providers (clusters) and 300 outpatients with symptomatic hip or knee osteoarthritis. INTERVENTION: The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved delivery of patient-specific osteoarthritis treatment recommendations to primary care providers through the electronic medical record. MEASUREMENTS: The primary outcome was total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months. Secondary outcomes were WOMAC function and pain subscale scores, physical performance (Short Physical Performance Battery), and depressive symptoms (Patient Health Questionnaire-8). Linear mixed models that were adjusted for clustering of providers assessed between-group differences in improvement in outcomes. RESULTS: At 12 months, WOMAC scores were 4.1 points lower (indicating improvement) in the osteoarthritis intervention group versus usual care (95% CI, -7.2 to -1.1 points; P = 0.009). WOMAC function subscale scores were 3.3 points lower in the intervention group (CI, -5.7 to -1.0 points; P = 0.005). WOMAC pain subscale scores (P = 0.126), physical performance, and depressive symptoms did not differ between groups. Although more patients in the osteoarthritis intervention group received provider referral for recommended osteoarthritis treatments, the numbers who received them did not differ. LIMITATION: The study was conducted in a single Veterans Affairs medical center. CONCLUSION: The combined patient and provider intervention resulted in modest improvement in self-reported physical function in patients with hip and knee osteoarthritis. PRIMARY FUNDING SOURCE: Department of Veterans Affairs, Health Services Research and Development Service.

Effect of Allowing Choice of Diet on Weight Loss: A Randomized Trial.

BACKGROUND: Choosing a diet rather than being prescribed one could improve weight loss. OBJECTIVE: To examine whether offering choice of diet improves weight loss. DESIGN: Double-randomized preference trial of choice between 2 diets (choice) versus random assignment to a diet (comparator) over 48 weeks. (ClinicalTrials.gov: NCT01152359). SETTING: Outpatient clinic at a Veterans Affairs medical center. PATIENTS: Outpatients with a body mass index of at least 30 kg/m2. INTERVENTION: Choice participants received information about their food preferences and 2 diet options (low-carbohydrate diet [LCD] or low-fat diet [LFD]) before choosing and were allowed to switch diets at 12 weeks. Comparator participants were randomly assigned to 1 diet for 48 weeks. Both groups received group and telephone counseling for 48 weeks. MEASUREMENTS: The primary outcome was weight at 48 weeks. RESULTS: Of 105 choice participants, 61 (58%) chose the LCD and 44 (42%) chose the LFD; 5 (3 on the LCD and 2 on the LFD) switched diets at 12 weeks, and 87 (83%) completed measurements at 48 weeks. Of 102 comparator participants, 53 (52%) were randomly assigned to the LCD and 49 (48%) were assigned to the LFD; 88 (86%) completed measurements. At 48 weeks, estimated mean weight loss was 5.7 kg (95% CI, 4.3 to 7.0 kg) in the choice group and 6.7 kg (CI, 5.4 to 8.0 kg) in the comparator group (mean difference, -1.1 kg [CI, -2.9 to 0.8 kg]; P = 0.26). Secondary outcomes of dietary adherence, physical activity, and weight-related quality of life were similar between groups at 48 weeks. LIMITATIONS: Only 2 diet options were provided. Results from this sample of older veterans might not be generalizable to other populations. CONCLUSION: Contrary to expectations, the opportunity to choose a diet did not improve weight loss.

Pain coping skills training for African Americans with osteoarthritis (STAART): study protocol of a randomized controlled trial.

