Trial Outcomes & Findings for Enhanced, EHR-facilitated Cancer Symptom Control Pragmatic Clinical Trial (NCT NCT03892967)
NCT ID: NCT03892967
Last Updated: 2025-10-07
Results Overview
Measured by 11-point Numeric Rating Scales (NRS) for sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment at clinic encounters. Symptoms were assessed on a scale of 0 to 10 with higher scores indicating worse outcomes. Changes in sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment from baseline score were modeled jointly as a co-primary outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50207 participants
Primary outcome timeframe
Up to 46 months (beginning from a participants' index medical oncology encounter until death, last clinical encounter, or end of study)
Results posted on
2025-10-07
Participant Flow
From March 2019 to January 2023, 50,207 patients (in fifteen clusters) were enrolled and administered ePROMs in association with oncology visits.
Participants could be enrolled for more than one Period over the course of the study.
Unit of analysis: Clusters (provider groups)
Participant milestones
| Measure |
Sequence 1
Sequence 1 began usual care on 4/1/2019 and entered EHR-facilitated collaborative care starting on 10/1/2019 (Step 2) until end of study on 1/31/2023
|
Sequence 2
Sequence 2 began usual care on 4/1/2019 and entered EHR-facilitated collaborative care starting on 6/1/2020 (Step 3) until end of study on 1/31/2023
|
Sequence 3
Sequence 3 began usual care on 4/1/2019 and entered EHR-facilitated collaborative care starting on 2/1/2021 (Step 4) until end of study on 1/31/2023
|
Sequence 4
Sequence 4 began usual care on 4/1/2019 and entered EHR-facilitated collaborative care starting on 10/1/2021 (Step 5) until end of study on 1/31/2023
|
Sequence 5
Sequence 5 began usual care on 4/1/2019 and entered EHR-facilitated collaborative care starting on 6/1/2022 (Step 6) until end of study on 1/31/2023
|
|---|---|---|---|---|---|
|
Step 1: 4/1/2019-9/30/2019
STARTED
|
2709 3
|
4023 3
|
4353 3
|
3724 3
|
1906 3
|
|
Step 1: 4/1/2019-9/30/2019
Answered >=1 Electronic Patient Reported Outcome Measure
|
1992 3
|
3098 3
|
3314 3
|
2967 3
|
1467 3
|
|
Step 1: 4/1/2019-9/30/2019
Answered >=2 Electronic Patient Reported Outcome Measures
|
1426 3
|
2295 3
|
2530 3
|
2281 3
|
1178 3
|
|
Step 1: 4/1/2019-9/30/2019
COMPLETED
|
1426 3
|
2295 3
|
2530 3
|
2281 3
|
1178 3
|
|
Step 1: 4/1/2019-9/30/2019
NOT COMPLETED
|
1283 0
|
1728 0
|
1823 0
|
1443 0
|
728 0
|
|
Step 2: 10/1/2019-5/31/2020
STARTED
|
1877 3
|
2846 3
|
3490 3
|
2696 3
|
1599 3
|
|
Step 2: 10/1/2019-5/31/2020
Answered >=1 Electronic Patient Reported Outcome Measure
|
1615 3
|
2420 3
|
3121 3
|
2382 3
|
1445 3
|
|
Step 2: 10/1/2019-5/31/2020
Answered >=2 Electronic Patient Reported Outcome Measures
|
1403 3
|
2120 3
|
2716 3
|
2144 3
|
1233 3
|
|
Step 2: 10/1/2019-5/31/2020
COMPLETED
|
1403 3
|
2120 3
|
2716 3
|
2144 3
|
1233 3
|
|
Step 2: 10/1/2019-5/31/2020
NOT COMPLETED
|
474 0
|
726 0
|
774 0
|
552 0
|
366 0
|
|
Step 3: 6/1/2020-1/31/2021
STARTED
|
2360 3
|
3566 3
|
4516 3
|
3552 3
|
1541 3
|
|
Step 3: 6/1/2020-1/31/2021
Answered >=1 Electronic Patient Reported Outcome Measure
|
2047 3
|
3058 3
|
4121 3
|
3221 3
|
1413 3
|
|
Step 3: 6/1/2020-1/31/2021
Answered >=2 Electronic Patient Reported Outcome Measures
|
1650 3
|
2573 3
|
3606 3
|
2813 3
|
1261 3
|
|
Step 3: 6/1/2020-1/31/2021
COMPLETED
|
1650 3
|
2573 3
|
3606 3
|
2813 3
|
1261 3
|
|
Step 3: 6/1/2020-1/31/2021
NOT COMPLETED
|
710 0
|
993 0
|
910 0
|
739 0
|
280 0
|
|
Step 4: 2/1/2021-9/30/2021
STARTED
|
1954 3
