Trial Outcomes & Findings for Effect of Behavioral Nudges on Serious Illness Conversation Documentation (NCT NCT04867850)
NCT ID: NCT04867850
Last Updated: 2024-04-18
Results Overview
Measured at the patient level as a binary outcome (yes/no) among high-risk patients based on date of documented note including the SIC template in the Advanced Care Planning (ACP) section of the electronic medical record by any provider Outcomes were measured for patients only.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
4450 participants
Primary outcome timeframe
Within 6 months of the Index Visit (baseline)
Results posted on
2024-04-18
Participant Flow
A total of 4,450 patients were included in this study on serious illness conversations (SICs). These patients were seen by 163 clinicians across 65 oncologist-advanced practice provider (APP) clusters. Baseline measures and outcome data were collected for patients only.
Unit of analysis: Oncologist-APP Clusters
Participant milestones
| Measure |
Usual Care
Clinicians and patients will receive no further interventions beyond usual practice. Usual care for clinicians includes a nudge consisting of targeted text messages identifying patients at high risk of predicted 6-month mortality based on a validated machine learning prognostic algorithm.
Usual Care: Individual clinicians will receive an automated weekly email detailing a weekly roster of their upcoming repeat-patient visits (Index Visit) with patients at high risk of 6-month mortality as determined by a validated machine learning prognostic algorithm. Clinicians will receive a HIPAA compliant text message on the morning of the appointment reminding them to consider a serious illness conversation with patients on the list.
|
Clinician Nudge
Clinicians receive a nudge consisting of targeted text messages identifying patients at high risk of predicted 6-month mortality based on a validated machine learning prognostic algorithm as well as performance feedback compared to peers.
Clinician Nudge: Clinicians will receive the usual care weekly email and text message described above under Usual Care. In addition, embedded in the weekly email, clinicians will receive performance feedback information detailing their documented SICs relative to those documented by peers.
|
Patient Nudge
Patients receive a nudge consisting of a normalizing message prompting patients to complete an electronic questionnaire designed to prime patients towards having an SIC.
Patient Nudge: Ahead of the Index Visit, high risk patients as identified by the prognostic algorithm will receive a nudge via personal text message and email consisting of a normalizing message prompting patients with a personalized link to a short electronic questionnaire on SIC topics.
|
Clinician and Patient Nudge
Both strategies described above will be used.
Clinician Nudge: Clinicians will receive the usual care weekly email and text message described above under Usual Care. In addition, embedded in the weekly email, clinicians will receive performance feedback information detailing their documented SICs relative to those documented by peers.
Patient Nudge: Ahead of the Index Visit, high risk patients as identified by the prognostic algorithm will receive a nudge via personal text message and email consisting of a normalizing message prompting patients with a personalized link to a short electronic questionnaire on SIC topics.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1004 32
|
1179 33
|
997 0
|
1270 0
|
|
Overall Study
COMPLETED
|
1004 29
|
1179 31
|
997 0
|
1270 0
|
|
Overall Study
NOT COMPLETED
|
0 3
|
0 2
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
Baseline characteristics by cohort
| Measure |
Usual Care
n=1004 Participants
Clinicians and patients will receive no further interventions beyond usual practice. Usual care for clinicians includes a nudge consisting of targeted text messages identifying patients at high risk of predicted 6-month mortality based on a validated machine learning prognostic algorithm.
Usual Care: Individual clinicians will receive an automated weekly email detailing a weekly roster of their upcoming repeat-patient visits (Index Visit) with patients at high risk of 6-month mortality as determined by a validated machine learning prognostic algorithm. Clinicians will receive a HIPAA compliant text message on the morning of the appointment reminding them to consider a serious illness conversation with patients on the list.
|
Clinician Nudge
n=1179 Participants
Clinicians receive a nudge consisting of targeted text messages identifying patients at high risk of predicted 6-month mortality based on a validated machine learning prognostic algorithm as well as performance feedback compared to peers.
Clinician Nudge: Clinicians will receive the usual care weekly email and text message described above under Usual Care. In addition, embedded in the weekly email, clinicians will receive performance feedback information detailing their documented SICs relative to those documented by peers.
|
Patient Nudge
n=997 Participants
Patients receive a nudge consisting of a normalizing message prompting patients to complete an electronic questionnaire designed to prime patients towards having an SIC.
Patient Nudge: Ahead of the Index Visit, high risk patients as identified by the prognostic algorithm will receive a nudge via personal text message and email consisting of a normalizing message prompting patients with a personalized link to a short electronic questionnaire on SIC topics.
|
Clinician and Patient Nudge
n=1270 Participants
Both strategies described above will be used.
Clinician Nudge: Clinicians will receive the usual care weekly email and text message described above under Usual Care. In addition, embedded in the weekly email, clinicians will receive performance feedback information detailing their documented SICs relative to those documented by peers.
