Trial Outcomes & Findings for Communication and Activation in Pain to Enhance Relationships and Treat Pain With Equity (NCT NCT03562793)
NCT ID: NCT03562793
Last Updated: 2023-12-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
250 participants
Primary outcome timeframe
3 months
Results posted on
2023-12-19
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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).
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|---|---|---|
|
Overall Study
STARTED
|
124
|
126
|
|
Overall Study
3 Months
|
103
|
120
|
|
Overall Study
6 Months
|
100
|
113
|
|
Overall Study
COMPLETED
|
99
|
104
|
|
Overall Study
NOT COMPLETED
|
25
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
Baseline characteristics by cohort
| Measure |
COOPERATE Intervention Arm
n=124 Participants
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.
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.
|
Attention Control Arm
n=126 Participants
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).
|
Total
n=250 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
61.3 years
STANDARD_DEVIATION 10.1 • n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
60.6 years
STANDARD_DEVIATION 9.9 • n=7 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
61.0 years
STANDARD_DEVIATION 10 • n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
24 Participants
n=7 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
43 Participants
n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
|
Sex: Female, Male
Male
|
105 Participants
n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
102 Participants
n=7 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
207 Participants
n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
2 Participants
n=7 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
3 Participants
n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
123 Participants
n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
124 Participants
n=7 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
247 Participants
n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
0 Participants
n=7 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
0 Participants
n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
0 Participants
n=7 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
0 Participants
n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
0 Participants
n=7 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
0 Participants
n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
0 Participants
n=7 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
0 Participants
n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
|
Race (NIH/OMB)
Black or African American
|
124 Participants
n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
126 Participants
n=7 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
250 Participants
n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
0 Participants
n=7 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
0 Participants
n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
0 Participants
n=7 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
0 Participants
n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
0 Participants
n=7 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
0 Participants
n=5 Participants • Overall study population is 250. There were 126 randomized to the control group and 124 randomized to the intervention group.
|
|
Region of Enrollment
United States
|
124 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPatient 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.
Outcome measures
| Measure |
COOPERATE Intervention Arm
n=103 Participants
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.
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.
|
Attention Control Arm
n=120 Participants
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).
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|---|---|---|
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Patient Activation
|
60.39 units on a scale
Standard Deviation 13.55
|
57.58 units on a scale
Standard Deviation 13.51
|
PRIMARY outcome
Timeframe: 6 monthsPatient 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.
Outcome measures
| Measure |
COOPERATE Intervention Arm
n=100 Participants
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.
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.
|
Attention Control Arm
n=113 Participants
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).
|
|---|---|---|
|
Patient Activation
|
62.82 units on a scale
Standard Deviation 15.96
|
58.18 units on a scale
Standard Deviation 13.97
|
PRIMARY outcome
Timeframe: BaselinePatient 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.
Outcome measures
| Measure |
COOPERATE Intervention Arm
n=124 Participants
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.
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.
|
Attention Control Arm
n=126 Participants
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).
|
|---|---|---|
|
Patient Activation
|
55.69 units on a scale
Standard Deviation 13.92
|
57.45 units on a scale
Standard Deviation 13.07
|
PRIMARY outcome
Timeframe: 9 monthsPatient 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.
Outcome measures
| Measure |
COOPERATE Intervention Arm
n=99 Participants
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.
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.
|
Attention Control Arm
n=104 Participants
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).
|
|---|---|---|
|
Patient Activation
|
61.56 units on a scale
Standard Deviation 14.13
|
58.56 units on a scale
Standard Deviation 12.64
|
SECONDARY outcome
Timeframe: 3 monthsPerceived 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.
Outcome measures
| Measure |
COOPERATE Intervention Arm
n=103 Participants
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.
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.
|
Attention Control Arm
n=120 Participants
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).
|
|---|---|---|
|
Communication Self-Efficacy (Perceived Efficacy in Patient-Physician Interactions--PEPPI)
|
38.27 units on a scale
Standard Deviation 9.63
|
36.65 units on a scale
Standard Deviation 10.81
|
SECONDARY outcome
Timeframe: 3 monthsBrief 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.
