CClinicalTrials.gg
CompletedNCT04716621Updated Jan 22, 2021

Computerized Decision Support Tool for Pain Management in Primary Care

An interventional study of Early intervention and Delayed intervention in Chronic Pain, sponsored by MJHS Institute for Innovation in Palliative Care. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-22.

Sponsored by MJHS Institute for Innovation in Palliative Care · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 7 years 2 months after the study started (first participant enrolled Nov 2013, registered Jan 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
528
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Chronic Pain

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03

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 699 are open to participants now.

This study's enrollment of 528 is above the median of 60 across 2,160 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

MJHS Institute for Innovation in Palliative Care is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

-

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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
528 participants (actual)

Study arms

  • 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

  • Other
    Delayed intervention

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

    Other: Delayed intervention

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.

  • OtherDelayed 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: From baseline to 6 months following intervention implementation

  2. 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.

    Time frame: From baseline to 6 months following intervention implementation

  3. Pain Interference with Function

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

    Time frame: From baseline to 6 months following intervention implementation

Secondary outcomes

  1. 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.

    Time frame: From 6 to 12 months following intervention implementation

  2. 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.

    Time frame: From 6 to 12 months following intervention implementation

  3. Pain Interference with Function

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

    Time frame: From 6 to 12 months following intervention implementation

  4. Uptake of the PMSS-PC intervention tool

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

    Time frame: From baseline to 12 months following intervention implementation

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04716621
Lead sponsor
MJHS Institute for Innovation in Palliative Care
Collaborators
Pfizer, The Institute for Family Health
Responsible party
Sponsor
First posted
Jan 20, 2021
Start date
Nov 11, 2013
Primary completion
Apr 2016
Completion
Apr 2016
Last update
Jan 22, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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