|
3468 3
|
4626 3
|
3606 3
|
1472 3
|
|
Step 4: 2/1/2021-9/30/2021
Answered >=1 Electronic Patient Reported Outcome Measure
|
1660 3
|
3028 3
|
4259 3
|
3273 3
|
1328 3
|
|
Step 4: 2/1/2021-9/30/2021
Answered >=2 Electronic Patient Reported Outcome Measures
|
1369 3
|
2575 3
|
3664 3
|
2776 3
|
1157 3
|
|
Step 4: 2/1/2021-9/30/2021
COMPLETED
|
1369 3
|
2575 3
|
3664 3
|
2776 3
|
1157 3
|
|
Step 4: 2/1/2021-9/30/2021
NOT COMPLETED
|
585 0
|
893 0
|
962 0
|
830 0
|
315 0
|
|
Step 5: 10/1/2021-5/31/2022
STARTED
|
1859 3
|
3185 3
|
4504 3
|
3796 3
|
1303 3
|
|
Step 5: 10/1/2021-5/31/2022
Answered >=1 Electronic Patient Reported Outcome Measure
|
1639 3
|
2796 3
|
4119 3
|
3495 3
|
1161 3
|
|
Step 5: 10/1/2021-5/31/2022
Answered >=2 Electronic Patient Reported Outcome Measures
|
1351 3
|
2340 3
|
3479 3
|
3045 3
|
1001 3
|
|
Step 5: 10/1/2021-5/31/2022
COMPLETED
|
1351 3
|
2340 3
|
3479 3
|
3045 3
|
1001 3
|
|
Step 5: 10/1/2021-5/31/2022
NOT COMPLETED
|
508 0
|
845 0
|
1025 0
|
751 0
|
302 0
|
|
Step 6: 6/1/2022-1/31/2023
STARTED
|
2206 3
|
3208 3
|
4668 3
|
3804 3
|
1541 3
|
|
Step 6: 6/1/2022-1/31/2023
Answered >=1 Electronic Patient Reported Outcome Measure
|
1940 3
|
2828 3
|
4233 3
|
3487 3
|
1329 3
|
|
Step 6: 6/1/2022-1/31/2023
Answered >=2 Electronic Patient Reported Outcome Measures
|
1409 3
|
2031 3
|
3270 3
|
2735 3
|
1055 3
|
|
Step 6: 6/1/2022-1/31/2023
COMPLETED
|
1409 3
|
2031 3
|
3270 3
|
2735 3
|
1055 3
|
|
Step 6: 6/1/2022-1/31/2023
NOT COMPLETED
|
797 0
|
1177 0
|
1398 0
|
1069 0
|
486 0
|
Reasons for withdrawal
| Measure |
Sequence 1
Sequence 1 began usual care on 4/1/2019 and entered EHR-facilitated collaborative care starting on 10/1/2019 (Step 2) until end of study on 1/31/2023
|
Sequence 2
Sequence 2 began usual care on 4/1/2019 and entered EHR-facilitated collaborative care starting on 6/1/2020 (Step 3) until end of study on 1/31/2023
|
Sequence 3
Sequence 3 began usual care on 4/1/2019 and entered EHR-facilitated collaborative care starting on 2/1/2021 (Step 4) until end of study on 1/31/2023
|
Sequence 4
Sequence 4 began usual care on 4/1/2019 and entered EHR-facilitated collaborative care starting on 10/1/2021 (Step 5) until end of study on 1/31/2023
|
Sequence 5
Sequence 5 began usual care on 4/1/2019 and entered EHR-facilitated collaborative care starting on 6/1/2022 (Step 6) until end of study on 1/31/2023
|
|---|---|---|---|---|---|
|
Step 1: 4/1/2019-9/30/2019
Participants did not answer at least two surveys and were not included in the analytic cohort
|
1283
|
1728
|
1823
|
1443
|
728
|
|
Step 2: 10/1/2019-5/31/2020
Participants did not answer at least two surveys and were not included in the analytic cohort
|
474
|
726
|
774
|
552
|
366
|
|
Step 3: 6/1/2020-1/31/2021
Participants did not answer at least two surveys and were not included in the analytic cohort
|
710
|
993
|
910
|
739
|
280
|
|
Step 4: 2/1/2021-9/30/2021
Participants did not answer at least two surveys and were not included in the analytic cohort
|
585
|
893
|
962
|
830
|
315
|
|
Step 5: 10/1/2021-5/31/2022
Participants did not answer at least two surveys and were not included in the analytic cohort
|
508
|
845
|
1025
|
751
|
302
|
|
Step 6: 6/1/2022-1/31/2023
Participants did not answer at least two surveys and were not included in the analytic cohort
|
797
|
1177
|
1398
|
1069
|
486
|
Baseline Characteristics
Enhanced, EHR-facilitated Cancer Symptom Control Pragmatic Clinical Trial
Baseline characteristics by cohort
| Measure |
Usual Care (Control)
n=16180 Participants
Participants were administered ePROM surveillance alone.
