Trial Outcomes & Findings for Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (NCT NCT03609177)
NCT ID: NCT03609177
Last Updated: 2025-10-21
Results Overview
Any advance directive (e.g., living will, POLST, etc.) and changes of resuscitation orders or any indication in the EHR of a goals-of-care or advance care planning conversation
COMPLETED
NA
13800 participants
6 months
2025-10-21
Participant Flow
Recruitment was from April, 2020 - November, 2022. Locations: 36 cancer clinics
This is a stepped-wedge, cluster randomized trial where clinics were randomized at various steps to move from a control period to the intervention periods. A total of 13,800 unique participants from 29 clinics were enrolled in the study. Participants could have contributed data multiple times during any step of the study.
Unit of analysis: clinic
Participant milestones
| Measure |
Sequence 1: Control (6 Months), Intervention (24 Months)
Clinics participated in a baseline control period for 6 months followed by 24 months of intervention
|
Sequence 2: Control (12 Months), Intervention (18 Months)
Clinics participated in control periods for 12 months followed by 18 months of intervention
|
Sequence 3: Control (18 Months), Intervention (12 Months)
Clinics participated in control periods for 18 months followed by 12 months of intervention
|
Sequence 4: Control (24 Months), Intervention (6 Months)
Clinics participated in control periods for 24 months followed by 6 months of intervention
|
|---|---|---|---|---|
|
Baseline
STARTED
|
1571 6
|
1604 9
|
1151 9
|
1376 5
|
|
Baseline
Intervention
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Baseline
Control
|
1571 6
|
1604 9
|
1151 9
|
1376 5
|
|
Baseline
COMPLETED
|
1571 6
|
1604 0
|
1151 0
|
1376 5
|
|
Baseline
NOT COMPLETED
|
0 0
|
0 9
|
0 9
|
0 0
|
|
Step 1
STARTED
|
1593 6
|
1538 9
|
1152 9
|
1253 5
|
|
Step 1
Intervention
|
1593 6
|
0 0
|
0 0
|
0 0
|
|
Step 1
Control
|
0 0
|
1538 9
|
1152 9
|
1253 5
|
|
Step 1
COMPLETED
|
1593 6
|
1538 9
|
1152 9
|
1253 5
|
|
Step 1
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Step 2
STARTED
|
1741 6
|
1589 9
|
1033 6
|
1440 5
|
|
Step 2
Intervention
|
1741 6
|
1589 9
|
0 0
|
0 0
|
|
Step 2
Control
|
0 0
|
0 0
|
1033 6
|
1440 5
|
|
Step 2
COMPLETED
|
1741 6
|
1589 9
|
1033 6
|
1440 5
|
|
Step 2
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Step 3
STARTED
|
1961 6
|
1464 9
|
1177 9
|
1485 5
|
|
Step 3
Intervention
|
1961 6
|
1464 9
|
1177 9
|
0 0
|
|
Step 3
Control
|
0 0
|
0 0
|
0 0
|
1485 5
|
|
Step 3
COMPLETED
|
1961 6
|
1461 9
|
1177 9
|
1485 5
|
|
Step 3
NOT COMPLETED
|
0 0
|
3 0
|
0 0
|
0 0
|
|
Step 4
STARTED
|
1789 6
|
1519 9
|
1318 9
|
1603 5
|
|
Step 4
Intervention
|
1789 6
|
1519 9
|
1318 9
|
1603 5
|
|
Step 4
Control
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Step 4
COMPLETED
|
1789 6
|
1519 9
|
1318 9
|
1603 5
|
|
Step 4
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=15754 Participants
Patients with cancer being seen at the 30 oncology clinics will be exposed to clinicians who have had communication skills training (Vital Talk) and who are using video decision aids (ACP Decisions). Our main outcome is advance care planning documentation.
Clinician Communication Skills Training: Communication skills training
Advance Care Planning (ACP) Decisions Videos Decisions Aids: ACP Decisions video decision aids
Video Declarations (ViDec): Recording of patient advance care planning videos
|
Usual Care Arm
n=13603 Participants
Patients who were not exposed to any intervention
|
Total
n=29357 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.4 Years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
74.6 Years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
74.5 Years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7284 Participants
n=5 Participants
|
6729 Participants
n=7 Participants
|
14013 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8470 Participants
n=5 Participants
|
6874 Participants
n=7 Participants
|
15344 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
454 Participants
n=5 Participants
|
392 Participants
n=7 Participants
|
846 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14750 Participants
n=5 Participants
|
12,801 Participants
n=7 Participants
|
27551 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
550 Participants
n=5 Participants
|
410 Participants
n=7 Participants
|
960 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
35 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
556 Participants
n=5 Participants
|
479 Participants
n=7 Participants
|
1035 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1978 Participants
n=5 Participants
|
1455 Participants
n=7 Participants
|
3433 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11830 Participants
n=5 Participants
|
10441 Participants
n=7 Participants
|
22271 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1347 Participants
n=5 Participants
|
1188 Participants
n=7 Participants
|
2535 Participants
n=5 Participants
|
|
Language
English
|
15096 Participants
n=5 Participants
|
13067 Participants
n=7 Participants
|
28163 Participants
n=5 Participants
|
|
Language
Other
|
554 Participants
n=5 Participants
|
490 Participants
n=7 Participants
|
1044 Participants
n=5 Participants
|
|
Language
Unknown
|
104 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The primary outcome measure was assessed at the participant level (all eligible patients) and not at the unit level.
Any advance directive (e.g., living will, POLST, etc.) and changes of resuscitation orders or any indication in the EHR of a goals-of-care or advance care planning conversation
Outcome measures
| Measure |
Intervention Arm
n=15754 Participants
Patients with cancer being seen at the 30 oncology clinics will be exposed to clinicians who have had communication skills training (Vital Talk) and who are using video decision aids (ACP Decisions). Our main outcome is advance care planning documentation.
Clinician Communication Skills Training: Communication skills training
Advance Care Planning (ACP) Decisions Videos Decisions Aids: ACP Decisions video decision aids
Video Declarations (ViDec): Recording of patient advance care planning videos
|
Usual Care Arm
n=13603 Participants
Patients who were not exposed to any intervention
|
|---|---|---|
|
Number of Participants With Advance Care Planning Documentation
Baseline
|
0 Participants
|
1163 Participants
|
|
Number of Participants With Advance Care Planning Documentation
Step 1
|
349 Participants
|
901 Participants
|
|
Number of Participants With Advance Care Planning Documentation
Step 2
|
886 Participants
|
511 Participants
|
|
Number of Participants With Advance Care Planning Documentation
Step 3
|
1047 Participants
|
259 Participants
|
|
Number of Participants With Advance Care Planning Documentation
Step 4
|
1698 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The secondary outcome measure was assessed at the participant level (all eligible patients) and not at the unit level.
Documented choices regarding CPR and mechanical ventilation in the EHR
Outcome measures
| Measure |
Intervention Arm
n=15754 Participants
Patients with cancer being seen at the 30 oncology clinics will be exposed to clinicians who have had communication skills training (Vital Talk) and who are using video decision aids (ACP Decisions). Our main outcome is advance care planning documentation.
Clinician Communication Skills Training: Communication skills training
Advance Care Planning (ACP) Decisions Videos Decisions Aids: ACP Decisions video decision aids
Video Declarations (ViDec): Recording of patient advance care planning videos
|
Usual Care Arm
n=13603 Participants
Patients who were not exposed to any intervention
|
|---|---|---|
|
Number of Participants With CODE Status Limitations
Baseline
|
0 Participants
|
303 Participants
|
|
Number of Participants With CODE Status Limitations
Step 1
|
58 Participants
|
205 Participants
|
|
Number of Participants With CODE Status Limitations
Step 2
|
155 Participants
|
142 Participants
|
|
Number of Participants With CODE Status Limitations
Step 3
|
280 Participants
|
74 Participants
|
|
Number of Participants With CODE Status Limitations
Step 4
|
354 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The secondary outcome measure was assessed at the participant level (all eligible patients) and not at the unit level.
Use of palliative care services (consults, outpatient visits) in the EHR
Outcome measures
| Measure |
Intervention Arm
n=15754 Participants
Patients with cancer being seen at the 30 oncology clinics will be exposed to clinicians who have had communication skills training (Vital Talk) and who are using video decision aids (ACP Decisions). Our main outcome is advance care planning documentation.
Clinician Communication Skills Training: Communication skills training
Advance Care Planning (ACP) Decisions Videos Decisions Aids: ACP Decisions video decision aids
Video Declarations (ViDec): Recording of patient advance care planning videos
|
Usual Care Arm
n=13603 Participants
Patients who were not exposed to any intervention
|
|---|---|---|
|
Rate of Palliative Care Consultation
Step 1
|
102 Participants
|
375 Participants
|
|
Rate of Palliative Care Consultation
Step 2
|
324 Participants
|
253 Participants
|
|
Rate of Palliative Care Consultation
Baseline
|
0 Participants
|
531 Participants
|
|
Rate of Palliative Care Consultation
Step 3
|
443 Participants
|
128 Participants
|
|
Rate of Palliative Care Consultation
Step 4
|
648 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The secondary outcome measure was assessed at the participant level (all eligible patients) and not at the unit level.
Use of hospice documented in the EHR
Outcome measures
| Measure |
Intervention Arm
n=15754 Participants
Patients with cancer being seen at the 30 oncology clinics will be exposed to clinicians who have had communication skills training (Vital Talk) and who are using video decision aids (ACP Decisions). Our main outcome is advance care planning documentation.
Clinician Communication Skills Training: Communication skills training
Advance Care Planning (ACP) Decisions Videos Decisions Aids: ACP Decisions video decision aids
Video Declarations (ViDec): Recording of patient advance care planning videos
|
Usual Care Arm
n=13603 Participants
Patients who were not exposed to any intervention
|
|---|---|---|
|
Rate of Hospice Use
Baseline
|
0 Participants
|
491 Participants
|
|
Rate of Hospice Use
Step 1
|
50 Participants
|
348 Participants
|
|
Rate of Hospice Use
Step 2
|
260 Participants
|
202 Participants
|
|
Rate of Hospice Use
Step 3
|
350 Participants
|
108 Participants
|
|
Rate of Hospice Use
Step 4
|
468 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The secondary outcome measure was assessed at the participant level (all eligible patients) and not at the unit level.
(in person survey) patient confidence that they will receive the right care at the right time by their health system. The scale ranged from 1 Not at all confident to 5 Very confident. Higher values represent a better outcome.
Outcome measures
| Measure |
Intervention Arm
n=196 Participants
Patients with cancer being seen at the 30 oncology clinics will be exposed to clinicians who have had communication skills training (Vital Talk) and who are using video decision aids (ACP Decisions). Our main outcome is advance care planning documentation.
Clinician Communication Skills Training: Communication skills training
Advance Care Planning (ACP) Decisions Videos Decisions Aids: ACP Decisions video decision aids
Video Declarations (ViDec): Recording of patient advance care planning videos
|
Usual Care Arm
n=122 Participants
Patients who were not exposed to any intervention
|
|---|---|---|
|
Confidence in Future Care
None to little confidence
|
4 Participants
|
4 Participants
|
|
Confidence in Future Care
Somewhat confident
|
13 Participants
|
8 Participants
|
|
Confidence in Future Care
Fairly confident
|
27 Participants
|
15 Participants
|
|
Confidence in Future Care
Very Confident
|
137 Participants
|
90 Participants
|
|
Confidence in Future Care
Unknown
|
15 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The secondary outcome measure was assessed at the participant level (all eligible patients) and not at the unit level.
(In person survey) patient satisfaction with communication and decision making.The scale range is from 1- Strongly Disagree to 5 - Strongly Disagree. Higher values represent better outcomes. Subscales were combined questions were summed to compute a total score. The lowest possible score is a 9 and the highest possible score is 45. Lower scores indicate lower communication and decisional satisfaction.
Outcome measures
| Measure |
Intervention Arm
n=196 Participants
Patients with cancer being seen at the 30 oncology clinics will be exposed to clinicians who have had communication skills training (Vital Talk) and who are using video decision aids (ACP Decisions). Our main outcome is advance care planning documentation.
Clinician Communication Skills Training: Communication skills training
Advance Care Planning (ACP) Decisions Videos Decisions Aids: ACP Decisions video decision aids
Video Declarations (ViDec): Recording of patient advance care planning videos
|
Usual Care Arm
n=122 Participants
Patients who were not exposed to any intervention
|
|---|---|---|
|
Communication and Decisional Satisfaction
|
44 units on a scale
Interval 39.0 to 45.0
|
44 units on a scale
Interval 37.0 to 45.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The secondary outcome measure was assessed at the participant level (all eligible patients) and not at the unit level.
(In person survey) patient regret regarding decision making. The response range is 1 - Strongly Disagree to 5 - Strongly agree. Higher numbers represent a worse outcome. Scale questions were summed to compute a total score. The lowest possible score is 2 and the highest possible score is 10. Lower scores indicate less decisional regret.
Outcome measures
| Measure |
Intervention Arm
n=196 Participants
Patients with cancer being seen at the 30 oncology clinics will be exposed to clinicians who have had communication skills training (Vital Talk) and who are using video decision aids (ACP Decisions). Our main outcome is advance care planning documentation.
Clinician Communication Skills Training: Communication skills training
Advance Care Planning (ACP) Decisions Videos Decisions Aids: ACP Decisions video decision aids
Video Declarations (ViDec): Recording of patient advance care planning videos
|
Usual Care Arm
n=122 Participants
Patients who were not exposed to any intervention
|
|---|---|---|
|
Decisional Regret
|
2 units on a scale
Interval 2.0 to 4.0
|
2 units on a scale
Interval 2.0 to 4.0
|
Adverse Events
Advance Care Planning
Advance Care Planning-Video Declaration
Comprehensive Record Review of ACP
Main Study Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
James Tulsky, MD, Chair of Suppportive Oncology Department
Dana Farber Cancer Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place