NCT02113592

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
850

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

April 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

May 18, 2022

Completed
Last Updated

August 28, 2023

Status Verified

April 1, 2022

Enrollment Period

3.8 years

First QC Date

April 7, 2014

Results QC Date

January 7, 2022

Last Update Submit

August 24, 2023

Conditions

Chronic Non-malignant Pain

Keywords

Pain managementOpioid usePragmaticCollaborative carePrimary care

Outcome Measures

Primary Outcomes (1)

  • Pain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form ("PEGS")

    Reliable and valid tool that measures patients' pain intensity and functional interference. The primary outcome of pain impact is assessed with the 4-item PEGS scale, a composite of pain intensity, and interference with enjoyment of life, general activity, and sleep (range, 0-10, higher score = worse pain impact).

    Collected every 3 months for 1 year

Secondary Outcomes (7)

  • Pain-related Disability

    Collected every 3 months for 1 year

  • Average Daily Dose of Opioids

    Collected every 3 months for 1 year

  • Patient Satisfaction

    Collected at baseline and 6 months (post-treatment)

  • Health Care Costs

    Collected for 1 year post-randomization

  • Count of Health Care Encounters by Type (Health Care Utilization)

    Collected for 1 year post-randomization

  • +2 more secondary outcomes

Study Arms (2)

Interdisciplinary pain program

EXPERIMENTAL

Interdisciplinary pain program, which includes behavioral health, nurse case management, physical therapy, and pharmacy embedded in primary care.

Behavioral: Interdisciplinary pain program

Treatment as usual

NO INTERVENTION

Patients in this arm will receive care as usual and utilize services as they currently exist in the health plan system.

Interventions

Interdisciplinary pain programBEHAVIORAL

Interdisciplinary pain program, which includes behavioral health, nurse case management, physical therapy, and pharmacy embedded in primary care.

Interdisciplinary pain program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Kaiser Permanente health plan membership of at least 180 days duration
  • 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
  • Pain diagnosis within the past year (based on ICD-9 or ICD-10 diagnostic codes)
  • English speaking

You may not qualify if:

  • Currently enrolled in intensive addiction medicine services or evidence of active substance dependence
  • Cognitive impairment severe enough to preclude patient's participation in a behavioral/lifestyle change program
  • Current malignant cancer diagnosis
  • Having received hospice or other end-of-life palliative care within past year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kaiser Permanente Center for Health Research

Atlanta, Georgia, 30305, United States

Location

Kaiser Permanente Center for Health Research

Honolulu, Hawaii, 96817, United States

Location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Related Publications (6)

  • 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.

    PMID: 35352703RESULT

  • 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.

    PMID: 34724405RESULT

  • 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.

    PMID: 32083219DERIVED

  • 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.

    PMID: 29633139DERIVED

  • 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.

    PMID: 29522897DERIVED

  • 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.

    PMID: 26772801DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Lynn DeBar, PhD, MPH, Principal Investigator
Organization
Kaiser Permanente Washington Health Research Institute
lynn.debar@kp.org
206-287-2900

Study Officials

  • Lynn DeBar, PhD, MPH

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2014

First Posted

April 14, 2014

Study Start

April 10, 2014

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

August 28, 2023

Results First Posted

May 18, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(3)