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Trial record 1 of 1 for:    NCT02113592
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Pain Program for Active Coping & Training (PPACT-UH3)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Oregon Health and Science University
Duke University
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT02113592
First received: April 7, 2014
Last updated: February 7, 2017
Last verified: February 2017
  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: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Health Services Research
Official Title: Collaborative Care for Chronic Pain in Primary Care

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Brief Pain Inventory [ Time Frame: Collected every 3 months for 1 year ]
    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 ]

    Utilization includes, but is no limited to: Primary care, ER,urgent care, Pain clinic, Addiction medicine, Neurology, Orthopedics, Rheumatology, Mental health, and pain-related procedures and diagnostics.

    Costs will be measured based on patient utilization of above services and medication costs (opioids and adjuvants used for pain management).



Other Outcome Measures:
  • 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 will be assessed by asking the following two questions:

    • In the past 3 months, how satisfied have you been with your primary care services? (Very dissatisfied, Mildly dissatisfied, Indifferent, Mostly satisfied, Very satisfied)
    • In the past 3 months, how satisfied have you been with the pain services you have received? ((Very dissatisfied, Mildly dissatisfied, Indifferent, Mostly satisfied, Very satisfied)


Estimated Enrollment: 2000
Study Start Date: March 2014
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (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 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 1,200-plus 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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  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: NCT02113592

Locations
United States, Georgia
Kaiser Permanente Center for Health Research
Atlanta, Georgia, United States, 30305
United States, Hawaii
Kaiser Permanente Center for Health Research
Honolulu, Hawaii, United States, 96817
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, MPH Kaiser Permanente
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02113592     History of Changes
Other Study ID Numbers: 4UH3NS088731-02 
Study First Received: April 7, 2014
Last Updated: February 7, 2017
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on February 20, 2017