Trial Outcomes & Findings for Clinical Reminder Changes to Increase Smoking Cessation Treatment in Outpatient Psychiatry (NCT NCT04071795)
NCT ID: NCT04071795
Last Updated: 2023-04-28
Results Overview
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.
COMPLETED
NA
140 participants
Up to Month 6
2023-04-28
Participant Flow
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
Participant milestones
| Measure |
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.
|
Opt-Out Reminder - Patients
Patients of psychiatrists randomized to the opt-out reminder arm.
|
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.
|
Opt In Reminder - Patients
Patients of psychiatrists randomized to the opt-in reminder arm.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
58
|
240
|
82
|
303
|
|
Overall Study
COMPLETED
|
34
|
240
|
55
|
303
|
|
Overall Study
NOT COMPLETED
|
24
|
0
|
27
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Reminder Changes to Increase Smoking Cessation Treatment in Outpatient Psychiatry
Baseline characteristics by cohort
| Measure |
Opt Out Reminder
n=34 Participants
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.
|
Opt In Reminder
n=55 Participants
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.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 16.8 • n=93 Participants
|
66.6 years
STANDARD_DEVIATION 9.23 • n=4 Participants
|
64.4 years
STANDARD_DEVIATION 12.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=93 Participants
|
49 Participants
n=4 Participants
|
81 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
68 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=93 Participants
|
55 participants
n=4 Participants
|
89 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to Month 6Population: 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.
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.
Outcome measures
| Measure |
Opt-Out Reminder - Patients of Participating Psychiatrists
n=240 Participants
Mental health patients with documented current smoking in the medical record who visited a psychiatrist randomized to receive the Opt-Out reminder.
|
Opt-In Reminder - Patients of Participating Psychiatrists
n=303 Participants
Mental health patients with documented current smoking in the medical record who visited a psychiatrist randomized to receive the Opt-In reminder.
|
|---|---|---|
|
Number of Patients Screened for Smoking
|
240 Participants
|
303 Participants
|
PRIMARY outcome
Timeframe: Up to Month 6Population: 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.
Number of people with documented current smoking in the medical record who were prescribed cessation medication.
Outcome measures
| Measure |
Opt-Out Reminder - Patients of Participating Psychiatrists
n=240 Participants
Mental health patients with documented current smoking in the medical record who visited a psychiatrist randomized to receive the Opt-Out reminder.
|
Opt-In Reminder - Patients of Participating Psychiatrists
n=303 Participants
Mental health patients with documented current smoking in the medical record who visited a psychiatrist randomized to receive the Opt-In reminder.
|
|---|---|---|
|
Number of Smokers Prescribed a Cessation Medication
|
63 Participants
|
47 Participants
|
PRIMARY outcome
Timeframe: Up to Month 6Population: 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.
Number of people with documented current smoking in the medical record for whom counseling referrals were ordered.
Outcome measures
| Measure |
Opt-Out Reminder - Patients of Participating Psychiatrists
n=240 Participants
Mental health patients with documented current smoking in the medical record who visited a psychiatrist randomized to receive the Opt-Out reminder.
|
Opt-In Reminder - Patients of Participating Psychiatrists
n=303 Participants
Mental health patients with documented current smoking in the medical record who visited a psychiatrist randomized to receive the Opt-In reminder.
|
|---|---|---|
|
Number of Smokers Referred to Counseling
|
59 Participants
|
24 Participants
|
Adverse Events
Opt Out Reminder
Opt In Reminder
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place