Trial Outcomes & Findings for Pain Program for Active Coping & Training (NCT NCT02113592)
NCT ID: NCT02113592
Last Updated: 2023-08-28
Results Overview
Reliable and valid tool that measures patients' pain intensity and functional interference. The primary outcome of pain impact is assessed with the 4-item PEGS scale, a composite of pain intensity, and interference with enjoyment of life, general activity, and sleep (range, 0-10, higher score = worse pain impact).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
850 participants
Primary outcome timeframe
Collected every 3 months for 1 year
Results posted on
2023-08-28
Participant Flow
Unit of analysis: Primary care provider cluster
Participant milestones
| Measure |
Cognitive Behavioral Therapy (CBT) Intervention
Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.
|
Usual Care
Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.
|
|---|---|---|
|
Overall Study
STARTED
|
433 53
|
417 53
|
|
Overall Study
COMPLETED
|
414 53
|
402 53
|
|
Overall Study
NOT COMPLETED
|
19 0
|
15 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pain Program for Active Coping & Training
Baseline characteristics by cohort
| Measure |
Cognitive Behavioral Therapy (CBT) Intervention
n=433 Participants
Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.
|
Usual Care
n=417 Participants
Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.
|
Total
n=850 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
59.2 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
60.3 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
287 Participants
n=5 Participants
|
286 Participants
n=7 Participants
|
573 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
146 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
277 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic ethnicity
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White (race)
|
334 Participants
n=5 Participants
|
317 Participants
n=7 Participants
|
651 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American (race)
|
55 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other (race)
|
44 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
433 participants
n=5 Participants
|
417 participants
n=7 Participants
|
850 participants
n=5 Participants
|
|
Average daily dose of opioids
|
28.5 Morphine Milligram Equivalents (MME)
n=5 Participants
|
30.8 Morphine Milligram Equivalents (MME)
n=7 Participants
|
29.6 Morphine Milligram Equivalents (MME)
n=5 Participants
|
PRIMARY outcome
Timeframe: Collected every 3 months for 1 yearReliable and valid tool that measures patients' pain intensity and functional interference. The primary outcome of pain impact is assessed with the 4-item PEGS scale, a composite of pain intensity, and interference with enjoyment of life, general activity, and sleep (range, 0-10, higher score = worse pain impact).
Outcome measures
| Measure |
Cognitive Behavioral Therapy (CBT) Intervention
n=414 Participants
Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.
|
Usual Care
n=402 Participants
Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.
|
|---|---|---|
|
Pain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form ("PEGS")
3-Month Follow-Up
|
5.486 score on a scale
Interval 5.272 to 5.699
|
6.210 score on a scale
Interval 5.994 to 6.426
|
|
Pain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form ("PEGS")
6-Month Follow-Up
|
5.516 score on a scale
Interval 5.316 to 5.715
|
6.197 score on a scale
Interval 5.994 to 6.399
|
|
Pain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form ("PEGS")
Baseline
|
6.485 score on a scale
Interval 6.29 to 6.681
|
6.645 score on a scale
Interval 6.447 to 6.843
|
|
Pain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form ("PEGS")
9-Month Follow-up
|
5.546 score on a scale
Interval 5.342 to 5.75
|
6.183 score on a scale
Interval 5.976 to 6.39
|
|
Pain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form ("PEGS")
12-Month Follow-Up
|
5.576 score on a scale
Interval 5.349 to 5.803
|
6.170 score on a scale
Interval 5.94 to 6.4
|
SECONDARY outcome
Timeframe: Collected every 3 months for 1 yearPain-related disability will be assessed using the 24-item Roland Morris Disability Questionnaire (range, 0-1, higher score = worse function)
Outcome measures
| Measure |
Cognitive Behavioral Therapy (CBT) Intervention
n=414 Participants
Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.
|
Usual Care
n=402 Participants
Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.
