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Improving Chronic Pain Treatment in Primary Care (SEACAP)

Primary Purpose

Pain, Chronic Disease, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Assistance with Pain treatment
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring veterans, pain and chronic disease, disease management, depression, primary health care, practice guidelines, guideline adherence, narcotics, patient compliance, randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Portland Health Care System, Portland, OR

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Assistance with Pain Treatment

Treatment as usual

Arm Description

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

Treatment as usual

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adjusted Change in Depression Severity
Patient Health Questionnaire-9 depression rating scale. Range 0-27 with higher scores representing higher depression severity
Adjusted Change in Pain Interference
Chronic Pain Grade interference score. Range 0 to 100 with higher scores representing greater pain interference (worse outcome)
Global Impression of Change
Global impression of change score. Rated at 12 months capturing patient impression of change over past 6 months. Range 1-7 with lower scores representing greater improvement
Adjusted Change in Health Related Quality of Life
EQ-5D. Range 3-15 with higher scores representing worse health states

Full Information

First Posted
August 9, 2005
Last Updated
January 18, 2019
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00129480
Brief Title
Improving Chronic Pain Treatment in Primary Care
Acronym
SEACAP
Official Title
Improving the Treatment of Chronic Pain in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Background: Chronic pain is very common, and associated with substantial impairment and increased healthcare utilization. Implementation of treatment guidelines has been problematic, and chronic pain remains undertreated. Because of the prevalence of chronic pain among veterans, the VHA created a National Pain Management Strategy and adopted pain as the "5th vital sign." Objectives: Our primary objective was to determine to what extent a collaborative intervention improves chronic pain-related outcomes (pain-related function, pain severity and depression severity) in a VA primary care setting over six and 12 months. We also investigated to what extent the intervention affected 1) treatment of comorbid depression, 2) adherence of providers to guidelines for chronic pain, 3) patient and provider satisfaction and attitudes related to chronic pain treatment, and 4) incremental benefit (pain disability-free days) and incremental health services costs. Methods: The study was a cluster randomized controlled trial of a collaborative care intervention "Assistance with Pain Treatment" (APT) versus treatment as usual (TAU) at five primary care clinics of one Department of Veterans Affairs Medical Center. 401 patients and 42 primary care clinicians participated. APT included a 2-session clinician education program, patient assessment, education and activation, symptom monitoring, feedback and recommendations to clinicians and facilitation of specialty care. We randomized clinicians to APT or TAU, and nested patients within clinician intervention status. Patients were recruited via mailings and advertising flyers; those with chart-documented musculoskeletal pain diagnoses who reported at least moderate pain severity and pain-related function (Chronic Pain Grade [CPG]) lasting at least 12 weeks were invited to participate. Participants completed questionnaires at baseline, 3, 6 and 12 months, with a subset re-assessed at 30 months. Primary outcomes were Roland-Morris Disability scores and CPG pain intensity scale scores over 12 months. Depression was assessed using Patient Health Questionnaire 9 [PHQ-9] scores. Intervention effects on patient outcome variables were tested using intention-to-treat analyses with multilevel models; patient-level covariates of age, sex, baseline depression severity, baseline opioid status (yes/no), and medical morbidity were included. To quantify provider adherence to pain treatment guidelines, we created the Pain Process Measure (PPM), a chart review checklist. Clinicians completed a baseline 23-item survey of attitudes and behaviors related to chronic pain management, job satisfaction, and satisfaction with local pain resources. Patient satisfaction measures included patient-rated global impression of change, global VA health care satisfaction, health-related quality of life, and receipt and rating of effectiveness of VA chronic pain treatment. Pain disability-free days were calculated from Roland-Morris Disability Questionnaire scores. Data on VA treatment costs were obtained from the VA's Decision Support System for all utilization except certain intervention activities that were tracked in a separate study database. Status: Complete.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic Disease, Depression
Keywords
veterans, pain and chronic disease, disease management, depression, primary health care, practice guidelines, guideline adherence, narcotics, patient compliance, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
401 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Assistance with Pain Treatment
Arm Type
Experimental
Arm Description
Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Assistance with Pain treatment
Intervention Description
Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months.
Primary Outcome Measure Information:
Title
Adjusted Change in Pain-related Function (Roland Disability Score)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Adjusted Change in Depression Severity
Description
Patient Health Questionnaire-9 depression rating scale. Range 0-27 with higher scores representing higher depression severity
Time Frame
12 months
Title
Adjusted Change in Pain Interference
Description
Chronic Pain Grade interference score. Range 0 to 100 with higher scores representing greater pain interference (worse outcome)
Time Frame
12 month
Title
Global Impression of Change
Description
Global impression of change score. Rated at 12 months capturing patient impression of change over past 6 months. Range 1-7 with lower scores representing greater improvement
Time Frame
12 months
Title
Adjusted Change in Health Related Quality of Life
Description
EQ-5D. Range 3-15 with higher scores representing worse health states
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Dementia or cognitive disturbance Diagnoses of fibromyalgia, chronic fatigue or somatization disorder Terminal illness Designated guardian Drug-seeking behavior flag in medical record
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven K. Dobscha, MD
Organizational Affiliation
VA Portland Health Care System, Portland, OR
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16937344
Citation
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.
Results Reference
background
PubMed Identifier
19318652
Citation
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.
Results Reference
result
PubMed Identifier
18291290
Citation
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.
Results Reference
result
PubMed Identifier
18565008
Citation
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.
Results Reference
result
PubMed Identifier
17537251
Citation
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.
Results Reference
result
PubMed Identifier
19952802
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
20851057
Citation
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.
Results Reference
result
PubMed Identifier
21185119
Citation
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.
Results Reference
result
PubMed Identifier
18777608
Citation
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.
Results Reference
result
PubMed Identifier
22234716
Citation
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.
Results Reference
result
PubMed Identifier
21562923
Citation
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.
Results Reference
result
PubMed Identifier
21943325
Citation
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.
Results Reference
result
PubMed Identifier
25554014
Citation
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.
Results Reference
result

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Improving Chronic Pain Treatment in Primary Care

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