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

Palliative Care Clinical Trial

— TELESM  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02821143
• Other study ID #: RC31/15/7835
• Status: Withdrawn
• Phase: N/A
• Start date: January 2019
• Est. completion date: July 2020

Study information

• Verified date: January 2022
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Palliative Care

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Patient quality of life	Assessed by Palliative Care Outcome Scale (PCOS)	1 month after inclusion
Secondary	Patient quality of life	Assessed by Palliative Care Outcome Scale (PCOS)	3 month after inclusion
Secondary	Patient quality of life	Assessed by Palliative Care Outcome Scale (PCOS)	6 month after inclusion
Secondary	Patient quality of life	Assessed by Palliative Care Outcome Scale (PCOS)	Last patient's 3 days of life
Secondary	Caregivers satisfaction	Assessed through a satisfaction survey	through the end of study (24 months)
Secondary	Economical evaluation	Evaluation of taking care costs with french social security scheme data	through the end of study (24 months)