|
EHR-facilitated Collaborative Care (Intervention)
n=19084 Participants
Participants were administered ePROMs during EHR-facilitated collaborative care (ECC) periods. Automated responses, matched to symptom type and intensity, appeared following a patient's report of an actionable symptom, defined as \>=4/10 on a numeric rating scale (NRS). For any actionable symptom, respondents were asked if they wanted to receive symptom-specific self-management resources. For severe symptoms, \>=7/10, respondents were asked if they wanted to work remotely with a Symptom Care Manager (SCM) to develop an individualized symptom management plan.
|
Total
n=35264 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age · <=35
|
566 Participants
n=5 Participants
|
646 Participants
n=7 Participants
|
1212 Participants
n=5 Participants
|
|
Age, Customized
Age · 35-45
|
1200 Participants
n=5 Participants
|
1514 Participants
n=7 Participants
|
2714 Participants
n=5 Participants
|
|
Age, Customized
Age · 45-55
|
2336 Participants
n=5 Participants
|
2877 Participants
n=7 Participants
|
5213 Participants
n=5 Participants
|
|
Age, Customized
Age · 55-65
|
4188 Participants
n=5 Participants
|
4993 Participants
n=7 Participants
|
9181 Participants
n=5 Participants
|
|
Age, Customized
Age · 65-75
|
4933 Participants
n=5 Participants
|
5871 Participants
n=7 Participants
|
10804 Participants
n=5 Participants
|
|
Age, Customized
Age · 75-85
|
2466 Participants
n=5 Participants
|
2689 Participants
n=7 Participants
|
5155 Participants
n=5 Participants
|
|
Age, Customized
Age · >85
|
491 Participants
n=5 Participants
|
494 Participants
n=7 Participants
|
985 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9621 Participants
n=5 Participants
|
11138 Participants
n=7 Participants
|
20759 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6559 Participants
n=5 Participants
|
7946 Participants
n=7 Participants
|
14505 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15982 Participants
n=5 Participants
|
18816 Participants
n=7 Participants
|
34798 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
134 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
323 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
64 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
62 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
248 Participants
n=5 Participants
|
357 Participants
n=7 Participants
|
605 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
149 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
329 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15468 Participants
n=5 Participants
|
18189 Participants
n=7 Participants
|
33657 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
|
246 Participants
n=5 Participants
|
266 Participants
n=7 Participants
|
512 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16180 participants
n=5 Participants
|
19084 participants
n=7 Participants
|
35264 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 46 months (beginning from a participants' index medical oncology encounter until death, last clinical encounter, or end of study)Population: The analytic cohort includes trial participants who completed 2 or more NRS assessments.
Measured by 11-point Numeric Rating Scales (NRS) for sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment at clinic encounters. Symptoms were assessed on a scale of 0 to 10 with higher scores indicating worse outcomes. Changes in sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment from baseline score were modeled jointly as a co-primary outcome.
Outcome measures
| Measure |
Usual Care (Control)
n=16180 Participants
Participants were administered ePROM surveillance alone.
|
EHR-facilitated Collaborative Care (Intervention)
n=19084 Participants
Participants were administered ePROMs during EHR-facilitated collaborative care (ECC) periods. Automated responses, matched to symptom type and intensity, appeared following a patient's report of an actionable symptom, defined as \>=4/10 on a numeric rating scale (NRS). For any actionable symptom, respondents were asked if they wanted to receive symptom-specific self-management resources. For severe symptoms, \>=7/10, respondents were asked if they wanted to work remotely with a Symptom Care Manager (SCM) to develop an individualized symptom management plan.
|
|---|---|---|
|
Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores.
Anxiety
|
2.09 score on a scale
Interval 2.05 to 2.13
|
1.98 score on a scale
Interval 1.94 to 2.02
|
|
Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores.
Depression
|
1.90 score on a scale
Interval 1.86 to 1.93
|
1.81 score on a scale
Interval 1.78 to 1.85
|
|
Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores.
Fatigue
|
3.27 score on a scale
Interval 3.22 to 3.32
|
3.21 score on a scale
Interval 3.15 to 3.26
|
|
Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores.
Pain
|
2.18 score on a scale
Interval 2.12 to 2.24
|
2.14 score on a scale
Interval 2.09 to 2.2
|
|
Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores.
Impaired Physical Function
|
2.75 score on a scale
Interval 2.69 to 2.8
|
2.78 score on a scale
Interval 2.72 to 2.84
|
|
Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores.
Sleep
|
2.46 score on a scale
Interval 2.41 to 2.51
|
2.39 score on a scale
Interval 2.34 to 2.44
|
PRIMARY outcome
Timeframe: Up to 46 months (beginning from a participants' index medical oncology encounter until death, last clinical encounter, or end of study)Population: The analytic cohort includes trial participants who completed 2 or more NRS assessments and reported at least 1 NRS score \>= 4/10
Measured by 11-point Numeric Rating Scales (NRS) for sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment at clinic encounters. Symptoms were assessed on a scale of 0 to 10 with higher scores indicating worse outcomes. Changes in sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment following any NRS score of \>=4/10 modeled jointly as a co-primary outcome.
Outcome measures
| Measure |
Usual Care (Control)
n=9839 Participants
Participants were administered ePROM surveillance alone.
|
EHR-facilitated Collaborative Care (Intervention)
n=13084 Participants
Participants were administered ePROMs during EHR-facilitated collaborative care (ECC) periods. Automated responses, matched to symptom type and intensity, appeared following a patient's report of an actionable symptom, defined as \>=4/10 on a numeric rating scale (NRS). For any actionable symptom, respondents were asked if they wanted to receive symptom-specific self-management resources. For severe symptoms, \>=7/10, respondents were asked if they wanted to work remotely with a Symptom Care Manager (SCM) to develop an individualized symptom management plan.
|
|---|---|---|
|
Physical Function Numerical Rating Scale (NRS) Scores
Anxiety
|
2.51 units on a scale
Interval 2.05 to 2.63
|
2.37 units on a scale
Interval 2.24 to 2.49
|
|
Physical Function Numerical Rating Scale (NRS) Scores
Depression
|
2.27 units on a scale
Interval 2.14 to 2.4
|
2.17 units on a scale
Interval 2.04 to 2.3
|
|
Physical Function Numerical Rating Scale (NRS) Scores
Fatigue
|
3.96 units on a scale
Interval 3.8 to 4.12
|
3.87 units on a scale
Interval 3.72 to 4.03
|
|
Physical Function Numerical Rating Scale (NRS) Scores
Pain
|
2.53 units on a scale
Interval 2.37 to 2.69
|
2.55 units on a scale
Interval 2.39 to 2.7
|
|
Physical Function Numerical Rating Scale (NRS) Scores
Physical function impairment
|
3.23 units on a scale
Interval 3.05 to 3.42
|
3.30 units on a scale
Interval 3.11 to 3.48
|
|
Physical Function Numerical Rating Scale (NRS) Scores
Sleep
|
2.91 units on a scale
Interval 2.75 to 3.06
|
2.85 units on a scale
Interval 2.7 to 3.01
|
SECONDARY outcome
Timeframe: Baseline to 46 monthsPopulation: Patients who answered \>=1 Anxiety PROMIS-CAT were analyzed.
Measured PROMIS-CAT T-scores up to every four months, depending on visit frequency. A T-score of 50 represents the average score for the U.S. general population, with a standard deviation of 10. A higher score indicates a worse outcome. PROMIS-CAT T-scores were averaged for the control and intervention periods.
