207 Participants Needed

Telehealth Advance Care Planning for Myeloid Leukemia

(SICP RCT Trial)

KP
CF
BG
Overseen ByBecky Gravenstede
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Rochester
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of this treatment for Telehealth Advance Care Planning for Myeloid Leukemia?

The Serious Illness Care Program (SICP), when adapted for telehealth, has been shown to help older patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) share their values with their care team, potentially improving end-of-life care. Additionally, in oncology settings, the SICP has led to more frequent and better-quality conversations about patient goals and values, reducing anxiety and depression among patients with advanced cancer.12345

Is the Telehealth Advance Care Planning for Myeloid Leukemia safe for humans?

The Serious Illness Care Program (SICP), which has been adapted for telehealth, is a communication intervention aimed at improving conversations about values for patients with serious illnesses. It has been shown to reduce anxiety and depression in patients with advanced cancer, suggesting it is generally safe for human use.12356

How is the Telehealth Serious Illness Care Program treatment different from other treatments for myeloid leukemia?

The Telehealth Serious Illness Care Program is unique because it focuses on improving communication about personal values and goals for patients with serious illnesses like myeloid leukemia, using telehealth to facilitate these conversations. Unlike traditional treatments that focus on medical interventions, this program helps align patient care with what matters most to them, providing a more personalized approach to end-of-life care.13789

What is the purpose of this trial?

The objective of this project is to conduct a pilot randomized trial to assess the preliminary efficacy of a telehealth-delivered Serious Illness Care Program on healthcare communication, patient anxiety and distress, as well as completion of advance directives (specifically MOLST and healthcare proxy forms) for older patients with acute myeloid leukemia, myelodysplastic syndrome, and similar myeloid malignancies.

Research Team

Kah Poh Loh, B.Med.Sci., M.B.B.Ch., B.A ...

Kah Poh Loh, MD

Principal Investigator

University of Rochester

Eligibility Criteria

This trial is for individuals aged 60 or older with certain blood disorders, including acute myeloid leukemia and myelodysplastic syndrome. Participants must be receiving outpatient care, able to give informed consent, and speak English.

Inclusion Criteria

English-speaking
I am 60 years old or older.
Able to provide informed consent
See 2 more

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Telehealth Intervention

Participants receive the telehealth-delivered Serious Illness Care Program, including the Serious Illness Conversation Guide and education materials

2 months
Telehealth sessions

Follow-up

Participants are monitored for healthcare communication, anxiety, and distress

2 months

Long-term Follow-up

Participants are monitored for completion of advance directives and other long-term outcomes

Up to 2 years

Treatment Details

Interventions

  • Education Control
  • Telehealth Serious Illness Care Program
Trial Overview The study is testing a telehealth program designed to improve healthcare communication and reduce patient anxiety. It also aims to increase the completion of advance directives like MOLST (medical orders for life-sustaining treatment) forms.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Telehealth Serious Illness Care ProgramExperimental Treatment1 Intervention
The adapted telehealth Serious Illness Care Program is a multilevel intervention engaging the patient, caregiver, clinician, and system. It consists of tools, training, and system change. Tools include: 1) The Serious Illness Conversation Guide for clinicians; and 2) Education materials for patients on the importance of Serious Illness Conversations (Patient Preparation Pamphlet) and of the involvement of caregivers (Family Communication Guide).
Group II: ControlExperimental Treatment1 Intervention
Education materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version"

Telehealth Serious Illness Care Program is already approved in United States for the following indications:

🇺🇸
Approved in United States as Serious Illness Care Program for:
  • Advance care planning for serious illnesses such as acute myeloid leukemia, myelodysplastic syndrome, and similar myeloid malignancies

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials
883
Recruited
555,000+

Findings from Research

The Serious Illness Care Program (SICP), adapted for telehealth, is viewed positively by older patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) as a way to facilitate important conversations about their values and preferences regarding end-of-life care.
A qualitative study involving 45 participants (25 clinicians, 15 patients, and 5 caregivers) revealed that serious illness conversations via telehealth can enhance understanding of diagnoses and should be a routine part of care, helping align treatment with patient values.
Adaptation of Serious Illness Care Program to be delivered via telehealth for older patients with hematologic malignancy.LoCastro, M., Sanapala, C., Mendler, JH., et al.[2023]
The Serious Illness Care Program (SICP) was successfully implemented at Stanford Health Care, engaging 5,349 unique patients in serious illness conversations, which improved the quality and timing of these important discussions.
Key factors for successful implementation included innovative clinical workflows, the use of machine learning to identify eligible patients, and the involvement of nonphysician care team members, highlighting a collaborative approach to patient care.
Lessons Learned from a Multi-Site, Team-Based Serious Illness Care Program Implementation at an Academic Medical Center.Seevaratnam, B., Wang, S., Fong, R., et al.[2023]
The Serious Illness Care Program (SICP) significantly improved the quality and timing of conversations about values and goals for patients with advanced cancer, leading to reduced anxiety and depression among participants.
For successful integration of the SICP into routine care, ongoing leadership support, training, and adaptation for diverse patient needs are essential, along with future research on translating these conversations into personalized care plans.
The Serious Illness Care Program in Oncology: Evidence, Real-World Implementation and Ongoing Barriers.Karim, S., Levine, O., Simon, J.[2022]

References

Adaptation of Serious Illness Care Program to be delivered via telehealth for older patients with hematologic malignancy. [2023]
Lessons Learned from a Multi-Site, Team-Based Serious Illness Care Program Implementation at an Academic Medical Center. [2023]
The Serious Illness Care Program in Oncology: Evidence, Real-World Implementation and Ongoing Barriers. [2022]
Real World Implementation of the Serious Illness Care Program in Cancer Care: Results of a Quality Improvement Initiative. [2021]
Clinicians' Perspectives After Implementation of the Serious Illness Care Program: A Qualitative Study. [2022]
Serious Illness Care Programme-contextual factors and implementation strategies: a qualitative study. [2022]
Access to Palliative Care Consultation and Advance Care Planning for Adults with High-Risk Leukemia. [2019]
Advance Care Planning and Palliative Care Integration for Patients Undergoing Hematopoietic Stem-Cell Transplantation. [2020]
Perspectives on Advance Care Planning for Patients with Hematologic Malignancy: An International Clinician Questionnaire. [2021]
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