Trial Outcomes & Findings for An Inpatient Advance Care Planning Intervention for Older Patients With Hematologic Malignancies (NCT NCT05433090)

NCT ID: NCT05433090

Last Updated: 2026-03-31

Results Overview

Retention rate is the percentage of consented patients who completed the ACP intervention visit. A retention rate of \>70% was considered feasible.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

41 participants

Primary outcome timeframe

From consent until completion of the ACP intervention visit, usually within 1 week.

Results posted on

2026-03-31

Participant Flow

Eligible patients being managed in the inpatient setting at the University of Rochester Medical Center (URMC) Wilmot Cancer Institute (WCI), were identified by treating physicians, APPs, hematology/oncology fellows, nurses, and study coordinators. Patients were recruited from November 2022 to October 2024.

57 patients were approached, and 41 consented (consent rate: 71.9%). The most common reasons patients declined to participate were a reluctance to complete surveys (n=8), feeling overwhelmed by their current situation (n=5), or a belief that discussing their preferences with the care team would not be helpful (n=3).

Participant milestones

Participant milestones
Measure
Advanced Care Planning
This is a single-arm pilot study. After completing baseline measures, all patients received an inpatient Advanced Care Planning (ACP) intervention. Before the visit, patients received a preparation pamphlet. The APP/hematology/oncology fellow used the "Serious Illness Care Guide" during the ACP intervention to discuss advanced care planning and end of life care with the patient. At the end of the visit, patients received a "Family Guide" to help communicate with their family about the visit.
Overall Study
STARTED
41
Overall Study
Completed ACP Intervention
38
Overall Study
COMPLETED
35
Overall Study
NOT COMPLETED
6

Reasons for withdrawal

Reasons for withdrawal
Measure
Advanced Care Planning
This is a single-arm pilot study. After completing baseline measures, all patients received an inpatient Advanced Care Planning (ACP) intervention. Before the visit, patients received a preparation pamphlet. The APP/hematology/oncology fellow used the "Serious Illness Care Guide" during the ACP intervention to discuss advanced care planning and end of life care with the patient. At the end of the visit, patients received a "Family Guide" to help communicate with their family about the visit.
Overall Study
Patient Discharged Before ACP Intervention
3
Overall Study
Withdrawal by Subject
1
Overall Study
Death
2

Baseline Characteristics

An Inpatient Advance Care Planning Intervention for Older Patients With Hematologic Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Advanced Care Planning
n=41 Participants
This is a single-arm pilot study. After completing baseline measures, all patients received an inpatient Advanced Care Planning (ACP) intervention. Before the visit, patients received a preparation pamphlet. The APP/hematology/oncology fellow used the "Serious Illness Care Guide" during the ACP intervention to discuss advanced care planning and end of life care with the patient. At the end of the visit, patients received a "Family Guide" to help communicate with their family about the visit.
Age, Continuous
68 Years
STANDARD_DEVIATION 4.3 • n=4 Participants
Sex: Female, Male
Female
22 Participants
n=4 Participants
Sex: Female, Male
Male
19 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
41 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=4 Participants
Race (NIH/OMB)
Asian
0 Participants
n=4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=4 Participants
Race (NIH/OMB)
White
40 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=4 Participants
Education
High school or below
12 Participants
n=4 Participants
Education
Training after high school or some college/university
12 Participants
n=4 Participants
Education
College/University graduate
11 Participants
n=4 Participants
Education
Post Graduate level
5 Participants
n=4 Participants
Education
Other
1 Participants
n=4 Participants
Marital status
Married/long term, committed significant other
24 Participants
n=4 Participants
Marital status
Divorced
3 Participants
n=4 Participants
Marital status
Single
5 Participants
n=4 Participants
Marital status
Widowed
9 Participants
n=4 Participants
Employment status
Employed
10 Participants
n=4 Participants
Employment status
Retired
28 Participants
n=4 Participants
Employment status
Unemployed
1 Participants
n=4 Participants
Employment status
Homemaker
0 Participants
n=4 Participants
Employment status
Other
2 Participants
n=4 Participants
Caregiver living with the patient
Partner (spouse/significant other)
25 Participants
n=4 Participants
Caregiver living with the patient
Child/children
1 Participants
n=4 Participants
Caregiver living with the patient
None
15 Participants
n=4 Participants
Caregiver not living with the patient
Partner (spouse/significant other)
5 Participants
n=4 Participants
Caregiver not living with the patient
Child/children
8 Participants
n=4 Participants
Caregiver not living with the patient
Other relative(s)
2 Participants
n=4 Participants
Caregiver not living with the patient
None
26 Participants
n=4 Participants
Cancer diagnosis
Acute lymphoblastic leukemia
3 Participants
n=4 Participants
Cancer diagnosis
Acute myeloid leukemia
25 Participants
n=4 Participants
Cancer diagnosis
Central Nervous System Lymphoma
1 Participants
n=4 Participants
Cancer diagnosis
Lymphoma
3 Participants
n=4 Participants
Cancer diagnosis
Multiple myeloma
4 Participants
n=4 Participants
Cancer diagnosis
Myelodysplastic syndrome
4 Participants
n=4 Participants
Cancer diagnosis
Plasma cell leukemia
1 Participants
n=4 Participants
Cancer diagnosis duration
<6 months
24 Participants
n=4 Participants
Cancer diagnosis duration
>= 6 months
17 Participants
n=4 Participants
Cancer health literacy
Adequate literacy
39 Participants
n=4 Participants
Cancer health literacy
Limited literacy
2 Participants
n=4 Participants

