TeleSICP: A Telehealth Advance Care Planning Intervention

Sponsor

University of Rochester (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05875805

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myeloid Malignancy Acute Myeloid Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasm Myelofibrosis	Behavioral: Telehealth Serious Illness Care Program Other: Education Control	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Sep 30, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Behavioral: 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).
Other: Control Education materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version"	Other: Education Control Education materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version"

Arm

Intervention/Treatment

Experimental: 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).

Behavioral: Telehealth Serious Illness Care Program

Other: Control

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

Other: Education Control

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

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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