NCT02821143

Brief Summary

Investigators hypothesize that telemedicine may be an effective tool to improve palliative care in nursing home, by providing on-site specialized and interprofessional consultation. The objective of this study is to assess the impact of telemedicine in decreasing the rate of hospitalization, compared with usual care, in nursing home resident with palliative care needs.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2019

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
2.5 years until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

January 27, 2022

Status Verified

January 1, 2022

Enrollment Period

1.5 years

First QC Date

June 29, 2016

Last Update Submit

January 26, 2022

Conditions

Palliative Care

Keywords

TelemedicineNursing HomeHospitalization

Outcome Measures

Primary Outcomes (1)

  • Evaluation of tele-expertise effectiveness on hospitalization rates

    Evaluation by proportion of subject hospitalized at least one time during follow-up period

    through the end of study (24 months)

Secondary Outcomes (8)

  • Evaluation of tele-expertise effectiveness on emergency

    through the end of study (24 months)

  • Evaluation of tele-expertise effectiveness on last 15 days of life hospitalization rates

    through the end of study (24 months)

  • Patient quality of life

    1 month after inclusion

  • Patient quality of life

    3 month after inclusion

  • Patient quality of life

    6 month after inclusion

  • +3 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Every patient identified as belonging to a palliative care after the inclusion criteria will receive intervention with a follow-up with Telemedicine consultation

Other: Telemedicine consultation

Control group

OTHER

Every patient identified as belonging to a palliative care after the inclusion criteria will receive Usual palliative care

Other: usual palliative care

Interventions

usual palliative careOTHER

Residents in the control group will receive usual palliative care usually delivered in their nursing homes , according to the habits of the healthcare team and their physician.

Control group
Telemedicine consultationOTHER

Establishment of an initial multiprofessional Telemedicine consultation involving a palliative care physician and / or geriatrician, and other physician coordinator of nursing homes, health care team and if possible the patient's treating physician (patient and / or family may participate if they want to). The aim is to define and formalize: * Aid to collection and application of advanced directives according to Leonetti Act if the resident is able to do so, or collection of confidence personal choices. * Definition of the objectives of care and patient's life and therapeutic adaptation with a focus on pain and uncomfortable symptoms. * Access to a mobile team of palliative care or geriatric hospitalization at home, a hospice network, if the patient's situation requires. * In case of medical worsening : Possibility of access to consultations and use of emergency by tele-expertise or decision support within a maximum period of 72 hours, with the same objectives that above.

Intervention group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Residents with palliative care needs:
  • Diagnosis of advanced or terminal disease: advanced cancer, advanced congestive Hearth Failure, end-stage pulmonary disease, end-stage hepatic disease, end-stage neurologic disease, other end-stage medical diagnosis.
  • ≥ A unplanned acute hospital episodes within the past 6 months
  • Activity of daily life ≤ 1 and/or bed/chair ridden residents for at least 30 days.
  • Weight loss ≥ 10% of body weight in the last 6 months.
  • The " surprise question " approach: " Would I be surprised if this patient died within the next 6-12 months? "
  • Informed and written consent by the patient or the legal representative or the reliable person when appropriate.
  • General Practitioner agreement.

You may not qualify if:

  • No agreement of study participation of patients or legal representative or the reliable person when appropriate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Sandrine Sourdet, MD

    University Hospital of Toulouse

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 1, 2016

Study Start

January 1, 2019

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

January 27, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share