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Trial record 27 of 37 for:    Developmental Disabilities | ( Map: Oregon, United States )

Improving Chronic Pain Treatment in Primary Care (SEACAP)

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ClinicalTrials.gov Identifier: NCT00129480
Recruitment Status : Completed
First Posted : August 11, 2005
Results First Posted : February 24, 2015
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pain
Chronic Disease
Depression
Intervention Behavioral: Assistance with Pain treatment
Enrollment 401
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Assistance With Pain Treatment Treatment as Usual
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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
Arm/Group Title Assistance With Pain Treatment Treatment as Usual Total
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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 Number of Baseline Participants 187 214 401
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Veterans receiving healthcare in VA primary care
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 187 participants 214 participants 401 participants
61.3  (12.3) 62.1  (11.2) 61.7  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 187 participants 214 participants 401 participants
Female
15
   8.0%
18
   8.4%
33
   8.2%
Male
172
  92.0%
196
  91.6%
368
  91.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 187 participants 214 participants 401 participants
White 168 189 357
Black 2 5 7
American Indian/Alaska Native 7 6 13
Unknown 10 14 24
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 187 participants 214 participants 401 participants
187
 100.0%
214
 100.0%
401
 100.0%
1.Primary Outcome
Title Adjusted Change in Pain-related Function (Roland Disability Score)
Hide 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
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Assistance With Pain Treatment (Intervention) Treatment as Usual
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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
Overall Number of Participants Analyzed 187 214
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-1.4
(-2.0 to -.71)
-0.2
(-0.8 to 0.4)
2.Secondary Outcome
Title Adjusted Change in Depression Severity
Hide Description Patient Health Questionnaire-9 depression rating scale. Range 0-27 with higher scores representing higher depression severity
Time Frame 12 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Assistance With Pain Treatment (Intervention) Treatment as Usual
Hide 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
Overall Number of Participants Analyzed 187 214
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-3.7
(-4.9 to -0.24)
-1.2
(-4.9 to -0.24)
3.Secondary Outcome
Title Adjusted Change in Pain Interference
Hide Description Chronic Pain Grade interference score. Range 0 to 100 with higher scores representing greater pain interference (worse outcome)
Time Frame 12 month
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Assistance With Pain Treatment (Intervention) Treatment as Usual
Hide 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
Overall Number of Participants Analyzed 187 214
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-5.7
(-9.8 to -1.7)
2.3
(-1.6 to 6.1)
4.Secondary Outcome
Title Global Impression of Change
Hide 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
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Assistance With Pain Treatment (Intervention) Treatment as Usual
Hide 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
Overall Number of Participants Analyzed 187 214
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
3.7
(3.5 to 3.8)
4.4
(4.3 to 4.6)
5.Secondary Outcome
Title Adjusted Change in Health Related Quality of Life
Hide Description EQ-5D. Range 3-15 with higher scores representing worse health states
Time Frame 12 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Assistance With Pain Treatment (Intervention) Treatment as Usual
Hide 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
Overall Number of Participants Analyzed 187 214
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.02
(-0.05 to 0.01)
-0.04
(-0.05 to -0.02)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Assistance With Pain Treatment Treatment as Usual
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Assistance With Pain Treatment Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/187 (0.00%)   0/214 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Assistance With Pain Treatment Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/187 (0.00%)   0/214 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Steven K. Dobscha MD
Organization: Portland VA Medical Center
Phone: 503-220-8262 ext 52207
Publications of Results:
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.
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00129480     History of Changes
Other Study ID Numbers: PMI 03-195
First Submitted: August 9, 2005
First Posted: August 11, 2005
Results First Submitted: June 10, 2014
Results First Posted: February 24, 2015
Last Update Posted: April 23, 2019