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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04716621
Enrollment
528
Registered
2021-01-20
Start date
2013-11-11
Completion date
2016-04-30
Last updated
2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

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.

Interventions

OTHEREarly 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 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.

Sponsors

Pfizer
CollaboratorINDUSTRY
The Institute for Family Health
CollaboratorOTHER
MJHS Institute for Innovation in Palliative Care
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

\-

Design outcomes

Primary

MeasureTime frameDescription
Worst Pain IntensityFrom baseline to 6 months following intervention implementationWorst 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 IntensityFrom baseline to 6 months following intervention implementationAverage 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 FunctionFrom baseline to 6 months following intervention implementationPain interference T-score, measured on the PROMIS Pain Interference Short Form. Higher scores indicate more pain interference with function.

Secondary

MeasureTime frameDescription
Worst Pain IntensityFrom 6 to 12 months following intervention implementationWorst 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 IntensityFrom 6 to 12 months following intervention implementationAverage 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 FunctionFrom 6 to 12 months following intervention implementationPain 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 toolFrom baseline to 12 months following intervention implementationUse of the PMSS-PC decision support tool by primary care providers

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026