Trial Outcomes & Findings for Ambulatory Cancer Care Electronic Symptom Self-Reporting for Surgical Patients (NCT NCT03178045)
NCT ID: NCT03178045
Last Updated: 2023-06-23
Results Overview
To compare the effectiveness of Team Monitoring and Enhanced Feedback with regard to urgent care, emergency department visits, and readmissions up to 30 days post-operatively.
Recruitment status
COMPLETED
Target enrollment
2793 participants
Primary outcome timeframe
30 days
Results posted on
2023-06-23
Participant Flow
Participant milestones
| Measure |
Team Monitoring
Team monitoring is the current standard of care for patients at the Josie Robertson Surgical Center (JRSC) at Memorial Sloan Kettering Cancer Center (MSK). Patients report their symptoms via an electronic questionnaire called the Recovery Tracker, delivered through an in-house informatics platform known as the ambulatory cancer care electronic symptom self-reporting (ACCESS) system. The healthcare team receives portal-secure message alerts if patients report symptoms above a specified threshold and contact the patient by phone during business hours. Given the need for real-time feedback for some symptoms, patients who report very severe symptoms receive a bold red alert instructing them to immediately contact their care team or seek medical attention.
|
Enhanced Feedback
In the enhanced feedback cohort, the ACCESS system provides tailored normative data visualizations that offer context and education to patients regarding expected symptom severity. The feedback report consists of periodically updated PRO data from previous patients that are stratified by surgical procedure and postoperative date. As a result, patients can see their recovery trajectories relative to others who have undergone the same procedure. Care is 'patient-activated', in that patients use the information about expected symptoms to decide whether they should call the care team, for instance, if they experience symptoms that are more severe or more prolonged than expected. Similar to the team monitoring cohort, patients who report very severe symptoms are instructed to immediately contact their physician's office, and the care team receives an alert.
|
|---|---|---|
|
Overall Study
STARTED
|
1396
|
1397
|
|
Overall Study
COMPLETED
|
1310
|
1314
|
|
Overall Study
NOT COMPLETED
|
86
|
83
|
Reasons for withdrawal
| Measure |
Team Monitoring
Team monitoring is the current standard of care for patients at the Josie Robertson Surgical Center (JRSC) at Memorial Sloan Kettering Cancer Center (MSK). Patients report their symptoms via an electronic questionnaire called the Recovery Tracker, delivered through an in-house informatics platform known as the ambulatory cancer care electronic symptom self-reporting (ACCESS) system. The healthcare team receives portal-secure message alerts if patients report symptoms above a specified threshold and contact the patient by phone during business hours. Given the need for real-time feedback for some symptoms, patients who report very severe symptoms receive a bold red alert instructing them to immediately contact their care team or seek medical attention.
|
Enhanced Feedback
In the enhanced feedback cohort, the ACCESS system provides tailored normative data visualizations that offer context and education to patients regarding expected symptom severity. The feedback report consists of periodically updated PRO data from previous patients that are stratified by surgical procedure and postoperative date. As a result, patients can see their recovery trajectories relative to others who have undergone the same procedure. Care is 'patient-activated', in that patients use the information about expected symptoms to decide whether they should call the care team, for instance, if they experience symptoms that are more severe or more prolonged than expected. Similar to the team monitoring cohort, patients who report very severe symptoms are instructed to immediately contact their physician's office, and the care team receives an alert.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
|
Overall Study
Surgery Cancelled/Relocated
|
34
|
30
|
|
Overall Study
Procedure Ineligible Post-Operatively/Pr
|
47
|
46
|
Baseline Characteristics
Ambulatory Cancer Care Electronic Symptom Self-Reporting for Surgical Patients
Baseline characteristics by cohort
| Measure |
Team Monitoring
n=1 Participants
Team monitoring is the current standard of care for patients at the Josie Robertson Surgical Center (JRSC) at Memorial Sloan Kettering Cancer Center (MSK). Patients report their symptoms via an electronic questionnaire called the Recovery Tracker, delivered through an in-house informatics platform known as the ambulatory cancer care electronic symptom self-reporting (ACCESS) system. The healthcare team receives portal-secure message alerts if patients report symptoms above a specified threshold and contact the patient by phone during business hours. Given the need for real-time feedback for some symptoms, patients who report very severe symptoms receive a bold red alert instructing them to immediately contact their care team or seek medical attention.
