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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opt Out | Experimental | Training and Academic Detailing |
|
| Opt In | Experimental | Training and Academic Detailing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opt-Out Reminder | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erin Rogers, DrPH | New York Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32617528 | Derived | 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. |
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In this study, psychiatrists practicing at the VA New York Harbor Healthcare System were enrolled and randomized to either the Opt-Out Reminder group (n=58) or Opt-In Reminder group (n=82).
A waiver of informed consent was granted to extract data on patients (Opt-Out Reminder, n=240; Opt-In Reminder, n=303) who were seen by the participating psychiatrists. These patients were not considered to be enrolled participants
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| ID | Title | Description |
|---|---|---|
| FG000 | Opt Out Reminder - Psychiatrists | Psychiatrists in the Opt-Out Reminder group received a clinical reminder that included a standing nicotine replacement therapy (NRT) order and a referral to cessation counseling that automatically generated unless the provider actively opted-out. |
| FG001 | Opt-Out Reminder - Patients | Patients of psychiatrists randomized to the opt-out reminder arm. |
| FG002 | Opt In Reminder - Psychiatrists | Psychiatrists in the Opt-In Reminder group received a reminder that encouraged the psychiatrist to offer cessation medications and referral to cessation counseling to patients interested in quitting. |
| FG003 | Opt In Reminder - Patients | Patients of psychiatrists randomized to the opt-in reminder arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline data were only collected from participating psychiatrists. A waiver of informed consent was granted to extract data on patients who were seen by the participating psychiatrists. No baseline data were collected for these patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | Opt Out Reminder | Psychiatrists in the Opt-Out Reminder group received a clinical reminder that included a standing nicotine replacement therapy (NRT) order and a referral to cessation counseling that automatically generated unless the provider actively opted-out. |
| BG001 | Opt In Reminder |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Count of Participants | Participants | Up to Month 6 |
|
6 Months
Adverse Event/Serious Adverse Events/All-Cause Mortality data were collected only for participating psychiatrists. AE/SAE/All-Cause Mortality data were not collected for Participants with extracted outcome measure data who visited the participating psychiatrists. Thus, the number of participants analyzed for AEs/SAEs/All-Cause Mortality in the Opt-Out Reminder and Opt-In Reminder arms is 34 and 55, respectively (equal to the number of psychiatrists who completed the trial in each arm).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Opt Out Reminder | Psychiatrists in the Opt-Out Reminder group received a clinical reminder that included a standing nicotine replacement therapy (NRT) order and a referral to cessation counseling that automatically generated unless the provider actively opted-out. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin Rogers | NYU Langone Health | 6465012544 | Erin.Rogers@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 11, 2019 | Feb 10, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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2 arm cluster randomized study design
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| Opt-In Reminder | Behavioral | 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 |
|
Psychiatrists in the Opt-In Reminder group received a reminder that encouraged the psychiatrist to offer cessation medications and referral to cessation counseling to patients interested in quitting. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Opt-In Reminder - Patients of Participating Psychiatrists | Mental health patients with documented current smoking in the medical record who visited a psychiatrist randomized to receive the Opt-In reminder. |
|
|
| Primary | Number of Smokers Prescribed a Cessation Medication | Number of people with documented current smoking in the medical record who were prescribed cessation medication. | 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. | Posted | Count of Participants | Participants | Up to Month 6 |
|
|
|
| Primary | Number of Smokers Referred to Counseling | Number of people with documented current smoking in the medical record for whom counseling referrals were ordered. | 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. | Posted | Count of Participants | Participants | Up to Month 6 |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Opt In Reminder | Psychiatrists in the Opt-In Reminder group received a reminder that encouraged the psychiatrist to offer cessation medications and referral to cessation counseling to patients interested in quitting. | 0 | 55 | 0 | 55 | 0 | 55 |
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