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Pain Program for Active Coping & Training (PPACT-UH2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01888146
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : December 23, 2015
Oregon Health and Science University
Duke University
Information provided by (Responsible Party):
Kaiser Permanente

Tracking Information
First Submitted Date  ICMJE May 16, 2013
First Posted Date  ICMJE June 27, 2013
Last Update Posted Date December 23, 2015
Study Start Date  ICMJE May 2013
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
Brief Pain Inventory [ Time Frame: Collected every 3 months for 1 year ]
Reliable and valid tool that measures patients' pain intensity and functional interference.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
Health care utilization and cost [ Time Frame: Collected every 3 months for 1 year ]
Primary care and specialty care services
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 25, 2013)
  • Morphine equivalents [ Time Frame: Collected every 3 months for 1 year ]
    Opioid dose measured in morphine equivalents
  • Patient satisfaction [ Time Frame: Collected every 3 months for 1 year ]
    Patient satisfaction with health care services
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE Pain Program for Active Coping & Training
Official Title  ICMJE Collaborative Care for Chronic Pain in 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 proposing a mixed-methods, cluster-randomized pragmatic clinical trial that will evaluate the integration of psychosocial services within the primary care environment. This project will implement 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 will be an integrated program that will guide all care for intervention patients. We will compare this primary care-based intervention to usual care using systematic, clinic-based assessments. During the initial phase, we will pilot the intervention with up to 50 patients in the Kaiser Permanente Northwest (KPNW) region with patients 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 pilot portion of the project is in preparation for the effective implementation of a large-scale, cluster-randomized pragmatic clinical trial to be conducted throughout three regions of Kaiser Permanente - Northwest, Georgia, and Hawaii comparing this primary care based multidisciplinary intervention to usual care in these settings.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Chronic Non-malignant Pain
Intervention  ICMJE Behavioral: Interdisciplinary pain program
Interdisciplinary pain program, which includes behavioral health, nurse case management, physical therapy, and pharmacy embedded in primary care.
Study Arms  ICMJE
  • Experimental: Interdisciplinary pain program
    Interdisciplinary pain program, which includes behavioral health, nurse case management, physical therapy, and pharmacy embedded in primary care.
    Intervention: Behavioral: Interdisciplinary pain program
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 14, 2015)
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2013)
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Paneled to a primary care provider practicing at one of the primary care clinics participating in the study
  • ≥18 years of age at time of inclusion. Current adult KP member (18 years or older)
  • Within the last 180 days either:

    • 90 day supply of short acting opioid spanning at least 120 days
    • or more long acting opioid dispenses
  • Pain diagnostic ICD-9 code within the past 180 days

    • Diagnostic categories include but are not limited to: Back pain, neck pain, fibromyalgia, arthritis, myofascial pain, neuropathies, migraine, tension headache, temporomandibular joint disorder, carpal tunnel syndrome, nonspecific chronic pain, abdominal pain, pelvic pain
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01888146
Other Study ID Numbers  ICMJE 1UH2AT007788-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kaiser Permanente
Study Sponsor  ICMJE Kaiser Permanente
Collaborators  ICMJE
  • Oregon Health and Science University
  • Duke University
Investigators  ICMJE
Principal Investigator: Lynn DeBar, PhD, MHP Kaiser Permanente
PRS Account Kaiser Permanente
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP