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

NCT05433090 | Completed Results

• 1 other identifier: UOCPC22039
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to assess the preliminary efficacy of an inpatient advance care planning intervention on outcomes in older patients with hematologic malignancies

Conditions

Hematologic Malignancies

Keywords

Advance Care Planning Intervention; Serious Illness Conversation; Hematologic Malignancies

Outcome Measures

Primary Outcomes (1)

• Retention Rate

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

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

Secondary Outcomes (2)

• Advance Directive Completion - HCP

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

• Advance Directive Completion - MOLST

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

Study Arms (1)

Experimental

EXPERIMENTAL

Patients will participate in an inpatient advance care planning intervention.

Behavioral: Inpatient serious illness care program

Interventions

Inpatient serious illness care program BEHAVIORAL

Inpatient advance care planning intervention that will be delivered by advanced care practitioners or hematology/oncology fellow physicians. The intervention will be an adapted version of the serious illness care program.

Experimental

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥60 years
• A diagnosis of hematologic malignancy \[including but not limited to acute leukemia, myeloid malignancies (e.g., atypical CML, MDS/MPN overlap syndromes, CMML), multiple myeloma, lymphoma, or any other hematologic malignancies based on the primary oncologist's judgment\]
• Able to provide informed consent
• Being managed in the inpatient setting
• English-speaking

You may not qualify if:

• None

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (2)

• LoCastro M, Baran AM, Liesveld JL, Huselton E, Becker MW, O'Dwyer KM, Aljitawi OS, Baumgart M, Snyder E, Kluger B, Loh KP, Mendler JH. Portable medical orders and end-of-life measures in acute myeloid leukemia and myelodysplastic syndromes. Blood Adv. 2021 Dec 28;5(24):5554-5564. doi: 10.1182/bloodadvances.2021004775.

  PMID: 34525170 BACKGROUND

• Marissa Locastro, Ying Wang, Soroush Mortaz-Hedjri, Danielle Frumusa, Tracy Natale, Jessica Cohen, Nicole Yates, Jenna Podlucky, Tristan Yu, Thomas Carroll, Jane L. Liesveld, Megan Baumgart, Sandra Sabtka, Dwight Hettler, Nicole Kaplan, Jason H. Mendler, Kah Poh Loh; An Inpatient Advance Care Planning Intervention for Older Patients with Hematologic Malignancies: A Single-Arm Pilot Study. Blood 2024; 144 (Supplement 1): 5054. doi: https://doi.org/10.1182/blood-2024-206137

  RESULT

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Limitations and Caveats

This was a single-center study with a relatively small sample size (enrolled n=41).

Results Point of Contact

• Title: Kah Poh Loh
• Organization: University of Rochester Medical Center

kahpoh_loh@urmc.rochester.edu

585-276-4353

Study Officials

• Kah Poh Loh

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Department of Medicine, Hematology/Oncology (SMD)

Model Details: The intervention used in this study is an inpatient advance care planning intervention. We will adapt the Serious Illness Care Program, an evidence-based intervention that promotes serious illness conversation between patients and clinicians, to be used by advance practice providers and hematology/oncology fellow physicians in the inpatient setting.

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 27, 2022
• Study Start: November 23, 2022
• Primary Completion: August 23, 2024
• Study Completion: November 14, 2024
• Last Updated: March 31, 2026
• Results First Posted: February 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available for 7 years after the study closes, from approximately November 15, 2025 until November 15, 2030.
• Access Criteria: The protocol is publicly available on ClinicalTrials.gov.

Locations

US (1)