|
Enhanced Feedback
n=1 Participants
In the enhanced feedback cohort, the ACCESS system provides tailored normative data visualizations that offer context and education to patients regarding expected symptom severity. The feedback report consists of periodically updated PRO data from previous patients that are stratified by surgical procedure and postoperative date. As a result, patients can see their recovery trajectories relative to others who have undergone the same procedure. Care is 'patient-activated', in that patients use the information about expected symptoms to decide whether they should call the care team, for instance, if they experience symptoms that are more severe or more prolonged than expected. Similar to the team monitoring cohort, patients who report very severe symptoms are instructed to immediately contact their physician's office, and the care team receives an alert.
|
Total
n=2624 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
n=5 Participants
|
54 years
n=7 Participants
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
948 Participants
n=5 Participants
|
933 Participants
n=7 Participants
|
1881 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
362 Participants
n=5 Participants
|
381 Participants
n=7 Participants
|
743 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
80 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1146 Participants
n=5 Participants
|
1163 Participants
n=7 Participants
|
2309 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
84 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
80 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
74 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1073 Participants
n=5 Participants
|
1045 Participants
n=7 Participants
|
2118 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
81 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1310 Participants
n=5 Participants
|
1314 Participants
n=7 Participants
|
2624 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysTo compare the effectiveness of Team Monitoring and Enhanced Feedback with regard to urgent care, emergency department visits, and readmissions up to 30 days post-operatively.
Outcome measures
| Measure |
Team Monitoring
n=1 Participants
Team monitoring is the current standard of care for patients at the Josie Robertson Surgical Center (JRSC) at Memorial Sloan Kettering Cancer Center (MSK). Patients report their symptoms via an electronic questionnaire called the Recovery Tracker, delivered through an in-house informatics platform known as the ambulatory cancer care electronic symptom self-reporting (ACCESS) system. The healthcare team receives portal-secure message alerts if patients report symptoms above a specified threshold and contact the patient by phone during business hours. Given the need for real-time feedback for some symptoms, patients who report very severe symptoms receive a bold red alert instructing them to immediately contact their care team or seek medical attention.
|
Enhanced Feedback
n=1 Participants
In the enhanced feedback cohort, the ACCESS system provides tailored normative data visualizations that offer context and education to patients regarding expected symptom severity. The feedback report consists of periodically updated PRO data from previous patients that are stratified by surgical procedure and postoperative date. As a result, patients can see their recovery trajectories relative to others who have undergone the same procedure. Care is 'patient-activated', in that patients use the information about expected symptoms to decide whether they should call the care team, for instance, if they experience symptoms that are more severe or more prolonged than expected. Similar to the team monitoring cohort, patients who report very severe symptoms are instructed to immediately contact their physician's office, and the care team receives an alert.
|
Difference in Participants Anxiety
Difference in Participants Anxiety Measured by PROCTCAE Survey
|
|---|---|---|---|
|
Rates of UCC Visits and Readmissions Between the Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-operatively
UCC with Readmission within 30 days
|
31 Participants
|
38 Participants
|
—
|
|
Rates of UCC Visits and Readmissions Between the Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-operatively
UCC without Readmission within 30 days
|
44 Participants
|
60 Participants
|
—
|
|
Rates of UCC Visits and Readmissions Between the Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-operatively
Readmission within 30 days
|
32 Participants
|
39 Participants
|
—
|
|
Rates of UCC Visits and Readmissions Between the Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-operatively
No UCC or Readmissions within 30 days
|
1203 Participants
|
1177 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 days post-operativelyTo evaluate the difference in nursing phone calls between each study arm up to 30 days post-operatively.
