Computerized Decision Support Tool for Pain Management in Primary Care
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Early intervention
Delayed intervention
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- Treated at the Institute for Family Health
- Spoke English or Spanish
- Received one or more prescriptions for an opioid or nonopioid analgesic during the past three months
- Pain screening at the prior three office visits documented scores >3 on the 0-6 scale (FACES, Hicks et al., 2001).
- Willingness to complete questionnaires three times
- A commitment to return to the practice
- Reachable by phone
- No evidence of psychopathology or cognitive impairment severe enough to prevent informed consent or completing the survey instruments
Exclusion Criteria:
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Early intervention
Delayed intervention
Arm Description
Three sites received the Pain Management Support System for Primary Care (PMSS-PC) integrated into the Electronic Health Record.
Delayed wait-list control group. Three additional sites received the intervention 6 months after the first arm.
Outcomes
Primary Outcome Measures
Worst Pain Intensity
Worst pain intensity score on the Brief Pain Inventory-Short Form. Scores range from 0-10, with higher scores indicating more severe worst pain intensity.
Average Pain Intensity
Average pain intensity score on the Brief Pain Inventory-Short Form. Scores range from 0-10, with higher scores indicating more severe average pain intensity.
Pain Interference with Function
Pain interference T-score, measured on the PROMIS Pain Interference Short Form. Higher scores indicate more pain interference with function.
Secondary Outcome Measures
Worst Pain Intensity
Worst pain intensity score on the Brief Pain Inventory-Short Form. Scores range from 0-10, with higher scores indicating more severe worst pain intensity.
Average Pain Intensity
Average pain intensity score on the Brief Pain Inventory-Short Form. Scores range from 0-10, with higher scores indicating more severe average pain intensity.
Pain Interference with Function
Pain interference T-score, measured on the PROMIS Pain Interference Short Form. Higher scores indicate more pain interference with function.
Uptake of the PMSS-PC intervention tool
Use of the PMSS-PC decision support tool by primary care providers
Full Information
NCT ID
NCT04716621
First Posted
January 15, 2021
Last Updated
January 19, 2021
Sponsor
MJHS Institute for Innovation in Palliative Care
Collaborators
Pfizer, The Institute for Family Health
1. Study Identification
Unique Protocol Identification Number
NCT04716621
Brief Title
Computerized Decision Support Tool for Pain Management in Primary Care
Official Title
Pain Management in Primary Care: A Randomized Controlled Trial of a Computerized Decision Support Tool
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 11, 2013 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MJHS Institute for Innovation in Palliative Care
Collaborators
Pfizer, The Institute for Family Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chronic pain is highly prevalent, compromises quality of life, and increases care utilization. Primary care providers are challenged to provide effective treatments, use opioid therapy appropriately, and address the adverse consequences of pain. Technology-enabled decision support tools may provide a means to improve pain management in primary care.
The objective of this study was to evaluate a novel electronic health record (EHR)-based decision support tool-plus-education intervention for pain management in primary care.
Detailed Description
This randomized, wait-list controlled trial evaluated a novel EHR-based system for pain management among patients with chronic pain in six practices of a Federally Qualified Health Center network in New York.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
528 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early intervention
Arm Type
Experimental
Arm Description
Three sites received the Pain Management Support System for Primary Care (PMSS-PC) integrated into the Electronic Health Record.
Arm Title
Delayed intervention
Arm Type
Other
Arm Description
Delayed wait-list control group. Three additional sites received the intervention 6 months after the first arm.
Intervention Type
Other
Intervention Name(s)
Early intervention
Intervention Description
The Pain Management Support System for Primary Care (PMSS-PC) generated "best practice alerts" and gave clinicians access to a pain assessment template, measures of psychological distress and substance use, guidelines for drug and non-drug therapies, and facilitated referrals. At implementation, clinicians at the practices were offered in-person and virtual education through six webinars on best practices for pain.
Intervention Type
Other
Intervention Name(s)
Delayed intervention
Intervention Description
Delayed wait-list control group. The second arm involved three additional sites receiving the PMSS-PC intervention 6 months after the first arm. Initial outcomes from the PMSS-PC Experimental Intervention arm were compared to those of this Wait-list Control arm.
Primary Outcome Measure Information:
Title
Worst Pain Intensity
Description
Worst pain intensity score on the Brief Pain Inventory-Short Form. Scores range from 0-10, with higher scores indicating more severe worst pain intensity.
Time Frame
From baseline to 6 months following intervention implementation
Title
Average Pain Intensity
Description
Average pain intensity score on the Brief Pain Inventory-Short Form. Scores range from 0-10, with higher scores indicating more severe average pain intensity.
Time Frame
From baseline to 6 months following intervention implementation
Title
Pain Interference with Function
Description
Pain interference T-score, measured on the PROMIS Pain Interference Short Form. Higher scores indicate more pain interference with function.
Time Frame
From baseline to 6 months following intervention implementation
Secondary Outcome Measure Information:
Title
Worst Pain Intensity
Description
Worst pain intensity score on the Brief Pain Inventory-Short Form. Scores range from 0-10, with higher scores indicating more severe worst pain intensity.
Time Frame
From 6 to 12 months following intervention implementation
Title
Average Pain Intensity
Description
Average pain intensity score on the Brief Pain Inventory-Short Form. Scores range from 0-10, with higher scores indicating more severe average pain intensity.
Time Frame
From 6 to 12 months following intervention implementation
Title
Pain Interference with Function
Description
Pain interference T-score, measured on the PROMIS Pain Interference Short Form. Higher scores indicate more pain interference with function.
Time Frame
From 6 to 12 months following intervention implementation
Title
Uptake of the PMSS-PC intervention tool
Description
Use of the PMSS-PC decision support tool by primary care providers
Time Frame
From baseline to 12 months following intervention implementation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Treated at the Institute for Family Health
Spoke English or Spanish
Received one or more prescriptions for an opioid or nonopioid analgesic during the past three months
Pain screening at the prior three office visits documented scores >3 on the 0-6 scale (FACES, Hicks et al., 2001).
Willingness to complete questionnaires three times
A commitment to return to the practice
Reachable by phone
No evidence of psychopathology or cognitive impairment severe enough to prevent informed consent or completing the survey instruments
Exclusion Criteria:
-
12. IPD Sharing Statement
Learn more about this trial
Computerized Decision Support Tool for Pain Management in Primary Care
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