Computerized Decision Support Tool for Pain Management in Primary Care

Pain Management in Primary Care: A Randomized Controlled Trial of a Computerized Decision Support Tool

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Early intervention; Other: Delayed intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 528
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Treated at the Institute for Family Health
2. Spoke English or Spanish
3. Received one or more prescriptions for an opioid or nonopioid analgesic during the past three months
4. Pain screening at the prior three office visits documented scores >3 on the 0-6 scale (FACES, Hicks et al., 2001).
5. Willingness to complete questionnaires three times
6. A commitment to return to the practice
7. Reachable by phone
8. No evidence of psychopathology or cognitive impairment severe enough to prevent informed consent or completing the survey instruments

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early intervention; Three sites received the Pain Management Support System for Primary Care (PMSS-PC) integrated into the Electronic Health Record.	Other: Early intervention; 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.
Other: Delayed intervention; Delayed wait-list control group. Three additional sites received the intervention 6 months after the first arm.	Other: Delayed intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to 6 months following intervention implementation
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.	From baseline to 6 months following intervention implementation
Pain Interference with Function	Pain interference T-score, measured on the PROMIS Pain Interference Short Form. Higher scores indicate more pain interference with function.	From baseline to 6 months following intervention implementation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From 6 to 12 months following intervention implementation
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.	From 6 to 12 months following intervention implementation
Pain Interference with Function	Pain interference T-score, measured on the PROMIS Pain Interference Short Form. Higher scores indicate more pain interference with function.	From 6 to 12 months following intervention implementation
Uptake of the PMSS-PC intervention tool	Use of the PMSS-PC decision support tool by primary care providers	From baseline to 12 months following intervention implementation

Collaborators and Investigators

• Sponsor: MJHS Institute for Innovation in Palliative Care
• Collaborators: Pfizer; The Institute for Family Health

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2013
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 8408357

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No