Outcome measures
| Measure |
Team Monitoring
n=1310 Participants
Team monitoring is the current standard of care for patients at the Josie Robertson Surgical Center (JRSC) at Memorial Sloan Kettering Cancer Center (MSK). Patients report their symptoms via an electronic questionnaire called the Recovery Tracker, delivered through an in-house informatics platform known as the ambulatory cancer care electronic symptom self-reporting (ACCESS) system. The healthcare team receives portal-secure message alerts if patients report symptoms above a specified threshold and contact the patient by phone during business hours. Given the need for real-time feedback for some symptoms, patients who report very severe symptoms receive a bold red alert instructing them to immediately contact their care team or seek medical attention.
|
Enhanced Feedback
n=1314 Participants
In the enhanced feedback cohort, the ACCESS system provides tailored normative data visualizations that offer context and education to patients regarding expected symptom severity. The feedback report consists of periodically updated PRO data from previous patients that are stratified by surgical procedure and postoperative date. As a result, patients can see their recovery trajectories relative to others who have undergone the same procedure. Care is 'patient-activated', in that patients use the information about expected symptoms to decide whether they should call the care team, for instance, if they experience symptoms that are more severe or more prolonged than expected. Similar to the team monitoring cohort, patients who report very severe symptoms are instructed to immediately contact their physician's office, and the care team receives an alert.
|
Difference in Participants Anxiety
Difference in Participants Anxiety Measured by PROCTCAE Survey
|
|---|---|---|---|
|
Difference in Total Number of Nursing Follow-up Calls Between Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-Operatively
|
3.79 Nursing Calls
Standard Deviation 3.14
|
3.40 Nursing Calls
Standard Deviation 2.71
|
—
|
SECONDARY outcome
Timeframe: 30 days post-operativelyTo evaluate the difference in unplanned clinic visits and phone referrals to clinic between each study arm up to 30 days post-operatively.
Outcome measures
| Measure |
Team Monitoring
n=1310 Participants
Team monitoring is the current standard of care for patients at the Josie Robertson Surgical Center (JRSC) at Memorial Sloan Kettering Cancer Center (MSK). Patients report their symptoms via an electronic questionnaire called the Recovery Tracker, delivered through an in-house informatics platform known as the ambulatory cancer care electronic symptom self-reporting (ACCESS) system. The healthcare team receives portal-secure message alerts if patients report symptoms above a specified threshold and contact the patient by phone during business hours. Given the need for real-time feedback for some symptoms, patients who report very severe symptoms receive a bold red alert instructing them to immediately contact their care team or seek medical attention.
|
Enhanced Feedback
n=1314 Participants
In the enhanced feedback cohort, the ACCESS system provides tailored normative data visualizations that offer context and education to patients regarding expected symptom severity. The feedback report consists of periodically updated PRO data from previous patients that are stratified by surgical procedure and postoperative date. As a result, patients can see their recovery trajectories relative to others who have undergone the same procedure. Care is 'patient-activated', in that patients use the information about expected symptoms to decide whether they should call the care team, for instance, if they experience symptoms that are more severe or more prolonged than expected. Similar to the team monitoring cohort, patients who report very severe symptoms are instructed to immediately contact their physician's office, and the care team receives an alert.
|
Difference in Participants Anxiety
Difference in Participants Anxiety Measured by PROCTCAE Survey
|
|---|---|---|---|
|
Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively
0 Clinic Visits
|
349 Participants
|
347 Participants
|
—
|
|
Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively
1 Clinic Visit
|
467 Participants
|
476 Participants
|
—
|
|
Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively
2 Clinic Visits
|
301 Participants
|
282 Participants
|
—
|
|
Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively
3 Clinic Visits
|
129 Participants
|
137 Participants
|
—
|
|
Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively
4 Clinic Visits
|
49 Participants
|
52 Participants
|
—
|
|
Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively
5 Clinic Visits
|
9 Participants
|
15 Participants
|
—
|
|
Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively
6 Clinic Visits
|
5 Participants
|
4 Participants
|
—
|
|
Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively
7 Clinic Visits
|
0 Participants
|
1 Participants
|
—
|
|
Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively
8 Clinic Visits
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 days post-operativelyTo evaluate the difference in pain management referrals between each study arm up to 30 days post-operatively.