PRIMARY outcome

Timeframe: From consent until completion of the ACP intervention visit, usually within 1 week.

Population: All consented participants who underwent baseline assessment.

Retention rate is the percentage of consented patients who completed the ACP intervention visit. A retention rate of \>70% was considered feasible.

Outcome measures

Outcome measures
Measure
Advanced Care Planning
n=41 Participants
This is a single-arm pilot study. After completing baseline measures, all patients received an inpatient Advanced Care Planning (ACP) intervention. Before the visit, patients received a preparation pamphlet. The APP/hematology/oncology fellow used the "Serious Illness Care Guide" during the ACP intervention to discuss advanced care planning and end of life care with the patient. At the end of the visit, patients received a "Family Guide" to help communicate with their family about the visit.
Retention Rate
Retained - completed ACP intervention
38 Participants
Retention Rate
Not retained - didn't complete ACP intervention
3 Participants

SECONDARY outcome

Timeframe: From baseline (pre-intervention) to 1 year post-intervention. The time interval is approximately 1 year.

Population: All participants who consented and completed baseline measures. Baseline and post-intervention data represent paired data from the same participants who completed both timepoints.

Data on the patient's completion of scanned healthcare proxy form that was completed with their physician was collected via the electronic medical record. This is expressed as a percentage.

Outcome measures

Outcome measures
Measure
Advanced Care Planning
n=41 Participants
This is a single-arm pilot study. After completing baseline measures, all patients received an inpatient Advanced Care Planning (ACP) intervention. Before the visit, patients received a preparation pamphlet. The APP/hematology/oncology fellow used the "Serious Illness Care Guide" during the ACP intervention to discuss advanced care planning and end of life care with the patient. At the end of the visit, patients received a "Family Guide" to help communicate with their family about the visit.
Advance Directive Completion - HCP
Baseline · HCP Completed
23 Participants
Advance Directive Completion - HCP
Baseline · HCP Not Completed
18 Participants
Advance Directive Completion - HCP
After ACP Intervention · HCP Completed
31 Participants
Advance Directive Completion - HCP
After ACP Intervention · HCP Not Completed
10 Participants

SECONDARY outcome

Timeframe: From baseline (pre-intervention) to 1 year post-intervention. The time interval is approximately 1 year.

Population: All participants who consented and completed baseline measures. Baseline and post-intervention data represent paired data from the same participants who completed both timepoints.

Data on the patient's completion of scanned medical order for life sustaining treatment (MOLST) form that was completed with their clinician was collected via the electronic medical record. This is expressed as a percentage.

Outcome measures

Outcome measures
Measure
Advanced Care Planning
n=41 Participants
This is a single-arm pilot study. After completing baseline measures, all patients received an inpatient Advanced Care Planning (ACP) intervention. Before the visit, patients received a preparation pamphlet. The APP/hematology/oncology fellow used the "Serious Illness Care Guide" during the ACP intervention to discuss advanced care planning and end of life care with the patient. At the end of the visit, patients received a "Family Guide" to help communicate with their family about the visit.
Advance Directive Completion - MOLST
Baseline · MOLST Completed
7 Participants
Advance Directive Completion - MOLST
Baseline · MOLST Not Completed
34 Participants
Advance Directive Completion - MOLST
After ACP Intervention · MOLST Completed
20 Participants
Advance Directive Completion - MOLST
After ACP Intervention · MOLST Not Completed
21 Participants

Adverse Events

Advanced Care Planning

Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kah Poh Loh

University of Rochester Medical Center

Phone: 585-276-4353

Results disclosure agreements

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