Back to resultsAn Inpatient Advance Care Planning Intervention for Older Patients With Hematologic Malignancies (APP SICP)
Primary Purpose
Hematologic Malignancies
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inpatient serious illness care program
Sponsored by
About this trial
This is an interventional health services research trial for Hematologic Malignancies focused on measuring Advance Care Planning Intervention, Serious Illness Conversation, Hematologic Malignancies
Eligibility Criteria
Inclusion Criteria:
- Age ≥60 years
- A diagnosis of AML or high or very high risk MDS defined by IPSS-R
- Able to provide informed consent
- Being managed in the inpatient setting
- English-speaking
Exclusion Criteria:
- None
Sites / Locations
- University of RochesterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Patients will participate in an inpatient advance care planning intervention.
Outcomes
Primary Outcome Measures
Completion of advance directives
Data on completion of advance directives will be collected via the electronic medical record. This will include explicit statement of the patient's medical preferences for end of life care in a note, scanned medical order for life sustaining treatment (MOLST) form that was completed with their clinician, and/or scanned healthcare proxy form that was completed with their clinician. This will be expressed as a percentage.
Secondary Outcome Measures
End of life quality indicators
End of life quality indicators will be extracted from the electronic medical record. These metrics will include hospice enrollment, palliative care referral, chemotherapy administration within the last 2 weeks of life, emergency department visits in the last 30 days of life, intensive care unit admissions in the last 30 days of life, hospitalizations in the last 30 days of life, use of life-sustaining treatments in the last 30 days of life, transfusions in the last 7 days of life, and place of death. These will be expressed as percentages.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05433090
Brief Title
An Inpatient Advance Care Planning Intervention for Older Patients With Hematologic Malignancies
Acronym
APP SICP
Official Title
An Inpatient Advance Care Planning Intervention for Older Patients With Hematologic Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancies
Keywords
Advance Care Planning Intervention, Serious Illness Conversation, Hematologic Malignancies
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Patients will participate in an inpatient advance care planning intervention.
Intervention Type
Behavioral
Intervention Name(s)
Inpatient serious illness care program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Completion of advance directives
Description
Data on completion of advance directives will be collected via the electronic medical record. This will include explicit statement of the patient's medical preferences for end of life care in a note, scanned medical order for life sustaining treatment (MOLST) form that was completed with their clinician, and/or scanned healthcare proxy form that was completed with their clinician. This will be expressed as a percentage.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
End of life quality indicators
Description
End of life quality indicators will be extracted from the electronic medical record. These metrics will include hospice enrollment, palliative care referral, chemotherapy administration within the last 2 weeks of life, emergency department visits in the last 30 days of life, intensive care unit admissions in the last 30 days of life, hospitalizations in the last 30 days of life, use of life-sustaining treatments in the last 30 days of life, transfusions in the last 7 days of life, and place of death. These will be expressed as percentages.
Time Frame
Up to 5 years following their participation in the study or death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
• None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kah Poh Loh
Phone
585-275-4401
Email
kahpoh_loh@urmc.rochester.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kah Poh Loh
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kah Poh Loh
Phone
585-275-4401
Email
Kahpoh_Loh@URMC.Rochester.edu
First Name & Middle Initial & Last Name & Degree
Marissa LoCastro
Phone
585-275-4391
Email
Marissa_LoCastro@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Kah Poh Loh
First Name & Middle Initial & Last Name & Degree
Marissa LoCastro
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
A final study protocol including a description of the study participants, measurements, data, and analyses will be made publicly available before the publication date of the study findings. This will be available through the University of Rochester Cancer Center Community Oncology Research Program Research Base Protocol and Data Sharing Committee. The database will be de-identified prior to becoming publicly available. Published manuscripts will be available in portable document format.
IPD Sharing Time Frame
Data will be available for 7 years (starting from accrual of first participant)
Citations:
PubMed Identifier
34525170
Citation
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.
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An Inpatient Advance Care Planning Intervention for Older Patients With Hematologic Malignancies
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