A Telehealth Advance Care Planning Intervention

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Telehealth Advance Care Planning Intervention for Older Patients With Myeloid Malignancies: A Pilot Randomized Controlled Trial

Conditions
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Myeloid Malignancy, Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasm, Myelofibrosis

Intervention / Treatment
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* Behavioral: Telehealth Serious Illness Care Program
* Other: Education Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥60 years A diagnosis of acute myeloid leukemia , myelodysplastic syndrome (MDS), or similar myeloid malignancies (including but not limited to MDS/myeloproliferative neoplasms overlap syndrome, myelofibrosis) Being managed in the outpatient settings Able to provide informed consent English-speaking Exclusion Criteria: - None

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehealth Serious Illness Care Program<br>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). | Behavioral: Telehealth Serious Illness Care Program<br>* 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).<br>|
| Other: Control<br>Education materials developed by the NCI on Communication in Cancer Care (PDQ®) - Patient Version | Other: Education Control<br>* Education materials developed by the NCI on Communication in Cancer Care (PDQ®) - Patient Version<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Month 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distress: Distress Thermometer | 1-item question for distress, range 0-10; higher scores indicate greater distress | 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 | 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 | Throughout the study, up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older adults, Myeloid malignancies, Geriatric hematology, Serious illness conversations