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OpenTrials
Completed

NCT Number: NCT04716621

Computerized Decision Support Tool for Pain Management in Primary Care

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

-

Treatment and study plan

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.

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.

Primary outcomes

  1. Worst Pain Intensity

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Worst Pain Intensity

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: From baseline to 12 months following intervention implementation

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

Sponsors and collaborators

Lead sponsor

MJHS Institute for Innovation in Palliative Care

Other

Collaborators

  • Pfizer
  • The Institute for Family Health

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 20, 2021
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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