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Completed

NCT Number: NCT05252767

Patient Engagement in Perioperative Pain Management Project

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.

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Key information

Conditions

Pain, Postoperative Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opioid Use Disorder Opioid-Related Disorders Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Participation Postoperative Complications Signs and Symptoms Substance-Related Disorders Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Engagement Tools

Behavioral

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

Behavioral

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

Primary outcomes

  1. Patient engagement as assessed by a patient engagement survey

    Time frame: 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 outcomes

  1. Opioid consumption as assessed by daily morphine milligram equivalents

    Time frame: 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

  2. Pain level as assessed by the Brief Pain Inventory

    Time frame: 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)

  3. Pain level as assessed by the Present Pain Intensity scale of the McGill Pain Questionnaire

    Time frame: 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)

  4. Pain level as assessed by the Pain Catastrophizing Scale

    Time frame: 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)

  5. Functional status as assessed by the Insomnia Severity Index

    Time frame: 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)

  6. Functional status as assessed by the 36-Item Short Form Health Survey

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 23, 2022
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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