|
|---|---|---|
|
Pain-related Disability
Baseline
|
0.672 score on a scale
Interval 0.652 to 0.691
|
0.692 score on a scale
Interval 0.672 to 0.711
|
|
Pain-related Disability
3-Month Follow-Up
|
0.612 score on a scale
Interval 0.591 to 0.633
|
0.675 score on a scale
Interval 0.654 to 0.696
|
|
Pain-related Disability
6-Month Follow-Up
|
0.609 score on a scale
Interval 0.59 to 0.629
|
0.678 score on a scale
Interval 0.658 to 0.698
|
|
Pain-related Disability
9-Month Follow-Up
|
0.607 score on a scale
Interval 0.586 to 0.627
|
0.681 score on a scale
Interval 0.66 to 0.701
|
|
Pain-related Disability
12-Month Follow-Up
|
0.604 score on a scale
Interval 0.581 to 0.626
|
0.683 score on a scale
Interval 0.661 to 0.706
|
SECONDARY outcome
Timeframe: Collected every 3 months for 1 yearAverage daily dose of opioids per 3-month quarter measured in morphine milligram equivalents (MME)
Outcome measures
| Measure |
Cognitive Behavioral Therapy (CBT) Intervention
n=414 Participants
Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.
|
Usual Care
n=402 Participants
Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.
|
|---|---|---|
|
Average Daily Dose of Opioids
9-Month Follow-Up
|
44.571 MME/day
Interval 37.396 to 51.745
|
54.430 MME/day
Interval 47.142 to 61.719
|
|
Average Daily Dose of Opioids
12-Month Follow-Up
|
43.536 MME/day
Interval 36.085 to 50.986
|
53.298 MME/day
Interval 45.725 to 60.871
|
|
Average Daily Dose of Opioids
Baseline
|
47.458 MME/day
Interval 40.647 to 54.269
|
55.252 MME/day
Interval 48.333 to 62.171
|
|
Average Daily Dose of Opioids
3-Month Follow-Up
|
46.641 MME/day
Interval 39.61 to 53.627
|
56.695 MME/day
Interval 49.556 to 63.834
|
|
Average Daily Dose of Opioids
6-Month Follow-Up
|
45.606 MME/day
Interval 38.574 to 52.638
|
55.563 MME/day
Interval 48.421 to 62.704
|
SECONDARY outcome
Timeframe: Collected at baseline and 6 months (post-treatment)Patient satisfaction with health care services will be assessed using two distinct items: * \[Satisfaction with primary care services\]: In the past 3 months, how satisfied have you been with your primary care services? (1, Very dissatisfied; 2, Mildly dissatisfied; 3, Indifferent; 4, Mostly satisfied; 5, Very satisfied) * \[Satisfaction with pain services\]: In the past 3 months, how satisfied have you been with the pain services you have received? (1, Very dissatisfied; 2, Mildly dissatisfied; 3, Indifferent; 4, Mostly satisfied; 5, Very satisfied) Each item is scored individually; (range=1-5, higher score = greater satisfaction)
Outcome measures
| Measure |
Cognitive Behavioral Therapy (CBT) Intervention
n=414 Participants
Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.
|
Usual Care
n=402 Participants
Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.
|
|---|---|---|
|
Patient Satisfaction
Satisfaction with primary care services (Baseline)
|
4.263 score on a scale
Interval 4.162 to 4.365
|
4.237 score on a scale
Interval 4.134 to 4.339
|
|
Patient Satisfaction
Satisfaction with primary care services (Post-Treatment)
|
4.240 score on a scale
Interval 4.115 to 4.365
|
3.984 score on a scale
Interval 3.856 to 4.112
|
|
Patient Satisfaction
Satisfaction with pain services (Baseline)
|
3.658 score on a scale
Interval 3.54 to 3.776
|
3.581 score on a scale
Interval 3.461 to 3.7
|
|
Patient Satisfaction
Satisfaction with pain services (Post-Treatment)
|
4.080 score on a scale
Interval 3.954 to 4.205
|
3.667 score on a scale
Interval 3.538 to 3.796
|
SECONDARY outcome
Timeframe: Collected for 1 year post-randomizationCosts were measured based on patient utilization of health care services and all prescription/medication costs. The costs of health care encounters during the 1-year follow-up were estimated using the standardized relative resource cost algorithm (SRRCA). Pain-related health care costs were based on the pain-related health care encounters identified using diagnostic and procedure coding.
