PainCOOPERATENCT03562793
Communication and Activation in Pain to Enhance Relationships and Treat Pain With Equity
A study testing Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity (COOPERATE) in people with Pain, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity (COOPERATE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Black or African American Veteran
- Have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, shoulder) for 3 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain
- Being tested
- Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity (COOPERATE)
- Keywords
- pain, healthcare disparities, communication
- Medical subject headings
- Pain, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity (COOPERATE)Behavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 9 months
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 3 months
Anxiety
GAD 7. Construct: Anxiety. Validated 7-item measure to assess anxiety. Range 0 - 21. Lower scores are better outcomes.
Measured: 3 months
Pain Coping
Coping Strategies Questionnaire. Construct: Pain coping. A 14-item measure of pain coping strategies. Range 0-84. Lower scores are better outcomes.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 9 months
Anxiety
GAD 7. Construct: Anxiety. Validated 7-item measure to assess anxiety. Range 0 - 21. Lower scores are better outcomes.
Measured: Baseline
Anxiety
GAD 7. Construct: Anxiety. Validated 7-item measure to assess anxiety. Range 0 - 21. Lower scores are better outcomes.
Measured: 6 months
Anxiety
GAD 7. Construct: Anxiety. Validated 7-item measure to assess anxiety. Range 0 - 21. Lower scores are better outcomes.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start1 Oct 2018
- Primary completion31 May 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with behavioral intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Marianne Sassi Matthias, PhD MS BA, Principal investigator, Richard L. Roudebush VA Medical Center, Indianapolis, IN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562793
- Sponsor's protocol ID
- IIR 17-032
- Other IDs
- 1712397218
- Acronym
- COOPERATE
- Status last verified
- Mar 2023
- First submitted
- 7 Jun 2018
- Last updated
- 19 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34718764Matthias 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.
PubMed 35568376Matthias 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.
PubMed 35999166Matthias 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.
PubMed 36245163Matthias 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.
PubMed 36376625Shanahan ML, Rand KL, Galloway A, Matthias MS. Treatment Goals and Preferences of Black Veterans with Chronic Musculoskeletal Pain. J Pain. 2024 Jul;25(7):104487. doi: 10.1016/j.jpain.2024.02.001. Epub 2024 Feb 7.
PubMed 38336030Matthias 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.
PubMed 37733487
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication and Activation in Pain to Enhance Relationships and Treat Pain With Equity (COOPERATE)
- ClinicalTrials.gov ID
- NCT03562793
- Acronym / sponsor ID
- COOPERATE / IIR 17-032
- Conditions
- Pain
- Keywords
- pain, healthcare disparities, communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Posted 19 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial with behavioral intervention.
| Arm | Type | Receives |
|---|---|---|
| COOPERATE Intervention Arm | Experimental | Behavioral: Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity (COOPERATE)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. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Black or African American Veteran
- Have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, shoulder) for 3 months
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity (COOPERATE)Also: 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. | Behavioural | COOPERATE Intervention Arm |
Primary outcome
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.
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.
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.
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.
17 secondary outcomes
Communication Self-Efficacy (Perceived Efficacy in Patient-Physician Interactions--PEPPI)
Time frame: 3 months
Pain Intensity and Interference (Brief Pain Inventory)
Time frame: 3 months
Depression (PHQ8)
Time frame: 3 months
Anxiety
Time frame: 3 months
Pain Coping
Time frame: Change from baseline to 3 months
Communication Self-Efficacy (Perceived Efficacy in Patient-Physician Interactions--PEPPI)
Time frame: Baseline
Communication Self-Efficacy (Perceived Efficacy in Patient-Physician Interactions--PEPPI)
Time frame: 6 months
Communication Self-Efficacy (Perceived Efficacy in Patient-Physician Interactions--PEPPI)
Time frame: 9 months
Pain Intensity and Interference (Brief Pain Inventory)
Time frame: Baseline
Pain Intensity and Interference (Brief Pain Inventory)
Time frame: 6 months
Pain Intensity and Interference (Brief Pain Inventory)
Time frame: 9 months
Depression (PHQ8)
Time frame: Baseline
Depression (PHQ8)
Time frame: 6 months
Depression (PHQ8)
Time frame: 9 months
Anxiety
Time frame: Baseline
Anxiety
Time frame: 6 months
Anxiety
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34718764Matthias 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.
- Results publication: PubMed 35568376Matthias 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.
- Results publication: PubMed 35999166Matthias 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.
- Results publication: PubMed 36245163Matthias 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.
- Results publication: PubMed 36376625Matthias 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.
- Derived from this study: PubMed 38336030Shanahan ML, Rand KL, Galloway A, Matthias MS. Treatment Goals and Preferences of Black Veterans with Chronic Musculoskeletal Pain. J Pain. 2024 Jul;25(7):104487. doi: 10.1016/j.jpain.2024.02.001. Epub 2024 Feb 7.
- Derived from this study: PubMed 37733487Matthias 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Sassi Matthias, PhD MS BA principal investigator
Richard L. Roudebush VA Medical Center, Indianapolis, IN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity (COOPERATE) in people with Pain, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Activation (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03562793, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.