NCT04071795

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 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 6, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2021

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

April 28, 2023

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

August 23, 2019

Results QC Date

February 10, 2023

Last Update Submit

April 6, 2023

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (3)

  • Number of Patients Screened for Smoking

    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

    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

    Number of people with documented current smoking in the medical record for whom counseling referrals were ordered.

    Up to Month 6

Study Arms (2)

Opt Out

EXPERIMENTAL

Training and Academic Detailing

Behavioral: Opt-Out Reminder

Opt In

EXPERIMENTAL

Training and Academic Detailing

Behavioral: Opt-In Reminder

Interventions

Opt-Out ReminderBEHAVIORAL

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
Opt-In ReminderBEHAVIORAL

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

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (1)

  • Rogers ES, Wysota C, Prochaska JJ, Tenner C, Dognin J, Wang B, Sherman SE. A behavioral economic intervention to increase psychiatrist adherence to tobacco treatment guidelines: a provider-randomized study protocol. Implement Sci Commun. 2020;1:32. doi: 10.1186/s43058-020-00011-x. Epub 2020 Feb 25.

    PMID: 32617528DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Results Point of Contact

Title
Erin Rogers
Organization
NYU Langone Health
Erin.Rogers@nyulangone.org
6465012544

Study Officials

  • Erin Rogers, DrPH

    New York Langone Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 arm cluster randomized study design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 28, 2019

Study Start

January 6, 2020

Primary Completion

February 24, 2021

Study Completion

February 24, 2021

Last Updated

April 28, 2023

Results First Posted

April 28, 2023

Record last verified: 2023-04

Locations

US(1)