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

Observational Study to Characterize the Relationship Between Preoperative Depressive Symptoms and Opioid Use/Misuse After Surgery

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use

• Study Type: Observational
• Enrollment (Actual): 718

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University School of Medicine
    • Stanford, California, United States, 94304
      • Stanford Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective surgery at Stanford Hospital.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to Opioid Cessation	Assessed after surgery up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Misuse	Participant score on the Current Opioid Misuse Measure will be used to assess opioid misuse	Assessed after surgery up to 1 year

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2019
• Primary Completion (Actual): March 3, 2024
• Study Completion (Actual): March 3, 2024

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 43163

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No