Patient Engagement in Perioperative Pain Management Project

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05252767
• Other study ID #: IRB00307176
• Secondary ID: R01CE003150
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: February 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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