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Computerized Decision Support Tool for Pain Management in Primary Care

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Early intervention
Delayed intervention
Sponsored by
MJHS Institute for Innovation in Palliative Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Early intervention

    Delayed intervention

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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.
    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.
    Pain Interference with Function
    Pain 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 tool
    Use of the PMSS-PC decision support tool by primary care providers

    Full Information

    First Posted
    January 15, 2021
    Last Updated
    January 19, 2021
    Sponsor
    MJHS Institute for Innovation in Palliative Care
    Collaborators
    Pfizer, The Institute for Family Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04716621
    Brief Title
    Computerized Decision Support Tool for Pain Management in Primary Care
    Official Title
    Pain Management in Primary Care: A Randomized Controlled Trial of a Computerized Decision Support Tool
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    November 11, 2013 (Actual)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    MJHS Institute for Innovation in Palliative Care
    Collaborators
    Pfizer, The Institute for Family Health

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Pain

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    528 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Early intervention
    Arm Type
    Experimental
    Arm Description
    Three sites received the Pain Management Support System for Primary Care (PMSS-PC) integrated into the Electronic Health Record.
    Arm Title
    Delayed intervention
    Arm Type
    Other
    Arm Description
    Delayed wait-list control group. Three additional sites received the intervention 6 months after the first arm.
    Intervention Type
    Other
    Intervention Name(s)
    Early intervention
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Delayed intervention
    Intervention Description
    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 Outcome Measure Information:
    Title
    Worst Pain Intensity
    Description
    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
    Title
    Average Pain Intensity
    Description
    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
    Title
    Pain Interference with Function
    Description
    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 Outcome Measure Information:
    Title
    Worst Pain Intensity
    Description
    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
    Title
    Average Pain Intensity
    Description
    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
    Title
    Pain Interference with Function
    Description
    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
    Title
    Uptake of the PMSS-PC intervention tool
    Description
    Use of the PMSS-PC decision support tool by primary care providers
    Time Frame
    From baseline to 12 months following intervention implementation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: -

    12. IPD Sharing Statement

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    Computerized Decision Support Tool for Pain Management in Primary Care

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