Trial Outcomes & Findings for Improving Tobacco Treatment Rates for Outpatient Cancer Patients Who Smoke (NCT NCT04737031)

NCT ID: NCT04737031

Last Updated: 2024-02-13

Results Overview

Defined as the proportion of patients who received either a treatment referral (via the BPA or elsewhere in the EHR workflow) or a prescription for tobacco treatment medication (i.e., nicotine replacement, varenicline, or bupropion) Based on workflow issues and recommendations from the trial's Data and Safety Monitoring Board (DSMB), the primary outcome for this trial was adjusted to contain both referrals to TUTS and medication prescriptions.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

2146 participants

Primary outcome timeframe

through study completion, up to one year

Results posted on

2024-02-13

Participant Flow

2,146 patients were enrolled in this trial. They were seen by a total of 246 clinicians across 88 clusters. Outcome measures were collected for patients.

Unit of analysis: Clusters

Participant milestones

Participant milestones
Measure
Usual Care
Clinicians and patients will receive no further interventions beyond usual practice.
Clinician Nudge
Clinicians will receive a nudge via Best Practice Alert within the EMR Clinician Nudge: Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently "fires" a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to "acknowledge" or "opt-out" when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text.
Patient Nudge
Patients will receive a message sent through myPennMedicine following establishment of their smoking status. Patient Nudge: Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.
Clinician and Patient Nudge
Both strategies described above will be used. Clinician Nudge: Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently "fires" a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to "acknowledge" or "opt-out" when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text. Patient Nudge: Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.
Overall Study
STARTED
490 22
506 24
405 19
745 23
Overall Study
COMPLETED
490 22
475 24
312 19
518 23
Overall Study
NOT COMPLETED
0 0
31 0
93 0
227 0

Reasons for withdrawal

Reasons for withdrawal
Measure
Usual Care
Clinicians and patients will receive no further interventions beyond usual practice.
Clinician Nudge
Clinicians will receive a nudge via Best Practice Alert within the EMR Clinician Nudge: Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently "fires" a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to "acknowledge" or "opt-out" when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text.
Patient Nudge
Patients will receive a message sent through myPennMedicine following establishment of their smoking status. Patient Nudge: Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.
Clinician and Patient Nudge
Both strategies described above will be used. Clinician Nudge: Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently "fires" a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to "acknowledge" or "opt-out" when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text. Patient Nudge: Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.
Overall Study
Patients who did not have a treatment visit
0
31
93
227

