Clinical Reminder Changes to Increase Smoking Cessation Treatment in Outpatient Psychiatry

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT04071795
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 140
• Location: 1
• Arms: 2
• Actual Duration (Months): 13.6
• Patients Per Site Per Month: 10.3

Study Details

Study Description

Brief Summary

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 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).

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation	Behavioral: Opt-Out Reminder; Behavioral: Opt-In Reminder	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 2 arm cluster randomized study design2 arm cluster randomized study design
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Reminder Changes to Increase Smoking Cessation Treatment in Outpatient Psychiatry
• Actual Study Start Date: Jan 6, 2020
• Actual Primary Completion Date: Feb 24, 2021
• Actual Study Completion Date: Feb 24, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. the percent of patients screened for smoking [3 Years]

2. the percent of smokers prescribed a cessation medication [3 Years]

3. the percent of smokers referred to counseling [3 Years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health
• National Institute on Drug Abuse (NIDA)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT04071795
• Other Study ID Numbers: 19-00813
• First Posted: Aug 28, 2019
• Last Update Posted: May 13, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 13, 2022