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Patient-Centered Chronic Pain Care (IPRO)

Primary Purpose

Chronic Pain, Opioid Use, Musculoskeletal Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pain Manager + tailored implementation support
Sponsored by
University of Florida
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:

  • Primary care patients receiving care at a participating clinic
  • Patients with chronic non-cancer musculoskeletal pain and with a recent history of opioid use

Exclusion Criteria:

  • Due to the fact that the clinical decision support tool is currently available in English only, non-English speaking patients will not be eligible to participate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Pain Manager + tailored implementation support Pain Manager

    Pain Manager implementation in EHR

    Arm Description

    Pain Manager is a decision support tool. All study clinics will begin the trial with Pain Manager integrated and available in their EHR. Consistent with the stepped-wedge design, intensive implementation support (e.g, administrative support, technical support)will be provided to two clinics at once by a multidisciplinary team.

    Pain Manager is a decision support tool. All study clinics will begin the trial with Pain Manager integrated and available in their EHR. The other 6 clinics will have no additional tailor support.

    Outcomes

    Primary Outcome Measures

    Adoption
    Rate of qualifying patients seen for whom CDS use is documented

    Secondary Outcome Measures

    Reach
    Rate of clinic encounters where CDS is documented
    Shared decision making
    SDM-Q-9 questionnaire: 9-item Shared Decision Making Questionnaire
    Pain and function
    PEG-3: 3-item scale that measures pain on average, its interference with enjoyment of life, and with general activity
    Any opioid prescription
    Binary measure of treatment choice that increases opioid-related risks
    Opioid prescriptions ≥50 MME/day
    Binary measure of treatment choice that increases opioid-related risks
    Opioid prescriptions ≥90 MME/day
    Binary measure of treatment choice that increases opioid-related risks
    Benzodiazepine prescription concurrent with opioid prescription
    Binary measure of treatment choice that increases opioid-related risks
    Prescriptions for non-opioid pain medications
    Binary measure recommended by the CDC to decrease opioid-related risks
    Prescriptions for non-pharmacologic pain treatments
    Binary measure recommended by the CDC to decrease opioid-related risks
    Urine drug screen orders
    Binary measure recommended by the CDC to decrease opioid-related risks
    Naloxone prescriptions
    Binary measure recommended by the CDC to decrease opioid-related risks
    Prescription or referral for medication-assisted therapy (MAT)
    Binary measure recommended by the CDC to decrease opioid-related risks

    Full Information

    First Posted
    January 28, 2022
    Last Updated
    May 10, 2023
    Sponsor
    University of Florida
    Collaborators
    Agency for Healthcare Research and Quality (AHRQ)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05256394
    Brief Title
    Patient-Centered Chronic Pain Care
    Acronym
    IPRO
    Official Title
    Scaling Interoperable Clinical Decision Support for Patient-Centered Chronic Pain Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2023 (Anticipated)
    Primary Completion Date
    August 31, 2024 (Anticipated)
    Study Completion Date
    August 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Florida
    Collaborators
    Agency for Healthcare Research and Quality (AHRQ)

