Patient, Provider, and Combined Interventions for Managing Osteoarthritis in Primary Care

Osteoarthritis is a leading cause of pain and disability (13). Already a leading chronic health condition in primary care settings (4), osteoarthritis will become increasingly prevalent (58). Treatment involves a combination of behavioral, pharmacologic, and other clinical therapies (911); therefore, both patients and health care providers play key roles in effective management. However, studies have identified gaps in the use of key behavioral strategies, including physical activity and weight management (1214), as well as low use of some recommended clinical therapies (1520). These studies emphasize the need to improve the use of evidence-based osteoarthritis therapies. It is not known whether interventions focused on health care providers or patients may be more effective for improving osteoarthritis management and outcomes. Most previous osteoarthritis interventions occurred at the patient level, with little attempt to effect provider- or system-level changes. We previously reported that among a group of patients with osteoarthritis receiving care at a single Veterans Affairs medical center (VAMC), a combined patient and provider intervention resulted in statistically significant, modest improvements in physical function (21). This study extends this research area by separately examining patient-level, health care providerlevel, and combined osteoarthritis interventions in several primary care clinics. Methods The Institutional Review Board of Duke University Medical Center approved this study. Methods were published previously (22). Owing to our lack of awareness, the study was registered at ClinicalTrials.gov 15 days after the first participant was enrolled, which met institutional requirements but not the International Committee of Medical Journal Editors' requirement of registration before participant enrollment. Only 1 participant was enrolled, and no analyses were done before registration. Study Setting and Design This study was conducted within the Duke Primary Care Research Consortium. Ten primary care clinics were randomly assigned to provider intervention or control conditions, and patients within those clinics were assigned to patient intervention or control, resulting in 4 study groups: patient intervention, provider intervention, patientprovider intervention, and usual care. Randomization schedules for clinics and patients were computer generated by the statistician. Clinic randomizations were paired on the basis of type (family or internal medicine) as well as similarities in practice size (numbers of patients and providers) and rural versus urban location; 1 clinic in each pair was assigned to the provider intervention and 1 to the provider control group. Patient randomizations were stratified by race (white vs. nonwhite) and sex. All participants continued with usual care for osteoarthritis as recommended by their providers, with no restrictions. Participants and Recruitment All primary care providers (PCPs) at the study clinics were invited to participate; only 2 declined. Patients were eligible if they had osteoarthritis of the hip (based on radiographic evidence in the electronic medical record [EMR]) or knee (based on radiographic evidence in the EMR or satisfaction of American College of Rheumatology clinical criteria [23]), along with self-reported joint symptoms (pain, aching, stiffness, or swelling in or around a hip or knee joint with arthritis that was present or for which the patient used pain medications on most days during the past month) (24). Participants had to be overweight (body mass index [BMI] 25 kg/m2) and not currently meeting U.S. Department of Health and Human Services physical activity recommendations (150 minutes of aerobic activity and 2 sessions of muscle strengthening activity weekly) (25). Exclusion criteria are summarized in Appendix Table 1. Potential participants were identified from the EMR, were mailed an introductory letter, and were called for screening. Eligible patients gave consent, completed baseline assessments, and were informed of their randomization assignment by the study coordinator via telephone. Appendix Table 1. Exclusion Criteria Interventions Patient Behavioral Intervention for Osteoarthritis The intervention took place over 12 months and focused on physical activity, weight management, and cognitive behavioral strategies for managing pain (22). Telephone calls were scheduled twice per month for the first 6 months, then monthly for the last 6 months, and were delivered by a counselor with training in osteoarthritis and behavior change. Goal setting and action planning were major intervention components. Motivational interviewing strategies were used throughout the intervention (22, 26, 27). Participants were given written educational materials, an exercise video, and an audio CD of relaxation exercises. Provider Intervention The study team delivered the following patient-specific