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Tele-palliative Care in Rural Dialysis Patients

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Palliative care consultation
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring dialysis, end-stage kidney disease, supportive care, palliative care, rural health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Vermont Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Feasibility will be defined as the 1 month completion rate of the consult from time of participant recruitment to the consult.
We will define feasibility as the 1 month completion rate of the consult from time of participant recruitment to the consult.
Acceptability :We will measure acceptability of the telemedicine intervention using a 5-point likert scale.
We will measure acceptability of the telemedicine intervention using a 5-point likert scale.

Secondary Outcome Measures

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.
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.
Heard and Understood: Participants will rate on a 5-point scale whether they felt heard and understood during the palliative care consultation.
Participants will rate on a 5-point scale whether they felt heard and understood during the palliative care consultation.

Full Information

First Posted
November 13, 2018
Last Updated
October 4, 2022
Sponsor
University of Vermont
Collaborators
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT03744117
Brief Title
Tele-palliative Care in Rural Dialysis Patients
Official Title
Telemedicine Facilitated Palliative Care Consultations in Rural Dialysis Units
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 11, 2018 (Actual)
Primary Completion Date
January 23, 2020 (Actual)
Study Completion Date
July 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
dialysis, end-stage kidney disease, supportive care, palliative care, rural health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Palliative care consultation
Intervention Description
A palliative care consultation will occur via telemedicine with patients receiving maintenance dialysis.
Primary Outcome Measure Information:
Title
Feasibility will be defined as the 1 month completion rate of the consult from time of participant recruitment to the consult.
Description
We will define feasibility 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.
Title
Acceptability :We will measure acceptability of the telemedicine intervention using a 5-point likert scale.
Description
We will measure acceptability of the telemedicine intervention using a 5-point likert scale.
Time Frame
This will be assessed at 18 months.
Secondary Outcome Measure Information:
Title
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.
Description
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.
Title
Heard and Understood: Participants will rate on a 5-point scale whether they felt heard and understood during the palliative care consultation.
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katharine L Cheung, MD, PhD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33470899
Citation
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.
Results Reference
derived

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Tele-palliative Care in Rural Dialysis Patients

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