Tele-palliative Care in Rural Dialysis Patients

October 4, 2022 updated by: Katharine Cheung, University of Vermont

Telemedicine Facilitated Palliative Care Consultations in Rural Dialysis Units

Telemedicine (TM) is an innovative approach that has successfully facilitated palliative care consultations (PCC) in rural settings but not yet in dialysis. In this study, the investigators will deliver telemedicine-facilitated PCC to rural dialysis units leveraging an existing telehealth network.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Training of dialysis personnel: Dialysis staff will meet with the PI to review eligibility, recruitment and consent during a training meeting prior to beginning recruitment. Overview of the study goals and protocol will also be reviewed at quarterly renal dialysis meetings attended by all nephrologists and dialysis nursing supervisors.

Recruitment and informed consent procedures will occur chairside in the dialysis unit and will be performed by study personnel. Participants will complete a single-item Heard and Understood questionnaire and demographic survey with research personnel.

Consented individuals will be contacted by the research team to schedule an appointment via telemedicine. Scheduling of Telemedicine-palliative care consultation (TM-PCC) will occur as per usual care, based on availability of patient and family, clinician and space, and will be coordinated by study personnel with dialysis staff input. Attention will be paid to travel adjustments as necessary for dialysis patients.

PCC will occur at the dialysis unit. The clinician will be located at UVMMC, at a telemedicine station assigned for this task. The palliative care consult can happen during dialysis and using an iPad and headphones may be worn.

The intervention will occur while on dialysis, unless otherwise requested, using an iPad mounted on a portable stand. Dialysis or research staff will open the Zoom application for the patient and the PCC will occur via Zoom, an encrypted service used by UVMMC already for telemedicine. Headsets will be provided to the patient (and family) to cancel out ambient noise and to enhance privacy. Participants can also choose to have the palliative care consult before or after dialysis, or at home, if they have an internet connection.

The consult will be video-recorded in order to analyze the quality of communication and content of palliative care consults in dialysis patients. Most palliative care consults last about one hour. After the consult, participants will complete a questionnaire. This should not take more than 5-10 minutes.

There is only one visit required in this study. If participants desire follow-up with the palliative care team, this can be arranged but is not part of the study. We will assess outcomes at 6 months by reviewing the medical record for any hospitalizations, hospice enrollment, withdrawal from dialysis or other changes to dialysis treatment.

Per usual care, the palliative care clinician will summarize the consult and send this to the nephrologist and/or primary care provider.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients age 18 and older, receiving maintenance dialysis who are willing and capable of providing informed consent.

Exclusion Criteria:

  • Patients with dementia or other medical conditions that would impair their ability to consent, participate in conversation or complete questionnaires, or patients expected to transfer to a dialysis unit outside of Vermont within 6 months would be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
There is a single arm in this study. All patients will be assigned to receive the intervention, which is a palliative care consultation delivered by telemedicine.
Other: Palliative care consultation
A palliative care consultation will occur via telemedicine with patients receiving maintenance dialysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility will be defined as the 1 month completion rate of the consult from time of participant recruitment to the consult.
Time Frame: This will be assessed at 18 months.
We will define feasibility as the 1 month completion rate of the consult from time of participant recruitment to the consult.
This will be assessed at 18 months.
Acceptability :We will measure acceptability of the telemedicine intervention using a 5-point likert scale.
Time Frame: This will be assessed at 18 months.
We will measure acceptability of the telemedicine intervention using a 5-point likert scale.
This will be assessed at 18 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of communication reported by patients:Quality of communication will be measured using an adapted form of the Quality of Communication survey tool. This consists of 6 questions, each with a score of 0-10.
Time Frame: The survey will be completed within 2 weeks of the intervention.
Quality of communication will be measured using an adapted form of the Quality of Communication survey tool. This consists of 6 questions, each with a score of 0-10.
The survey will be completed within 2 weeks of the intervention.
Heard and Understood: Participants will rate on a 5-point scale whether they felt heard and understood during the palliative care consultation.
Time Frame: This question will be completed within 2 weeks of the intervention.
Participants will rate on a 5-point scale whether they felt heard and understood during the palliative care consultation.
This question will be completed within 2 weeks of the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Collaborators

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Katharine L Cheung, MD, PhD, University of Vermont

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2018

Primary Completion (Actual)

January 23, 2020

Study Completion (Actual)

July 23, 2020

Study Registration Dates

First Submitted

November 13, 2018

First Submitted That Met QC Criteria

November 15, 2018

First Posted (Actual)

November 16, 2018

Study Record Updates

Last Update Posted (Actual)

October 6, 2022

Last Update Submitted That Met QC Criteria

October 4, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRMS 19-0081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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