Cooperative Pain Education and Self-management
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study will test the effectiveness of using enhanced facilitation strategies on
      implementation of an automated Interactive Voice Response (IVR) system as a means to remotely
      deliver in-home self-management support to Veterans with chronic pain. The implementation
      intervention uses an enhanced facilitation approach paired with automated case finding and
      direct patient outreach to encourage uptake of Cooperative Pain Education and Self-management
      (COPES). A nested effectiveness study will measure pre-post differences in pain-relevant
      outcomes (pain intensity, physical functioning and physical activity). The investigators will
      use a stepped wedge cluster design in which clusters will be randomized to the timing of the
      introduction of enhanced COPES implementation. Investigators will assess the efficacy of the
      facilitation based implementation strategy by evaluating COPES uptake in the implementation
      settings.
    

Detailed description: 
      Cognitive behavioral therapy (CBT) for chronic pain is a commonly used evidence-based
      self-management intervention. Though effective, CBT requires that patients attend multiple
      in-person visits and that highly trained staff be available to provide care. For these
      reasons CBT is resource intensive, often inaccessible to Veterans, and delivered unevenly
      across patients and facilities. In a Veterans Health Administration Office of Health Services
      Research and Development (HSR&D) IIR-funded trial, investigators found that CBT delivered
      primarily via an automated Interactive Voice Response (IVR) system (Cooperative Pain
      Education and Self-management or COPES) leads to patient-centered outcomes that are
      comparable to standard United States Department of Veterans Affairs (VA) approaches in which
      CBT is delivered in-person by a therapist over ten weekly sessions. In this study,
      implementation facilitation will be guided by the Consolidated Framework for Implementation
      Research (CFIR) which provides a set of constructs to identify potential barriers and
      facilitators to implementation. The primary objective of this project is to evaluate the
      effectiveness of the facilitation approach paired with automated case finding and direct
      patient outreach on uptake of COPES in the clinical care setting. Study investigators will
      specifically target Veterans who receive care at community-based outpatient clinics (CBOCs)
      because these sites typically have few or no therapists trained in CBT for chronic pain.

      Description of COPES: COPES is a 10-week, IVR-facilitated program of CBT for chronic pain.
      The primary components of COPES include: 1) a self-help handbook to teach Veterans pain
      self-management skills and describe the weekly skill practice goals, 2) a
      pedometer-facilitated progressive walking program (all COPES patients will be given an Omron
      Go Smart, Model HJ-112 pocket pedometer at the time of enrollment), and 3) daily, automated
      IVR calls to collect patient-reported pain intensity and pain-related interference, sleep
      quality, pedometer-measured step count, and adherence to the pain coping skill practice
      ratings. Participants will also receive a weekly, two to four minute pre-recorded,
      personalized therapist message via the IVR system based on the participant's IVR-recorded
      data. Therapists provide feedback on the participant's weekly average pain intensity, sleep,
      steps, and pain coping skill practice, note any changes from the prior week, and comment on
      symptom or activity patterns. Therapists also provide reinforcement for goal accomplishment,
      help patients make connections among pain, pain coping skill practice, and goal
      accomplishment, and assign a steps and skill practice goal for the upcoming week.

      Research Design: Study investigators will test the effectiveness of the facilitation approach
      to implement COPES as a means to remotely deliver in-home self-management support to Veterans
      with chronic pain. To evaluate the implementation's success, study investigators will conduct
      a multi-site, stepped wedge, Hybrid III trial in 17 CBOCs affiliated with three
      geographically dispersed sites (VA Boston, VA Palo Alto, and Roudebush VA in Indianapolis).
      Clusters (k=17 CBOCs) will be randomized to 6 different time periods proportional to
      approximate eligible patient population size. Each CBOC will serve as its own control for a
      period of time before "transitioning" into enhanced facilitation; the time of this transition
      is randomized in a stepped fashion. The primary outcome for evaluating implementation success
      will be patient enrollment in COPES. The secondary outcome will be provider referral. Other
      outcomes that will be investigated as part of the nested COPES effectiveness study will be
      Veterans' physical functioning, pain intensity, and physical activity.

      Methodology: Study investigators will evaluate the success of the implementation strategy by
      evaluating the proportion of patients who are offered enrollment in COPES who actually
      enroll. Additionally, study investigators will conduct a formative evaluation to inform,
      refine and evaluate implementation of COPES. The evaluation will include interviews with VA
      staff and patients with chronic back pain at the proposed implementation sites. Interview
      guides will be based on CFIR model constructs using questions adapted from the CFIR interview
      guide. Investigators will also measure pre-post differences in pain-relevant outcomes (pain
      intensity, physical functioning and physical activity).
    

Intervention name(s): Enhanced facilitation of COPES
Intervention type(s): Behavioral
Intervention description(s): Enhanced facilitation of COPES implementation consists of promotional meetings, automated case finding and proactive outreach to recruit patients, marketing and educational materials, local champion, and academic detailing.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: low back pain, chronic pain, cognitive behavior therapy