Patient Engagement in Perioperative Pain Management Project

Not Applicable

Completed

• Conditions: Opioid Use Disorder; Pain, Postoperative
• Interventions: Behavioral: Educational Guide; Behavioral: Patient Engagement Tools

• Registration Number: NCT05252767
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2022-02-14
• Study First Submitted QC: 2022-02-14
• Study First Posted: 2022-02-23
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

• All patients in Johns Hopkins Personalized Pain Program Clinic

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Exclusion Criteria

• Active suicidal ideation at study entry
• Primary psychotic disorder
• Non-English speaker

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort B - Educational Guide	Educational Guide	Participants randomized into the control cohort will receive a brief educational guide on general pain management.
Cohort A - Patient Engagement Tools	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.

Primary Outcome Measures

Name	Time	Method
Patient engagement as assessed by a patient engagement survey	Time of each participant's standard of care clinic visit, up to 1 year from enrollment	Patient engagement survey measures level of patient engagement on five-point Likert scale

Secondary Outcome Measures

Name	Time	Method
Opioid consumption as assessed by daily morphine milligram equivalents	Time of each participant's standard of care clinic visit, up to 1 year from enrollment	Daily morphine milligram equivalents (MME) indicates potency of an opioid dosage compared to morphine
Pain level as assessed by the Brief Pain Inventory	Time of each participant's standard of care clinic visit, up to 1 year from enrollment	Brief Pain Inventory assesses pain severity and impact of pain on functional status on 10-point scale (1=no pain, no interference and 10 = worst pain, complete interference)
Pain level as assessed by the Present Pain Intensity scale of the McGill Pain Questionnaire	Time of each participant's standard of care clinic visit, up to 1 year from enrollment	Present Pain Intensity scale of the McGill Pain Questionnaire measures pain intensity on 4-point scale (0 = none, 3 = severe)
Pain level as assessed by the Pain Catastrophizing Scale	Time of each participant's standard of care clinic visit, up to 1 year from enrollment	Pain Catastrophizing Scale measures level of pain catastrophizing (0 = not at all, 4 = all the time)
Functional status as assessed by the Insomnia Severity Index	Time of each participant's standard of care clinic visit, up to 1 year from enrollment	Insomnia Severity Index measures severity of insomnia on five-point scale (0=none, 4=severe, were score of 0-7 indicates no clinically significant insomnia and score of 22-28 indicates clinical or severe insomnia)
Functional status as assessed by the 36-Item Short Form Health Survey	Time of each participant's standard of care clinic visit, up to 1 year from enrollment	36-Item Short Form Health Survey measures overall health status (converted into 0-100 scale, were lower score indicates more disability)

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States