A Proactive Walking Trial to Reduce Pain in Black Veterans
Condition: Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain
Study type: Interventional

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.
    

Intervention name(s): Intervention Condition
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Musculoskeletal Pain; Walking; African American; Telephone Coaching; Pedometer