Outcome measures
| Measure |
COOPERATE Intervention Arm
n=103 Participants
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.
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.
|
Attention Control Arm
n=120 Participants
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).
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|---|---|---|
|
Pain Intensity and Interference (Brief Pain Inventory)
|
5.02 units on a scale
Standard Deviation 2.45
|
5.31 units on a scale
Standard Deviation 2.28
|
SECONDARY outcome
Timeframe: 3 monthsPatient Health Questionnaire (PHQ)-8. Construct: Depression. Validated 8-item measure assessing depression severity. Range 0 - 24. Lower scores are better outcomes.
Outcome measures
| Measure |
COOPERATE Intervention Arm
n=103 Participants
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.
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.
|
Attention Control Arm
n=120 Participants
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).
|
|---|---|---|
|
Depression (PHQ8)
|
8.50 units on a scale
Standard Deviation 5.79
|
9.08 units on a scale
Standard Deviation 5.86
|
SECONDARY outcome
Timeframe: 3 monthsGAD 7. Construct: Anxiety. Validated 7-item measure to assess anxiety. Range 0 - 21. Lower scores are better outcomes.
Outcome measures
| Measure |
COOPERATE Intervention Arm
n=103 Participants
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.
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.
|
Attention Control Arm
n=120 Participants
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).
|
|---|---|---|
|
Anxiety
|
6.70 units on a scale
Standard Deviation 5.77
|
7.21 units on a scale
Standard Deviation 6.03
|
SECONDARY outcome
Timeframe: Change from baseline to 3 monthsCoping Strategies Questionnaire. Construct: Pain coping. A 14-item measure of pain coping strategies. Range 0-84. Lower scores are better outcomes.
Outcome measures
| Measure |
COOPERATE Intervention Arm
n=103 Participants
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.
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.
|
Attention Control Arm
n=120 Participants
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).
|
|---|---|---|
|
Pain Coping
|
14.42 units on a scale
Standard Deviation 5.94
|
13.91 units on a scale
Standard Deviation 5.60
|
SECONDARY outcome
Timeframe: BaselinePerceived 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.
Outcome measures
| Measure |
COOPERATE Intervention Arm
n=124 Participants
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.
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.
|
Attention Control Arm
n=126 Participants
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).
|
|---|---|---|
|
Communication Self-Efficacy (Perceived Efficacy in Patient-Physician Interactions--PEPPI)
|
34.64 units on a scale
Standard Deviation 11.30
|
35.73 units on a scale
Standard Deviation 10.56
|
SECONDARY outcome
Timeframe: 6 monthsPerceived 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.
Outcome measures
| Measure |
COOPERATE Intervention Arm
n=100 Participants
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.
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.
|
Attention Control Arm
n=113 Participants
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).
|
|---|---|---|
|
Communication Self-Efficacy (Perceived Efficacy in Patient-Physician Interactions--PEPPI)
|
39.41 units on a scale
Standard Deviation 9.69
|
37.90 units on a scale
Standard Deviation 9.06
|
SECONDARY outcome
Timeframe: 9 monthsPerceived 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.
Outcome measures
| Measure |
COOPERATE Intervention Arm
n=99 Participants
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.
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.
|
Attention Control Arm
n=104 Participants
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).
|
|---|---|---|
|
Communication Self-Efficacy (Perceived Efficacy in Patient-Physician Interactions--PEPPI)
|
39.46 units on a scale
Standard Deviation 9.67
|
37.98 units on a scale
Standard Deviation 9.11
|
SECONDARY outcome
Timeframe: BaselineBrief 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.
Outcome measures
| Measure |
COOPERATE Intervention Arm
n=124 Participants
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.
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.
|
Attention Control Arm
n=126 Participants
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).
|
|---|---|---|
|
Pain Intensity and Interference (Brief Pain Inventory)
|
5.67 units on a scale
Standard Deviation 2.15
|
5.35 units on a scale
Standard Deviation 2.11
|
SECONDARY outcome
Timeframe: 6 monthsBrief 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.
Outcome measures
| Measure |
COOPERATE Intervention Arm
n=100 Participants
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.
