A Telehealth Advance Care Planning Intervention (SICP RCT)

University of Rochester

Status: Enrolling

Conditions: Myeloid Malignancy; Myelofibrosis; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasm; Acute Myeloid Leukemia

Treatments: Other: Education Control; Behavioral: Telehealth Serious Illness Care Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05875805

UOCPC23038

Details and patient eligibility

About

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.

Full description

The Serious Illness Care Program (SICP) is an evidence-based intervention to enhance serious illness conversations between physicians and patients with advanced cancer. It consists of the Serious Illness Conversation Guide as well as training and system-level support for clinicians to conduct serious illness conversations. The investigators have previously adapted the SICP to be delivered via telehealth for older adults with myeloid malignancies. In this study, they will conduct a pilot randomized trial to assess the preliminary efficacy of a telehealth-delivered Serious Illness Care Program compared to an education control.

Enrollment: 207 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion and Exclusion Criteria for Patients

Inclusion criteria:

• Age ≥60 years
• A diagnosis of AML, MDS, and similar myeloid malignancies (including but not limited to MDS/MPN overlap syndrome, myelofibrosis)
• Being managed in the outpatient settings
• Able to provide informed consent
• English-speaking

Exclusion criteria:

• None

Inclusion and Exclusion Criteria for Caregivers

Inclusion criteria:

• Age ≥18 years
• Selected by patient when asked if there is a "family member, partner, friend, or caregiver with whom you discuss or who can be helpful in health-related matters"
• Able to provide informed consent
• English-speaking

Exclusion criteria:

• None

Inclusion and Exclusion Criteria for Oncology Providers

Inclusion criteria:

• Oncologists and/or APPs who will be conducting the telehealth-delivered ACP visit

Exclusion criteria:

• None

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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207 participants in 2 patient groups

Telehealth Serious Illness Care Program

Experimental group

Description:

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).

Treatment:

Behavioral: Telehealth Serious Illness Care Program

Control

Other group

Description:

Education materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version"

Treatment:

Other: Education Control