Patient and Provider Interventions for Managing Osteoarthritis in Primary Care

• ClinicalTrials.gov Identifier: NCT01130740
• Recruitment Status: Completed
• First Posted: May 26, 2010
• Results First Posted: January 26, 2015
• Last Update Posted: April 28, 2015
• Sponsor: US Department of Veterans Affairs
• Information provided by (Responsible Party): VA Office of Research and Development ( US Department of Veterans Affairs )

Study Description

Brief Summary:

Osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of disability among veterans. Many veterans with OA have significant pain and functional limitations, even though they receive some medical care for their OA. Efforts are needed to help veterans to improve OA-related outcomes. This study will examine a comprehensive approach to helping veterans manage their OA-related symptoms, in the context of a VA clinical setting. The study examines an intervention aimed at helping veterans with behaviors that are known to improve OA-related pain and function (such as exercise, weight management, and coping with pain), as well as helping providers to implement evidence-based recommendations for clinical care. The intervention is relatively low cost and easy to disseminate, with the patient component being telephone based. Therefore, if effective, this intervention could be implemented widely across the VA healthcare system.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis	Behavioral: Osteoarthritis Intervention	Not Applicable

Detailed Description:

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. The objective of this study is examine 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 will be the first study to intervene at a both the patient and provider levels for managing OA.

This will be 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 will randomize 30 primary care providers at the Durham VAMC and affiliated community based outpatient clinics to either intervention or control groups. We will then enroll 10 patients from each provider (5 White, 5 Non-White). The patient component of the intervention will be a twelve-month program that includes the following elements: written educational materials (focused on exercise, weight management, and cognitive behavioral pain management), an exercise video tailored for patients with lower extremity OA, and telephone calls by a counselor to support behavior change. The provider component of the intervention will involve giving information on patients' OA symptoms and treatment, as well as patient-specific evidence-based recommendations for care. Providers will have access to this information, as well as facilitated referrals for patient-specific treatment recommendations (e.g. physical therapy, orthopedics), at the point of clinical care, via electronic medical records. The primary time point for outcome assessment will be at 12-months. We will also assess a limited set of outcomes via telephone at 6-months. The primary outcome will be the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC). Secondary outcomes will include objective physical function (Short Physical Performance Test) and depressive symptoms (PHQ-8). The main study analyses will compare outcomes between the intervention and control groups. We will also assess the cost-effectiveness of the intervention.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Health Services Research
• Official Title: Patient and Provider Interventions for Managing Osteoarthritis in Primary Care
• Study Start Date: August 2011
• Actual Primary Completion Date: December 2013
• Actual Study Completion Date: January 2014

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Arm 1; usual care
Experimental: Arm 2; Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.	Behavioral: Osteoarthritis Intervention; Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.

Outcome Measures

Primary Outcome Measures :

1. Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) [ Time Frame: 12-months ]
   Self-report measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items) in the past two weeks. All items are rated on a 5-point Likert scale ranging from "none" (0) to "severe / extreme" (4), for a total of range of 0-96. Higher scores indicate worse symptoms and poorer function. The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section.

Secondary Outcome Measures :

1. Short Physical Performance Test Protocol [ Time Frame: 12-months ]

   This is a series of 5 tests covering the domains of balance (3 tests), gait speed (8 foot walk) and time to rise from a chair and return to the seated position five times. The total score ranges from 0 (worst performance) to 12 (best performance).

   The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section.

2. PHQ-8 [ Time Frame: 12-months ]
   This is an 8-item self-report scale, all items are rated on a score of 0-3, for a total range of 0-24. Higher scores indicate more depressive symptoms. The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section.

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• radiographic evidence of hip OA and / or radiographic of or meets clinical criteria for knee OA
• current joint symptoms
• BMI >=25
• physically inactive

Exclusion Criteria:

• Diagnosis of rheumatoid arthritis, fibromyalgia, or other systemic rheumatic disease
• Hospitalized for a stroke, myocardial infarction or coronary artery revascularization in the past 3 months
• Active diagnosis of psychosis or serious personality disorder
• On waiting list for / planning arthroplasty
• Severely impaired hearing or speech (patients must be able to respond to phone calls)
• Unable to speak English
• No access to a telephone
• Participating in another OA intervention or other lifestyle change study
• Dementia or other memory loss condition
• Current, uncontrolled substance abuse disorder
• Motor neuron diseases, Parkinson's Disease, multiple sclerosis
• Quadriplegic or paraplegic
• Serious / terminal illness as indicated by referral to hospice or palliative care
• Other self-reported health problem that would prohibit participation in the study
• Nursing home resident
• Other health conditions or personal issues judged by a study team member or primary care physician to make the patient inappropriate for the study
• Female participants: pregnant or planning to become pregnant
• Metastatic Cancer
• History of gout in knee or hip
• Total joint replacement (knee or hip) surgery, other knee or hip surgery, meniscus tear (verified by MRI), or ACL tear in the past 6 months
• Have not seen their VA-assigned primary health care provider for more than a year

Contacts and Locations

Locations

United States, North Carolina

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States, 27705

Sponsors and Collaborators

US Department of Veterans Affairs

Investigators

• Principal Investigator: Kelli Dominick Allen, PhD; Durham VA Medical Center, Durham, NC

More Information

Publications of Results:

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 Jr. Patient and provider interventions for managing osteoarthritis in primary care: protocols for two randomized controlled trials. BMC Musculoskelet Disord. 2012 Apr 24;13:60. doi: 10.1186/1471-2474-13-60.

Sperber N, Hall KS, Allen K, DeVellis BM, Lewis M, Callahan LF. The role of symptoms and self-efficacy in predicting physical activity change among older adults with arthritis. J Phys Act Health. 2014 Mar;11(3):528-35. doi: 10.1123/jpah.2012-0030. Epub 2013 Feb 8.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Taylor SS, Hughes JM, Coffman CJ, Jeffreys AS, Ulmer CS, Oddone EZ, Bosworth HB, Yancy WS Jr, Allen KD. Prevalence of and characteristics associated with insomnia and obstructive sleep apnea among veterans with knee and hip osteoarthritis. BMC Musculoskelet Disord. 2018 Mar 9;19(1):79. doi: 10.1186/s12891-018-1993-y.

Allen KD, Yancy WS Jr, Bosworth HB, Coffman CJ, Jeffreys AS, Datta SK, McDuffie J, Strauss JL, Oddone EZ. A Combined Patient and Provider Intervention for Management of Osteoarthritis in Veterans: A Randomized Clinical Trial. Ann Intern Med. 2016 Jan 19;164(2):73-83. doi: 10.7326/M15-0378. Epub 2015 Dec 22.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT01130740
• Other Study ID Numbers: IIR 10-126
• First Posted: May 26, 2010
• Results First Posted: January 26, 2015
• Last Update Posted: April 28, 2015
• Last Verified: September 2014

Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):

Osteoarthritis; Exercise; Diet; Coping Skills; Education, Medical

Additional relevant MeSH terms:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases