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Pain Program for Active Coping & Training (PPACT-UH3)

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ClinicalTrials.gov Identifier: NCT02113592
Recruitment Status : Completed
First Posted : April 14, 2014
Last Update Posted : November 20, 2018
Sponsor:
Collaborators:
Oregon Health and Science University
Duke University
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Drug Abuse (NIDA)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Kaiser Permanente

Tracking Information
First Submitted Date  ICMJE April 7, 2014
First Posted Date  ICMJE April 14, 2014
Last Update Posted Date November 20, 2018
Study Start Date  ICMJE March 2014
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2018)
4-Item Version of Brief Pain Inventory-Short Form ("PEGS") [ 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
 (submitted: April 10, 2014)
Brief Pain Inventory [ Time Frame: Collected every 3 months for 1 year ]
Reliable and valid tool that measures patients' pain intensity and functional interference.
Change History Complete list of historical versions of study NCT02113592 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2014)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE
 (submitted: April 10, 2014)
  • 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)
Original Other Outcome Measures  ICMJE 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 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.

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
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
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2018)
851
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2014)
2000
Actual Study Completion Date February 2018
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers 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 NCT02113592
Other Study ID Numbers  ICMJE 4UH3NS088731-02( U.S. NIH Grant/Contract )
UH2AT007788 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Kaiser Permanente
Study Sponsor  ICMJE Kaiser Permanente
Collaborators  ICMJE
  • Oregon Health and Science University
  • Duke University
  • National Institutes of Health (NIH)
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • National Institute on Drug Abuse (NIDA)
  • National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Lynn DeBar, PhD, MPH Kaiser Permanente
PRS Account Kaiser Permanente
Verification Date November 2018

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