BACKGROUND: African Americans bear a disproportionate burden of osteoarthritis (OA), with higher prevalence rates, more severe pain, and more functional limitations. One key barrier to addressing these disparities has been limited engagement of African Americans in the development and evaluation of behavioral interventions for management of OA. Pain Coping Skills Training (CST) is a cognitive-behavioral intervention with shown efficacy to improve OA-related pain and other outcomes. Emerging data indicate pain CST may be a promising intervention for reducing racial disparities in OA symptom severity. However, there are important gaps in this research, including incorporation of stakeholder perspectives (e.g. cultural appropriateness, strategies for implementation into clinical practice) and testing pain CST specifically among African Americans with OA. This study will evaluate the effectiveness of a culturally enhanced pain CST program among African Americans with OA. METHODS/DESIGN: This is a randomized controlled trial among 248 participants with symptomatic hip or knee OA, with equal allocation to a pain CST group and a wait list (WL) control group. The pain CST program incorporated feedback from patients and other stakeholders and involves 11 weekly telephone-based sessions. Outcomes are assessed at baseline, 12 weeks (primary time point), and 36 weeks (to assess maintenance of treatment effects). The primary outcome is the Western Ontario and McMaster Universities Osteoarthritis Index, and secondary outcomes include self-efficacy, pain coping, pain interference, quality of life, depressive symptoms, and global assessment of change. Linear mixed models will be used to compare the pain CST group to the WL control group and explore whether participant characteristics are associated with differential improvement in the pain CST program. This research is in compliance with the Helsinki Declaration and was approved by the Institutional Review Boards of the University of North Carolina at Chapel Hill, Durham Veterans Affairs Medical Center, East Carolina University, and Duke University Health System. DISCUSSION: This culturally enhanced pain CST program could have a substantial impact on outcomes for African Americans with OA and may be a key strategy in the reduction of racial health disparities. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02560922 , registered 9/22/2015.

Shared medical appointments for patients with diabetes mellitus: a systematic review.

OBJECTIVES: Shared medical appointments (SMAs) are an increasingly used system-redesign strategy for improving access to and quality of chronic illness care. We conducted a systematic review of the existing literature on SMA interventions for patients with diabetes in order to understand their impact on outcomes. DATA SOURCES: MEDLINE, EMBASE, CINAHL, PsycINFO, and Web of Science from January 1996 through April 2012. PubMed search updated June 2013. STUDY SELECTION: English-language peer-reviewed publications of randomized controlled trials (RCTs), nonrandomized cluster controlled trials, controlled before-and-after studies, or interrupted time-series designs conducted among adult patients with diabetes. Two independent reviewers used prespecified criteria to screen titles and abstracts for full text review. STUDY APPRAISAL AND SYNTHESIS METHODS: Two different reviewers abstracted data and rated study quality and strength of evidence. When possible, we used random-effects models to synthesize the effects quantitatively, reporting by a weighted difference of the means when the same scale was used across studies, and a standardized mean difference when the scales differed. We measured heterogeneity in study effects using Forest Plots, Cochran's Q, and I(2), and explored heterogeneity by using subgroup analyses for categorical variables and meta-regression analyses for continuous or discrete variables. Outcomes not suitable to meta-analysis were summarized qualitatively. RESULTS: Twenty-five articles representing 17 unique studies compared SMA interventions with usual care. Among patients with diabetes, SMAs improved hemoglobin A1c (∆ = -0.55 percentage points [95 % CI, -0.11 to -0.99]); improved systolic blood pressure (∆ = -5.2 mmHg [95 % CI, -3.0 to -7.4]); and did not improve LDL cholesterol (∆ = -6.6 mg/dl [95 % CI, 2.8 to -16.1]). Nonbiophysical outcomes, including economic outcomes, were reported too infrequently to meta-analyze, or to draw conclusions from. The A1c result had significant heterogeneity among studies, likely secondary to the heterogeneity among included SMA interventions. LIMITATION: Heterogeneity among the components of diabetes SMAs leads to uncertainty about what makes a particular SMA successful. CONCLUSION: SMA interventions improve biophysical outcomes among patients with diabetes. There was inadequate literature to determine SMA effects on patient experience, utilization, and costs.

Clinic variation in recruitment metrics, patient characteristics and treatment use in a randomized clinical trial of osteoarthritis management.

BACKGROUND: The Patient and PRovider Interventions for Managing Osteoarthritis (OA) in Primary Care (PRIMO) study is one of the first health services trials targeting OA in a multi-site, primary care network. This multi-site approach is important for assessing generalizability of the interventions. These analyses describe heterogeneity in clinic and patient characteristics, as well as recruitment metrics, across PRIMO study clinics. METHODS: Baseline data were obtained from the PRIMO study, which enrolled n = 537 patients from ten Duke Primary Care practices. The following items were examined across clinics with descriptive statistics: (1) Practice Characteristics, including primary care specialty, numbers and specialties of providers, numbers of patients age 55+, urban/rural location and county poverty level; (2) Recruitment Metrics, including rates of eligibility, refusal and randomization; (3) Participants' Characteristics, including demographic and clinical data (general and OA-related); and (4) Participants' Self-Reported OA Treatment Use, including pharmacological and non-pharmacological therapies. Intraclass correlation coefficients (ICCs) were computed for participant characteristics and OA treatment use to describe between-clinic variation. RESULTS: Study clinics varied considerably across all measures, with notable differences in numbers of patients age 55+ (1,507-5,400), urban/rural location (ranging from "rural" to "small city"), and proportion of county households below poverty level (12%-26%). Among all medical records reviewed, 19% of patients were initially eligible (10%-31% across clinics), and among these, 17% were randomized into the study (13%-21% across clinics). There was considerable between-clinic variation, as measured by the ICC (>0.01), for the following patient characteristics and OA treatment use variables: age (means: 60.4-66.1 years), gender (66%-88% female), race (16%-61% non-white), low income status (5%-27%), presence of hip OA (26%-68%), presence both knee and hip OA (23%-61%), physical therapy for knee OA (24%-61%) and hip OA (0%-71%), and use of knee brace with metal supports (0%-18%). CONCLUSIONS: Although PRIMO study sites were part of one primary care practice network in one health care system, clinic and patient characteristics varied considerably, as did OA treatment use. This heterogeneity illustrates the importance of including multiple, diverse sites in trials for knee and hip OA, to enhance the generalizability and evaluate potential for real-world implementation. CLINICAL TRIAL REGISTRATION NUMBER: NCT 01435109.

The Cardiovascular Intervention Improvement Telemedicine Study (CITIES): rationale for a tailored behavioral and educational pharmacist-administered intervention for achieving cardiovascular disease risk reduction.

BACKGROUND: Hypertension, hyperlipidemia, and diabetes are significant, but often preventable, contributors to cardiovascular disease (CVD) risk. Medication and behavioral nonadherence are significant barriers to successful hypertension, hyperlidemia, and diabetes management. Our objective was to describe the theoretical framework underlying a tailored behavioral and educational pharmacist-administered intervention for achieving CVD risk reduction. MATERIALS AND METHODS: Adults with poorly controlled hypertension and/or hyperlipidemia were enrolled from three outpatient primary care clinics associated with the Durham Veterans Affairs Medical Center (Durham, NC). Participants were randomly assigned to receive a pharmacist-administered, tailored, 1-year telephone-based intervention or usual care. The goal of the study was to reduce the risk for CVD through a theory-driven intervention to increase medication adherence and improve health behaviors. RESULTS: Enrollment began in November 2011 and is ongoing. The target sample size is 500 patients. CONCLUSIONS: The Cardiovascular Intervention Improvement Telemedicine Study (CITIES) intervention has been designed with a strong theoretical underpinning. The theoretical foundation and intervention are designed to encourage patients with multiple comorbidities and poorly controlled CVD risk factors to engage in home-based monitoring and tailored telephone-based interventions. Evidence suggests that clinical pharmacist-administered telephone-based interventions may be efficiently integrated into primary care for patients with poorly controlled CVD risk factors.

Telemedicine cardiovascular risk reduction in veterans.

BACKGROUND: Patients with co-occurrence of hypertension, hyperlipidemia, and diabetes have an increased risk of cardiovascular disease (CVD) events. Comprehensive programs addressing both tailored patient self-management and pharmacotherapy are needed to address barriers to optimal cardiovascular risk reduction. We are examining a Clinical pharmacy specialist-, telephone-administered intervention, relying on home monitoring, with a goal of providing tailored medication and behavioral intervention to Veterans with CVD risk. METHODS: Randomized controlled trial including patients with hypertension (blood pressure >150/100 mm Hg) or elevated low density liporotein (>130 mg/dL). Longitudinal changes in CVD risk profile and improvement in health behaviors over time will be examined. CONCLUSION: Given the national prevalence of CVD and the dismal rates of risk factor control, intensive but easily disseminated interventions are required to treat this epidemic. This study will be an important step in testing the effectiveness of a behavioral and medication intervention to improve CVD control among Veterans.