A Telehealth Advance Care Planning Intervention

Not Applicable

Recruiting

• Conditions: Myelodysplastic Syndromes; Myeloid Malignancy; Acute Myeloid Leukemia; Myelofibrosis; Myelodysplastic/Myeloproliferative Neoplasm
• Interventions: Other: Education Control; Behavioral: Telehealth Serious Illness Care Program

• Registration Number: NCT05875805
• Lead Sponsor: University of Rochester

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-05-16
• Study First Submitted QC: 2023-05-16
• Study First Posted: 2023-05-25
• Study Start: 2024-05-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-03
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Education Control	Education materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version"
Telehealth Serious Illness Care Program	Telehealth Serious Illness Care Program	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).

Primary Outcome Measures

Name	Time	Method
Healthcare Communication: Health Care Climate Questionnaire	Month 2	5-item questionnaire assessing patients' and caregivers' satisfaction with patient-clinician communication, range 0-20; higher score is better

Secondary Outcome Measures

Name	Time	Method
Completion of advance directives	Throughout the study, up to 2 years	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
Distress: Distress Thermometer	Month 2	1-item question for distress, range 0-10; higher scores indicate greater distress
Anxiety Symptoms: Generalized Anxiety Disorder-7 (GAD-7)	Month 2	7-item screening tool for anxiety symptoms, total range 0-21); higher scores indicate greater anxiety symptoms

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States