The Impact of Telemedicine to Support Palliative Care Resident in Nursing Home

NCT ID: NCT02821143

Last Updated: 2022-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-31

Study Completion Date

2020-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

According to current statistics, approximately 12 % of all deaths in France occur in Nursing Home, with the number over 25% in USA. With the ageing of the population, this rate is expected to dramatically increase in the next years, to reach 40% in USA in 2020. Yet, there is some evidence that palliative care is often inadequate in Nursing Home: there is a difficulty to recognize residents who might benefit palliative care and their needs, an underassessment and under-treatment of pain and other end-of-life symptoms, and frequent burdensome treatments and hospitalizations. Several programs including palliative care consult service (with outside consultant), Nursing Home-based palliative care or Nursing Home-hospice partnerships, have succeeded in delivering high-quality palliative care in Nursing Home. But, to our knowledge, no studies examined the benefit of telemedicine for palliative care in nursing home.

During a 6 month-inclusion period, residents with palliative care needs will be included in both arms. In the intervention group, Telemedicine consultations involving Nursing Home staff and the palliative and/or geriatric unit from the University Hospital, will be organized systematically at inclusion and during the follow-up if needed. In both groups, hospitalizations and emergency hospitalizations, quality of life of the resident, satisfaction of the nursing home staff and health costs will be recorded during 6 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Palliative Care

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

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

Group Type EXPERIMENTAL

Telemedicine consultation

Intervention Type OTHER

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.

Control group

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

Group Type OTHER

usual palliative care

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

usual palliative care

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.

Intervention Type OTHER

Telemedicine consultation

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 Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* No agreement of study participation of patients or legal representative or the reliable person when appropriate.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sandrine Sourdet, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Toulouse

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RC31/15/7835

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.