Outcome measures
| Measure |
Cognitive Behavioral Therapy (CBT) Intervention
n=412 Participants
Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.
|
Usual Care
n=402 Participants
Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.
|
|---|---|---|
|
Health Care Costs
Total Health Care Costs
|
21,372 Dollars
|
25,648 Dollars
|
|
Health Care Costs
Total Pain-Related Health Care Costs
|
9,395 Dollars
|
11,343 Dollars
|
SECONDARY outcome
Timeframe: Collected for 1 year post-randomizationTotal Ambulatory Encounters includes encounters in the following health care service categories: Primary care; Physical therapy; Pain clinic; Other specialty medical care; Mental health; Complementary and alternative medicine; ED, urgent care, and observation beds; Hospital ambulatory visits; Same day surgeries; and Home health. Total Pain-Related Ambulatory Encounters are a subset of Total Ambulatory Encounters and were identified using CPT, HCPCS, and ICD-9-PCS or ICD-10-PCS codes
Outcome measures
| Measure |
Cognitive Behavioral Therapy (CBT) Intervention
n=412 Participants
Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.
|
Usual Care
n=402 Participants
Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.
|
|---|---|---|
|
Count of Health Care Encounters by Type (Health Care Utilization)
Total Ambulatory Encounters
|
20.85 Health care encounters
Interval 19.4 to 22.41
|
21.59 Health care encounters
Interval 20.07 to 23.22
|
|
Count of Health Care Encounters by Type (Health Care Utilization)
Total Pain-Related Ambulatory Encounters
|
10.42 Health care encounters
Interval 9.62 to 11.28
|
10.11 Health care encounters
Interval 9.33 to 10.96
|
|
Count of Health Care Encounters by Type (Health Care Utilization)
Telephone or Email Encounters
|
24.04 Health care encounters
Interval 22.57 to 25.6
|
23.18 Health care encounters
Interval 21.75 to 24.71
|
|
Count of Health Care Encounters by Type (Health Care Utilization)
Inpatient Hospital Encounters
|
0.22 Health care encounters
Interval 0.17 to 0.28
|
0.28 Health care encounters
Interval 0.22 to 0.36
|
SECONDARY outcome
Timeframe: Collected for 1 year post-randomizationInpatient hospital days is the average number of days that patients stayed in hospital (total number of days spent by inpatients during the 1 year post-randomization divided by the total number of inpatient admissions)
Outcome measures
| Measure |
Cognitive Behavioral Therapy (CBT) Intervention
n=412 Participants
Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.
|
Usual Care
n=402 Participants
Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.
|
|---|---|---|
|
Inpatient Hospital Days (Health Care Utilization)
|
0.86 Days
Interval 0.59 to 1.26
|
0.22 Days
Interval 0.13 to 0.39
|
SECONDARY outcome
Timeframe: Collected for 1 year post-randomizationTotal Pharmacy Dispenses is a count of the unique medication prescriptions dispensed.
Outcome measures
| Measure |
Cognitive Behavioral Therapy (CBT) Intervention
n=412 Participants
Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.
|
Usual Care
n=402 Participants
Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.
|
|---|---|---|
|
Total Pharmacy Dispenses (Health Care Utilization)
|
50.45 Prescriptions dispensed
Interval 48.53 to 52.44
|
52.22 Prescriptions dispensed
Interval 50.21 to 54.3
|
Adverse Events
Cognitive Behavioral Therapy (CBT) Intervention
Serious events: 94 serious events
Other events: 0 other events
Deaths: 4 deaths
Usual Care
Serious events: 112 serious events
Other events: 0 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Cognitive Behavioral Therapy (CBT) Intervention
n=433 participants at risk
Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care.
|
Usual Care
n=417 participants at risk
Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction.
|
|---|---|---|
|
General disorders
Hospitalization
|
21.7%
94/433 • Number of events 116 • Participants were monitored for serious adverse events during the one-year period of study participation.
The only adverse events monitored were serious adverse events, defined as hospitalizations and deaths, assessed systematically from electronic health record data. Assessments were conducted every 6 months throughout the study and reviewed by an independent monitor. For deaths, chart abstraction determined relatedness.
|
26.9%
112/417 • Number of events 171 • Participants were monitored for serious adverse events during the one-year period of study participation.
The only adverse events monitored were serious adverse events, defined as hospitalizations and deaths, assessed systematically from electronic health record data. Assessments were conducted every 6 months throughout the study and reviewed by an independent monitor. For deaths, chart abstraction determined relatedness.
|
Other adverse events
Adverse event data not reported
Additional Information
Lynn DeBar, PhD, MPH, Principal Investigator
Kaiser Permanente Washington Health Research Institute
Phone: 206-287-2900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place