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Patient Engagement in Perioperative Pain Management Project

Primary Purpose

Pain, Postoperative, Opioid Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Engagement Tools
Educational Guide
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pain, Postoperative focused on measuring Patient engagement, Patient activation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Cohort A - Patient Engagement Tools

Cohort B - Educational Guide

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Patient engagement as assessed by a patient engagement survey
Patient engagement survey measures level of patient engagement on five-point Likert scale

Secondary Outcome Measures

Opioid consumption as assessed by daily morphine milligram equivalents
Daily morphine milligram equivalents (MME) indicates potency of an opioid dosage compared to morphine
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)
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)
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)
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)
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)

Full Information

First Posted
February 14, 2022
Last Updated
February 7, 2023
Sponsor
Johns Hopkins University
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT05252767
Brief Title
Patient Engagement in Perioperative Pain Management Project
Official Title
Evaluation of an Intervention for Improving Patient Engagement in Perioperative Pain Management
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Opioid Use Disorder
Keywords
Patient engagement, Patient activation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A - Patient Engagement Tools
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort B - Educational Guide
Arm Type
Sham Comparator
Arm Description
Participants randomized into the control cohort will receive a brief educational guide on general pain management.
Intervention Type
Behavioral
Intervention Name(s)
Patient Engagement Tools
Intervention Description
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
Intervention Name(s)
Educational Guide
Intervention Description
Control participants will receive a brief educational guide about pain management.
Primary Outcome Measure Information:
Title
Patient engagement as assessed by a patient engagement survey
Description
Patient engagement survey measures level of patient engagement on five-point Likert scale
Time Frame
Time of each participant's standard of care clinic visit, up to 1 year from enrollment
Secondary Outcome Measure Information:
Title
Opioid consumption as assessed by daily morphine milligram equivalents
Description
Daily morphine milligram equivalents (MME) indicates potency of an opioid dosage compared to morphine
Time Frame
Time of each participant's standard of care clinic visit, up to 1 year from enrollment
Title
Pain level as assessed by the Brief Pain Inventory
Description
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 Frame
Time of each participant's standard of care clinic visit, up to 1 year from enrollment
Title
Pain level as assessed by the Present Pain Intensity scale of the McGill Pain Questionnaire
Description
Present Pain Intensity scale of the McGill Pain Questionnaire measures pain intensity on 4-point scale (0 = none, 3 = severe)
Time Frame
Time of each participant's standard of care clinic visit, up to 1 year from enrollment
Title
Pain level as assessed by the Pain Catastrophizing Scale
Description
Pain Catastrophizing Scale measures level of pain catastrophizing (0 = not at all, 4 = all the time)
Time Frame
Time of each participant's standard of care clinic visit, up to 1 year from enrollment
Title
Functional status as assessed by the Insomnia Severity Index
Description
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 Frame
Time of each participant's standard of care clinic visit, up to 1 year from enrollment
Title
Functional status as assessed by the 36-Item Short Form Health Survey
Description
36-Item Short Form Health Survey measures overall health status (converted into 0-100 scale, were lower score indicates more disability)
Time Frame
Time of each participant's standard of care clinic visit, up to 1 year from enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anping Xie, PhD
Phone
410-637-6296
Email
axie1@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anping Xie, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel Kim, BS
Phone
410-637-6296
Email
skim172@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Anping Xie, PhD
First Name & Middle Initial & Last Name & Degree
Marie Hanna, MD, MEHP

12. IPD Sharing Statement

Plan to Share IPD
No

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Patient Engagement in Perioperative Pain Management Project

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