Outcome measures
| Measure |
Team Monitoring
n=1310 Participants
Team monitoring is the current standard of care for patients at the Josie Robertson Surgical Center (JRSC) at Memorial Sloan Kettering Cancer Center (MSK). Patients report their symptoms via an electronic questionnaire called the Recovery Tracker, delivered through an in-house informatics platform known as the ambulatory cancer care electronic symptom self-reporting (ACCESS) system. The healthcare team receives portal-secure message alerts if patients report symptoms above a specified threshold and contact the patient by phone during business hours. Given the need for real-time feedback for some symptoms, patients who report very severe symptoms receive a bold red alert instructing them to immediately contact their care team or seek medical attention.
|
Enhanced Feedback
n=1314 Participants
In the enhanced feedback cohort, the ACCESS system provides tailored normative data visualizations that offer context and education to patients regarding expected symptom severity. The feedback report consists of periodically updated PRO data from previous patients that are stratified by surgical procedure and postoperative date. As a result, patients can see their recovery trajectories relative to others who have undergone the same procedure. Care is 'patient-activated', in that patients use the information about expected symptoms to decide whether they should call the care team, for instance, if they experience symptoms that are more severe or more prolonged than expected. Similar to the team monitoring cohort, patients who report very severe symptoms are instructed to immediately contact their physician's office, and the care team receives an alert.
|
Difference in Participants Anxiety
Difference in Participants Anxiety Measured by PROCTCAE Survey
|
|---|---|---|---|
|
Differences in Total Number of Pain Management Referrals Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively
0 Clinic Visit
|
1299 Participants
|
1302 Participants
|
—
|
|
Differences in Total Number of Pain Management Referrals Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively
1 Clinic Visit
|
10 Participants
|
11 Participants
|
—
|
|
Differences in Total Number of Pain Management Referrals Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively
2 Clinic Visits
|
1 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 days post-operativelyTo evaluate the difference in adverse events between each study arm up to 30 days post-operatively.
Outcome measures
| Measure |
Team Monitoring
n=1310 Participants
Team monitoring is the current standard of care for patients at the Josie Robertson Surgical Center (JRSC) at Memorial Sloan Kettering Cancer Center (MSK). Patients report their symptoms via an electronic questionnaire called the Recovery Tracker, delivered through an in-house informatics platform known as the ambulatory cancer care electronic symptom self-reporting (ACCESS) system. The healthcare team receives portal-secure message alerts if patients report symptoms above a specified threshold and contact the patient by phone during business hours. Given the need for real-time feedback for some symptoms, patients who report very severe symptoms receive a bold red alert instructing them to immediately contact their care team or seek medical attention.
|
Enhanced Feedback
n=1314 Participants
In the enhanced feedback cohort, the ACCESS system provides tailored normative data visualizations that offer context and education to patients regarding expected symptom severity. The feedback report consists of periodically updated PRO data from previous patients that are stratified by surgical procedure and postoperative date. As a result, patients can see their recovery trajectories relative to others who have undergone the same procedure. Care is 'patient-activated', in that patients use the information about expected symptoms to decide whether they should call the care team, for instance, if they experience symptoms that are more severe or more prolonged than expected. Similar to the team monitoring cohort, patients who report very severe symptoms are instructed to immediately contact their physician's office, and the care team receives an alert.
