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

NCT ID: NCT05412342

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

718 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-10

Study Completion Date

2024-03-03

Brief Summary

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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.

Detailed Description

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Conditions

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Opioid Use

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Hah

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford University School of Medicine

Palo Alto, California, United States

Site Status

Stanford Health Care

Stanford, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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43163

Identifier Type: -

Identifier Source: org_study_id