Patient Engagement in Perioperative Pain Management Project

Evaluation of an Intervention for Improving Patient Engagement in Perioperative Pain Management

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Opioid Use Disorder
• Intervention / Treatment: Behavioral: Patient Engagement Tools; Behavioral: Educational Guide

• Study Type: Interventional
• Enrollment (Actual): 178
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Sham Comparator: Cohort B - Educational Guide; Participants randomized into the control cohort will receive a brief educational guide on general pain management.	Behavioral: Educational Guide; Control participants will receive a brief educational guide about pain management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption as assessed by daily morphine milligram equivalents	Daily morphine milligram equivalents (MME) indicates potency of an opioid dosage compared to morphine	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	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)	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	Present Pain Intensity scale of the McGill Pain Questionnaire measures pain intensity on 4-point scale (0 = none, 3 = severe)	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	Pain Catastrophizing Scale measures level of pain catastrophizing (0 = not at all, 4 = all the time)	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	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)	Time of each participant's standard of care clinic visit, up to 1 year from enrollment
Functional status as assessed by the 36-Item Short Form Health Survey	36-Item Short Form Health Survey measures overall health status (converted into 0-100 scale, were lower score indicates more disability)	Time of each participant's standard of care clinic visit, up to 1 year from enrollment

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Anping Xie, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: February 14, 2022
• First Submitted That Met QC Criteria: February 14, 2022
• First Posted (Actual): February 23, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Patient engagement; Patient activation
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Postoperative Complications; Pain; Neurologic Manifestations; Narcotic-Related Disorders; Pain, Postoperative; Opioid-Related Disorders
• Other Study ID Numbers: IRB00307176; R01CE003150 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No