Baseline Characteristics

Improving Tobacco Treatment Rates for Outpatient Cancer Patients Who Smoke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Clinician Nudge
n=506 Participants
Clinicians will receive a nudge via Best Practice Alert within the EMR Clinician Nudge: Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently "fires" a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to "acknowledge" or "opt-out" when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text.
Patient Nudge
n=405 Participants
Patients will receive a message sent through myPennMedicine following establishment of their smoking status. Patient Nudge: Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.
Usual Care
n=490 Participants
Clinicians and patients will receive no further interventions beyond usual practice.
Clinician and Patient Nudge
n=745 Participants
Both strategies described above will be used. Clinician Nudge: Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently "fires" a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to "acknowledge" or "opt-out" when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text. Patient Nudge: Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.
Total
n=2146 Participants
Total of all reporting groups
Age, Continuous
61.2 years
STANDARD_DEVIATION 12.6 • n=7 Participants
62.8 years
STANDARD_DEVIATION 11.7 • n=5 Participants
61.9 years
STANDARD_DEVIATION 12.7 • n=5 Participants
60.7 years
STANDARD_DEVIATION 12.6 • n=4 Participants
61.5 years
STANDARD_DEVIATION 12.5 • n=21 Participants
Sex: Female, Male
Female
274 Participants
n=7 Participants
164 Participants
n=5 Participants
238 Participants
n=5 Participants
327 Participants
n=4 Participants
1003 Participants
n=21 Participants
Sex: Female, Male
Male
232 Participants
n=7 Participants
241 Participants
n=5 Participants
252 Participants
n=5 Participants
418 Participants
n=4 Participants
1143 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants
n=7 Participants
5 Participants
n=5 Participants
4 Participants
n=5 Participants
26 Participants
n=4 Participants
45 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
496 Participants
n=7 Participants
400 Participants
n=5 Participants
486 Participants
n=5 Participants
718 Participants
n=4 Participants
2100 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=7 Participants
0 Participants
n=5 Participants
2 Participants
n=5 Participants
0 Participants
n=4 Participants
2 Participants
n=21 Participants
Race (NIH/OMB)
Asian
8 Participants
n=7 Participants
3 Participants
n=5 Participants
6 Participants
n=5 Participants
12 Participants
n=4 Participants
29 Participants
n=21 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
3 Participants
n=21 Participants
Race (NIH/OMB)
Black or African American
151 Participants
n=7 Participants
86 Participants
n=5 Participants
114 Participants
n=5 Participants
200 Participants
n=4 Participants
551 Participants
n=21 Participants
Race (NIH/OMB)
White
318 Participants
n=7 Participants
283 Participants
n=5 Participants
333 Participants
n=5 Participants
488 Participants
n=4 Participants
1422 Participants
n=21 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=7 Participants
5 Participants
n=5 Participants
4 Participants
n=5 Participants
5 Participants
n=4 Participants
16 Participants
n=21 Participants
Race (NIH/OMB)
Unknown or Not Reported
25 Participants
n=7 Participants
27 Participants
n=5 Participants
31 Participants
n=5 Participants
40 Participants
n=4 Participants
123 Participants
n=21 Participants
Region of Enrollment
United States
506 participants
n=7 Participants
405 participants
n=5 Participants
490 participants
n=5 Participants
745 participants
n=4 Participants
2146 participants
n=21 Participants
Marital Status
Single
244 Participants
n=7 Participants
199 Participants
n=5 Participants
248 Participants
n=5 Participants
432 Participants
n=4 Participants
1123 Participants
n=21 Participants
Marital Status
Other
262 Participants
n=7 Participants
206 Participants
n=5 Participants
242 Participants
n=5 Participants
313 Participants
n=4 Participants
1023 Participants
n=21 Participants
Clinician Type (seen by patients)
Advanced Practice Provider (APP)
136 Participants
n=7 Participants
140 Participants
n=5 Participants
130 Participants
n=5 Participants
136 Participants
n=4 Participants
542 Participants
n=21 Participants
Clinician Type (seen by patients)
Physician
370 Participants
n=7 Participants
265 Participants
n=5 Participants
360 Participants
n=5 Participants
609 Participants
n=4 Participants
1604 Participants
n=21 Participants
Clinician Specialty (seen by patients)
Gynecologic oncology
21 Participants
n=7 Participants
11 Participants
n=5 Participants
8 Participants
n=5 Participants
0 Participants
n=4 Participants
40 Participants
n=21 Participants
Clinician Specialty (seen by patients)
Hematologic oncology
402 Participants
n=7 Participants
358 Participants
n=5 Participants
388 Participants
n=5 Participants
604 Participants
n=4 Participants
1752 Participants
n=21 Participants
Clinician Specialty (seen by patients)
Radiology oncology
83 Participants
n=7 Participants
36 Participants
n=5 Participants
94 Participants
n=5 Participants
141 Participants
n=4 Participants
354 Participants
n=21 Participants
Days between arm assignment and engagement
73.42 days
STANDARD_DEVIATION 76.1 • n=7 Participants
64.84 days
STANDARD_DEVIATION 66.4 • n=5 Participants
68.16 days
STANDARD_DEVIATION 69.9 • n=5 Participants
72.00 days
STANDARD_DEVIATION 71.7 • n=4 Participants
70.10 days
STANDARD_DEVIATION 71.40 • n=21 Participants

PRIMARY outcome

Timeframe: through study completion, up to one year

Population: Outcome measures were not collected for clinicians.

Defined as the proportion of patients who received either a treatment referral (via the BPA or elsewhere in the EHR workflow) or a prescription for tobacco treatment medication (i.e., nicotine replacement, varenicline, or bupropion) Based on workflow issues and recommendations from the trial's Data and Safety Monitoring Board (DSMB), the primary outcome for this trial was adjusted to contain both referrals to TUTS and medication prescriptions.

Outcome measures

Outcome measures
Measure
Usual Care
n=490 Participants
Clinicians and patients will receive no further interventions beyond usual practice.
Clinician Nudge
n=506 Participants
Clinicians will receive a nudge via Best Practice Alert within the EMR Clinician Nudge: Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently "fires" a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to "acknowledge" or "opt-out" when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text.
Patient Nudge
n=405 Participants
Patients will receive a message sent through myPennMedicine following establishment of their smoking status. Patient Nudge: Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.
Clinician and Patient Nudge
n=745 Participants
Both strategies described above will be used. Clinician Nudge: Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently "fires" a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to "acknowledge" or "opt-out" when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text. Patient Nudge: Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.
Penetration (Rate of Referral to TUTS or Medication Prescription)
66 Participants
180 Participants
40 Participants
222 Participants

SECONDARY outcome

Timeframe: Up to 30 days following baseline

Population: This outcome was only assessed for patients who were referred to TUTS. Outcome measures were not collected for clinicians.