Outcome measures
| Measure |
Usual Care (Control)
n=19952 Participants
Participants were administered ePROM surveillance alone.
|
EHR-facilitated Collaborative Care (Intervention)
n=25970 Participants
Participants were administered ePROMs during EHR-facilitated collaborative care (ECC) periods. Automated responses, matched to symptom type and intensity, appeared following a patient's report of an actionable symptom, defined as \>=4/10 on a numeric rating scale (NRS). For any actionable symptom, respondents were asked if they wanted to receive symptom-specific self-management resources. For severe symptoms, \>=7/10, respondents were asked if they wanted to work remotely with a Symptom Care Manager (SCM) to develop an individualized symptom management plan.
|
|---|---|---|
|
Change in Anxiety Score
|
51.86451 score on a scale
Standard Deviation 9.036415
|
51.35445 score on a scale
Standard Deviation 9.303022
|
SECONDARY outcome
Timeframe: Baseline to 46 monthsPopulation: Patients who answered \>=1 Depression PROMIS-CAT were analyzed.
Measured PROMIS-CAT T-score up to every four months, depending on visit frequency. A T-score of 50 represents the average score for the U.S. general population, with a standard deviation of 10. A higher score indicates a worse outcome. PROMIS-CAT T-scores were averaged for the control and intervention periods.
Outcome measures
| Measure |
Usual Care (Control)
n=19979 Participants
Participants were administered ePROM surveillance alone.
|
EHR-facilitated Collaborative Care (Intervention)
n=25498 Participants
Participants were administered ePROMs during EHR-facilitated collaborative care (ECC) periods. Automated responses, matched to symptom type and intensity, appeared following a patient's report of an actionable symptom, defined as \>=4/10 on a numeric rating scale (NRS). For any actionable symptom, respondents were asked if they wanted to receive symptom-specific self-management resources. For severe symptoms, \>=7/10, respondents were asked if they wanted to work remotely with a Symptom Care Manager (SCM) to develop an individualized symptom management plan.
|
|---|---|---|
|
Change in Depression Score
|
49.05267 score on a scale
Standard Deviation 8.642265
|
48.49032 score on a scale
Standard Deviation 8.666607
|
SECONDARY outcome
Timeframe: Baseline to 46 monthsPopulation: Patients who answered \>=1 Pain Interference PROMIS-CAT were analyzed.
Measured PROMIS-CAT T-score up to every four months, depending on visit frequency. A T-score of 50 represents the average score for the U.S. general population, with a standard deviation of 10. A higher score indicates a worse outcome. PROMIS-CAT T-scores were averaged for the control and intervention periods.
Outcome measures
| Measure |
Usual Care (Control)
n=20225 Participants
Participants were administered ePROM surveillance alone.
|
EHR-facilitated Collaborative Care (Intervention)
n=26516 Participants
Participants were administered ePROMs during EHR-facilitated collaborative care (ECC) periods. Automated responses, matched to symptom type and intensity, appeared following a patient's report of an actionable symptom, defined as \>=4/10 on a numeric rating scale (NRS). For any actionable symptom, respondents were asked if they wanted to receive symptom-specific self-management resources. For severe symptoms, \>=7/10, respondents were asked if they wanted to work remotely with a Symptom Care Manager (SCM) to develop an individualized symptom management plan.
|
|---|---|---|
|
Change in Average Pain Interference Over the Past Week
|
52.57027 score on a scale
Standard Deviation 9.80923
|
53.2717 score on a scale
Standard Deviation 9.918807
|
SECONDARY outcome
Timeframe: Baseline to 46 monthsPopulation: Patients who answered \>=1 Physical Function PROMIS-CAT were analyzed.
Measured PROMIS-CAT up to every four months, depending on visit frequency. A T-score of 50 represents the average score for the U.S. general population, with a standard deviation of 10. A higher score indicates a better outcome. PROMIS-CAT T-scores were averaged for the control and intervention periods.
Outcome measures
| Measure |
Usual Care (Control)
n=20070 Participants
Participants were administered ePROM surveillance alone.
|
EHR-facilitated Collaborative Care (Intervention)
n=26239 Participants
Participants were administered ePROMs during EHR-facilitated collaborative care (ECC) periods. Automated responses, matched to symptom type and intensity, appeared following a patient's report of an actionable symptom, defined as \>=4/10 on a numeric rating scale (NRS). For any actionable symptom, respondents were asked if they wanted to receive symptom-specific self-management resources. For severe symptoms, \>=7/10, respondents were asked if they wanted to work remotely with a Symptom Care Manager (SCM) to develop an individualized symptom management plan.
|
|---|---|---|
|
Change in Physical Function Score
|
43.83007 score on a scale
Standard Deviation 9.641792
|
43.18325 score on a scale
Standard Deviation 9.561469
|
SECONDARY outcome
Timeframe: Up to 46 months (beginning from a participants' index medical oncology encounter until death, 18 months after last clinical encounter, or end of study)Population: Utilization data were available for the entire E2C2 trial cohort irrespective of ePROM completion. To assess robustness, we conducted analyses that included the full cohort, the \>=1 ePROM completers, and the \>=2 ePROM completers. In addition, we created subgroups based on residential proximity to a trial site to assess the extent of care provided at non-participating institutions. Here we report the patients who completed 1 or more surveys and resided within 120 miles from a trial site.
