PPACT: Pain Program for Active Coping & Training

• Sponsor: Kaiser Permanente (Other)
• Overall Status: Completed
• CT.gov ID: NCT02113592
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS) (NIH), Duke University (Other), Oregon Health and Science University (Other)
• Enrollment: 850
• Locations: 3
• Arms: 2
• Actual Duration (Months): 45.8
• Patients Per Site: 283.3
• Patients Per Site Per Month: 6.2

Study Details

Study Description

Brief Summary

The overall aim of this study is to adopt an integrative rehabilitation approach for helping patients adopt self-management skills for managing chronic pain, limiting use of opioid medications, and identifying exacerbating factors amenable to treatment (e.g., depression, sleep problems) that is feasible and sustainable within the primary care setting.

Condition or Disease	Intervention/Treatment	Phase
Chronic Non-malignant Pain	Behavioral: Interdisciplinary pain program	N/A

Detailed Description

Pain is a common and very costly public health problem. Common chronic pain conditions are expensive and pervasive, affecting at least 116 million American adults at an annual cost of $560 billion in direct medical treatment costs and lost productivity, and disproportionally affect vulnerable populations. Pain is the primary reason patients seek medical care and, as the first point of contact, primary care providers (PCPs) deliver the majority of that care. Unfortunately, PCPs face many challenges in managing these patients' care and often have little specific training in pain medicine. Yet with proper system support, PCPs are in the best position to coordinate pain management longitudinally. While pharmacotherapy is the predominant treatment approach for many PCPs, this limits the patient's role to taking medication, and he or she can become a passive recipient of care-leading to poor outcomes, potential overmedication, and possible disillusionment with the medical system. Further, increases in opiate prescribing for pain treatment-amidst increasing awareness of adverse outcomes, including addiction-and limited efficacy suggest the importance of broader treatment approaches that focus on patients' improvement of functioning. Although opiates may reduce pain symptoms while prescribed, patients are unlikely to experience significant and sustained improvements without the use of other nonpharmacologic pain management approaches. Medical management of patients with persistent pain and complex problems is often fragmented, which leads patients to seek a wide variety of primary and specialty care services in an effort to manage their pain and related conditions. Such fragmented care leads to poorer outcomes and significantly increases health care costs as patients often receive unneeded diagnostic and medical procedures. While research has identified evidence-based multidisciplinary behavioral treatment approaches that are effective for such patients and can even prevent the disability associated with persistent pain when offered earlier in the course of care, these interventions are rarely available in everyday practice settings and will require data from pragmatic clinical trials to change the care paradigm.

To address these issues, we are conducting a large-scale, mixed-methods, cluster-randomized pragmatic clinical trial throughout three regions of Kaiser Permanente - Northwest, Georgia, and Hawaii. This trial will evaluate the integration of multidisciplinary services within the primary care environment as compared to usual care in these settings. This project embeds an intervention into everyday clinical practice flow utilizing assessment measures and intervention staff directly from the clinical care system rather than utilizing a research-developed and administered structure. The intervention is an integrated, interdisciplinary program that guides all pain-related care for intervention patients. This study compares this primary care-based intervention to usual care using systematic, clinic-based assessments. The trial will include up to 1,000 patients and 500 primary care providers (half of each receiving active treatment) with intervention care being delivered by behavioral specialists, nurses, physical therapists, pharmacists, and other affiliated staff. Patients include those selected by their primary care providers who have non-malignant chronic pain (pain persisting for ≥ 3 months) and who are on long-term opiate therapy for the treatment of their condition. This intervention brings together elements often available in health plans but organized in a less integrated fashion, and it will ensure flexibility in implementation to best fit individual clinic environments and the needs of chronic pain patients on long-term opiate therapy.

Study Design

• Study Type: Interventional
• Actual Enrollment: 850 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Collaborative Care for Chronic Pain in Primary Care
• Actual Study Start Date: Apr 10, 2014
• Actual Primary Completion Date: Feb 1, 2018
• Actual Study Completion Date: Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interdisciplinary pain program Interdisciplinary pain program, which includes behavioral health, nurse case management, physical therapy, and pharmacy embedded in primary care.	Behavioral: Interdisciplinary pain program; Interdisciplinary pain program, which includes behavioral health, nurse case management, physical therapy, and pharmacy embedded in primary care.
No Intervention: Treatment as usual Patients in this arm will receive care as usual and utilize services as they currently exist in the health plan system.

Outcome Measures

Primary Outcome Measures

1. Pain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form ("PEGS") [Collected every 3 months for 1 year]

   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).

Secondary Outcome Measures

1. Pain-related Disability [Collected every 3 months for 1 year]

   Pain-related disability will be assessed using the 24-item Roland Morris Disability Questionnaire (range, 0-1, higher score = worse function)

2. Average Daily Dose of Opioids [Collected every 3 months for 1 year]

   Average daily dose of opioids per 3-month quarter measured in morphine milligram equivalents (MME)

3. Patient Satisfaction [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)

4. Health Care Costs [Collected for 1 year post-randomization]

   Costs 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.

5. Count of Health Care Encounters by Type (Health Care Utilization) [Collected for 1 year post-randomization]

   Total 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

6. Inpatient Hospital Days (Health Care Utilization) [Collected for 1 year post-randomization]

   Inpatient 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)

7. Total Pharmacy Dispenses (Health Care Utilization) [Collected for 1 year post-randomization]

   Total Pharmacy Dispenses is a count of the unique medication prescriptions dispensed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Patient inclusion criteria are:

1. Adult (18 years of age or older) Kaiser Permanente (KP) health plan members from the KP Northwest, KP Georgia, and KP Hawaii regions who receive their primary care services from participating primary care providers

2. Kaiser Permanente health plan membership of at least 180 days duration

3. Long term opioid use defined by: 90+ day supply of short acting opioid spanning at least 120 days or 2 or more long acting opioid dispense in the past 180 days

4. Pain diagnosis within the past year (based on ICD-9 or ICD-10 diagnostic codes)

5. English speaking

Patient exclusion criteria are:

1. Currently enrolled in intensive addiction medicine services or evidence of active substance dependence

2. Cognitive impairment severe enough to preclude patient's participation in a behavioral/lifestyle change program

3. Current malignant cancer diagnosis

4. Having received hospice or other end-of-life palliative care within past year

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente Center for Health Research	Atlanta	Georgia	United States	30305
2	Kaiser Permanente Center for Health Research	Honolulu	Hawaii	United States	96817
3	Kaiser Permanente Center for Health Research	Portland	Oregon	United States	97227

Sponsors and Collaborators

• Kaiser Permanente
• National Institute of Neurological Disorders and Stroke (NINDS)
• Duke University
• Oregon Health and Science University

Investigators

• Principal Investigator: Lynn DeBar, PhD, MPH, Kaiser Permanente

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 7, 2015

More Information

Publications

None provided.

• Responsible Party: Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT02113592
• Other Study ID Numbers: Pro00004169; UH3NS088731
• First Posted: Apr 14, 2014
• Last Update Posted: May 18, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Kaiser Permanente: Pain management; Opioid use; Pragmatic; Collaborative care; Primary care

Study Results

Participant Flow

Arm/Group Title	Cognitive Behavioral Therapy (CBT) Intervention	Usual Care
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	433	417
COMPLETED	414	402
NOT COMPLETED	19	15

Baseline Characteristics

Arm/Group Title	Cognitive Behavioral Therapy (CBT) Intervention	Usual Care	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	433	417	850
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.4 (11.9)	59.2 (12.4)	60.3 (12.2)
Sex: Female, Male (Count of Participants)
Female	287 66.3%	286 68.6%	573 67.4%
Male	146 33.7%	131 31.4%	277 32.6%
Race/Ethnicity, Customized (Count of Participants)
Hispanic ethnicity	16 3.7%	12 2.9%	28 3.3%
White (race)	334 77.1%	317 76%	651 76.6%
Black or African American (race)	55 12.7%	55 13.2%	110 12.9%
Other (race)	44 10.2%	45 10.8%	89 10.5%
Region of Enrollment (participants) [Number]
United States	433 100%	417 100%	850 100%
Average daily dose of opioids (Morphine Milligram Equivalents (MME)) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Morphine Milligram Equivalents (MME)]	28.5	30.8	29.6

Outcome Measures

1. Primary Outcome

Title	Pain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form ("PEGS")
Description	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).
Time Frame	Collected every 3 months for 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cognitive Behavioral Therapy (CBT) Intervention	Usual Care
Arm/Group Description	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.	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.
Measure Participants	414	402
Baseline	6.485	6.645
3-Month Follow-Up	5.486	6.210
6-Month Follow-Up	5.516	6.197
9-Month Follow-up	5.546	6.183
12-Month Follow-Up	5.576	6.170

2. Secondary Outcome

Title	Pain-related Disability
Description	Pain-related disability will be assessed using the 24-item Roland Morris Disability Questionnaire (range, 0-1, higher score = worse function)
Time Frame	Collected every 3 months for 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cognitive Behavioral Therapy (CBT) Intervention	Usual Care
Arm/Group Description	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.	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.
Measure Participants	414	402
Baseline	0.672	0.692
3-Month Follow-Up	0.612	0.675
6-Month Follow-Up	0.609	0.678
9-Month Follow-Up	0.607	0.681
12-Month Follow-Up	0.604	0.683

3. Secondary Outcome

Title	Average Daily Dose of Opioids
Description	Average daily dose of opioids per 3-month quarter measured in morphine milligram equivalents (MME)
Time Frame	Collected every 3 months for 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cognitive Behavioral Therapy (CBT) Intervention	Usual Care
Arm/Group Description	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.	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.
Measure Participants	414	402
Baseline	47.458	55.252
3-Month Follow-Up	46.641	56.695
6-Month Follow-Up	45.606	55.563
9-Month Follow-Up	44.571	54.430
12-Month Follow-Up	43.536	53.298

4. Secondary Outcome

Title	Patient Satisfaction
Description	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)
Time Frame	Collected at baseline and 6 months (post-treatment)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cognitive Behavioral Therapy (CBT) Intervention	Usual Care
Arm/Group Description	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.	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.
Measure Participants	414	402
Satisfaction with primary care services (Baseline)	4.263	4.237
Satisfaction with primary care services (Post-Treatment)	4.240	3.984
Satisfaction with pain services (Baseline)	3.658	3.581
Satisfaction with pain services (Post-Treatment)	4.080	3.667

5. Secondary Outcome

Title	Health Care Costs
Description	Costs 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.
Time Frame	Collected for 1 year post-randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cognitive Behavioral Therapy (CBT) Intervention	Usual Care
Arm/Group Description	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.	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.
Measure Participants	412	402
Total Health Care Costs	21,372	25,648
Total Pain-Related Health Care Costs	9,395	11,343

6. Secondary Outcome

Title	Count of Health Care Encounters by Type (Health Care Utilization)
Description	Total 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
Time Frame	Collected for 1 year post-randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cognitive Behavioral Therapy (CBT) Intervention	Usual Care
Arm/Group Description	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.	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.
Measure Participants	412	402
Total Ambulatory Encounters	20.85	21.59
Total Pain-Related Ambulatory Encounters	10.42	10.11
Telephone or Email Encounters	24.04	23.18
Inpatient Hospital Encounters	0.22	0.28

7. Secondary Outcome

Title	Inpatient Hospital Days (Health Care Utilization)
Description	Inpatient 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)
Time Frame	Collected for 1 year post-randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cognitive Behavioral Therapy (CBT) Intervention	Usual Care
Arm/Group Description	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.	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.
Measure Participants	412	402
Mean (95% Confidence Interval) [Days]	0.86	0.22

8. Secondary Outcome

Title	Total Pharmacy Dispenses (Health Care Utilization)
Description	Total Pharmacy Dispenses is a count of the unique medication prescriptions dispensed.
Time Frame	Collected for 1 year post-randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cognitive Behavioral Therapy (CBT) Intervention	Usual Care
Arm/Group Description	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.	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.
Measure Participants	412	402
Mean (95% Confidence Interval) [Prescriptions dispensed]	50.45	52.22

Adverse Events

Time Frame	Participants were monitored for serious adverse events during the one-year period of study participation.
Adverse Event Reporting Description	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.
Arm/Group Title	Cognitive Behavioral Therapy (CBT) Intervention		Usual Care
Arm/Group Description	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.		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.
All Cause Mortality
	Cognitive Behavioral Therapy (CBT) Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/433 (0.9%)		8/417 (1.9%)
Serious Adverse Events
	Cognitive Behavioral Therapy (CBT) Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	94/433 (21.7%)		112/417 (26.9%)
General disorders
Hospitalization	94/433 (21.7%)	116	112/417 (26.9%)	171
Other (Not Including Serious) Adverse Events
	Cognitive Behavioral Therapy (CBT) Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.