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Characterizing the Association Between Preoperative Depressive Symptoms and Opioid Use/Misuse After Surgery

Sponsor
Stanford University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05412342
Collaborator
(none)
687
Enrollment
2
Locations
48.7
Anticipated Duration (Months)
343.5
Patients Per Site
7.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This observational study aims to characterize the relationship between preoperative depressive symptoms and opioid use/ misuse after surgery using a perioperative learning health care system. We will follow a prospective cohort of patients undergoing elective surgery.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    687 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Observational Study to Characterize the Relationship Between Preoperative Depressive Symptoms and Opioid Use/Misuse After Surgery
    Actual Study Start Date :
    May 10, 2019
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Jun 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Patients undergoing elective operations

    We will follow a prospective cohort of 558 patients, undergoing any elective surgery at Stanford Hospital. Subjects will undergo baseline and longitudinal testing via a (including NIH Patient-Reported Outcomes Measurement Information System- PROMIS measures of emotional distress). After surgery, participants will report weekly changes in opioid use, pain, and adverse events; and monthly changes in opioid misuse for 1 year.

    Outcome Measures

    Primary Outcome Measures

    1. Time to Opioid Cessation [Assessed after surgery up to 1 year]

    Secondary Outcome Measures

    1. Opioid Misuse [Assessed after surgery up to 1 year]

      Participant score on the Current Opioid Misuse Measure will be used to assess opioid misuse

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1. Age 18+

    2. Planning to undergo surgery

    3. English speaking

    4. Ability and willingness to complete questionnaires and assessments

    Exclusion Criteria:

    1. Any conditions causing inability to complete assessments (education, cognitive ability, mental status, medical status)

    2. Known Pregnancy

    3. Elevated Suicidality

    4. Enrollment in a conflicting perioperative trial

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University School of Medicine Palo Alto California United States 94304
    2 Stanford Health Care Stanford California United States 94304

    Sponsors and Collaborators

    • Stanford University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jennifer Hah, Assistant Professor, Stanford University
    ClinicalTrials.gov Identifier:
    NCT05412342
    Other Study ID Numbers:
    • 43163
    First Posted:
    Jun 9, 2022
    Last Update Posted:
    Jun 9, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Depression

    Study Results

    No Results Posted as of Jun 9, 2022