ER visits, hospitalizations, and ICU admissions
Outcome measures
| Measure |
Usual Care (Control)
n=13090 Participants
Participants were administered ePROM surveillance alone.
|
EHR-facilitated Collaborative Care (Intervention)
n=15220 Participants
Participants were administered ePROMs during EHR-facilitated collaborative care (ECC) periods. Automated responses, matched to symptom type and intensity, appeared following a patient's report of an actionable symptom, defined as \>=4/10 on a numeric rating scale (NRS). For any actionable symptom, respondents were asked if they wanted to receive symptom-specific self-management resources. For severe symptoms, \>=7/10, respondents were asked if they wanted to work remotely with a Symptom Care Manager (SCM) to develop an individualized symptom management plan.
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|---|---|---|
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Health Care Utilization
Hospitalizations
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3415 events
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3009 events
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Health Care Utilization
ED visits
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4331 events
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3495 events
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Health Care Utilization
ICU admissions
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940 events
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722 events
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SECONDARY outcome
Timeframe: Up to 46 months (beginning from a participants' index medical oncology encounter until death or end of study)Population: The analyses were restricted to the subgroup of patients with breast cancer being treated with docetaxel/cyclophosphamide in order to ensure comparable receipt of chemotherapeutic regimens between the comparator groups. Because docetaxel and cyclophosphamide may be first-/second-line therapy for breast cancer, a large participant subgroup that offered adequate power was chosen. Patients who crossed over from usual care to EHR-facilitated collaborative care were excluded from this analysis.
Number of doses of docetaxel and cyclophosphamide administered.
Outcome measures
| Measure |
Usual Care (Control)
n=198 Participants
Participants were administered ePROM surveillance alone.
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EHR-facilitated Collaborative Care (Intervention)
n=128 Participants
Participants were administered ePROMs during EHR-facilitated collaborative care (ECC) periods. Automated responses, matched to symptom type and intensity, appeared following a patient's report of an actionable symptom, defined as \>=4/10 on a numeric rating scale (NRS). For any actionable symptom, respondents were asked if they wanted to receive symptom-specific self-management resources. For severe symptoms, \>=7/10, respondents were asked if they wanted to work remotely with a Symptom Care Manager (SCM) to develop an individualized symptom management plan.
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|---|---|---|
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Adherence to Cancer Treatment
Number of doses of docetaxel administered
|
3.530303 number of doses administered
Standard Deviation 1.088281
|
3.765625 number of doses administered
Standard Deviation 0.6458148
|
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Adherence to Cancer Treatment
Number of doses of cyclophosphamide administered
|
3.707071 number of doses administered
Standard Deviation 0.973151
|
3.78125 number of doses administered
Standard Deviation 0.7310601
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SECONDARY outcome
Timeframe: Up to 46 months (beginning from a participants' index medical oncology encounter until death or end of study)Vital status (living or deceased) was determined by Accurint record search across multiple sources, including the Social Security Death Index
Outcome measures
| Measure |
Usual Care (Control)
n=16180 Participants
Participants were administered ePROM surveillance alone.
|
EHR-facilitated Collaborative Care (Intervention)
n=24874 Participants
Participants were administered ePROMs during EHR-facilitated collaborative care (ECC) periods. Automated responses, matched to symptom type and intensity, appeared following a patient's report of an actionable symptom, defined as \>=4/10 on a numeric rating scale (NRS). For any actionable symptom, respondents were asked if they wanted to receive symptom-specific self-management resources. For severe symptoms, \>=7/10, respondents were asked if they wanted to work remotely with a Symptom Care Manager (SCM) to develop an individualized symptom management plan.
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|---|---|---|
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Number of Deceased Participants
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2214 Participants
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3192 Participants
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Adverse Events
Usual Care (Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2214 deaths
EHR-facilitated Collaborative Care (Intervention)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3192 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