A Telehealth Advance Care Planning Intervention

University of Rochester207 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

207

Conditions

Myeloid Malignancy Acute Myeloid Leukemia

Interventions

Telehealth Serious Illness Care ProgramBEHAVIORAL

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).

Education ControlOTHER

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

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Healthcare Communication: Health Care Climate Questionnaire

5-item questionnaire assessing patients' and caregivers' satisfaction with patient-clinician communication, range 0-20; higher score is better

Time frame: Month 2

Secondary Outcomes

Distress: Distress Thermometer

1-item question for distress, range 0-10; higher scores indicate greater distress

Time frame: Month 2

Anxiety Symptoms: Generalized Anxiety Disorder-7 (GAD-7)

7-item screening tool for anxiety symptoms, total range 0-21); higher scores indicate greater anxiety symptoms

Time frame: Month 2

Completion of advance directives

Percentage of patients who complete advance directives which include the Medical or Physician Orders for Life-Sustaining Treatment (MOST/POLST) forms, living will, durable power of attorney for healthcare, and healthcare proxy forms, as well as date of completion

Time frame: Throughout the study, up to 2 years

A Telehealth Advance Care Planning Intervention

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts