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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

13800 participants

Primary outcome timeframe

6 months

Results posted on

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

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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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

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

Advance Care Planning-Video Declaration

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

Comprehensive Record Review of ACP

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

Main Study Arm

Serious events: 0 serious events
Other events: 0 other events
Deaths: 3958 deaths

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

Phone: 617-582-9201

Results disclosure agreements

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