Computerized Decision Support Tool for Pain Management in Primary Care

NCT04716621 | Completed

• 1 other identifier: 8408357
• Study Type: interventional
• Target: 528
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Worst Pain Intensity

  From 6 to 12 months following intervention implementation

• Average Pain Intensity

  From 6 to 12 months following intervention implementation

• Pain Interference with Function

  From 6 to 12 months following intervention implementation

• Uptake of the PMSS-PC intervention tool

  From baseline to 12 months following intervention implementation

Study Arms (2)

Early intervention

EXPERIMENTAL

Three sites received the Pain Management Support System for Primary Care (PMSS-PC) integrated into the Electronic Health Record.

Other: Early intervention

Delayed intervention

OTHER

Delayed wait-list control group. Three additional sites received the intervention 6 months after the first arm.

Other: Delayed intervention

Interventions

Early intervention OTHER

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.

Early intervention

Delayed intervention OTHER

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.

Delayed intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Chronic Pain

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 20, 2021
• Study Start: November 11, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: January 22, 2021

Record last verified: 2021-01