osteoarthritis treatment recommendations to PCPs, based on treatment guidelines (11, 28, 29): refer to physical therapist, refer for evaluation for knee brace, refer to weight management program, refer to physical activity program, perform or refer for intra-articular injection, recommend topical nonsteroidal anti-inflammatory drug or capsaicin, add gastroprotective agent or remove nonsteroidal anti-inflammatory drug in patients at high risk for peptic ulcer disease, discuss new or alternate pain medication, and refer to orthopedic evaluation for joint replacement surgery. We developed algorithms based on patient data (Appendix Table 2) regarding when each treatment option would be reasonable for a PCP to consider for a patient (22). However, decisions regarding whether to recommend these treatments to patients were at the discretion of the PCPs. The study team monitored upcoming visits for provider intervention participants, and recommendations were delivered only once per participant, before the first routine visit after enrollment. Most recommendations were delivered via the Duke EMR, but 22 were delivered via secure e-mail during an EMR transition. Appendix Table 2. Provider Intervention Recommendations and Algorithms Outcome Measures The primary and secondary analyses include measures at baseline through 12 months. Analyses of maintenance effects (18 and 24 months) will be presented separately. All outcomes (including osteoarthritis treatment use) were assessed in person at baseline and 12 months, except for 48 participants who could not return at 12 months but completed some measures via telephone. The primary outcome also was assessed via telephone at 6 months. Outcomes assessors were blind to randomization. Participants were reimbursed $25 and $10 for in-person and phone assessments, respectively. Primary Outcomes The primary outcome was the total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a self-reported measure of lower-extremity pain (5 items), stiffness (2 items), and function (17 items) in the past 2 weeks (3032). All items are rated on a 5-point Likert scale ranging from none to extreme (total range, 0 to 96; higher scores indicate worse symptoms and function). Secondary Outcomes We examined WOMAC pain and function subscales separately. We also administered the Short Physical Performance Battery (33), which includes 3 tests of balance, a timed 8-foot walk, and 5 chair stands. The total score ranges from 0 (worst performance) to 12 (best performance). Depressive symptoms were assessed with the 8-item Patient Health Questionnaire (PHQ-8) (34), with scores ranging from 0 to 24. Physical Activity and BMI Several exploratory measures were collected (22); here, we focus on physical activity and BMI, because they assess core patient intervention components. Self-reported physical activity was measured with the Community Healthy Activities Model Program for Seniors (CHAMPS) (35, 36); we report the weekly frequency and duration of all exercise, as well as moderate- or higher-intensity exercise, during the past 4 weeks. Height and weight were measured to calculate BMI; when 12-month follow-up measures were administered via telephone, weight was self-reported. Osteoarthritis Treatment Use and Recommendations We describe the proportions of participants who reported receiving the following treatments during the study period: physical therapy for knee or hip osteoarthritis, new knee brace use, joint injections, a change in oral pain medications, new use of topical creams, and joint replacement surgery. We assessed osteoarthritis treatment use via self-report, because the EMR would not capture care received outside the Duke system. For the provider intervention groups, we also report the proportions of participants for whom each treatment recommendation was given to the PCP by the study team. Data regarding recommendations or referrals given to patients by PCPs were not collected. Participant Characteristics We collected patient-reported characteristics, including age, sex, race/ethnicity (white vs. nonwhite), household financial situation (with inadequate income meaning just enough or not enough to meet basic expenses), education level, marital status, work status (employed or student vs. other), disabled (positive response to disabled in the work status question), general self-rated health (excellent, very good, or good vs. fair or poor), and duration of osteoarthritis symptoms. Adverse Events At each study encounter, we inquired about hip and knee injuries or surgeries. We noted other adverse events that participants reported to the study team during regular contact or that were discovered during study-related EMR review. Sample Size The estimated sample size of 140 participants per group (56 per clinic) was based on detecting a 15% improvement in WOMAC scores at 12 months for either of 2 primary hypotheses, with 80% power and a type I error rate of 0.05. Sample size calculations were based on methods for appropriate an