Telehealth Advance Care Planning for Myeloid Leukemia

(SICP RCT Trial)

Overseen By Becky Gravenstede

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: None

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

207 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new telehealth program aimed at improving communication about serious illnesses for individuals with certain blood cancers, such as acute myeloid leukemia and myelodysplastic syndrome. The goal is to determine if this program can reduce patient anxiety and stress while encouraging the completion of important healthcare documents. Participants will either receive standard education materials or take part in the Telehealth Serious Illness Care Program, which includes conversation guides and educational tools. This trial suits English-speaking patients over 60 with these cancers who receive care outside the hospital. As an unphased trial, it offers a unique opportunity to contribute to innovative care strategies that could enhance patient support and communication.

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 prior data suggests that this telehealth program is safe for patients with myeloid leukemia?

Research has shown that the Telehealth Serious Illness Care Program is generally safe and well-tolerated by older patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Studies have found that patients find this telehealth program not only feasible but also easy and acceptable to use. These studies reported no major safety issues or harmful effects. Instead, patients found the program helpful and easy to manage. This suggests that the program is a safe option for those considering joining a clinical trial involving the telehealth Serious Illness Care Program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Telehealth Serious Illness Care Program for myeloid leukemia because it offers a fresh approach to patient care. Unlike traditional in-person consultations, this program leverages telehealth to facilitate crucial conversations about serious illness, making it more accessible and convenient for patients and caregivers. It provides structured tools like the Serious Illness Conversation Guide for clinicians and educational materials for patients, aiming to enhance communication and decision-making. This approach could lead to improved patient satisfaction and better alignment of care with patient values, setting it apart from the usual focus on medical treatment alone.

What evidence suggests that this trial's treatments could be effective for myeloid leukemia?

Research shows that the Telehealth Serious Illness Care Program, a treatment arm in this trial, improves communication among patients, caregivers, and doctors. Doctors learned important information about patient preferences through the program. Studies also show that this telehealth approach increases caregiver involvement in patient care. Older adults with acute myeloid leukemia and similar conditions found the program easy to use and helpful for discussing serious illness topics. The program aims to reduce patient anxiety and encourage the completion of important healthcare documents. Overall, early feedback suggests it supports better healthcare conversations and planning. ^{3 4 6 7 8}

Who Is on the Research Team?

Kah Poh Loh, MD

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

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

Exclusion Criteria

N/A

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Telehealth Serious Illness Care Program Experimental Treatment 1 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: Control Experimental Treatment 1 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

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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) effectively changed clinician behavior by providing training and tools, leading to more meaningful and person-centered conversations about goals of care beyond just resuscitation preferences.

Clinicians reported that the SICP facilitated deeper discussions about patient values and care preferences, which may improve the overall quality of care for seriously ill patients, although challenges like time constraints and relationship dynamics were noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinicians' Perspectives After Implementation of the Serious Illness Care Program: A Qualitative Study. Lagrotteria, A., Swinton, M., Simon, J., et al.[2022]

The Serious Illness Care Programme (SICP) successfully implemented clinician training and an electronic health record (EHR) template for serious illness conversations, but clinician engagement was limited due to cultural barriers in the clinical environment.

Effective implementation strategies included leadership involvement, local champions, and EHR-based feedback, which were crucial for overcoming barriers and improving the adoption of serious illness conversations in health systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious Illness Care Programme-contextual factors and implementation strategies: a qualitative study. Paladino, J., Sanders, J., Kilpatrick, LB., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 50 high-risk leukemia patients, only 16% received palliative care consultations despite a high symptom burden, indicating a significant gap in access to supportive care for this vulnerable group.

Only 24% of patients had complete advance care planning documentation, highlighting missed opportunities for addressing patient preferences and improving quality of care in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Access to Palliative Care Consultation and Advance Care Planning for Adults with High-Risk Leukemia. Freeman, AT., Wood, WA., Fox, A., et al.[2019]

In a study of 601 patients who underwent hematopoietic stem-cell transplantation (HSCT), nearly all had their code status documented, but only 19% received palliative care consultations, indicating a gap in integrating advance care planning with HSCT treatment.

Most patients (85%) died in the hospital, and only 15% were enrolled in hospice care, highlighting the need for improved access to palliative care and advance directives in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advance Care Planning and Palliative Care Integration for Patients Undergoing Hematopoietic Stem-Cell Transplantation. Wang, WS., Ma, JD., Nelson, SH., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Serious Illness Care Program in Oncology: Evidence, Real-World Implementation and Ongoing Barriers. Karim, S., Levine, O., Simon, J.[2022]

A survey of 111 physicians revealed that only 15.5% routinely engage in advance care planning (ACP) for patients with hematologic malignancies, highlighting a significant gap in proactive discussions about patient care preferences.

Most ACP discussions occur during critical illness or disease recurrence, but barriers such as concerns about patient and family reactions hinder more frequent and earlier conversations, indicating a need for improved communication strategies in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives on Advance Care Planning for Patients with Hematologic Malignancy: An International Clinician Questionnaire. Spring, J., McKinlay, J., Puxty, K., et al.[2021]

The serious illness care program (SICP) was implemented in two oncology clinics, resulting in 15 serious illness conversations, with a high documentation rate of 93% in the electronic medical record (EMR).

Although the SICP improved documentation rates from 4.2% to 5.4% for one clinician and from 0% to 7.3% for another, the initiative did not meet the goal of conducting at least 24 conversations, indicating the need for further improvements in facilitating these important discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real World Implementation of the Serious Illness Care Program in Cancer Care: Results of a Quality Improvement Initiative. Karim, S., Lupichuk, S., Tan, A., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10733103/

Telehealth serious illness care program for older adults ... This study assesses the feasibility and usability of a telehealth-delivered Serious Illness Care Program (SICP) for older adults with AML and MDS.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.11078

Clinicians' perspectives on the Telehealth Serious Illness ... Clinicians felt they gained useful information from asking about the patient's goals (6/7, 86%) and that the telehealth SICP was effective in ...

3. formative.jmir.org formative.jmir.org/2024/1/e58503

Clinicians' Perspectives on the Telehealth Serious Illness ... We previously conducted a pilot study testing the telehealth Serious Illness Care Program (SICP) for older adults with acute myeloid leukemia ( ...

4. ajmc.com ajmc.com/view/telehealth-can-drive-more-meaningful-sic-conversations-in-mds-aml

Telehealth Can Drive More Meaningful Serious Illness ... Clinicians' perspective on the telehealth serious illness care program for older adults with myeloid malignancies: single-arm pilot study.

5. ashpublications.org ashpublications.org/bloodadvances/article/7/9/1871/493739/Adaptation-of-Serious-Illness-Care-Program-to-be

Adaptation of Serious Illness Care Program to be delivered via ... We adapted the SICP for delivery via telehealth to older patients with AML or MDS. We conducted a single-center qualitative study of 45 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38088668/

Telehealth serious illness care program for older adults with ... This study assesses the feasibility and usability of a telehealth-delivered Serious Illness Care Program (SICP) for older adults with AML and MDS.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04745676

A Telehealth Advance Care Planning Intervention for Older ... This is a pilot study to evaluate the usability and feasibility of a telehealth-delivered advance care planning intervention among 20 older patients with acute ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05875805

A Telehealth Advance Care Planning Intervention 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 ...