Patient Engagement in Perioperative Pain Management Project

NCT ID: NCT05252767

Last Updated: 2024-02-08

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

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-08-31

Brief Summary

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Previously, the study team evaluated the implementation and effectiveness of the Johns Hopkins Perioperative Pain Program (PPP), which coordinates continuum of care for surgical patients on chronic opioid therapy throughout the perioperative period. Based on the findings of that project, the study team developed an educational intervention intended to improve patient engagement in perioperative pain management. In this project, the study team will formally implement a randomized controlled trial to evaluate the effectiveness of the intervention developed.

Detailed Description

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Conditions

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Pain, Postoperative Opioid Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Cohort A - Patient Engagement Tools

Participants will be enrolled from the a pain management clinic. Participants randomized into the experimental cohort will receive access to a clinic brochure, clinic website, as well as 'My Pain Passport' and 'My Treatment Plan' tools.

Group Type EXPERIMENTAL

Patient Engagement Tools

Intervention Type BEHAVIORAL

Experimental participants will receive the patient engagement tools or the educational guide after randomization. The participants in the experimental cohort will utilize the tools between visits with their clinic providers. During visits, clinic providers will review the completed tools with participants.

Cohort B - Educational Guide

Participants randomized into the control cohort will receive a brief educational guide on general pain management.

Group Type SHAM_COMPARATOR

Educational Guide

Intervention Type BEHAVIORAL

Control participants will receive a brief educational guide about pain management.

Interventions

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Patient Engagement Tools

Experimental participants will receive the patient engagement tools or the educational guide after randomization. The participants in the experimental cohort will utilize the tools between visits with their clinic providers. During visits, clinic providers will review the completed tools with participants.

Intervention Type BEHAVIORAL

Educational Guide

Control participants will receive a brief educational guide about pain management.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* All patients in Johns Hopkins Personalized Pain Program Clinic

Exclusion Criteria

* Active suicidal ideation at study entry
* Primary psychotic disorder
* Non-English speaker
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anping Xie, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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R01CE003150

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00307176

Identifier Type: -

Identifier Source: org_study_id

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