Palliative CareTELESMNCT02821143
The Impact of Telemedicine to Support Palliative Care Resident in Nursing Home
A study testing usual palliative care and Telemedicine consultation in people with Palliative Care, run by University Hospital, Toulouse.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Palliative Care
- What is being tested?
- usual palliative care and Telemedicine consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- No agreement of study participation of patients or legal representative or the reliable person when appropriate.
About this study
Official title: 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.
Read the 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.
- Conditions
- Palliative Care
- Being tested
- usual palliative care, Telemedicine consultation
- Keywords
- Telemedicine, Nursing Home, Hospitalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Telemedicine consultation |
| Control group | Other | Every patient identified as belonging to a palliative care after the inclusion criteria will receive Usual palliative care Receives: Other: usual palliative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of tele-expertise effectiveness on hospitalization rates
Evaluation by proportion of subject hospitalized at least one time during follow-up period
Measured: through the end of study (24 months)
Secondary outcomes (8)
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
Measured: 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
Measured: through the end of study (24 months)
Patient quality of life
Assessed by Palliative Care Outcome Scale (PCOS)
Measured: 1 month after inclusion
Patient quality of life
Assessed by Palliative Care Outcome Scale (PCOS)
Measured: 3 month after inclusion
Patient quality of life
Assessed by Palliative Care Outcome Scale (PCOS)
Measured: 6 month after inclusion
Patient quality of life
Assessed by Palliative Care Outcome Scale (PCOS)
Measured: Last patient's 3 days of life
Caregivers satisfaction
Assessed through a satisfaction survey
Measured: through the end of study (24 months)
Economical evaluation
Evaluation of taking care costs with french social security scheme data
Measured: through the end of study (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startJan 2019 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Why it stopped: Realization not possible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandrine Sourdet, MD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821143
- Sponsor's protocol ID
- RC31/15/7835
- Acronym
- TELESM
- Status last verified
- Jan 2022
- First submitted
- 29 Jun 2016
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Telemedicine to Support Palliative Care Resident in Nursing Home: a Cluster Randomized Control Study.
- ClinicalTrials.gov ID
- NCT02821143
- Acronym / sponsor ID
- TELESM / RC31/15/7835
- Conditions
- Palliative Care
- Keywords
- Telemedicine, Nursing Home, Hospitalization
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Realization not possible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Telemedicine consultationEvery patient identified as belonging to a palliative care after the inclusion criteria will receive intervention with a follow-up with Telemedicine consultation |
| Control group | Other | Other: usual palliative careEvery patient identified as belonging to a palliative care after the inclusion criteria will receive Usual palliative care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Residents with palliative care needs:
- Informed and written consent by the patient or the legal representative or the reliable person when appropriate.
- General Practitioner agreement.
Key exclusion criteria (1 listed)
- No agreement of study participation of patients or legal representative or the reliable person when appropriate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| usual palliative careResidents 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. | Other | Control group |
| Telemedicine consultationEstablishment 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 | Intervention group |
Primary outcome
Evaluation of tele-expertise effectiveness on hospitalization rates
Time frame: through the end of study (24 months)
Evaluation by proportion of subject hospitalized at least one time during follow-up period
8 secondary outcomes
Evaluation of tele-expertise effectiveness on emergency
Time frame: through the end of study (24 months)
Evaluation of tele-expertise effectiveness on last 15 days of life hospitalization rates
Time frame: through the end of study (24 months)
Patient quality of life
Time frame: 1 month after inclusion
Patient quality of life
Time frame: 3 month after inclusion
Patient quality of life
Time frame: 6 month after inclusion
Patient quality of life
Time frame: Last patient's 3 days of life
Caregivers satisfaction
Time frame: through the end of study (24 months)
Economical evaluation
Time frame: through the end of study (24 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandrine Sourdet, MD principal investigator
University Hospital of Toulouse
Questions about this trial
What is this clinical trial studying?
A study testing usual palliative care and Telemedicine consultation in people with Palliative Care, run by University Hospital, Toulouse.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of tele-expertise effectiveness on hospitalization rates (time frame: through the end of study (24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.