|
Difference in Participants Anxiety
Difference in Participants Anxiety Measured by PROCTCAE Survey
|
|---|---|---|---|
|
Differences in Adverse Events Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively
0 Adverse Events
|
1260 Participants
|
1258 Participants
|
—
|
|
Differences in Adverse Events Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively
1 Adverse Event
|
47 Participants
|
56 Participants
|
—
|
|
Differences in Adverse Events Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively
2 Adverse Events
|
3 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 10 days post-operativelyThis analysis utilized 3 anxiety items from the PRO-CTCAE survey. The responses were defined on a scale of 0-4 with higher scores representing stronger agreement with the item (higher anxiety). The 3 items were summed to generate an overall score ranging from 0-12. 139 patients responded to only some of the 3 items and were counted as a missing value for the overall sum score. As the surveys were repeated daily, longitudinal mixed effects regression was used to test the association between the anxiety sum score and randomization arm after adjusting for time, randomization strata, and an interaction between randomization arm and time with a random intercept for patient.
Outcome measures
| Measure |
Team Monitoring
n=1310 Participants
Team monitoring is the current standard of care for patients at the Josie Robertson Surgical Center (JRSC) at Memorial Sloan Kettering Cancer Center (MSK). Patients report their symptoms via an electronic questionnaire called the Recovery Tracker, delivered through an in-house informatics platform known as the ambulatory cancer care electronic symptom self-reporting (ACCESS) system. The healthcare team receives portal-secure message alerts if patients report symptoms above a specified threshold and contact the patient by phone during business hours. Given the need for real-time feedback for some symptoms, patients who report very severe symptoms receive a bold red alert instructing them to immediately contact their care team or seek medical attention.
|
Enhanced Feedback
n=1314 Participants
In the enhanced feedback cohort, the ACCESS system provides tailored normative data visualizations that offer context and education to patients regarding expected symptom severity. The feedback report consists of periodically updated PRO data from previous patients that are stratified by surgical procedure and postoperative date. As a result, patients can see their recovery trajectories relative to others who have undergone the same procedure. Care is 'patient-activated', in that patients use the information about expected symptoms to decide whether they should call the care team, for instance, if they experience symptoms that are more severe or more prolonged than expected. Similar to the team monitoring cohort, patients who report very severe symptoms are instructed to immediately contact their physician's office, and the care team receives an alert.
|
Difference in Participants Anxiety
n=2624 Participants
Difference in Participants Anxiety Measured by PROCTCAE Survey
|
|---|---|---|---|
|
Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE)
Post-Op Day 4
|
2.8 reduction in anxiety score
Interval 2.6 to 3.0
|
2.8 reduction in anxiety score
Interval 2.6 to 3.0
|
0.07 reduction in anxiety score
Interval -0.12 to 0.26
|
|
Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE)
Post-Op Day 2
|
0.03 reduction in anxiety score
Interval 0.02 to 0.05
|
3.0 reduction in anxiety score
Interval 2.8 to 3.3
|
0.15 reduction in anxiety score
Interval -0.07 to 0.35
|
|
Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE)
Post-Op Day 5
|
2.7 reduction in anxiety score
Interval 2.5 to 2.9
|
2.7 reduction in anxiety score
Interval 2.5 to 2.9
|
0.03 reduction in anxiety score
Interval -0.15 to 0.21
|
|
Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE)
Post-Op Day 6
|
2.6 reduction in anxiety score
Interval 2.4 to 2.8
|
2.6 reduction in anxiety score
Interval 2.4 to 2.8
|
-0.01 reduction in anxiety score
Interval -0.18 to 0.16
|
|
Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE)
Post-Op Day 3
|
2.9 reduction in anxiety score
Interval 2.7 to 3.1
|
2.9 reduction in anxiety score
Interval 2.7 to 3.1
|
0.11 reduction in anxiety score
Interval -0.09 to 0.31
|
|
Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE)
Post-Op Day 7
|
2.5 reduction in anxiety score
Interval 2.3 to 2.7
|
2.5 reduction in anxiety score
Interval 2.3 to 2.7
|
-0.05 reduction in anxiety score
Interval -0.22 to 0.12
|
|
Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE)
Post-Op Day 8
|
2.5 reduction in anxiety score
Interval 2.3 to 2.7
|
2.4 reduction in anxiety score
Interval 2.2 to 2.6
|
-0.08 reduction in anxiety score
Interval -0.26 to 0.08
|
|
Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE)
Post-Op Day 9
|
2.4 reduction in anxiety score
Interval 2.2 to 2.6
|
2.3 reduction in anxiety score
Interval 2.1 to 2.5
|
-0.12 reduction in anxiety score
Interval -0.3 to 0.04
|
|
Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE)
Post-Op Day 10
|
2.3 reduction in anxiety score
Interval 2.1 to 2.5
|
2.2 reduction in anxiety score
Interval 1.9 to 2.4
|
-0.16 reduction in anxiety score
Interval -0.35 to 0.01
|
SECONDARY outcome
Timeframe: 14 days post-operativelyTo evaluate the difference in patient engagement between each study arm at 14 days post-operatively adjusting for strata and preoperative PAM overall score. The survey consists of 10 items with five response options: strongly disagree, disagree, undecided, agree and strongly agree defined on a scale of 1-5 with higher scores representing stronger agreement with the item. The items in the PAM survey were combined to generate an overall mean score at each timepoint - a theoretical score of 0-100. A higher score indicates stronger patient engagement. If a patient is missing a response to an item(s), the overall score is considered missing for that patient/timepoint. Participants who answered the survey were included in this analysis. 560 patients were analyzed in the Team Monitoring Arm and 541 were analyzed in the Enhanced Feedback Arm.
Outcome measures
| Measure |
Team Monitoring
n=560 Participants
Team monitoring is the current standard of care for patients at the Josie Robertson Surgical Center (JRSC) at Memorial Sloan Kettering Cancer Center (MSK). Patients report their symptoms via an electronic questionnaire called the Recovery Tracker, delivered through an in-house informatics platform known as the ambulatory cancer care electronic symptom self-reporting (ACCESS) system. The healthcare team receives portal-secure message alerts if patients report symptoms above a specified threshold and contact the patient by phone during business hours. Given the need for real-time feedback for some symptoms, patients who report very severe symptoms receive a bold red alert instructing them to immediately contact their care team or seek medical attention.
|
Enhanced Feedback
n=541 Participants
In the enhanced feedback cohort, the ACCESS system provides tailored normative data visualizations that offer context and education to patients regarding expected symptom severity. The feedback report consists of periodically updated PRO data from previous patients that are stratified by surgical procedure and postoperative date. As a result, patients can see their recovery trajectories relative to others who have undergone the same procedure. Care is 'patient-activated', in that patients use the information about expected symptoms to decide whether they should call the care team, for instance, if they experience symptoms that are more severe or more prolonged than expected. Similar to the team monitoring cohort, patients who report very severe symptoms are instructed to immediately contact their physician's office, and the care team receives an alert.
|
Difference in Participants Anxiety
Difference in Participants Anxiety Measured by PROCTCAE Survey
|
|---|---|---|---|
|
Differences in Patient Engagement Between Cohorts at 14 Days Post-Operatively Utilizing the Patient Activation Measure (PAM) and Adjusting for Strata and Pre-Operative PAM Score
|
3.39 PAM Score at 14 Days
Standard Deviation 0.40
|
3.37 PAM Score at 14 Days
Standard Deviation 0.43
|
—
|
SECONDARY outcome
Timeframe: 60 days post-operativelyTo evaluate the difference in patient engagement between each study arm 60 days post-operatively adjusting for strata and preoperative PAM overall score. The survey consists of 10 items with five response options: strongly disagree, disagree, undecided, agree and strongly agree defined on a scale of 1-5 with higher scores representing stronger agreement with the item. The items in the PAM survey were combined to generate an overall mean score at each timepoint - a theoretical score of 0-100. A higher score indicates stronger patient engagement. If a patient is missing a response to an item(s), the overall score is considered missing for that patient/timepoint. 465 participants form the Team Monitoring Arm and 460 participants from the Enhanced Feedback arm were analyzed who answered the Patient Activation Measure at POD 60.
