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Pain Program for Active Coping & Training

Collaborative Care for Chronic Pain in Primary Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02113592
Acronym
PPACT
Enrollment
850
Registered
2014-04-14
Start date
2014-04-10
Completion date
2018-02-28
Last updated
2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Non-malignant Pain

Keywords

Pain management, Opioid use, Pragmatic, Collaborative care, Primary care

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.

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.

Interventions

Interdisciplinary pain program, which includes behavioral health, nurse case management, physical therapy, and pharmacy embedded in primary care.

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
Duke University
CollaboratorOTHER
Oregon Health and Science University
CollaboratorOTHER
Kaiser Permanente
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Pain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form (PEGS)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).

Secondary

MeasureTime frameDescription
Average Daily Dose of OpioidsCollected every 3 months for 1 yearAverage daily dose of opioids per 3-month quarter measured in morphine milligram equivalents (MME)
Patient SatisfactionCollected 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)
Health Care CostsCollected 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.
Pain-related DisabilityCollected 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)
Inpatient Hospital Days (Health Care Utilization)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)
Total Pharmacy Dispenses (Health Care Utilization)Collected for 1 year post-randomizationTotal Pharmacy Dispenses is a count of the unique medication prescriptions dispensed.
Count of Health Care Encounters by Type (Health Care Utilization)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

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
433
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.
417
Total850

Baseline characteristics

CharacteristicCognitive Behavioral Therapy (CBT) InterventionUsual CareTotal
Age, Continuous61.4 years
STANDARD_DEVIATION 11.9
59.2 years
STANDARD_DEVIATION 12.4
60.3 years
STANDARD_DEVIATION 12.2
Average daily dose of opioids28.5 Morphine Milligram Equivalents (MME)30.8 Morphine Milligram Equivalents (MME)29.6 Morphine Milligram Equivalents (MME)
Race/Ethnicity, Customized
Black or African American (race)
55 Participants55 Participants110 Participants
Race/Ethnicity, Customized
Hispanic ethnicity
16 Participants12 Participants28 Participants
Race/Ethnicity, Customized
Other (race)
44 Participants45 Participants89 Participants
Race/Ethnicity, Customized
White (race)
334 Participants317 Participants651 Participants
Region of Enrollment
United States
433 participants417 participants850 participants
Sex: Female, Male
Female
287 Participants286 Participants573 Participants
Sex: Female, Male
Male
146 Participants131 Participants277 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
4 / 4338 / 417
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
94 / 433112 / 417

Outcome results

Primary

Pain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form (PEGS)

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

ArmMeasureGroupValue (MEAN)
Cognitive Behavioral Therapy (CBT) InterventionPain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form (PEGS)3-Month Follow-Up5.486 score on a scale
Cognitive Behavioral Therapy (CBT) InterventionPain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form (PEGS)9-Month Follow-up5.546 score on a scale
Cognitive Behavioral Therapy (CBT) InterventionPain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form (PEGS)6-Month Follow-Up5.516 score on a scale
Cognitive Behavioral Therapy (CBT) InterventionPain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form (PEGS)12-Month Follow-Up5.576 score on a scale
Cognitive Behavioral Therapy (CBT) InterventionPain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form (PEGS)Baseline6.485 score on a scale
Usual CarePain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form (PEGS)12-Month Follow-Up6.170 score on a scale
Usual CarePain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form (PEGS)Baseline6.645 score on a scale
Usual CarePain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form (PEGS)3-Month Follow-Up6.210 score on a scale
Usual CarePain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form (PEGS)6-Month Follow-Up6.197 score on a scale
Usual CarePain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form (PEGS)9-Month Follow-up6.183 score on a scale
Secondary

Average Daily Dose of Opioids

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

Time frame: Collected every 3 months for 1 year

ArmMeasureGroupValue (MEAN)
Cognitive Behavioral Therapy (CBT) InterventionAverage Daily Dose of OpioidsBaseline47.458 MME/day
Cognitive Behavioral Therapy (CBT) InterventionAverage Daily Dose of Opioids6-Month Follow-Up45.606 MME/day
Cognitive Behavioral Therapy (CBT) InterventionAverage Daily Dose of Opioids3-Month Follow-Up46.641 MME/day
Cognitive Behavioral Therapy (CBT) InterventionAverage Daily Dose of Opioids9-Month Follow-Up44.571 MME/day
Cognitive Behavioral Therapy (CBT) InterventionAverage Daily Dose of Opioids12-Month Follow-Up43.536 MME/day
Usual CareAverage Daily Dose of Opioids9-Month Follow-Up54.430 MME/day
Usual CareAverage Daily Dose of Opioids12-Month Follow-Up53.298 MME/day
Usual CareAverage Daily Dose of OpioidsBaseline55.252 MME/day
Usual CareAverage Daily Dose of Opioids3-Month Follow-Up56.695 MME/day
Usual CareAverage Daily Dose of Opioids6-Month Follow-Up55.563 MME/day
Secondary

Count of Health Care Encounters by Type (Health Care Utilization)

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

ArmMeasureGroupValue (MEAN)
Cognitive Behavioral Therapy (CBT) InterventionCount of Health Care Encounters by Type (Health Care Utilization)Total Ambulatory Encounters20.85 Health care encounters
Cognitive Behavioral Therapy (CBT) InterventionCount of Health Care Encounters by Type (Health Care Utilization)Total Pain-Related Ambulatory Encounters10.42 Health care encounters
Cognitive Behavioral Therapy (CBT) InterventionCount of Health Care Encounters by Type (Health Care Utilization)Telephone or Email Encounters24.04 Health care encounters
Cognitive Behavioral Therapy (CBT) InterventionCount of Health Care Encounters by Type (Health Care Utilization)Inpatient Hospital Encounters0.22 Health care encounters
Usual CareCount of Health Care Encounters by Type (Health Care Utilization)Inpatient Hospital Encounters0.28 Health care encounters
Usual CareCount of Health Care Encounters by Type (Health Care Utilization)Total Ambulatory Encounters21.59 Health care encounters
Usual CareCount of Health Care Encounters by Type (Health Care Utilization)Telephone or Email Encounters23.18 Health care encounters
Usual CareCount of Health Care Encounters by Type (Health Care Utilization)Total Pain-Related Ambulatory Encounters10.11 Health care encounters
Secondary

Health Care Costs

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

ArmMeasureGroupValue (MEAN)
Cognitive Behavioral Therapy (CBT) InterventionHealth Care CostsTotal Health Care Costs21,372 Dollars
Cognitive Behavioral Therapy (CBT) InterventionHealth Care CostsTotal Pain-Related Health Care Costs9,395 Dollars
Usual CareHealth Care CostsTotal Health Care Costs25,648 Dollars
Usual CareHealth Care CostsTotal Pain-Related Health Care Costs11,343 Dollars
Secondary

Inpatient Hospital Days (Health Care Utilization)

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

ArmMeasureValue (MEAN)
Cognitive Behavioral Therapy (CBT) InterventionInpatient Hospital Days (Health Care Utilization)0.86 Days
Usual CareInpatient Hospital Days (Health Care Utilization)0.22 Days
Secondary

Pain-related Disability

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

ArmMeasureGroupValue (MEAN)
Cognitive Behavioral Therapy (CBT) InterventionPain-related Disability3-Month Follow-Up0.612 score on a scale
Cognitive Behavioral Therapy (CBT) InterventionPain-related Disability9-Month Follow-Up0.607 score on a scale
Cognitive Behavioral Therapy (CBT) InterventionPain-related Disability6-Month Follow-Up0.609 score on a scale
Cognitive Behavioral Therapy (CBT) InterventionPain-related Disability12-Month Follow-Up0.604 score on a scale
Cognitive Behavioral Therapy (CBT) InterventionPain-related DisabilityBaseline0.672 score on a scale
Usual CarePain-related Disability12-Month Follow-Up0.683 score on a scale
Usual CarePain-related DisabilityBaseline0.692 score on a scale
Usual CarePain-related Disability3-Month Follow-Up0.675 score on a scale
Usual CarePain-related Disability6-Month Follow-Up0.678 score on a scale
Usual CarePain-related Disability9-Month Follow-Up0.681 score on a scale
Secondary

Patient Satisfaction

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)

ArmMeasureGroupValue (MEAN)
Cognitive Behavioral Therapy (CBT) InterventionPatient SatisfactionSatisfaction with primary care services (Post-Treatment)4.240 score on a scale
Cognitive Behavioral Therapy (CBT) InterventionPatient SatisfactionSatisfaction with primary care services (Baseline)4.263 score on a scale
Cognitive Behavioral Therapy (CBT) InterventionPatient SatisfactionSatisfaction with pain services (Baseline)3.658 score on a scale
Cognitive Behavioral Therapy (CBT) InterventionPatient SatisfactionSatisfaction with pain services (Post-Treatment)4.080 score on a scale
Usual CarePatient SatisfactionSatisfaction with pain services (Post-Treatment)3.667 score on a scale
Usual CarePatient SatisfactionSatisfaction with pain services (Baseline)3.581 score on a scale
Usual CarePatient SatisfactionSatisfaction with primary care services (Baseline)4.237 score on a scale
Usual CarePatient SatisfactionSatisfaction with primary care services (Post-Treatment)3.984 score on a scale
Secondary

Total Pharmacy Dispenses (Health Care Utilization)

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

Time frame: Collected for 1 year post-randomization

ArmMeasureValue (MEAN)
Cognitive Behavioral Therapy (CBT) InterventionTotal Pharmacy Dispenses (Health Care Utilization)50.45 Prescriptions dispensed
Usual CareTotal Pharmacy Dispenses (Health Care Utilization)52.22 Prescriptions dispensed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026