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IIR 17-032 – HSR&D Study

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IIR 17-032
Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity (COOPERATE)
Marianne Sassi Matthias PhD MS BA
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, IN
Funding Period: July 2018 - June 2022

BACKGROUND/RATIONALE:
Chronic pain affects 40-70% of Veterans and amounts to over $600 billion/year in direct medical costs and lost worker productivity. Racial disparities in pain treatment have been extensively documented. Minority patients, including Veterans, are more likely to be undertreated for pain. Minority Veterans have pain documented less frequently, undergo more urine drug tests, and are more likely to be referred for substance abuse evaluation than White Veterans. Compounding these pain care disparities, minority Veterans exhibit lower levels of patient activation than Whites. Patient activation-having knowledge, confidence, and skills to manage health-is associated with better health experiences, self-management, and outcomes. Low activation is frequently manifested in poorer communication among minority patients. Minority patients are less likely to share their concerns with providers, ask questions, and prepare for their clinic visits. This poor communication is associated with lower quality care, poorer patient-provider relationships, and treatment non-adherence. The poorer communication experienced by minorities is exacerbated by the documented difficulties in patient-provider communication about chronic pain and its treatment-particularly where opioids are concerned.

OBJECTIVE(S):
We will recruit Black Veterans with chronic pain and compare a 6-session telephone-delivered patient activation and communication intervention with an attention control. We have the following specific aims:

Aim 1: (primary aim). Test the effects of COOPERATE on key Veteran outcomes. We hypothesize that at 3 months (primary end point), 6 months, and 9 months (sustained effects) from baseline, Black Veterans randomized to the COOPERATE intervention will report greater:
a)increases in patient activation (primary outcome),
b)increases in communication self-efficacy,
c)improvements in pain intensity and interference,
d)improvements in psychological functioning.

Aim 2: Examine mediating and moderating effects in COOPERATE. We hypothesize that
a)patient activation will mediate the effect of COOPERATE on clinical outcomes (pain and psychological functioning), and
b)working alliance will moderate the effect of COOPERATE on patient activation.

Aim 3: (pre-implementation aim). Understand facilitators and barriers to implementing COOPERATE. Using the RE-AIM framework, we will conduct qualitative interviews with a purposefully selected subsample of intervention Veterans and with clinicians to better prepare for implementing COOPERATE.

METHODS:
COOPERATE is a Hybrid Type 1 study, designed to test effectiveness while also examining implementation facilitators and barriers. COOPERATE will enroll 250 Black Veterans with chronic musculoskeletal pain from primary care clinics. Veterans will be randomized either to the COOPERATE intervention or to an attention control arm. For Aim 1 we will test the effects of COOPERATE at 3 (primary end point), 6, and 9 months (sustained effects) on patient activation (primary outcome), communication self-efficacy, pain intensity and interference, and psychological functioning. Aim 2 will examine patient activation as a mediator of clinical outcomes, and working alliance as a moderator of COOPERATE's effect on patient activation. In Aim 3, our pre-implementation aim, we will use qualitative methods to understand facilitators and barriers to implementing COOPERATE. Guided by the RE-AIM framework, we will interview a purposefully selected subsample of intervention Veterans, and clinicians from primary care and the chronic pain clinic, to better prepare for COOPERATE's implementation.

FINDINGS/RESULTS:
There are no findings yet.

IMPACT:
Healthcare disparities are well documented, especially in pain care. COOPERATE focuses on two important, yet frequently neglected, areas for improvement in minority health: patient activation and communication. This is especially important in chronic pain care, since numerous treatment options with a wide range of risks and benefits exist, and since minorities are offered fewer of these pain treatment options. Helping minority Veterans to become more active in their care is critical for improving chronic pain care. This is especially important in light of VA efforts such as the Opioid Safety Initiative, designed to improve safety for Veterans, but which also require engaged, active patients as Veterans must explore alternative pain treatments with their providers-treatments that are feasible for Veterans' individual lifestyles and consistent with their symptom priorities and treatment goals.

PUBLICATIONS:
None at this time.


DRA: Musculoskeletal Disorders
DRE: TRL - Applied/Translational, Treatment - Efficacy/Effectiveness Clinical Trial, Treatment - Implementation
Keywords: Ethnicity/Race, Pain, Patient-Provider Interaction
MeSH Terms: none