Patient Engagement in Perioperative Pain Management Project

NCT05252767 | Completed

• 2 other identifiers: IRB00307176R01CE003150
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Opioid Use Disorder

Keywords

Patient engagement; Patient activation

Outcome Measures

Primary Outcomes (1)

• Patient engagement as assessed by a patient engagement survey

  Patient engagement survey measures level of patient engagement on five-point Likert scale

  Time of each participant's standard of care clinic visit, up to 1 year from enrollment

Secondary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Cohort A - Patient Engagement Tools

EXPERIMENTAL

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.

Behavioral: Patient Engagement Tools

Cohort B - Educational Guide

SHAM COMPARATOR

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

Behavioral: Educational Guide

Interventions

Patient Engagement Tools 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 A - Patient Engagement Tools

Educational Guide BEHAVIORAL

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

Cohort B - Educational Guide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients in Johns Hopkins Personalized Pain Program Clinic

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Opioid-Related Disorders; Patient Participation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Anping Xie, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 23, 2022
• Study Start: February 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)