NCT03744117

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 13, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2020

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

1.3 years

First QC Date

November 13, 2018

Last Update Submit

October 4, 2022

Conditions

End Stage Renal Disease

Keywords

dialysisend-stage kidney diseasesupportive carepalliative carerural health

Outcome Measures

Primary Outcomes (2)

  • 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.

    This will be assessed at 18 months.

  • 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.

    This will be assessed at 18 months.

Secondary Outcomes (2)

  • 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.

    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.

    This question will be completed within 2 weeks of the intervention.

Study Arms (1)

Intervention Arm

EXPERIMENTAL

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

Interventions

Palliative care consultationOTHER

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

Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Related Publications (1)

  • 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.

    PMID: 33470899DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Katharine L Cheung, MD, PhD

    University of Vermont

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator, Assistant Professor of Medicine

Study Record Dates

First Submitted

November 13, 2018

First Posted

November 16, 2018

Study Start

October 11, 2018

Primary Completion

January 23, 2020

Study Completion

July 23, 2020

Last Updated

October 6, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)