Clinical trial NCT03562793: Communication and Activation in Pain to Enhance Relationships and Treat Pain With Equity
Official title: Communication and Activation in Pain to Enhance Relationships and Treat Pain With Equity (COOPERATE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: pain
healthcare disparities
communication
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-06-19
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with behavioral intervention.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Black or African American Veteran
* 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

Primary outcomes:
measure: Patient Activation
timeFrame: 3 months
measure: Patient Activation
timeFrame: 6 months
measure: Patient Activation
timeFrame: Baseline
measure: Patient Activation
timeFrame: 9 months
Secondary outcomes:
measure: Communication Self-Efficacy (Perceived Efficacy in Patient-Physician Interactions--PEPPI)
timeFrame: 3 months
measure: Pain Intensity and Interference (Brief Pain Inventory)
timeFrame: 3 months
measure: Depression (PHQ8)
timeFrame: 3 months
measure: Anxiety
timeFrame: 3 months
measure: Pain Coping
timeFrame: Change from baseline to 3 months
measure: Communication Self-Efficacy (Perceived Efficacy in Patient-Physician Interactions--PEPPI)
timeFrame: Baseline
measure: Communication Self-Efficacy (Perceived Efficacy in Patient-Physician Interactions--PEPPI)
timeFrame: 6 months
measure: Communication Self-Efficacy (Perceived Efficacy in Patient-Physician Interactions--PEPPI)
timeFrame: 9 months
measure: Pain Intensity and Interference (Brief Pain Inventory)
timeFrame: Baseline
measure: Pain Intensity and Interference (Brief Pain Inventory)
timeFrame: 6 months
measure: Pain Intensity and Interference (Brief Pain Inventory)
timeFrame: 9 months
measure: Depression (PHQ8)
timeFrame: Baseline
measure: Depression (PHQ8)
timeFrame: 6 months
measure: Depression (PHQ8)
timeFrame: 9 months
measure: Anxiety
timeFrame: Baseline
measure: Anxiety
timeFrame: 6 months
measure: Anxiety
timeFrame: 9 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Richard L. Roudebush VA Medical Center, Indianapolis, IN
state: Indiana
Study officials:
affiliation: Richard L. Roudebush VA Medical Center, Indianapolis, IN
name: Marianne Sassi Matthias, PhD MS BA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matthias MS, Hirsh AT, Ofner S, Daggy J. Exploring the Relationships Among Social Support, Patient Activation, and Pain-Related Outcomes. Pain Med. 2022 Apr 8;23(4):676-685. doi: 10.1093/pm/pnab306.
citation: Matthias MS, Adams J, Burgess DJ, Daggy J, Eliacin J, Flores P, Hirsh AT, Myers LJ, Perkins AJ, Menen T, Procento P, Rand KL, Salyers MP, Shanahan ML, Bair MJ. Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity (COOPERATE): Rationale, study design, methods, and sample characteristics. Contemp Clin Trials. 2022 Jul;118:106790. doi: 10.1016/j.cct.2022.106790. Epub 2022 May 12.
citation: Matthias MS, Adams J, Burgess D, Daggy J, Eliacin J, Flores P, Hirsh AT, Myers LJ, Perkins AJ, Menen T, Philip Procento, Rand KL, Salyers MP, Shanahan ML, Bair MJ. Corrigendum to: Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity (COOPERATE): Rationale, study design, methods, and sample characteristics (Contemporary Clinical Trials, volume 118, article number 106790). Contemp Clin Trials. 2022 Sep;120:106883. doi: 10.1016/j.cct.2022.106883. Epub 2022 Aug 20. No abstract available.
citation: Matthias MS, Adams J, Burgess DJ, Daggy J, Gowan TM, Perkins AJ, Eliacin J. Effects of the COVID-19 Pandemic on Black Veterans' Mental Health: A Qualitative Investigation. J Health Care Poor Underserved. 2022;33(3):1275-1290. doi: 10.1353/hpu.2022.0112.
citation: Matthias MS, Burgess DJ, Eliacin J. Healthcare Access and Delivery During the COVID-19 Pandemic for Black Veterans with Chronic Pain: a Qualitative Study. J Gen Intern Med. 2023 Mar;38(4):1024-1029. doi: 10.1007/s11606-022-07884-9. Epub 2022 Nov 14.