Defined as the number of patients who make a pharmacologically-assisted quit attempt using any of the seven pharmacotherapies within 30 days of the initial oncology visit, divided by the total number of referred patients

Outcome measures

Outcome measures
Measure
Usual Care
n=66 Participants
Clinicians and patients will receive no further interventions beyond usual practice.
Clinician Nudge
n=180 Participants
Clinicians will receive a nudge via Best Practice Alert within the EMR Clinician Nudge: Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently "fires" a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to "acknowledge" or "opt-out" when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text.
Patient Nudge
n=40 Participants
Patients will receive a message sent through myPennMedicine following establishment of their smoking status. Patient Nudge: Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.
Clinician and Patient Nudge
n=222 Participants
Both strategies described above will be used. Clinician Nudge: Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently "fires" a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to "acknowledge" or "opt-out" when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text. Patient Nudge: Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.
Treatment Engagement Rates (Medication)
52 Participants
66 Participants
28 Participants
88 Participants

SECONDARY outcome

Timeframe: Up to 90 days after Repeat Visit

Population: This outcome was only assessed for patients who were referred to TUTS. Outcome measures were not collected for clinicians.

Defined as the number of patients who receive a quit-line referral or in-person or telephone cessation counseling, divided by the total number of TUTS-engaged patients

Outcome measures

Outcome measures
Measure
Usual Care
n=66 Participants
Clinicians and patients will receive no further interventions beyond usual practice.
Clinician Nudge
n=180 Participants
Clinicians will receive a nudge via Best Practice Alert within the EMR Clinician Nudge: Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently "fires" a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to "acknowledge" or "opt-out" when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text.
Patient Nudge
n=40 Participants
Patients will receive a message sent through myPennMedicine following establishment of their smoking status. Patient Nudge: Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.
Clinician and Patient Nudge
n=222 Participants
Both strategies described above will be used. Clinician Nudge: Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently "fires" a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to "acknowledge" or "opt-out" when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text. Patient Nudge: Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.
Treatment Engagement Rate (Behavioral)
0 Participants
131 Participants
0 Participants
133 Participants

SECONDARY outcome

Timeframe: Up to 90 days after Repeat Visit

Population: This outcome was assessed for patients with whom TUTS staff were able to successfully follow up. Outcome measures were not collected for clinicians.

Defined as the number of TUTS-referred patients who make any quit attempt, divided by the total number of TUTS-referred patients

Outcome measures

Outcome measures
Measure
Usual Care
Clinicians and patients will receive no further interventions beyond usual practice.
Clinician Nudge
n=18 Participants
Clinicians will receive a nudge via Best Practice Alert within the EMR Clinician Nudge: Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently "fires" a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to "acknowledge" or "opt-out" when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text.
Patient Nudge
Patients will receive a message sent through myPennMedicine following establishment of their smoking status. Patient Nudge: Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.
Clinician and Patient Nudge
n=24 Participants
Both strategies described above will be used. Clinician Nudge: Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently "fires" a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to "acknowledge" or "opt-out" when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text. Patient Nudge: Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.
Quit Attempt Rate
0 Participants
14 Participants
0 Participants
18 Participants

SECONDARY outcome

Timeframe: Up to 90 days after Repeat Visit

Population: This outcome was assessed for patients with whom TUTS staff were able to successfully follow up. Outcome measures were not collected for clinicians.

Defined as the total number of TUTS-referred patients self-reporting 7-day point prevalence abstinence at a 90-day follow-up assessment, divided by the total number of TUTS-referred patients

Outcome measures

Outcome measures
Measure
Usual Care
Clinicians and patients will receive no further interventions beyond usual practice.
Clinician Nudge
n=18 Participants
Clinicians will receive a nudge via Best Practice Alert within the EMR Clinician Nudge: Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently "fires" a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to "acknowledge" or "opt-out" when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text.
Patient Nudge
Patients will receive a message sent through myPennMedicine following establishment of their smoking status. Patient Nudge: Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.
Clinician and Patient Nudge
n=24 Participants
Both strategies described above will be used. Clinician Nudge: Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently "fires" a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next visit after the screening encounter, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to "acknowledge" or "opt-out" when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text. Patient Nudge: Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the screening encounter). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician.
Abstinence Rate
0 Participants
2 Participants
0 Participants
1 Participants

Adverse Events

Usual Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Clinician Nudge

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

Patient Nudge

Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths

Clinician and Patient Nudge

Serious events: 0 serious events
Other events: 0 other events
Deaths: 18 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert Schnoll, PhD

University of Pennsylvania

Phone: 215.746.7143

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place