Smoking CessationNCT04071795

Clinical Reminder Changes to Increase Smoking Cessation Treatment in Outpatient Psychiatry

A study testing Opt-Out Reminder and Opt-In Reminder in people with Smoking Cessation, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Smoking Cessation
What is being tested?: Opt-Out Reminder and Opt-In Reminder
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 1 siteUnited States
Study dates: 6 Jan 2020to 24 Feb 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

NYU Langone Health
New York, New York, 10016

Other trials in United States

About this study

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).

Conditions: Smoking Cessation
Being tested: Opt-Out Reminder, Opt-In Reminder
Medical subject headings: Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Opt-Out ReminderBehavioural
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-In ReminderBehavioural
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

Study groups in NCT04071795
Study group	Role	What they receive
Opt Out	Experimental	Training and Academic Detailing Receives: Behavioral: Opt-Out Reminder
Opt In	Experimental	Training and Academic Detailing Receives: Behavioral: Opt-In Reminder

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Up to Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jan 202024 Feb 2021

First posted28 Aug 2019
Study start6 Jan 2020
Primary completion24 Feb 2021
Study completion24 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Smoking CessationStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 2 arm cluster randomized study design
Masking: None (open label)
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04071795
Sponsor's protocol ID: 19-00813
Status last verified: Apr 2023
First submitted: 23 Aug 2019
Last updated: 28 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 32617528

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Reminder Changes to Increase Smoking Cessation Treatment in Outpatient Psychiatry
ClinicalTrials.gov ID: NCT04071795
Acronym / sponsor ID: 19-00813
Conditions: Smoking Cessation
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 6 Jan 2020 (actual)
Primary completion: 24 Feb 2021 (actual)
Study completion: 24 Feb 2021 (actual)
First posted: 28 Aug 2019 (actual)
Results: Posted 28 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 2 arm cluster randomized study design

Arm	Type	Receives
Opt Out	Experimental	Behavioral: Opt-Out ReminderTraining and Academic Detailing
Opt In	Experimental	Behavioral: Opt-In ReminderTraining and Academic Detailing

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Opt-Out Reminderhalf 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	Behavioural	Opt Out
Opt-In ReminderHalf 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	Behavioural	Opt In

Primary outcome

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.
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.
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.

Results and safety

Results posted to the registry on 28 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Opt Out Reminder - Psychiatrists	58	34
Opt-Out Reminder - Patients	240	240
Opt In Reminder - Psychiatrists	82	55
Opt In Reminder - Patients	303	303

Primary outcome: Number of Patients Screened for Smoking

Time frame: Up to Month 6. Count of participants. Unit: Participants

Measure	Opt-Out Reminder - Patients of Participating Psychiatrists n = 240	Opt-In Reminder - Patients of Participating Psychiatrists n = 303
Value	240	303

Population analysed: A waiver of HIPAA authorization was granted to abstract patient electronic health record (EHR) data from VA administrative data for the purposes of analysis of the primary outcomes. The overall number of participants analyzed represents patients (Participants) with available EHR data (Opt-Out Reminder Group, n = 240; Opt-In Reminder Group = 303) who visited a participating psychiatrist.

Primary outcome: Number of Smokers Prescribed a Cessation Medication

Time frame: Up to Month 6. Count of participants. Unit: Participants

Measure	Opt-Out Reminder - Patients of Participating Psychiatrists n = 240	Opt-In Reminder - Patients of Participating Psychiatrists n = 303
Value	63	47

Primary outcome: Number of Smokers Referred to Counseling

Time frame: Up to Month 6. Count of participants. Unit: Participants

Measure	Opt-Out Reminder - Patients of Participating Psychiatrists n = 240	Opt-In Reminder - Patients of Participating Psychiatrists n = 303
Value	59	24

Adverse events

Time frame: 6 Months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Opt Out Reminder	0 of 34 (0%)	0 of 34 (0%)	0 of 34
Opt In Reminder	0 of 55 (0%)	0 of 55 (0%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32617528Rogers 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.

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PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Erin Rogers, DrPH principal investigator

New York Langone Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Opt-Out Reminder and Opt-In Reminder in people with Smoking Cessation, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients Screened for Smoking (time frame: Up to Month 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04071795, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.