Cooperative Pain Education and Self-management

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).

Inclusion Criteria:

Veterans COPES:

1. Back-pain-related International Classification of Diseases (ICD)-9 diagnosis

2. Pain intensity rating of ≥4 (indicating moderate pain) on the 0-10 Numerical Rating
Scale on at least two separate outpatient encounters at a CBOC in the prior year

3. CBOC patient at VA Boston, VA Palo Alto or Roudebush VA

Veterans Interviews:

1. Those who are eligible for COPES, but who have not been asked to enroll
(pre-implementation period)

2. Those who participate in COPES (post-implementation)

3. Those who decline enrollment in COPES (post-implementation)

4. CBOC patients at VA Boston, VA Palo Alto or Roudebush VA

Admin, Champion, Provider Interviews:

1. Employed at the project implementation sites

Exclusion Criteria:

Veterans (COPES & Interviews):

1. Diagnosis of cancer, dementia, schizophrenia, and active alcohol or substance abuse

2. Psychiatric hospitalization in the past 30 days

3. Patients who are designated as fall risks and/or have active diabetic foot ulcers

Admin, Champion, Provider Interviews:

1. Not employed at the project implementation sites