Opioid Use Disorder, Pain, Postoperative
Conditions
Keywords
Patient engagement, Patient activation
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.
Interventions
BEHAVIORALPatient 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.
BEHAVIORALEducational Guide
Control participants will receive a brief educational guide about pain management.
Sponsors
Centers for Disease Control and Prevention
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient engagement as assessed by a patient engagement survey | Time of each participant's standard of care clinic visit, up to 1 year from enrollment | Patient engagement survey measures level of patient engagement on five-point Likert scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | Time of each participant's standard of care clinic visit, up to 1 year from enrollment | Present Pain Intensity scale of the McGill Pain Questionnaire measures pain intensity on 4-point scale (0 = none, 3 = severe) |
| 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 | Daily morphine milligram equivalents (MME) indicates potency of an opioid dosage compared to morphine |
| 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 | 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 | Time of each participant's standard of care clinic visit, up to 1 year from enrollment | 36-Item Short Form Health Survey measures overall health status (converted into 0-100 scale, were lower score indicates more disability) |
| 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 | Pain Catastrophizing Scale measures level of pain catastrophizing (0 = not at all, 4 = all the time) |
Countries
United States
Outcome results
None listed