Patient Nudge: Ahead of the Index Visit, high risk patients as identified by the prognostic algorithm will receive a nudge via personal text message and email consisting of a normalizing message prompting patients with a personalized link to a short electronic questionnaire on SIC topics.
|
Total
n=4450 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66 years
n=99 Participants
|
68 years
n=107 Participants
|
67 years
n=206 Participants
|
68 years
n=7 Participants
|
67 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
556 Participants
n=99 Participants
|
594 Participants
n=107 Participants
|
558 Participants
n=206 Participants
|
644 Participants
n=7 Participants
|
2352 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
448 Participants
n=99 Participants
|
585 Participants
n=107 Participants
|
439 Participants
n=206 Participants
|
626 Participants
n=7 Participants
|
2098 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
36 Participants
n=7 Participants
|
122 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
975 Participants
n=99 Participants
|
1150 Participants
n=107 Participants
|
969 Participants
n=206 Participants
|
1234 Participants
n=7 Participants
|
4328 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
23 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
129 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
192 Participants
n=99 Participants
|
206 Participants
n=107 Participants
|
176 Participants
n=206 Participants
|
196 Participants
n=7 Participants
|
770 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
736 Participants
n=99 Participants
|
873 Participants
n=107 Participants
|
722 Participants
n=206 Participants
|
963 Participants
n=7 Participants
|
3294 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
29 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
48 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
64 Participants
n=7 Participants
|
217 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
1004 Participants
n=99 Participants
|
1179 Participants
n=107 Participants
|
997 Participants
n=206 Participants
|
1270 Participants
n=7 Participants
|
4450 Participants
n=31 Participants
|
|
Predicted odds of 180-day mortality (based on a validated machine learning algorithm; 0-1 scale)
|
.18 Avg. predicted probability of mortality
n=99 Participants
|
.19 Avg. predicted probability of mortality
n=107 Participants
|
.18 Avg. predicted probability of mortality
n=206 Participants
|
.19 Avg. predicted probability of mortality
n=7 Participants
|
.19 Avg. predicted probability of mortality
n=31 Participants
|
PRIMARY outcome
Timeframe: Within 6 months of the Index Visit (baseline)Measured at the patient level as a binary outcome (yes/no) among high-risk patients based on date of documented note including the SIC template in the Advanced Care Planning (ACP) section of the electronic medical record by any provider Outcomes were measured for patients only.
Outcome measures
| Measure |
Usual Care
n=1004 Participants
Clinicians and patients will receive no further interventions beyond usual practice. Usual care for clinicians includes a nudge consisting of targeted text messages identifying patients at high risk of predicted 6-month mortality based on a validated machine learning prognostic algorithm.
Usual Care: Individual clinicians will receive an automated weekly email detailing a weekly roster of their upcoming repeat-patient visits (Index Visit) with patients at high risk of 6-month mortality as determined by a validated machine learning prognostic algorithm. Clinicians will receive a HIPAA compliant text message on the morning of the appointment reminding them to consider a serious illness conversation with patients on the list.
|
Clinician Nudge
n=1179 Participants
Clinicians receive a nudge consisting of targeted text messages identifying patients at high risk of predicted 6-month mortality based on a validated machine learning prognostic algorithm as well as performance feedback compared to peers.
Clinician Nudge: Clinicians will receive the usual care weekly email and text message described above under Usual Care. In addition, embedded in the weekly email, clinicians will receive performance feedback information detailing their documented SICs relative to those documented by peers.
|
Patient Nudge
n=997 Participants
Patients receive a nudge consisting of a normalizing message prompting patients to complete an electronic questionnaire designed to prime patients towards having an SIC.
Patient Nudge: Ahead of the Index Visit, high risk patients as identified by the prognostic algorithm will receive a nudge via personal text message and email consisting of a normalizing message prompting patients with a personalized link to a short electronic questionnaire on SIC topics.
|
Clinician and Patient Nudge
n=1270 Participants
Both strategies described above will be used.
Clinician Nudge: Clinicians will receive the usual care weekly email and text message described above under Usual Care. In addition, embedded in the weekly email, clinicians will receive performance feedback information detailing their documented SICs relative to those documented by peers.
Patient Nudge: Ahead of the Index Visit, high risk patients as identified by the prognostic algorithm will receive a nudge via personal text message and email consisting of a normalizing message prompting patients with a personalized link to a short electronic questionnaire on SIC topics.
|
|---|---|---|---|---|
|
Number of High Risk Patients With Documentation of a Serious Illness Conversation (SIC)
|
112 Participants
|
136 Participants
|
115 Participants
|
179 Participants
|
SECONDARY outcome
Timeframe: Within 6 months of first repeat patient visit during trial periodPopulation: Data were not collected for this outcome because it reflected a different patient population than the one in this study. The workflow for identifying patients for this trial was based on patients having a risk score (risk of predicted 180-day mortality based on a validated machine-learning prognostic algorithm) exceeding a certain threshold ahead of their clinical appointment, and it was infeasible to track patients with a risk score below this threshold.
Measured at the patient level as a binary outcome (yes/no) among all cancer patients based on date of documented note including the SIC template in the Advanced Care Planning (ACP) section of the electronic medical record by any provider Outcomes were measured for patients only.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 6 months of the Index Visit (baseline)Measured at the patient level as a binary outcome (yes/no) among high-risk patients based on presence of a scheduled palliative care appointment Outcomes were measured for patients only.
