Osteoarthritis is one of the most common causes of pain and disability among Veterans. Evidence-based guidelines emphasize that adequate management of osteoarthritis (OA) requires a combination of both medical and behavioral modalities. However, many of the recommended guidelines are not regularly incorporated into clinical practice, and the recommended behavioral strategies (e.g., exercise and weight management) are not practiced by most patients. This study examined the effectiveness of a combined intervention for patients (involving exercise, weight management, and cognitive behavioral pain management) and providers (involving provision of patient-specific recommendations for care, based on evidence-based guidelines) for improving OA-related outcomes in a real-world VA clinical setting. To our knowledge this is the first study to intervene at both the patient and provider levels for managing OA.
The overall objective of this study was to compare the effects of a combined patient and provider intervention for OA, within primary care, on key patient-centered outcomes, compared to a usual care control group. Our primary hypothesis was as follows: Patients with knee and/or hip OA who receive a comprehensive intervention (including both patient-based and provider-based components) will have a larger, clinically relevant improvement in self-reported pain, stiffness and function, as measured by the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC), compared with usual care. Our secondary hypotheses were that the OA intervention would result in clinically relevant improvements in objectively assessed physical function (Short Physical Performance Battery, SPPB: 8-foot walk, balance test, chair stands) and depressive symptoms (Patient Health Questionnaire-8, PHQ-8), compared to usual care.
This was a randomized controlled trial of n=300 patients with symptomatic knee or hip OA, with equal assignment to 2 study arms: 1) Patient and Provider Intervention for OA, and 2) Usual Care Control. We randomized 30 primary care providers at the Durham VAMC and affiliated community based outpatient clinics to either intervention or control groups. We then aimed to enroll 10 patients (5 white, 5 non-white) from each provider. The patient component of the intervention was a twelve-month telephone-based program that involved supportive counseling for physical activity, weight management, and cognitive behavioral pain management. The provider component of the intervention involved delivery of patient-specific treatment recommendations, based on guidelines, at the point of care (via electronic medical record). The primary time point for outcome assessment was at 12 months, and we also collected a limited set of outcomes via telephone at 6 months. All analyses were intention-to-treat and performed using SAS v9.2 (Cary, NC). Linear mixed models were used for the primary and secondary outcomes, since they are all continuous measures. The primary predictors included indicator variables for 6 months (WOMAC only) and 12 months and treatment arm by follow-up time indicator interaction variables. For these repeated measures, we used an unstructured covariance; we also fit a random physician effect to account for clustering of patients within physician. Our primary inference was on the treatment by follow-up time indicator parameter, specifically the treatment by 12 month follow-up time point indicator variable, as this is the estimated difference between intervention and control arms. All available patient data were used; no observations were deleted due to missing follow-up data. The estimation procedure used in the mixed model framework for longitudinal analysis yields unbiased estimates of parameters when missing outcome are assumed to be ignorable (i.e., when missing values are related to either observed covariates or response variables but not to unobserved variables).
Among 1,433 patients who were approached via letter regarding study participation, 563 were ineligible, 570 declined participation, and 300 consented and were randomized to a study group. Among the 300 participants enrolled, 263 (87.7%) completed 6-month follow-up assessments, and 273 (91.0%) completed 12-month follow-up assessments; 17 (5.7%) were excluded from the study prior to the 12-month follow-up, 5 (1.2%) dropped out of the study, and 5 (1.2%) were lost to follow-up. The mean age of participants was 61.0 years (standard deviation (SD) = 9.2), 91% were men, and the mean body mass index was 33.8 kg/m2 (SD=5.8). 93% of participants had self-reported arthritis / arthritis symptoms in the knee, 55% in the hip, and 48% in both. The mean self-reported duration of arthritis symptoms was 14.2 years (SD=11.6).
Mean (SD) baseline scores were as follows: WOMAC total 48.4 (17.5), WOMAC pain 10.2 (4.0), WOMAC physical function 33.8 (13.0), PHQ-8 6.8 (5.4), SPPB 8.7 (2.0). Sixty-seven subjects were missing the SPPB at baseline, since some assessments were finished by phone and some subjects refused or were unable to complete the SPPB tasks. At 12 months, mean WOMAC total scores were 4.1 points lower in the intervention arm compared to control (95% CI,-7.2 to -1.1; p=0.009), indicating less pain, stiffness and functional limitations in the intervention group. Mean WOMAC pain and physical function subscales were 0.5 points lower (95% CI,-1.2 to 0.2; p=0.13) and 3.3 points lower (95% CI,-5.7 to -1.0; p=0.005) in the intervention group compared to the control group, respectively. For the secondary outcomes, PHQ-8 scores were 0.6 points lower (95% CI,-1.5 to 0.3; p=0.18) and SPPB scores were 0.6 points higher (95% CI, 0.1 to 1.1; p=0.02), indicating better function in the intervention group compared to the control group.