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.
|
Attention Control Arm
n=113 Participants
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).
|
|---|---|---|
|
Pain Intensity and Interference (Brief Pain Inventory)
|
5.19 units on a scale
Standard Deviation 2.41
|
5.10 units on a scale
Standard Deviation 2.37
|
SECONDARY outcome
Timeframe: 9 monthsBrief 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.
Outcome measures
| Measure |
COOPERATE Intervention Arm
n=99 Participants
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.
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.
|
Attention Control Arm
n=104 Participants
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).
|
|---|---|---|
|
Pain Intensity and Interference (Brief Pain Inventory)
|
5.46 units on a scale
Standard Deviation 2.38
|
5.02 units on a scale
Standard Deviation 2.35
|
SECONDARY outcome
Timeframe: BaselinePatient Health Questionnaire (PHQ)-8. Construct: Depression. Validated 8-item measure assessing depression severity. Range 0 - 24. Lower scores are better outcomes.
Outcome measures
| Measure |
COOPERATE Intervention Arm
n=124 Participants
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.
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.
|
Attention Control Arm
n=126 Participants
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).
|
|---|---|---|
|
Depression (PHQ8)
|
8.82 units on a scale
Standard Deviation 5.64
|
8.14 units on a scale
Standard Deviation 5.68
|
SECONDARY outcome
Timeframe: 6 monthsPatient Health Questionnaire (PHQ)-8. Construct: Depression. Validated 8-item measure assessing depression severity. Range 0 - 24. Lower scores are better outcomes.
Outcome measures
| Measure |
COOPERATE Intervention Arm
n=100 Participants
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.
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.
|
Attention Control Arm
n=113 Participants
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).
|
|---|---|---|
|
Depression (PHQ8)
|
8.33 units on a scale
Standard Deviation 5.90
|
8.69 units on a scale
Standard Deviation 6.02
|
SECONDARY outcome
Timeframe: 9 monthsPatient Health Questionnaire (PHQ)-8. Construct: Depression. Validated 8-item measure assessing depression severity. Range 0 - 24. Lower scores are better outcomes.
Outcome measures
| Measure |
COOPERATE Intervention Arm
n=99 Participants
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.
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.
|
Attention Control Arm
n=104 Participants
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).
|
|---|---|---|
|
Depression (PHQ8)
|
8.87 units on a scale
Standard Deviation 6.16
|
8.87 units on a scale
Standard Deviation 5.76
|
SECONDARY outcome
Timeframe: BaselineGAD 7. Construct: Anxiety. Validated 7-item measure to assess anxiety. Range 0 - 21. Lower scores are better outcomes.
Outcome measures
| Measure |
COOPERATE Intervention Arm
n=124 Participants
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.
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.
|
Attention Control Arm
n=126 Participants
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).
|
|---|---|---|
|
Anxiety
|
7.37 units on a scale
Standard Deviation 5.79
|
6.66 units on a scale
Standard Deviation 5.61
|
SECONDARY outcome
Timeframe: 6 monthsGAD 7. Construct: Anxiety. Validated 7-item measure to assess anxiety. Range 0 - 21. Lower scores are better outcomes.
Outcome measures
| Measure |
COOPERATE Intervention Arm
n=100 Participants
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.
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.
|
Attention Control Arm
n=113 Participants
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).
|
|---|---|---|
|
Anxiety
|
7.07 units on a scale
Standard Deviation 6.01
|
7.04 units on a scale
Standard Deviation 6.18
|
SECONDARY outcome
Timeframe: 9 monthsGAD 7. Construct: Anxiety. Validated 7-item measure to assess anxiety. Range 0 - 21. Lower scores are better outcomes.
Outcome measures
| Measure |
COOPERATE Intervention Arm
n=99 Participants
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.
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.
|
Attention Control Arm
n=104 Participants
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).
|
|---|---|---|
|
Anxiety
|
7.11 units on a scale
Standard Deviation 6.32
|
7.14 units on a scale
Standard Deviation 5.66
|
Adverse Events
COOPERATE Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Marianne Matthias
Richard L. Roudebush VA Medical Center
Phone: 317-988-4514
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place