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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
Older adults with hematologic malignancies receive more aggressive inpatient care at the end of life compared to patients with solid tumors. Advance care planning may promote early serious illness conversations for patients with hematologic malignancies, leading to less aggressive healthcare utilization at the end of life. This pilot aims to assess the preliminary efficacy of an inpatient advance care planning intervention on outcomes in older patients with hematologic malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Patients will participate in an inpatient advance care planning intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Advance Directive Completion - HCP | 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. | From baseline (pre-intervention) to 1 year post-intervention. The time interval is approximately 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
• None
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| Name | Affiliation | Role |
|---|---|---|
| Kah Poh Loh | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34525170 | Background | 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. | |
| Result | 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 | ||
| 41949389 |
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A final study protocol including a description of the study participants, measurements, data, and analyses will be available on clinicaltrials.gov before the results are published.
Data will be available for 7 years after the study closes, from approximately November 15, 2025 until November 15, 2030.
The protocol is publicly available on ClinicalTrials.gov.
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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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All participants who completed baseline measures (n = 41).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Retention Rate | Retention rate is the percentage of consented patients who completed the ACP intervention visit. A retention rate of >70% was considered feasible. | All consented participants who underwent baseline assessment. | Posted | Count of Participants | Participants | From consent until completion of the ACP intervention visit, usually within 1 week. |
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Patient adverse events and mortality were collected and reported from enrollment until the end of follow-up, up to approximately 2 months after enrollment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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This was a single-center study with a relatively small sample size (enrolled n=41).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kah Poh Loh | University of Rochester Medical Center | 585-276-4353 | kahpoh_loh@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2023 | Nov 13, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 17, 2024 | Dec 8, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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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.
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| Advance Directive Completion - MOLST |
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. |
| From baseline (pre-intervention) to 1 year post-intervention. The time interval is approximately 1 year. |
| Derived |
| LoCastro M, Wang Y, Baran A, Mortaz Hedjri S, Frumusa D, Natale T, Cohen J, Yates N, Podlucky J, Yu T, Carroll T, Liesveld J, Baumgart M, Sabatka S, Hettler D, Kaplan N, Mendler JH, Loh KP. An inpatient Serious Illness Care Program for older patients with hematologic malignancies: a single-arm pilot study. Blood Adv. 2026 Jun 23;10(12):4412-4422. doi: 10.1182/bloodadvances.2025018200. |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Education | Patient response to: "Highest level of education achieved." | Count of Participants | Participants |
|
| Marital status | Patient response to: "Marital status." | Count of Participants | Participants |
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| Employment status | Patient response to: "Employment status." | Count of Participants | Participants |
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| Caregiver living with the patient | Patient response to: "Who do you live with?" | Count of Participants | Participants |
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| Caregiver not living with the patient | Patient response to: "Do you have a caregiver who is not living with you?" | Count of Participants | Participants |
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| Cancer diagnosis | Count of Participants | Participants |
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| Cancer diagnosis duration | The length of time between date of diagnosis and baseline date. | Count of Participants | Participants |
|
| Cancer health literacy | Cancer Health Literacy Test-6 (CHLT-6) was used to assess patient cancer health literacy. | Count of Participants | Participants |
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|
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| Secondary | Advance Directive Completion - HCP | 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. | All participants who consented and completed baseline measures. Baseline and post-intervention data represent paired data from the same participants who completed both timepoints. | Posted | Count of Participants | Participants | From baseline (pre-intervention) to 1 year post-intervention. The time interval is approximately 1 year. |
|
|
|
| Secondary | Advance Directive Completion - MOLST | 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. | All participants who consented and completed baseline measures. Baseline and post-intervention data represent paired data from the same participants who completed both timepoints. | Posted | Count of Participants | Participants | From baseline (pre-intervention) to 1 year post-intervention. The time interval is approximately 1 year. |
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| 2 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
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| HCP Not Completed |
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| MOLST Not Completed |
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