This study shows that a combined provider- and patient-based intervention can improve multiple patient-centered outcomes for veterans with lower extremity OA. This intervention is low-cost and feasible to disseminate widely in the VA, and could therefore have an important impact for many veterans, as well as the VA healthcare system.
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- Allen KD, Bosworth HB, Brock DS, Chapman JG, Chatterjee R, Coffman CJ, Datta SK, Dolor RJ, Jeffreys AS, Juntilla KA, Kruszewski J, Marbrey LE, McDuffie J, Oddone EZ, Sperber N, Sochacki MP, Stanwyck C, Strauss JL, Yancy WS. Patient and provider interventions for managing osteoarthritis in primary care: protocols for two randomized controlled trials. BMC musculoskeletal disorders. 2012 Apr 24; 13(1):60.
- Taylor SS, Allen KD, Oddone EZ, Coffman CJ, Jeffreys AL. Cognitive mediators of change in physical functioning in response to a combined patient and provider intervention for managing osteoarthritis. Poster session presented at: VA Durham VAMC Annual Research Week; 2016 May 26; Durham, NC.
- Taylor SS, Allen KD, Oddone EZ, Coffman CJ, Jeffreys AL. Cognitive Mediators of Change in Physical Functioning in Response to a Combined Patient and Provider Intervention for Managing Osteoarthritis. Poster session presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2016 Apr 2; Washington, DC.
- Allen KD, Bosworth HB, Ike T, Jeffreys AL, Coffman CJ, Datta SK, McDuffie J, Oddone EZ, Strauss JL, Yancy WS. Randomized Clinical Trial of a Patient and Provider Intervention for Managing Osteoarthritis in Veterans. Poster session presented at: VA HSR&D / QUERI National Meeting; 2015 Jul 9; Philadelphia, PA.
- Allen KD, Bosworth HB, Chatterjee R, Coffman CJ, Corsino L, Jeffreys AL, Negbenebor N, Oddone EZ, Yancy WS. Prevalence and Predictors of Non-Surgical Osteoarthritis Treatment Among Patients in Primary Care Clinics. Poster session presented at: Osteoarthritis Research Society International World Congress on Osteoarthritis; 2015 Apr 30; Seattle, WA.
- Zullig LL, Bosworth HB, Jeffreys AL, Corsino L, Coffman CJ, Oddone EZ, Yancy WS, Allen KD. The Association of Comorbid Conditions with Patient Reported Outcomes among Patients with Osteoarthritis. Poster session presented at: VA Durham VAMC Annual Research Week; 2014 May 15; Durham, NC.
- Zullig LL, Bosworth HB, Jeffreys AL, Corsino F, Coffman C, Oddone EZ, Yancy WS, Allen KD. The Association of Comorbid Conditions with Patient Reported Outcomes Among Patients with Osteoarthritis. Poster session presented at: Osteoarthritis Research Society International World Congress on Osteoarthritis; 2014 Apr 18; Paris, France.
- Allen KD, Bosworth HB, Coffman CJ, Jeffreys AL, Oddone EZ, Yancy WS, Ulmer CS. Patient Characteristics Associated With Insomnia and Sleep Apnea in Knee and Hip OA. Presented at: Association of Rheumatology Health Professionals Annual Meeting; 2013 Oct 25; San Diego, CA.
- Goode A, Bosworth HB, Coffman CJ, Jeffreys AL, Oddone EZ, Yancy WS, Allen KD. Association of Back Pain with Functional Limitations in Patients with Knee and Hip Osteoarthritis. Presented at: American College of Rheumatology Annual Scientific Meeting; 2013 Oct 25; San Diego, CA.
- Allen KD. Associations of Frequent Predictable and Unpredictable Pain with Functional and Psychological Outcomes. Poster session presented at: VA Durham VAMC Annual Research Week; 2013 May 15; Durham, NC.
- Allen KD, Bosworth HB, Coffman CJ, Jeffreys AL, Oddone EZ, Yancy WS. Association of frequent predictable and unpredictable pain with functional and psychological outcomes. Paper presented at: Osteoarthritis Research Society International World Congress; 2013 Apr 18; Philadelphia, PA.
- Allen KD, Bosworth HB, Coffman CJ, Jeffreys AL, Oddone EZ, Yancy WS. Predictors of fatigue in patients with hip and knee osteoarthritis. Poster session presented at: Osteoarthritis Research Society International World Congress; 2013 Apr 18; Philadelphia, PA.
- Allen KD, Bosworth HB, Coffman CJ, Lindquist JH, Sperber N, Weinberger M, Oddone EZ. Effects of a Telephone Based OA Self-Management Program on Communication with Health Care Providers. Paper presented at: Association of Rheumatology Health Professionals Annual Meeting; 2012 Nov 14; Washington, DC.
Health Systems, Musculoskeletal Disorders
Treatment - Efficacy/Effectiveness Clinical Trial