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

NCT03562793 | Completed Results

• 2 other identifiers: IIR 17-0321712397218
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

pain; healthcare disparities; communication

Outcome Measures

Primary Outcomes (4)

• Patient Activation

  Patient Activation Measure (PAM). Construct: self-management self-efficacy (i.e., patient activation). 13-item patient activation measure assesses patient knowledge, skill, and confidence for self-management. Range 0 (lowest activation) - 100 (highest activation). Higher values are better outcomes.

  3 months

• Patient Activation

  Patient Activation Measure (PAM). Construct: self-management self-efficacy (i.e., patient activation). 13-item patient activation measure assesses patient knowledge, skill, and confidence for self-management. Range 0 (lowest activation) - 100 (highest activation). Higher values are better outcomes.

  6 months

• Patient Activation

  Patient Activation Measure (PAM). Construct: self-management self-efficacy (i.e., patient activation). 13-item patient activation measure assesses patient knowledge, skill, and confidence for self-management. Range 0 (lowest activation) - 100 (highest activation). Higher values are better outcomes.

  Baseline

• Patient Activation

  Patient Activation Measure (PAM). Construct: self-management self-efficacy (i.e., patient activation). 13-item patient activation measure assesses patient knowledge, skill, and confidence for self-management. Range 0 (lowest activation) - 100 (highest activation). Higher values are better outcomes.

  9 months

Secondary Outcomes (17)

• Communication Self-Efficacy (Perceived Efficacy in Patient-Physician Interactions--PEPPI)

  3 months

• Pain Intensity and Interference (Brief Pain Inventory)

  3 months

• Depression (PHQ8)

  3 months

• Anxiety

  3 months

• Pain Coping

  Change from baseline to 3 months

Study Arms (2)

COOPERATE Intervention Arm

EXPERIMENTAL

Intervention patients will focus on 1) goal clarification/prioritization; 2) communication skills. There are 6 total sessions delivered individually over 12 weeks: 4 sessions teaching skills (30 min each) and 2 booster sessions delivered once/month for the next 2 months. Intervention will be delivered by telephone.

Behavioral: Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity (COOPERATE)

Attention Control Arm

NO INTERVENTION

Veterans randomized to the control group will receive phone calls on the same schedule as intervention Veterans. During these phone calls, study staff will ask Veterans a series of questions about their pain, self-management activities, and any changes they have experienced since the last call. These phone calls are designed to control for attention only, and Veterans will not be offered specific information or advice about their pain or its management (with the exception of suggesting a doctor visit if warranted).

Interventions

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

. COOPERATE seeks to improve patient activation in minority Veterans with chronic pain by focusing on two major skill sets: 1) goal clarification and prioritization, and 2) communication skills (Table 1). By understanding, clarifying, and prioritizing goals, and having the skills to communicate their goals, priorities, and preferences to providers, Veterans will gain knowledge, confidence, and skills to be actively involved in managing their chronic pain. The intervention consists of 6 total sessions delivered individually over 12 weeks: 4 sessions focused on teaching skills related to goal clarification/prioritization and communication (30-minutes each), delivered weekly for the first 4 weeks, plus 2 booster sessions (20-25 minutes each) delivered once per month for the next 2 months.

Also known as: COOPERATE

COOPERATE Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Black or African American Veteran
• Have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, shoulder) for 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

Related Publications (6)

• 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.

  PMID: 34718764 RESULT

• 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.

  PMID: 35568376 RESULT

• 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.

  PMID: 35999166 RESULT

• 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.

  PMID: 36245163 RESULT

• 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.

  PMID: 36376625 RESULT

• Matthias MS, Daggy JK, Perkins AJ, Adams J, Bair MJ, Burgess DJ, Eliacin J, Flores P, Myers LJ, Menen T, Procento P, Rand KL, Salyers MP, Shanahan ML, Hirsh AT. Communication and activation in pain to enhance relationships and treat pain with equity (COOPERATE): a randomized clinical trial. Pain. 2024 Feb 1;165(2):365-375. doi: 10.1097/j.pain.0000000000003021. Epub 2023 Sep 21.

  PMID: 37733487 DERIVED

MeSH Terms

Conditions

Pain; Communication

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Dr. Marianne Matthias
• Organization: Richard L. Roudebush VA Medical Center

Marianne.Matthias@va.gov

317-988-4514

Study Officials

• Marianne Sassi Matthias, PhD MS BA

  Richard L. Roudebush VA Medical Center, Indianapolis, IN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blinded to treatment assignment when administering baseline outcome assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with behavioral intervention.

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: June 19, 2018
• Study Start: October 1, 2018
• Primary Completion: May 31, 2022
• Study Completion: September 30, 2022
• Last Updated: December 19, 2023
• Results First Posted: December 19, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)