SEACAP: Improving Chronic Pain Treatment in Primary Care

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00129480
• Collaborator: (none)
• Enrollment: 401
• Location: 1
• Arms: 2
• Duration (Months): 53.9
• Patients Per Site Per Month: 7.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Chronic Disease; Depression	Behavioral: Assistance with Pain treatment	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 401 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Improving the Treatment of Chronic Pain in Primary Care
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Assistance with Pain Treatment Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers	Behavioral: Assistance with Pain treatment; Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months.
No Intervention: Treatment as usual Treatment as usual

Outcome Measures

Primary Outcome Measures

1. Adjusted Change in Pain-related Function (Roland Disability Score) [12 months]

   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

1. Adjusted Change in Depression Severity [12 months]

   Patient Health Questionnaire-9 depression rating scale. Range 0-27 with higher scores representing higher depression severity

2. Adjusted Change in Pain Interference [12 month]

   Chronic Pain Grade interference score. Range 0 to 100 with higher scores representing greater pain interference (worse outcome)

3. Global Impression of Change [12 months]

   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

4. Adjusted Change in Health Related Quality of Life [12 months]

   EQ-5D. Range 3-15 with higher scores representing worse health states

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Portland Health Care System, Portland, OR	Portland	Oregon	United States	97239

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Steven K. Dobscha, MD, VA Portland Health Care System, Portland, OR

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00129480
• Other Study ID Numbers: PMI 03-195
• First Posted: Aug 11, 2005
• Last Update Posted: Apr 23, 2019
• Last Verified: Jan 1, 2019

• Keywords provided by VA Office of Research and Development: veterans; pain and chronic disease; disease management; depression; primary health care; practice guidelines; guideline adherence; narcotics; patient compliance; randomized controlled trial
• Additional relevant MeSH terms: Chronic Pain; Chronic Disease; Depression

Study Results

Participant Flow

Arm/Group Title	Assistance With Pain Treatment	Treatment as Usual
Arm/Group Description	Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months.	Pain treatment as usual
Period Title: Overall Study
STARTED	187	214
COMPLETED	187	214
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Assistance With Pain Treatment	Treatment as Usual	Total
Arm/Group Description	Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months.	Treatment as usual which includes standard pain care, clinician generated referrals for additional consultation and ancillary services	Total of all reporting groups
Overall Participants	187	214	401
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.3 (12.3)	62.1 (11.2)	61.7 (11.8)
Sex: Female, Male (Count of Participants)
Female	15 8%	18 8.4%	33 8.2%
Male	172 92%	196 91.6%	368 91.8%
Race/Ethnicity, Customized (Count of Participants)
White	168 89.8%	189 88.3%	357 89%
Black	2 1.1%	5 2.3%	7 1.7%
American Indian/Alaska Native	7 3.7%	6 2.8%	13 3.2%
Unknown	10 5.3%	14 6.5%	24 6%
Region of Enrollment (Count of Participants)
United States	187 100%	214 100%	401 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Assistance With Pain Treatment (Intervention)	Treatment as Usual
Arm/Group Description	Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months.	Pain treatment as usual
Measure Participants	187	214
Mean (95% Confidence Interval) [units on a scale]	-1.4	-0.2

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Assistance With Pain Treatment (Intervention)	Treatment as Usual
Arm/Group Description	Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months.	Pain treatment as usual
Measure Participants	187	214
Mean (95% Confidence Interval) [units on a scale]	-3.7	-1.2

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Assistance With Pain Treatment (Intervention)	Treatment as Usual
Arm/Group Description	Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months.	Pain treatment as usual
Measure Participants	187	214
Mean (95% Confidence Interval) [units on a scale]	-5.7	2.3

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Assistance With Pain Treatment (Intervention)	Treatment as Usual
Arm/Group Description	Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months.	Pain treatment as usual
Measure Participants	187	214
Mean (95% Confidence Interval) [units on a scale]	3.7	4.4

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Assistance With Pain Treatment (Intervention)	Treatment as Usual
Arm/Group Description	Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months.	Pain treatment as usual
Measure Participants	187	214
Mean (95% Confidence Interval) [units on a scale]	-0.02	-0.04

Adverse Events

Arm/Group Title	Assistance With Pain Treatment		Treatment as Usual
Arm/Group Description	Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months.		Treatment as usual, which includes standard pain care, clinician-generated referrals for additional consultation and ancillary services
All Cause Mortality
	Assistance With Pain Treatment		Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Assistance With Pain Treatment		Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/187 (0%)		0/214 (0%)
Other (Not Including Serious) Adverse Events
	Assistance With Pain Treatment		Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/187 (0%)		0/214 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.