Smoking Cessation
Conditions
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).
Interventions
BEHAVIORALOpt-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
BEHAVIORALOpt-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
Sponsors
National Institute on Drug Abuse (NIDA)
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
2 arm cluster randomized study design
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Screened for Smoking | 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 | 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 | Up to Month 6 | Number of people with documented current smoking in the medical record for whom counseling referrals were ordered. |
Countries
United States
Participant flow
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 34 |
| 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. | 55 |
| Total | 89 |
Baseline characteristics
| Characteristic | Opt Out Reminder | Total | Opt In Reminder |
|---|---|---|---|
| Age, Continuous | 62.6 years STANDARD_DEVIATION 16.8 | 64.4 years STANDARD_DEVIATION 12.8 | 66.6 years STANDARD_DEVIATION 9.23 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 17 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 68 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 39 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 16 Participants | 9 Participants |
| Race (NIH/OMB) White | 9 Participants | 28 Participants | 19 Participants |
| Region of Enrollment United States | 34 participants | 89 participants | 55 participants |
| Sex: Female, Male Female | 2 Participants | 8 Participants | 6 Participants |
| Sex: Female, Male Male | 32 Participants | 81 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 55 |
| other Total, other adverse events | 0 / 34 | 0 / 55 |
| serious Total, serious adverse events | 0 / 34 | 0 / 55 |
Outcome results
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.
Time frame: Up to Month 6
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Opt-Out Reminder - Patients of Participating Psychiatrists | Number of Patients Screened for Smoking | 240 Participants |
| Opt-In Reminder - Patients of Participating Psychiatrists | Number of Patients Screened for Smoking | 303 Participants |
Primary
Number of Smokers Prescribed a Cessation Medication
Number of people with documented current smoking in the medical record who were prescribed cessation medication.
Time frame: Up to Month 6
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Opt-Out Reminder - Patients of Participating Psychiatrists | Number of Smokers Prescribed a Cessation Medication | 63 Participants |
| Opt-In Reminder - Patients of Participating Psychiatrists | Number of Smokers Prescribed a Cessation Medication | 47 Participants |
Primary
Number of Smokers Referred to Counseling
Number of people with documented current smoking in the medical record for whom counseling referrals were ordered.
Time frame: Up to Month 6
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Opt-Out Reminder - Patients of Participating Psychiatrists | Number of Smokers Referred to Counseling | 59 Participants |
| Opt-In Reminder - Patients of Participating Psychiatrists | Number of Smokers Referred to Counseling | 24 Participants |