Trial Outcomes & Findings for Improving Chronic Pain Treatment in Primary Care (NCT NCT00129480)

NCT ID: NCT00129480

Last Updated: 2019-04-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 401 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2019-04-23

Participant Flow

Participant milestones

Measure	Assistance With Pain Treatment 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 Pain treatment as usual
Overall Study STARTED	187	214
Overall Study COMPLETED	187	214
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Chronic Pain Treatment in Primary Care

Baseline characteristics by cohort

Measure	Assistance With Pain Treatment n=187 Participants 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 n=214 Participants Treatment as usual which includes standard pain care, clinician generated referrals for additional consultation and ancillary services	Total n=401 Participants Total of all reporting groups
Age, Continuous	61.3 years STANDARD_DEVIATION 12.3 • n=5 Participants	62.1 years STANDARD_DEVIATION 11.2 • n=7 Participants	61.7 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	172 Participants n=5 Participants	196 Participants n=7 Participants	368 Participants n=5 Participants
Race/Ethnicity, Customized White	168 Participants n=5 Participants	189 Participants n=7 Participants	357 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized American Indian/Alaska Native	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment United States	187 Participants n=5 Participants	214 Participants n=7 Participants	401 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Assistance With Pain Treatment (Intervention) n=187 Participants 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 n=214 Participants Pain treatment as usual
Adjusted Change in Pain-related Function (Roland Disability Score)	-1.4 units on a scale Interval -2.0 to -0.71	-0.2 units on a scale Interval -0.8 to 0.4

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	Assistance With Pain Treatment (Intervention) n=187 Participants 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 n=214 Participants Pain treatment as usual
Adjusted Change in Depression Severity	-3.7 units on a scale Interval -4.9 to -0.24	-1.2 units on a scale Interval -4.9 to -0.24

SECONDARY outcome

Timeframe: 12 month

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

Outcome measures

Measure	Assistance With Pain Treatment (Intervention) n=187 Participants 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 n=214 Participants Pain treatment as usual
Adjusted Change in Pain Interference	-5.7 units on a scale Interval -9.8 to -1.7	2.3 units on a scale Interval -1.6 to 6.1

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Assistance With Pain Treatment (Intervention) n=187 Participants 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 n=214 Participants Pain treatment as usual
Global Impression of Change	3.7 units on a scale Interval 3.5 to 3.8	4.4 units on a scale Interval 4.3 to 4.6

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	Assistance With Pain Treatment (Intervention) n=187 Participants 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 n=214 Participants Pain treatment as usual
Adjusted Change in Health Related Quality of Life	-0.02 units on a scale Interval -0.05 to 0.01	-0.04 units on a scale Interval -0.05 to -0.02

Adverse Events

Assistance With Pain Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment as Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven K. Dobscha MD

Portland VA Medical Center

Phone: 503-220-8262

Email: steven.dobscha@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place