NCT00129480

Brief Summary

The primary objective of this study is to determine to what extent a collaborative intervention improves chronic pain-related outcomes in a VA primary care setting. We will also determine to what extent the intervention affects 1) treatment of co-occurring depression, 2) adherence of providers to guidelines for treating chronic pain, and 3) patient and provider satisfaction and attitudes related to chronic pain treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
401

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable pain

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

First Submitted

Initial submission to the registry

August 9, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2005

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

February 24, 2015

Completed
Last Updated

April 23, 2019

Status Verified

January 1, 2019

Enrollment Period

3 years

First QC Date

August 9, 2005

Results QC Date

June 10, 2014

Last Update Submit

January 18, 2019

Conditions

PainChronic DiseaseDepression

Keywords

veteranspain and chronic diseasedisease managementdepressionprimary health carepractice guidelinesguideline adherencenarcoticspatient compliancerandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Adjusted Change in Pain-related Function (Roland Disability Score)

    The Roland Morris Disability Questionnaire has 24 yes or no items. Each item is scored as 0 or 1. Item scores or summed to create total score with range 0 to 24. Higher scores represent greater disability. The Roland Morris has been widely used, has content and construct validity, internal consistency, and responsiveness to change among patients with chronic pain.

    12 months

Secondary Outcomes (4)

  • Adjusted Change in Depression Severity

    12 months

  • Adjusted Change in Pain Interference

    12 month

  • Global Impression of Change

    12 months

  • Adjusted Change in Health Related Quality of Life

    12 months

Study Arms (2)

Assistance with Pain Treatment

EXPERIMENTAL

Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers

Behavioral: Assistance with Pain treatment

Treatment as usual

NO INTERVENTION

Treatment as usual

Interventions

Assistance with Pain treatmentBEHAVIORAL

Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months.

Assistance with Pain Treatment

Eligibility Criteria

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

You may qualify if:

  • Patients currently receiving primary care at Portland VAMC
  • Diagnosed musculoskeletal chronic pain condition lasting at least 3 months
  • Currently experiencing moderate to severe symptoms as per screening
  • Willingness to complete 6 and 12 month interviews
  • Regular access to a telephone

You may not qualify if:

  • Dementia or cognitive disturbance
  • Diagnoses of fibromyalgia, chronic fatigue or somatization disorder Terminal illness
  • Designated guardian
  • Drug-seeking behavior flag in medical record

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

Related Publications (14)

  • Otis JD, Macdonald A, Dobscha SK. Integration and coordination of pain management in primary care. J Clin Psychol. 2006 Nov;62(11):1333-43. doi: 10.1002/jclp.20313.

    PMID: 16937344BACKGROUND

  • Dobscha SK, Corson K, Perrin NA, Hanson GC, Leibowitz RQ, Doak MN, Dickinson KC, Sullivan MD, Gerrity MS. Collaborative care for chronic pain in primary care: a cluster randomized trial. JAMA. 2009 Mar 25;301(12):1242-52. doi: 10.1001/jama.2009.377.

    PMID: 19318652RESULT

  • Morasco BJ, Dobscha SK. Prescription medication misuse and substance use disorder in VA primary care patients with chronic pain. Gen Hosp Psychiatry. 2008 Mar-Apr;30(2):93-9. doi: 10.1016/j.genhosppsych.2007.12.004.

    PMID: 18291290RESULT

  • Dobscha SK, Corson K, Leibowitz RQ, Sullivan MD, Gerrity MS. Rationale, design, and baseline findings from a randomized trial of collaborative care for chronic musculoskeletal pain in primary care. Pain Med. 2008 Nov;9(8):1050-64. doi: 10.1111/j.1526-4637.2008.00457.x. Epub 2008 Jun 18.

    PMID: 18565008RESULT

  • Dobscha SK, Leibowitz RQ, Flores JA, Doak M, Gerrity MS. Primary care provider preferences for working with a collaborative support team. Implement Sci. 2007 May 30;2:16. doi: 10.1186/1748-5908-2-16.

