Patient and Provider Interventions for Managing Osteoarthritis in Primary Care

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01130740
First received: May 24, 2010
Last updated: May 1, 2014
Last verified: April 2014
  Purpose

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 Intervention
Osteoarthritis
Behavioral: Osteoarthritis Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: Patient and Provider Interventions for Managing Osteoarthritis in Primary Care

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) [ Time Frame: 12-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Short Physical Performance Test Protocol [ Time Frame: 12-months ] [ Designated as safety issue: No ]
  • PHQ-8 [ Time Frame: 12-months ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: August 2011
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01130740

Locations
United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Investigators
Principal Investigator: Kelli Dominick Allen, PhD Durham VA Medical Center, Durham, NC
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01130740     History of Changes
Other Study ID Numbers: IIR 10-126
Study First Received: May 24, 2010
Last Updated: May 1, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Osteoarthritis
Exercise
Diet
Coping Skills
Education, Medical

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 24, 2014