Patient-Centered Chronic Pain Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-13

Study Completion Date

2025-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Pain Opioid Use Musculoskeletal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 1 month and 2 clinics switching from control to intervention at each of the 4 steps (for a total study duration of 5 months).

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Pain Manager + tailored implementation support Pain Manager

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.

Group Type ACTIVE_COMPARATOR

Pain Manager + tailored implementation support

Intervention Type BEHAVIORAL

Individualized training, technical assistance, and workflow assessments.

Pain Manager implementation in EHR

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pain Manager + tailored implementation support

Individualized training, technical assistance, and workflow assessments.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No