A Telehealth Advance Care Planning Intervention

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of Rochester

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Telehealth Serious Illness Care Program

    Behavioral

    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 Control

    Other intervention

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

Treatment groups

207 Participants
are divided into 2 treatment groups
Group A: Telehealth Serious Illness Care ProgramExperimental treatment 1 intervention
Group B: ControlOther 1 intervention

Trial outcomes

Primary outcomes

1

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

1

Distress: Distress Thermometer

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

Time frame
Month 2
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
3

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

Other outcomes

Sponsors and contacts

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