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Completed

NCT Number: NCT03562793

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

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.

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Key information

Conditions

Pain Behavior Communication Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: COOPERATE

Primary outcomes

  1. Patient Activation

    Time frame: 3 months

    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.

  2. Patient Activation

    Time frame: 6 months

    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. Patient Activation

    Time frame: Baseline

    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.

  4. Patient Activation

    Time frame: 9 months

    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.

Secondary outcomes

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

    Time frame: 3 months

    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.

  2. Pain Intensity and Interference (Brief Pain Inventory)

    Time frame: 3 months

    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. Depression (PHQ8)

    Time frame: 3 months

    Patient Health Questionnaire (PHQ)-8. Construct: Depression. Validated 8-item measure assessing depression severity. Range 0 - 24. Lower scores are better outcomes.

  4. Anxiety

    Time frame: 3 months

    GAD 7. Construct: Anxiety. Validated 7-item measure to assess anxiety. Range 0 - 21. Lower scores are better outcomes.

  5. Pain Coping

    Time frame: Change from baseline to 3 months

    Coping Strategies Questionnaire. Construct: Pain coping. A 14-item measure of pain coping strategies. Range 0-84. Lower scores are better outcomes.

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

    Time frame: Baseline

    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.

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

    Time frame: 6 months

    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.

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

    Time frame: 9 months

    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. Pain Intensity and Interference (Brief Pain Inventory)

    Time frame: Baseline

    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.

  10. Pain Intensity and Interference (Brief Pain Inventory)

    Time frame: 6 months

    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.

  11. Pain Intensity and Interference (Brief Pain Inventory)

    Time frame: 9 months

    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.

  12. Depression (PHQ8)

    Time frame: Baseline

    Patient Health Questionnaire (PHQ)-8. Construct: Depression. Validated 8-item measure assessing depression severity. Range 0 - 24. Lower scores are better outcomes.

  13. Depression (PHQ8)

    Time frame: 6 months

    Patient Health Questionnaire (PHQ)-8. Construct: Depression. Validated 8-item measure assessing depression severity. Range 0 - 24. Lower scores are better outcomes.

  14. Depression (PHQ8)

    Time frame: 9 months

    Patient Health Questionnaire (PHQ)-8. Construct: Depression. Validated 8-item measure assessing depression severity. Range 0 - 24. Lower scores are better outcomes.

  15. Anxiety

    Time frame: Baseline

    GAD 7. Construct: Anxiety. Validated 7-item measure to assess anxiety. Range 0 - 21. Lower scores are better outcomes.

  16. Anxiety

    Time frame: 6 months

    GAD 7. Construct: Anxiety. Validated 7-item measure to assess anxiety. Range 0 - 21. Lower scores are better outcomes.

  17. Anxiety

    Time frame: 9 months

    GAD 7. Construct: Anxiety. Validated 7-item measure to assess anxiety. Range 0 - 21. Lower scores are better outcomes.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: COOPERATE

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jun 19, 2018
Registry last updated
Dec 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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