Computerized Decision Support Tool for Pain Management in Primary Care

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04716621
• Other study ID #: 8408357
• Status: Completed
• Phase: N/A
• Start date: November 11, 2013
• Est. completion date: April 2016

Study information

• Verified date: January 2021
• Source: MJHS Institute for Innovation in Palliative Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 528
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
MJHS Institute for Innovation in Palliative Care	Pfizer, The Institute for Family Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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