Computerized Decision Support Tool for Pain Management in Primary Care

• Sponsor: MJHS Institute for Innovation in Palliative Care (Other)
• Overall Status: Completed
• CT.gov ID: NCT04716621
• Collaborator: Pfizer (Industry), The Institute for Family Health (Other)
• Enrollment: 528
• Arms: 2
• Actual Duration (Months): 28.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Other: Early intervention; Other: Delayed intervention	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 528 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Pain Management in Primary Care: A Randomized Controlled Trial of a Computerized Decision Support Tool
• Actual Study Start Date: Nov 11, 2013
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Worst Pain Intensity [From baseline to 6 months following intervention implementation]

   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.

2. Average Pain Intensity [From baseline to 6 months following intervention implementation]

   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.

3. Pain Interference with Function [From baseline to 6 months following intervention implementation]

   Pain interference T-score, measured on the PROMIS Pain Interference Short Form. Higher scores indicate more pain interference with function.

Secondary Outcome Measures

1. Worst Pain Intensity [From 6 to 12 months following intervention implementation]

   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.

2. Average Pain Intensity [From 6 to 12 months following intervention implementation]

   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.

3. Pain Interference with Function [From 6 to 12 months following intervention implementation]

   Pain interference T-score, measured on the PROMIS Pain Interference Short Form. Higher scores indicate more pain interference with function.

4. Uptake of the PMSS-PC intervention tool [From baseline to 12 months following intervention implementation]

   Use of the PMSS-PC decision support tool by primary care providers

Eligibility Criteria

Criteria

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

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:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• MJHS Institute for Innovation in Palliative Care
• Pfizer
• The Institute for Family Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MJHS Institute for Innovation in Palliative Care
• ClinicalTrials.gov Identifier: NCT04716621
• Other Study ID Numbers: 8408357
• First Posted: Jan 20, 2021
• Last Update Posted: Jan 22, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Chronic Pain

Study Results

No Results Posted as of Jan 22, 2021