Perioperative Recovery of Moods, Opioids, and Pain Trial (PROMPT)

N/ACompletedNCT02070003

Stanford University104 enrolled

Overview

The investigators aim to characterize the relationship between changes in emotional distress, opioid use, and pain throughout surgery and recovery. Additionally, the investigators aim to compare the effectiveness of post-surgical motivational interviewing and physician-guided opioid weaning vs. usual care on reducing persistent opioid use. Overall, the proposed research will advance knowledge regarding the role of psychological factors contributing to persistent opioid use after surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

104

Conditions

Opioid Cessation

Interventions

Motivational Interviewing and Physician Guided Opioid WeaningBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18+ * Undergoing a scheduled surgery * English speaking * Ability and willingness to complete questionnaires and assessments. Exclusion Criteria: * Any conditions causing inability to complete baseline, telephone and internet assessments (e.g. education, cognitive ability, mental status, medical status)at the discretion of the investigator. * Known Pregnancy * Elevated Suicidality as assessed by an answer of 2 or greater on question 9 of the Beck Depression Inventory assessing suicidal thoughts. * Coexisting Chronic Pain Disorder of moderate severity in area other than surgical target

Locations (1)

Stanford University School of Medicine

Palo Alto, California, United States

Outcomes

Primary Outcomes

Trial Feasibility - The proportion of people consented who complete the study in the group to which they were randomized

Factors that contribute to non-completion of the study, measured at baseline for each patient, will be analyzed.

Time frame: Duration of the study - up to 2 years per participant

Secondary Outcomes

Efficacy - time to opioid cessation

Time to opioid cessation between the two groups will be analyzed using survival analysis

Time frame: Duration of the trial - Up to 2 years per participant

Data from ClinicalTrials.gov

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