NCT01983228

A Proactive Walking Trial to Reduce Pain in Black Veterans

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The long term goal is to improve the quality and equity of chronic pain treatment among VA patients. The primary objective of this study is to improve pain outcomes among black VA patients with chronic, musculoskeletal (MSK) pain, who experience poorer pain treatment and outcomes than their white counterparts. The work proposed is expected to result in a non-pharmacological intervention, delivered by telephone, designed to reduce pain and improve functioning among black patients with MSK pain, by promoting walking. This intervention is specifically designed to address factors that contribute to MSK pain among black Veterans; however, the investigators expect that it will also benefit non-black Veterans. The proposed research is innovative, in its use of proactive outreach and recent advances in self-regulation strategies (such as Action Planning) to help black Veterans overcome psychological, environmental, utilization-related, and provider-related barriers that contribute to pain.

Detailed description

BACKGROUND/RATIONALE: Chronic musculoskeletal (MSK) pain is one of the most common conditions among Veterans, affecting approximately 60% of those seen in VA primary care. Although perceived effectiveness of chronic pain treatment is low among all VA patients, black patients are less likely than whites to perceive their treatment as effective, and are more likely to experience functional limitations due to pain. There is growing consensus that chronic pain is best addressed by a biopsychosocial approach that acknowledges the role of psychological and environmental contributors to pain, some of which differ by race and hence contribute to disparities. For example, blacks experience greater pain-related fear and lower self-efficacy in coping with pain (psychological contributors), and neighborhoods that make physical activity difficult (environmental contributors). However, there is a lack of effective interventions to improve pain treatment among minority patients, particularly those that target psychological and environmental contributors. OBJECTIVES: The long term goal is to improve the quality and equity of pain treatment in order to improve pain outcomes for all Veterans. The objective of this application is to test the effectiveness of a multi-component intervention that specifically targets known barriers to effective pain care among black Veterans with chronic MSK pain. The primary hypothesis is that a telephone-delivered intervention, which emphasizes walking and incorporates Action Planning, Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT) techniques, and the use of pedometers, will improve core chronic pain outcomes in black Veterans. Secondarily, we will determine whether our intervention also benefits non-black patients with MSK. METHODS: The investigators propose a randomized trial to test the effectiveness of the intervention compared with usual care (UC) among 500 patients with chronic MSK pain, with a minimum of 250 Black participants. Patients from the Atlanta VAMC will be identified using administrative data. Patients will be screened by phone, and, if eligible, will be mailed the baseline survey to complete and mail back. Eligible patients who complete the baseline survey will be randomly assigned to the usual care (UC) or intervention condition (IC). Intervention participants will receive a pedometer-mediated walking intervention that will incorporate Action Planning and the use of MI and CBT techniques. The intervention will be delivered in 6 telephone counseling sessions over three months. Patients in the UC condition will receive an informational brochure and a pedometer. The study is powered to find a difference between the IC and UC groups within the black and non-black groups. The primary outcome is chronic pain-related physical functioning, assessed by the revised Roland and Morris Disability Questionnaire, a measure recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). We will also examine whether the intervention improves other IMMPACT-recommended domains (pain intensity, emotional functioning, and ratings of overall improvement). Secondary objectives include examining potential mediators targeted by the intervention, exploring whether the intervention affects service utilization and use of opioid analgesics, and exploring whether the intervention reduces racial disparities in pain outcomes. Measures will be assessed by mail and phone survey at baseline, 3 months, and 6 months. Data analysis of primary aims will follow intent-to-treat methodology. FINDINGS: None at this time. STATUS: Focus groups were conducted at the Atlanta VAMC in September and October 2015. These focus groups provided valuable information that led us to refine our recruitment materials. Focus groups also yielded important information for our counselors, including potential communication barriers and barriers to walking. During January - April 2016, we conducted a pilot test of our intervention with 3 participants. We began the trial on July 2016. Recruitment and randomization were completed in June 2019. The intervention activities were completed in September 2019. Follow-up survey data collection is currently ongoing. IMPACT: The work proposed is expected to result in a non-pharmacological intervention, delivered by telephone, designed to reduce pain and improve functioning among black patients with MSK pain, by promoting walking.

Conditions

• Musculoskeletal Pain

Interventions

Type	Name	Description
BEHAVIORAL	Intervention Condition	Intervention participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study.

Timeline

• Start date: 2016-07-01
• Primary completion: 2020-02-27
• Completion: 2020-02-27
• First posted: 2013-11-13
• Last updated: 2023-07-27
• Results posted: 2021-06-09

Locations

1 site across 1 country: United States