Patient Engagement in Perioperative Pain Management Project

Study Overview
=================
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.

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

Conditions
-----------------
Pain, Postoperative, Opioid Use Disorder

Intervention / Treatment
-----------------
* Behavioral: Patient Engagement Tools
* Behavioral: Educational Guide


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A - Patient Engagement Tools<br>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<br>* 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.<br>|
| Sham Comparator: Cohort B - Educational Guide<br>Participants randomized into the control cohort will receive a brief educational guide on general pain management. | Behavioral: Educational Guide<br>* Control participants will receive a brief educational guide about pain management.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient engagement, Patient activation