    4. Oversight

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

    5. Study Description

    Brief Summary
    This study will adapt and scale existing AHRQ-supported interoperable CDS for patient-centered chronic pain care. The objective of this project is to study the adaptation and implementation of an existing interoperable CDS tool for pain treatment shared decision making, with tailored implementation support, in primary care clinical settings. The central hypothesis is that tailored implementation support will increase CDS adoption and shared decision making.
    Detailed Description
    This study will adapt and scale the use of existing AHRQ-supported interoperable CDS that aids patient-centered chronic pain treatment decision making. The research will generate critical evidence on scalable strategies to implement and evaluate interoperable CDS in real-world settings across different types of EHRs. The pragmatic trial will enhance the reach of interoperable CDS to more diverse populations. Together, these efforts will lead to important new technology and evidence that patients, clinicians, and health systems can use to improve care for millions of Americans who suffer from pain and other chronic conditions.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    This is a stepped-wedge, cluster randomized trial using mixed methods to assess the multilevel determinants of CDS implementation success. The investigators will use both quantitative and qualitative data to provide a comprehensive understanding of the clinical context of the participating sites before and after the trial, and identify system, clinic and provider-level factors that may influence the implementation process. In summary, this is a complete, open-cohort stepped-wedge cluster-randomized design with 5 time periods (including the baseline), with each period spanning 3 months and 2 clinics switching from control to intervention at each of the 4 steps (for a total study duration of 15 months).
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pain Manager + tailored implementation support Pain Manager
    Arm Type
    Active Comparator
    Arm Description
    Pain Manager is a decision support tool. All study clinics will begin the trial with Pain Manager integrated and available in their EHR. Consistent with the stepped-wedge design, intensive implementation support (e.g, administrative support, technical support)will be provided to two clinics at once by a multidisciplinary team.
    Arm Title
    Pain Manager implementation in EHR
    Arm Type
    No Intervention
    Arm Description
    Pain Manager is a decision support tool. All study clinics will begin the trial with Pain Manager integrated and available in their EHR. The other 6 clinics will have no additional tailor support.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Pain Manager + tailored implementation support
    Intervention Description
    Individualized training, technical assistance, and workflow assessments.
    Primary Outcome Measure Information:
    Title
    Adoption
    Description
    Rate of qualifying patients seen for whom CDS use is documented
    Time Frame
    During the implementation trial (15 months total)
    Secondary Outcome Measure Information:
    Title
    Reach
    Description
    Rate of clinic encounters where CDS is documented
    Time Frame
    During the implementation trial (15 months total)
    Title
    Shared decision making
    Description
    SDM-Q-9 questionnaire: 9-item Shared Decision Making Questionnaire
    Time Frame
    Immediately after the intervention
    Title
    Pain and function
    Description
    PEG-3: 3-item scale that measures pain on average, its interference with enjoyment of life, and with general activity
    Time Frame
    Baseline/pre-intervention, and at 1 and 3 months
    Title
    Any opioid prescription
    Description
    Binary measure of treatment choice that increases opioid-related risks
    Time Frame
    Baseline/pre-intervention, and at 1 and 3 months
    Title
    Opioid prescriptions ≥50 MME/day
    Description
    Binary measure of treatment choice that increases opioid-related risks
    Time Frame
    Baseline/pre-intervention, and at 1 and 3 months
    Title
    Opioid prescriptions ≥90 MME/day
    Description
    Binary measure of treatment choice that increases opioid-related risks
    Time Frame
    Baseline/pre-intervention, and at 1 and 3 months
    Title
    Benzodiazepine prescription concurrent with opioid prescription
    Description
    Binary measure of treatment choice that increases opioid-related risks
    Time Frame
    Baseline/pre-intervention, and at 1 and 3 months
    Title
    Prescriptions for non-opioid pain medications
    Description
    Binary measure recommended by the CDC to decrease opioid-related risks
    Time Frame
    Baseline/pre-intervention, and at 1 and 3 months
    Title
    Prescriptions for non-pharmacologic pain treatments
    Description
    Binary measure recommended by the CDC to decrease opioid-related risks
    Time Frame
    Baseline/pre-intervention, and at 1 and 3 months
    Title
    Urine drug screen orders
    Description
    Binary measure recommended by the CDC to decrease opioid-related risks
    Time Frame
    Baseline/pre-intervention, and at 1 and 3 months
    Title
    Naloxone prescriptions
    Description
    Binary measure recommended by the CDC to decrease opioid-related risks
    Time Frame
    Baseline/pre-intervention, and at 1 and 3 months
    Title
    Prescription or referral for medication-assisted therapy (MAT)
    Description
    Binary measure recommended by the CDC to decrease opioid-related risks
    Time Frame
    Baseline/pre-intervention, and at 1 and 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Primary care patients receiving care at a participating clinic Patients with chronic non-cancer musculoskeletal pain and with a recent history of opioid use Exclusion Criteria: Due to the fact that the clinical decision support tool is currently available in English only, non-English speaking patients will not be eligible to participate
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ramzi Salloum, Ph.D.
    Phone
    352-294-4997
    Email
    rsalloum@ufl.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christopher Harle, Ph.D.
    Organizational Affiliation
    University of Florida
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35841043
    Citation
    Salloum RG, Bilello L, Bian J, Diiulio J, Paz LG, Gurka MJ, Gutierrez M, Hurley RW, Jones RE, Martinez-Wittinghan F, Marcial L, Masri G, McDonnell C, Militello LG, Modave F, Nguyen K, Rhodes B, Siler K, Willis D, Harle CA. Study protocol for a type III hybrid effectiveness-implementation trial to evaluate scaling interoperable clinical decision support for patient-centered chronic pain management in primary care. Implement Sci. 2022 Jul 15;17(1):44. doi: 10.1186/s13012-022-01217-4.
    Results Reference
    derived

    Learn more about this trial

    Patient-Centered Chronic Pain Care

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