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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Behavioral: Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity (COOPERATE)

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.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202-2884
      • Richard L. Roudebush VA Medical Center, Indianapolis, IN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COOPERATE Intervention Arm; 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); . 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.; Other Names: COOPERATE
No Intervention: Attention Control Arm; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Coping	Coping Strategies Questionnaire. Construct: Pain coping. A 14-item measure of pain coping strategies. Range 0-84. Lower scores are better outcomes.	Change from baseline to 3 months
Communication Self-Efficacy (Perceived Efficacy in Patient-Physician Interactions--PEPPI)	Perceived Efficacy in Patient-Physician Interactions (PEPPI-5). Construct: patients' self-efficacy in obtaining medical info and getting most important concerns discussed with their doctors. Range 0 (lowest) - 50 (highest). Higher values are better outcomes.	3 months
Pain Intensity and Interference (Brief Pain Inventory)	Brief Pain Inventory (BPI). Construct: Pain Intensity and Interference. 11-item measure that assesses pain intensity and interference with activity. The Brief Pain Inventory (BPI) assesses two key domains-intensity and interference-recommended for pain studies and has been validated in primary care. The BPI is the average of pain intensity and pain interference scores. The pain intensity score is an average of 4 ratings of 0 (no pain) to 10 (pain as bad as you can imagine) for current, least, worst, and average pain in the past week. The pain interference score averages seven ratings, 0 (does not interfere) to 10 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Lower scores are better outcomes.	3 months
Depression (PHQ8)	Patient Health Questionnaire (PHQ)-8. Construct: Depression. Validated 8-item measure assessing depression severity. Range 0 - 24. Lower scores are better outcomes.	3 months
Anxiety	GAD 7. Construct: Anxiety. Validated 7-item measure to assess anxiety. Range 0 - 21. Lower scores are better outcomes.	3 months
Communication Self-Efficacy (Perceived Efficacy in Patient-Physician Interactions--PEPPI)	Perceived Efficacy in Patient-Physician Interactions (PEPPI-5). Construct: patients' self-efficacy in obtaining medical info and getting most important concerns discussed with their doctors. Range 0 (lowest) - 50 (highest). Higher values are better outcomes.	Baseline
Communication Self-Efficacy (Perceived Efficacy in Patient-Physician Interactions--PEPPI)	Perceived Efficacy in Patient-Physician Interactions (PEPPI-5). Construct: patients' self-efficacy in obtaining medical info and getting most important concerns discussed with their doctors. Range 0 (lowest) - 50 (highest). Higher values are better outcomes.	6 months
Communication Self-Efficacy (Perceived Efficacy in Patient-Physician Interactions--PEPPI)	Perceived Efficacy in Patient-Physician Interactions (PEPPI-5). Construct: patients' self-efficacy in obtaining medical info and getting most important concerns discussed with their doctors. Range 0 (lowest) - 50 (highest). Higher values are better outcomes.	9 months
Pain Intensity and Interference (Brief Pain Inventory)	Brief Pain Inventory (BPI). Construct: Pain Intensity and Interference. 11-item measure that assesses pain intensity and interference with activity. The Brief Pain Inventory (BPI) assesses two key domains-intensity and interference-recommended for pain studies and has been validated in primary care. The BPI is the average of pain intensity and pain interference scores. The pain intensity score is an average of 4 ratings of 0 (no pain) to 10 (pain as bad as you can imagine) for current, least, worst, and average pain in the past week. The pain interference score averages seven ratings, 0 (does not interfere) to 10 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Lower scores are better outcomes.	Baseline
Pain Intensity and Interference (Brief Pain Inventory)	Brief Pain Inventory (BPI). Construct: Pain Intensity and Interference. 11-item measure that assesses pain intensity and interference with activity. The Brief Pain Inventory (BPI) assesses two key domains-intensity and interference-recommended for pain studies and has been validated in primary care. The BPI is the average of pain intensity and pain interference scores. The pain intensity score is an average of 4 ratings of 0 (no pain) to 10 (pain as bad as you can imagine) for current, least, worst, and average pain in the past week. The pain interference score averages seven ratings, 0 (does not interfere) to 10 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Lower scores are better outcomes.	6 months
Pain Intensity and Interference (Brief Pain Inventory)	Brief Pain Inventory (BPI). Construct: Pain Intensity and Interference. 11-item measure that assesses pain intensity and interference with activity. The Brief Pain Inventory (BPI) assesses two key domains-intensity and interference-recommended for pain studies and has been validated in primary care. The BPI is the average of pain intensity and pain interference scores. The pain intensity score is an average of 4 ratings of 0 (no pain) to 10 (pain as bad as you can imagine) for current, least, worst, and average pain in the past week. The pain interference score averages seven ratings, 0 (does not interfere) to 10 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Lower scores are better outcomes.	9 months
Depression (PHQ8)	Patient Health Questionnaire (PHQ)-8. Construct: Depression. Validated 8-item measure assessing depression severity. Range 0 - 24. Lower scores are better outcomes.	Baseline
Depression (PHQ8)	Patient Health Questionnaire (PHQ)-8. Construct: Depression. Validated 8-item measure assessing depression severity. Range 0 - 24. Lower scores are better outcomes.	6 months
Depression (PHQ8)	Patient Health Questionnaire (PHQ)-8. Construct: Depression. Validated 8-item measure assessing depression severity. Range 0 - 24. Lower scores are better outcomes.	9 months
Anxiety	GAD 7. Construct: Anxiety. Validated 7-item measure to assess anxiety. Range 0 - 21. Lower scores are better outcomes.	Baseline
Anxiety	GAD 7. Construct: Anxiety. Validated 7-item measure to assess anxiety. Range 0 - 21. Lower scores are better outcomes.	6 months
Anxiety	GAD 7. Construct: Anxiety. Validated 7-item measure to assess anxiety. Range 0 - 21. Lower scores are better outcomes.	9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Covariate--Working alliance	Working Alliance Inventory (WAI). Construct: Patient-Provider Therapeutic Alliance--patient-provider agreement on treatment goals, collaboration, and mutual trust/liking. Range: 12-84. Higher scores are better outcomes.	Change from baseline to 3 months
Covariate--patient-provider gender and race concordance	The investigators will measure race and gender concordance between patients and their primary care providers. This is not a scale.	Baseline
Covariate--length of patient-provider relationship	The investigators will ask patients how long they have been seeing their primary care provider. This is not a scale but a continuous measure of length of relationship.	Baseline

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Marianne Sassi Matthias, PhD MS BA, Richard L. Roudebush VA Medical Center, Indianapolis, IN

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Contemp Clin Trials. 2022 Sep;120:106883.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: June 7, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: March 10, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: pain; healthcare disparities; communication
• Other Study ID Numbers: IIR 17-032; 1712397218 (Other Identifier: Indiana University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No