Outcome measures
| Measure |
Usual Care
n=1004 Participants
Clinicians and patients will receive no further interventions beyond usual practice. Usual care for clinicians includes a nudge consisting of targeted text messages identifying patients at high risk of predicted 6-month mortality based on a validated machine learning prognostic algorithm.
Usual Care: Individual clinicians will receive an automated weekly email detailing a weekly roster of their upcoming repeat-patient visits (Index Visit) with patients at high risk of 6-month mortality as determined by a validated machine learning prognostic algorithm. Clinicians will receive a HIPAA compliant text message on the morning of the appointment reminding them to consider a serious illness conversation with patients on the list.
|
Clinician Nudge
n=1179 Participants
Clinicians receive a nudge consisting of targeted text messages identifying patients at high risk of predicted 6-month mortality based on a validated machine learning prognostic algorithm as well as performance feedback compared to peers.
Clinician Nudge: Clinicians will receive the usual care weekly email and text message described above under Usual Care. In addition, embedded in the weekly email, clinicians will receive performance feedback information detailing their documented SICs relative to those documented by peers.
|
Patient Nudge
n=997 Participants
Patients receive a nudge consisting of a normalizing message prompting patients to complete an electronic questionnaire designed to prime patients towards having an SIC.
Patient Nudge: Ahead of the Index Visit, high risk patients as identified by the prognostic algorithm will receive a nudge via personal text message and email consisting of a normalizing message prompting patients with a personalized link to a short electronic questionnaire on SIC topics.
|
Clinician and Patient Nudge
n=1270 Participants
Both strategies described above will be used.
Clinician Nudge: Clinicians will receive the usual care weekly email and text message described above under Usual Care. In addition, embedded in the weekly email, clinicians will receive performance feedback information detailing their documented SICs relative to those documented by peers.
Patient Nudge: Ahead of the Index Visit, high risk patients as identified by the prognostic algorithm will receive a nudge via personal text message and email consisting of a normalizing message prompting patients with a personalized link to a short electronic questionnaire on SIC topics.
|
|---|---|---|---|---|
|
Number of High Risk Patients With a Palliative Care Referral
|
84 Participants
|
94 Participants
|
81 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: Within 6 months of the Index Visit (baseline)Population: Aggressive End-Of-Life Care was only assessed among the 773 decedents.
Measured at the patient level as a binary outcome (yes/no) among high-risk patients who die based on the presence of any of the following three criteria: chemotherapy within 14 days before death, hospitalization within 30 days before death, or admission to hospice 3 days or less before death Outcomes were measured for patients only.
Outcome measures
| Measure |
Usual Care
n=162 Participants
Clinicians and patients will receive no further interventions beyond usual practice. Usual care for clinicians includes a nudge consisting of targeted text messages identifying patients at high risk of predicted 6-month mortality based on a validated machine learning prognostic algorithm.
Usual Care: Individual clinicians will receive an automated weekly email detailing a weekly roster of their upcoming repeat-patient visits (Index Visit) with patients at high risk of 6-month mortality as determined by a validated machine learning prognostic algorithm. Clinicians will receive a HIPAA compliant text message on the morning of the appointment reminding them to consider a serious illness conversation with patients on the list.
|
Clinician Nudge
n=227 Participants
Clinicians receive a nudge consisting of targeted text messages identifying patients at high risk of predicted 6-month mortality based on a validated machine learning prognostic algorithm as well as performance feedback compared to peers.
Clinician Nudge: Clinicians will receive the usual care weekly email and text message described above under Usual Care. In addition, embedded in the weekly email, clinicians will receive performance feedback information detailing their documented SICs relative to those documented by peers.
|
Patient Nudge
n=157 Participants
Patients receive a nudge consisting of a normalizing message prompting patients to complete an electronic questionnaire designed to prime patients towards having an SIC.
Patient Nudge: Ahead of the Index Visit, high risk patients as identified by the prognostic algorithm will receive a nudge via personal text message and email consisting of a normalizing message prompting patients with a personalized link to a short electronic questionnaire on SIC topics.
|
Clinician and Patient Nudge
n=227 Participants
Both strategies described above will be used.
Clinician Nudge: Clinicians will receive the usual care weekly email and text message described above under Usual Care. In addition, embedded in the weekly email, clinicians will receive performance feedback information detailing their documented SICs relative to those documented by peers.
Patient Nudge: Ahead of the Index Visit, high risk patients as identified by the prognostic algorithm will receive a nudge via personal text message and email consisting of a normalizing message prompting patients with a personalized link to a short electronic questionnaire on SIC topics.
|
|---|---|---|---|---|
|
Number of Decedent High Risk Patients Who Received Aggressive End-Of-Life Care
|
76 Participants
|
95 Participants
|
62 Participants
|
97 Participants
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 162 deaths
Clinician Nudge
Serious events: 0 serious events
Other events: 0 other events
Deaths: 227 deaths
Patient Nudge
Serious events: 0 serious events
Other events: 0 other events
Deaths: 157 deaths
Clinician and Patient Nudge
Serious events: 0 serious events
Other events: 0 other events
Deaths: 227 deaths
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