Tele-palliative Care in Rural Dialysis Patients

NCT ID: NCT03744117

Last Updated: 2022-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-11
• Study Completion Date: 2020-07-23

Brief Summary

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.

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.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Palliative care consultation

Intervention Type: OTHER

A palliative care consultation will occur via telemedicine with patients receiving maintenance dialysis.

Interventions

Palliative care consultation

A palliative care consultation will occur via telemedicine with patients receiving maintenance dialysis.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Katharine Cheung

Primary Investigator, Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katharine L Cheung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

University of Vermont Medical Center

Burlington, Vermont, United States

Countries

United States

References

Cheung KL, Tamura MK, Stapleton RD, Rabinowitz T, LaMantia MA, Gramling R. Feasibility and Acceptability of Telemedicine-Facilitated Palliative Care Consultations in Rural Dialysis Units. J Palliat Med. 2021 Sep;24(9):1307-1313. doi: 10.1089/jpm.2020.0647. Epub 2021 Jan 19.

Reference Type: DERIVED

PMID: 33470899 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

CHRMS 19-0081

Identifier Type: -

Identifier Source: org_study_id