Communication and Activation in Pain to Enhance Relationships and Treat Pain With Equity



Status:Recruiting
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:3/22/2019
Start Date:October 1, 2018
End Date:June 30, 2022
Contact:Michael Weiner, MD MPH
Email:Michael.Weiner4@va.gov
Phone:(317) 988-2952

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Communication and Activation in Pain to Enhance Relationships and Treat Pain With Equity (COOPERATE)

Chronic pain affects approximately 100 million Americans and 40-70% of Veterans, and amounts
to over $600 billion/year in direct medical costs and lost worker productivity. Racial
disparities in pain care are well-documented, within and outside VA. Minorities are more
likely to be undertreated for pain, are subjected to more urine drug tests, and are referred
for substance abuse evaluation more frequently than Whites. Minority patients also exhibit
lower levels of engagement and active involvement in their healthcare, which leads to poorer
communication with providers and poorer outcomes. COOPERATE is a randomized controlled trial
testing an intervention to improve minority Veterans' active participation in their pain care
by focusing on 2 essential skill sets: 1) goal-setting and prioritization, and 2)
communication skills.

Background: 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.

Objectives: COOPERATE (Communication and Activation in Pain to Enhance Relationships and
Treat Pain with Equity) is a pragmatic randomized controlled trial of an intervention to
improve patient activation and communication with providers for minority Veterans with
chronic pain. COOPERATE focuses on 2 essential skill sets necessary to facilitate effective
patient activation: 1) goal-setting and prioritization, and 2) communication skills.
COOPERATE is delivered over the telephone in 6 sessions (4 weekly sessions followed by 2
booster session) over a period of 12 weeks. The primary study outcome is patient activation.

Methods: COOPERATE is a Hybrid Type 1 study, designed to test effectiveness while also
examining implementation facilitators and barriers. COOPERATE will enroll 250 minority
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 the
investigators 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. In Aim 2, the
pre-implementation aim, the investigators will use qualitative methods to understand
facilitators and barriers to implementing COOPERATE. Guided by the RE-AIM framework, the
investigators 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. Aim 3 is an exploratory aim to determine the effects of COOPERATE on
important relational indicators of high-quality care: working alliance (with providers), and
perceived discrimination in healthcare.

Innovation: 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.

Inclusion Criteria:

- Black or African American

- Have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee,
shoulder) for 3 months

Exclusion Criteria:

Patients will be excluded if electronic medical records indicate:

- a psychotic disorder diagnosis

- current substance use disorder

- severe medical conditions precluding participation (e.g., NY Heart Association Class
III or IV heart failure), or if the eligibility
We found this trial at
1
site
Indianapolis, Indiana 46202
Principal Investigator: Marianne Sassi Matthias, PhD MS BA
Phone: (317) 988-4789
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mi
from
Indianapolis, IN
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