    PMID: 17537251RESULT

  • Dickinson KC, Sharma R, Duckart JP, Corson K, Gerrity MS, Dobscha SK. VA healthcare costs of a collaborative intervention for chronic pain in primary care. Med Care. 2010 Jan;48(1):38-44. doi: 10.1097/MLR.0b013e3181bd49e2.

    PMID: 19952802RESULT

  • Morasco BJ, Dobscha SK. Impact of comorbid substance use disorder on pain functioning: 12-month follow-up evaluation. [Abstract]. Annals of behavioral medicine : a publication of the Society of Behavioral Medicine. 2010 Apr 1; 39(Suppl):S185.

    RESULT

  • Morasco BJ, Corson K, Turk DC, Dobscha SK. Association between substance use disorder status and pain-related function following 12 months of treatment in primary care patients with musculoskeletal pain. J Pain. 2011 Mar;12(3):352-9. doi: 10.1016/j.jpain.2010.07.010. Epub 2010 Sep 20.

    PMID: 20851057RESULT

  • Morasco BJ, Gritzner S, Lewis L, Oldham R, Turk DC, Dobscha SK. Systematic review of prevalence, correlates, and treatment outcomes for chronic non-cancer pain in patients with comorbid substance use disorder. Pain. 2011 Mar;152(3):488-497. doi: 10.1016/j.pain.2010.10.009. Epub 2010 Dec 23.

    PMID: 21185119RESULT

  • Dobscha SK, Corson K, Flores JA, Tansill EC, Gerrity MS. Veterans affairs primary care clinicians' attitudes toward chronic pain and correlates of opioid prescribing rates. Pain Med. 2008 Jul-Aug;9(5):564-71. doi: 10.1111/j.1526-4637.2007.00330.x.

    PMID: 18777608RESULT

  • Denneson LM, Corson K, Dobscha SK. Complementary and alternative medicine use among veterans with chronic noncancer pain. J Rehabil Res Dev. 2011;48(9):1119-28. doi: 10.1682/jrrd.2010.12.0243.

    PMID: 22234716RESULT

  • Morasco BJ, Duckart JP, Dobscha SK. Adherence to clinical guidelines for opioid therapy for chronic pain in patients with substance use disorder. J Gen Intern Med. 2011 Sep;26(9):965-71. doi: 10.1007/s11606-011-1734-5. Epub 2011 May 12.

    PMID: 21562923RESULT

  • Corson K, Doak MN, Denneson L, Crutchfield M, Soleck G, Dickinson KC, Gerrity MS, Dobscha SK. Primary care clinician adherence to guidelines for the management of chronic musculoskeletal pain: results from the study of the effectiveness of a collaborative approach to pain. Pain Med. 2011 Oct;12(10):1490-501. doi: 10.1111/j.1526-4637.2011.01231.x. Epub 2011 Sep 21.

    PMID: 21943325RESULT

  • Thielke S, Corson K, Dobscha SK. Collaborative care for pain results in both symptom improvement and sustained reduction of pain and depression. Gen Hosp Psychiatry. 2015 Mar-Apr;37(2):139-43. doi: 10.1016/j.genhosppsych.2014.11.007. Epub 2014 Nov 21.

    PMID: 25554014RESULT

MeSH Terms

Conditions

PainChronic DiseaseDepressionPatient Compliance

Interventions

Insemination, Artificial, HeterologousAnalgesia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic ProcessesBehavioral SymptomsBehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Intervention Hierarchy (Ancestors)

Insemination, ArtificialReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative TechniquesInseminationReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaAnesthesia and Analgesia

Results Point of Contact

Title
Steven K. Dobscha MD
Organization
Portland VA Medical Center
steven.dobscha@va.gov
503-220-8262

Study Officials

  • Steven K. Dobscha, MD

    VA Portland Health Care System, Portland, OR

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2005

First Posted

August 11, 2005

Study Start

January 1, 2006

Primary Completion

January 1, 2009

Study Completion

July 1, 2010

Last Updated

April 23, 2019

Results First Posted

February 24, 2015

Record last verified: 2019-01

Locations

US(1)