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

NCT ID: NCT02070003

Last Updated: 2020-07-10

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

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-26

Study Completion Date

2018-08-15

Brief Summary

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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.

Detailed Description

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Conditions

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Opioid Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Motivational Interviewing and Physician Guided Opioid Weaning

Patients will go through motivational interviewing with the study physician via phone once a week for 7 weeks, and once a month up to a year as applicable, until patient completes the protocol.

Group Type EXPERIMENTAL

Motivational Interviewing and Physician Guided Opioid Weaning

Intervention Type BEHAVIORAL

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Motivational Interviewing and Physician Guided Opioid Weaning

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
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

Principal Investigators

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Jennifer Hah, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Palo Alto, California, United States

Site Status

Countries

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United States

References

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Hah JM, Trafton JA, Narasimhan B, Krishnamurthy P, Hilmoe H, Sharifzadeh Y, Huddleston JI, Amanatullah D, Maloney WJ, Goodman S, Carroll I, Mackey SC. Efficacy of motivational-interviewing and guided opioid tapering support for patients undergoing orthopedic surgery (MI-Opioid Taper): A prospective, assessor-blind, randomized controlled pilot trial. EClinicalMedicine. 2020 Oct 16;28:100596. doi: 10.1016/j.eclinm.2020.100596. eCollection 2020 Nov.

Reference Type DERIVED
PMID: 33294812 (View on PubMed)

Other Identifiers

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26234

Identifier Type: -

Identifier Source: org_study_id

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