Outcome measures
| Measure |
Team Monitoring
n=465 Participants
Team monitoring is the current standard of care for patients at the Josie Robertson Surgical Center (JRSC) at Memorial Sloan Kettering Cancer Center (MSK). Patients report their symptoms via an electronic questionnaire called the Recovery Tracker, delivered through an in-house informatics platform known as the ambulatory cancer care electronic symptom self-reporting (ACCESS) system. The healthcare team receives portal-secure message alerts if patients report symptoms above a specified threshold and contact the patient by phone during business hours. Given the need for real-time feedback for some symptoms, patients who report very severe symptoms receive a bold red alert instructing them to immediately contact their care team or seek medical attention.
|
Enhanced Feedback
n=460 Participants
In the enhanced feedback cohort, the ACCESS system provides tailored normative data visualizations that offer context and education to patients regarding expected symptom severity. The feedback report consists of periodically updated PRO data from previous patients that are stratified by surgical procedure and postoperative date. As a result, patients can see their recovery trajectories relative to others who have undergone the same procedure. Care is 'patient-activated', in that patients use the information about expected symptoms to decide whether they should call the care team, for instance, if they experience symptoms that are more severe or more prolonged than expected. Similar to the team monitoring cohort, patients who report very severe symptoms are instructed to immediately contact their physician's office, and the care team receives an alert.
|
Difference in Participants Anxiety
Difference in Participants Anxiety Measured by PROCTCAE Survey
|
|---|---|---|---|
|
Differences in Patient Engagement Between Team Monitoring and Enhanced Feedback Cohorts at 60 Days Post-Operatively Utilizing the Patient Activation Measure (PAM) and Adjusting for Strata and Pre-Operative PAM Score
|
3.47 PAM Score at 60 Days
Standard Deviation 0.40
|
3.44 PAM Score at 60 Days
Standard Deviation 0.44
|
—
|
SECONDARY outcome
Timeframe: 14 days post-operativelyTo evaluate the difference in caregiver burden between each study arm at two timepoints: 14 days post-operatively. Scoring information for the CRA: The Caregiver Reaction Assessment involved 24 items given at 14 days and repeated at 60 days with the following potential responses: strongly disagree, disagree, undecided, agree, and strongly agree which we defined on a scale of 1-5 with higher scores representing stronger agreement with the item. These items are combined into 5 subscales: health problems, financial problems, lack of family support, disrupted schedule, and self-esteem. For each subscale, a total score was computed as the average of the subsequent item scores, with a range between 1 and 5. A higher score represented a stronger agreement with the attribute.
Outcome measures
| Measure |
Team Monitoring
n=1310 Participants
Team monitoring is the current standard of care for patients at the Josie Robertson Surgical Center (JRSC) at Memorial Sloan Kettering Cancer Center (MSK). Patients report their symptoms via an electronic questionnaire called the Recovery Tracker, delivered through an in-house informatics platform known as the ambulatory cancer care electronic symptom self-reporting (ACCESS) system. The healthcare team receives portal-secure message alerts if patients report symptoms above a specified threshold and contact the patient by phone during business hours. Given the need for real-time feedback for some symptoms, patients who report very severe symptoms receive a bold red alert instructing them to immediately contact their care team or seek medical attention.
|
Enhanced Feedback
n=1314 Participants
In the enhanced feedback cohort, the ACCESS system provides tailored normative data visualizations that offer context and education to patients regarding expected symptom severity. The feedback report consists of periodically updated PRO data from previous patients that are stratified by surgical procedure and postoperative date. As a result, patients can see their recovery trajectories relative to others who have undergone the same procedure. Care is 'patient-activated', in that patients use the information about expected symptoms to decide whether they should call the care team, for instance, if they experience symptoms that are more severe or more prolonged than expected. Similar to the team monitoring cohort, patients who report very severe symptoms are instructed to immediately contact their physician's office, and the care team receives an alert.
|
Difference in Participants Anxiety
Difference in Participants Anxiety Measured by PROCTCAE Survey
|
|---|---|---|---|
|
Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA).
