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

The Impact of Telemedicine to Support Palliative Care Resident in Nursing Home: a Cluster Randomized Control Study.

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.

Study Overview

• Status: Withdrawn
• Conditions: Palliative Care
• Intervention / Treatment: Other: Telemedicine consultation; Other: usual palliative care

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.
Other: Control group; Every patient identified as belonging to a palliative care after the inclusion criteria will receive Usual palliative care	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of tele-expertise effectiveness on emergency	Emergency hospitalization rates with proportion of subject hospitalized in emergency at least one time during follow-up period	through the end of study (24 months)
Evaluation of tele-expertise effectiveness on last 15 days of life hospitalization rates	proportion of subject hospitalized in the last 15 days of life at least one time during follow-up period	through the end of study (24 months)
Patient quality of life	Assessed by Palliative Care Outcome Scale (PCOS)	1 month after inclusion
Patient quality of life	Assessed by Palliative Care Outcome Scale (PCOS)	3 month after inclusion
Patient quality of life	Assessed by Palliative Care Outcome Scale (PCOS)	6 month after inclusion
Patient quality of life	Assessed by Palliative Care Outcome Scale (PCOS)	Last patient's 3 days of life
Caregivers satisfaction	Assessed through a satisfaction survey	through the end of study (24 months)
Economical evaluation	Evaluation of taking care costs with french social security scheme data	through the end of study (24 months)

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Sandrine Sourdet, MD, University Hospital of Toulouse

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: June 29, 2016
• First Submitted That Met QC Criteria: June 29, 2016
• First Posted (Estimate): July 1, 2016

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 26, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Telemedicine; Nursing Home; Hospitalization
• Other Study ID Numbers: RC31/15/7835

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No