Clinical trial NCT02821143: The Impact of Telemedicine to Support Palliative Care Resident in Nursing Home
Official title: The Impact of Telemedicine to Support Palliative Care Resident in Nursing Home: a Cluster Randomized Control Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Palliative Care
Keywords: Telemedicine
Nursing Home
Hospitalization
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of tele-expertise effectiveness on hospitalization rates
timeFrame: through the end of study (24 months)
Secondary outcomes:
measure: Evaluation of tele-expertise effectiveness on emergency
timeFrame: through the end of study (24 months)
measure: Evaluation of tele-expertise effectiveness on last 15 days of life hospitalization rates
timeFrame: through the end of study (24 months)
measure: Patient quality of life
timeFrame: 1 month after inclusion
measure: Patient quality of life
timeFrame: 3 month after inclusion
measure: Patient quality of life
timeFrame: 6 month after inclusion
measure: Patient quality of life
timeFrame: Last patient's 3 days of life
measure: Caregivers satisfaction
timeFrame: through the end of study (24 months)
measure: Economical evaluation
timeFrame: through the end of study (24 months)
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital of Toulouse
name: Sandrine Sourdet, MD
role: PRINCIPAL_INVESTIGATOR
References: