Clinical trial NCT02113592: Pain Program for Active Coping & Training
Official title: Collaborative Care for Chronic Pain in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Non-malignant Pain
Keywords: Pain management
Opioid use
Pragmatic
Collaborative care
Primary care
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Duke University
name: Oregon Health and Science University
First posted: 2014-04-14
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Pain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form ("PEGS")
timeFrame: Collected every 3 months for 1 year
Secondary outcomes:
measure: Pain-related Disability
timeFrame: Collected every 3 months for 1 year
measure: Average Daily Dose of Opioids
timeFrame: Collected every 3 months for 1 year
measure: Patient Satisfaction
timeFrame: Collected at baseline and 6 months (post-treatment)
measure: Health Care Costs
timeFrame: Collected for 1 year post-randomization
measure: Count of Health Care Encounters by Type (Health Care Utilization)
timeFrame: Collected for 1 year post-randomization
measure: Inpatient Hospital Days (Health Care Utilization)
timeFrame: Collected for 1 year post-randomization
measure: Total Pharmacy Dispenses (Health Care Utilization)
timeFrame: Collected for 1 year post-randomization
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Kaiser Permanente Center for Health Research
state: Georgia
city: Honolulu
country: United States
facility: Kaiser Permanente Center for Health Research
state: Hawaii
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
Study officials:
affiliation: Kaiser Permanente
name: Lynn DeBar, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith DH, O'Keeffe-Rosetti M, Leo MC, Mayhew M, Benes L, Bonifay A, Deyo RA, Elder CR, Keefe FJ, McMullen C, Owen-Smith A, Trinacty CM, Vollmer WM, DeBar L. Economic Evaluation: A Randomized Pragmatic Trial of a Primary Care-based Cognitive Behavioral Intervention for Adults Receiving Long-term Opioids for Chronic Pain. Med Care. 2022 Jun 1;60(6):423-431. doi: 10.1097/MLR.0000000000001713. Epub 2022 Mar 30.
citation: DeBar L, Mayhew M, Benes L, Bonifay A, Deyo RA, Elder CR, Keefe FJ, Leo MC, McMullen C, Owen-Smith A, Smith DH, Trinacty CM, Vollmer WM. A Primary Care-Based Cognitive Behavioral Therapy Intervention for Long-Term Opioid Users With Chronic Pain : A Randomized Pragmatic Trial. Ann Intern Med. 2022 Jan;175(1):46-55. doi: 10.7326/M21-1436. Epub 2021 Nov 2.
citation: Mayhew M, Leo MC, Vollmer WM, DeBar LL, Kiernan M. Interactive group-based orientation sessions: A method to improve adherence and retention in pragmatic clinical trials. Contemp Clin Trials Commun. 2020 Jan 21;17:100527. doi: 10.1016/j.conctc.2020.100527. eCollection 2020 Mar.
citation: Owen-Smith A, Mayhew M, Leo MC, Varga A, Benes L, Bonifay A, DeBar L. Automating Collection of Pain-Related Patient-Reported Outcomes to Enhance Clinical Care and Research. J Gen Intern Med. 2018 May;33(Suppl 1):31-37. doi: 10.1007/s11606-018-4326-9.
citation: DeBar L, Benes L, Bonifay A, Deyo RA, Elder CR, Keefe FJ, Leo MC, McMullen C, Mayhew M, Owen-Smith A, Smith DH, Trinacty CM, Vollmer WM. Interdisciplinary team-based care for patients with chronic pain on long-term opioid treatment in primary care (PPACT) - Protocol for a pragmatic cluster randomized trial. Contemp Clin Trials. 2018 Apr;67:91-99. doi: 10.1016/j.cct.2018.02.015. Epub 2018 Mar 6.
citation: Johnson KE, Neta G, Dember LM, Coronado GD, Suls J, Chambers DA, Rundell S, Smith DH, Liu B, Taplin S, Stoney CM, Farrell MM, Glasgow RE. Use of PRECIS ratings in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. Trials. 2016 Jan 16;17:32. doi: 10.1186/s13063-016-1158-y.