NCT01888146

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 27, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 23, 2015

Status Verified

December 1, 2015

Enrollment Period

1.1 years

First QC Date

May 16, 2013

Last Update Submit

December 21, 2015

Conditions

Keywords

Pain managementOpioid usePragmaticCollaborative carePrimary care

Outcome Measures

Primary Outcomes (1)

  • Brief Pain Inventory

    Reliable and valid tool that measures patients' pain intensity and functional interference.

    Collected every 3 months for 1 year

Secondary Outcomes (1)

  • Health care utilization and cost

    Collected every 3 months for 1 year

Other Outcomes (2)

  • Morphine equivalents

    Collected every 3 months for 1 year

  • Patient satisfaction

    Collected every 3 months for 1 year

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 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:

  • Paneled to a primary care provider practicing at one of the primary care clinics participating in the study
  • Within the last 180 days either:
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Lynn DeBar, PhD, MHP

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2013

First Posted

June 27, 2013

Study Start

May 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

December 23, 2015

Record last verified: 2015-12

Locations