Clinical Reminder Changes to Increase Smoking Cessation Treatment in Outpatient Psychiatry

April 6, 2023 updated by: NYU Langone Health
This study will use a scientifically robust, mixed-methods, two-arm cluster-randomized study design. Investigators will implement a tobacco use clinical reminder for outpatient psychiatrists practicing at the VA New York Harbor Healthcare System (N = 20). Half of the psychiatrists will receive a reminder that encourages the psychiatrist to offer cessation medications and referral to cessation counseling to patients interested in quitting (Opt-In Reminder). The other half will receive a clinical reminder that includes a standing nicotine replacement therapy (NRT) order and a referral to cessation counseling that will automatically generate unless the provider actively opts-out (Opt-Out Reminder). Prior to implementation of the reminders, psychiatrists in both arms will receive a one-hour training on tobacco treatment and individual education outreach to demonstrate the clinical reminder and answer questions (academic detailing).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Psychiatrists
  • Works in outpatient psychiatry at Manhattan or Brooklyn VA campus and has no plans to leave in the next 6 months
  • Patient Post-Visit Survey Population
  • Had a visit with a psychiatrist included in the study Current smoker

Exclusion Criteria:

  • Outpatient Psychiatrists:
  • None
  • Patient Post-Visit Survey Population:
  • Non-English speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Opt Out
Training and Academic Detailing
Behavioral: Opt-Out Reminder
half will receive a clinical reminder that includes a standing NRT order and a referral to cessation counseling that will automatically generate unless the provider actively opts-out
Experimental: Opt In
Training and Academic Detailing
Behavioral: Opt-In Reminder
Half of the psychiatrists will receive a reminder that encourages the psychiatrist to offer cessation medications and referral to cessation counseling to patients interested in quitting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Screened for Smoking
Time Frame: Up to Month 6
Number of patients with documented current smoking in the medical record who were screened for tobacco use during their psychiatry visit. Data derived from medial records.
Up to Month 6
Number of Smokers Prescribed a Cessation Medication
Time Frame: Up to Month 6
Number of people with documented current smoking in the medical record who were prescribed cessation medication.
Up to Month 6
Number of Smokers Referred to Counseling
Time Frame: Up to Month 6
Number of people with documented current smoking in the medical record for whom counseling referrals were ordered.
Up to Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Erin Rogers, DrPH, New York Langone Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2020

Primary Completion (Actual)

February 24, 2021

Study Completion (Actual)

February 24, 2021

Study Registration Dates

First Submitted

August 23, 2019

First Submitted That Met QC Criteria

August 26, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 19-00813

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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