Health Problems
|
2.40 score on CRA
Standard Deviation 0.46
|
2.45 score on CRA
Standard Deviation 0.52
|
—
|
|
Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA).
Financial Problems
|
1.76 score on CRA
Standard Deviation 0.85
|
1.78 score on CRA
Standard Deviation 0.88
|
—
|
|
Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA).
Lack of Family Support
|
1.59 score on CRA
Standard Deviation 0.61
|
1.75 score on CRA
Standard Deviation 0.66
|
—
|
|
Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA).
Disrupted Schedule
|
2.72 score on CRA
Standard Deviation 0.88
|
2.70 score on CRA
Standard Deviation 0.86
|
—
|
|
Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA).
Self Esteem
|
4.52 score on CRA
Standard Deviation 0.35
|
4.47 score on CRA
Standard Deviation 0.35
|
—
|
SECONDARY outcome
Timeframe: 60 days post-operativelyTo evaluate the difference in caregiver burden between each study arm at two timepoints: 60 days post-operatively. Scoring information for the CRA: The Caregiver Reaction Assessment involved 24 items given at 14 days and repeated at 60 days with the following potential responses: strongly disagree, disagree, undecided, agree, and strongly agree which we defined on a scale of 1-5 with higher scores representing stronger agreement with the item. These items are combined into 5 subscales: health problems, financial problems, lack of family support, disrupted schedule, and self-esteem. For each subscale, a total score was computed as the average of the subsequent item scores, with a range between 1 and 5. A higher score represented a stronger agreement with the attribute.
Outcome measures
| Measure |
Team Monitoring
n=1310 Participants
Team monitoring is the current standard of care for patients at the Josie Robertson Surgical Center (JRSC) at Memorial Sloan Kettering Cancer Center (MSK). Patients report their symptoms via an electronic questionnaire called the Recovery Tracker, delivered through an in-house informatics platform known as the ambulatory cancer care electronic symptom self-reporting (ACCESS) system. The healthcare team receives portal-secure message alerts if patients report symptoms above a specified threshold and contact the patient by phone during business hours. Given the need for real-time feedback for some symptoms, patients who report very severe symptoms receive a bold red alert instructing them to immediately contact their care team or seek medical attention.
|
Enhanced Feedback
n=1314 Participants
In the enhanced feedback cohort, the ACCESS system provides tailored normative data visualizations that offer context and education to patients regarding expected symptom severity. The feedback report consists of periodically updated PRO data from previous patients that are stratified by surgical procedure and postoperative date. As a result, patients can see their recovery trajectories relative to others who have undergone the same procedure. Care is 'patient-activated', in that patients use the information about expected symptoms to decide whether they should call the care team, for instance, if they experience symptoms that are more severe or more prolonged than expected. Similar to the team monitoring cohort, patients who report very severe symptoms are instructed to immediately contact their physician's office, and the care team receives an alert.
|
Difference in Participants Anxiety
Difference in Participants Anxiety Measured by PROCTCAE Survey
|
|---|---|---|---|
|
Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA).
Health Problems
|
2.34 score on CRA
Standard Deviation 0.47
|
2.44 score on CRA
Standard Deviation 0.50
|
—
|
|
Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA).
Financial Problems
|
1.93 score on CRA
Standard Deviation 0.91
|
1.90 score on CRA
Standard Deviation 0.90
|
—
|
|
Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA).
Lack of Family Support
|
1.71 score on CRA
Standard Deviation 0.65
|
1.76 score on CRA
Standard Deviation 0.73
|
—
|
|
Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA).
Disrupted Schedule
|
2.43 score on CRA
Standard Deviation 0.93
|
2.43 score on CRA
Standard Deviation 0.87
|
—
|
|
Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA).
Self Esteem
|
4.45 score on CRA
Standard Deviation 0.36
|
4.42 score on CRA
Standard Deviation 0.41
|
—
|
Adverse Events
Team Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Feedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Robert Allen Jr., MD
Memorial Sloan Kettering Cancer Center
Phone: 646-608-8041
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place