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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Oregon Health and Science University
Duke University
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01888146
First received: May 16, 2013
Last updated: February 21, 2014
Last verified: October 2013
  Purpose

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 Intervention
Chronic Non-malignant Pain
Behavioral: Interdisciplinary pain program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Collaborative Care for Chronic Pain in Primary Care

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Brief Pain Inventory [ Time Frame: Collected every 3 months for 1 year ] [ Designated as safety issue: No ]
    Reliable and valid tool that measures patients' pain intensity and functional interference.


Secondary Outcome Measures:
  • Health care utilization and cost [ Time Frame: Collected every 3 months for 1 year ] [ Designated as safety issue: No ]
    Primary care and specialty care services


Other Outcome Measures:
  • Morphine equivalents [ Time Frame: Collected every 3 months for 1 year ] [ Designated as safety issue: No ]
    Opioid dose measured in morphine equivalents

  • Patient satisfaction [ Time Frame: Collected every 3 months for 1 year ] [ Designated as safety issue: No ]
    Patient satisfaction with health care services


Estimated Enrollment: 50
Study Start Date: May 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01888146

Locations
United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Kaiser Permanente
Oregon Health and Science University
Duke University
Investigators
Principal Investigator: Lynn DeBar, PhD, MHP Kaiser Permanente
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01888146     History of Changes
Other Study ID Numbers: 1UH2AT007788-01
Study First Received: May 16, 2013
Last Updated: February 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
Pain management
Opioid use
Pragmatic
Collaborative care
Primary care

ClinicalTrials.gov processed this record on November 27, 2014