AgingNCT05731362
An ESD Model of Care for Older Adults Admitted to Hospital: a Protocol for a Descriptive Cohort Study
An observational study of Aging and Hospitalization, run by University of Limerick at 1 site in Ireland.
Trial summary
The MidWest multidisciplinary Community Intervention Teams (MD-CIT) comprise of specialist, healthcare teams that provide a rapid and integrated response to a patient with an acute episode of illness who requires enhanced services/acute intervention for a defined short period of time in the MidWest of Ireland. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Hospitalization, Function
- What is being tested?
- MDCIT Intervention
- How many people
- 0 participants
- Where
- 1 siteIreland
- Study dates
- Jan 2023to Dec 2023
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Older adult
Study population: Older adults admitted to general medical and surgical wards, trauma/orthopaedic wards and acute medical assessment units and subsequently discharged home with MDCIT support will be included.
Who may be able to join
- Older adults ≥ 65 years who are discharged home (community dwelling) from ULHG with a referral to the MDCIT service between December 2022 and June 2023 will be deemed eligible for recruitment
Who cannot join
- Those aged < 65 years discharged home from ULHG and referred to the MDCIT service
- Those deemed to not have decision making capacity to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Early Supported Discharge Model of Care for Older Adults Admitted to Hospital: a Protocol for a Descriptive Cohort Study
The MidWest multidisciplinary Community Intervention Teams (MD-CIT) comprise of specialist, healthcare teams that provide a rapid and integrated response to a patient with an acute episode of illness who requires enhanced services/acute intervention for a defined short period of time in the MidWest of Ireland. This is provided in the patient's home, thereby facilitating early discharge from the acute hospital setting.
The investigators are performing an evaluation of the MDCIT service provided to older adults admitted to UL Hospitals Group. The investigators will assess patients in hospital, at 30 days and at a six months.
- Conditions
- Aging, Hospitalization, Function
- Being tested
- MDCIT Intervention
- Keywords
- older adults, early supported discharge, cohort study, hospitalised, patient discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDCIT InterventionOther
The MidWest Multidisciplinary Community Intervention Teams (MDCIT) comprise of specialist, healthcare teams that provide a rapid and integrated response to a patient with an acute episode of illness who requires enhanced services/acute intervention for a defined short period of time. This is provided in the patient's home after an acute hospital admission, thereby facilitating early discharge. The MDCIT intervention is composed of occupational therapy, physiotherapy, and healthcare assistants, with nursing support as required.
The MDCIT therapists aim to make their first visit to patients within 24-48 hours of hospital discharge. Patients receive two-three visits per week, over a period of two to four weeks dependant on the patient's rehabilitation needs. Upon discharge from the MDCIT service, patients can be referred to community services as indicated by therapists.
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Ability
Function will be measured using the Barthel Index (BI). The BI scores a patient from 0-20, with a higher score indicating greater independence.
Measured: This will be measured at baseline.
Functional Ability
Function will be measured using the Barthel Index (BI). The BI scores a patient from 0-20, with a higher score indicating greater independence.
Measured: This will be measured at 30 days.
Functional Ability
Function will be measured using the Barthel Index (BI). The BI scores a patient from 0-20, with a higher score indicating greater independence.
Measured: This will be measured at 180 days.
Secondary outcomes (16)
Frailty Score
Frailty will be measured using the Clinical Frailty Scale (CFS). The CFS screens for frailty in older adults, with a minimum score of 1 considered least frail and a maximum score of 9 indicating severe frailty.
Measured: This will be measured at baseline.
Frailty Score
Frailty will be measured using the Clinical Frailty Scale (CFS). The CFS screens for frailty in older adults, with a minimum score of 1 considered least frail and a maximum score of 9 indicating severe frailty.
Measured: This will be measured at 30 days.
Frailty Score
Frailty will be measured using the Clinical Frailty Scale (CFS). The CFS screens for frailty in older adults, with a minimum score of 1 considered least frail and a maximum score of 9 indicating severe frailty.
Measured: This will be measured at 180 days.
Patient Quality of Life
Quality of Life will be measured using the EQ-5D-5L. This questionnaire asks a patient to rate their overall perceived health from a scale of 0-100 (0 = very poor; 100 = excellent).
Measured: This will be measured at baseline.
Patient Quality of Life
Quality of Life will be measured using the EQ-5D-5L. This questionnaire asks a patient to rate their overall perceived health from a scale of 0-100 (0 = very poor; 100 = excellent).
Measured: This will be measured at 30 days.
Patient Quality of Life
Quality of Life will be measured using the EQ-5D-5L. This questionnaire asks a patient to rate their overall perceived health from a scale of 0-100 (0 = very poor; 100 = excellent).
Measured: This will be measured at 180 days.
Quality of Care
Quality of Care will be measured using the Patient Assessment of Integrated Elderly Care. Patients are asked 20 questions across a Likert scale from 'none at all' to 'always.'
Measured: This will be measured at 30 days.
Quality of Care
Quality of Care will be measured using the Patient Assessment of Integrated Elderly Care. Patients are asked 20 questions across a Likert scale from 'none at all' to 'always.'
Measured: This will be measured at 1800 days.
Unscheduled ED Attendance(s)
ED hospital databases will be searched to identify ED attendances.
Measured: This will be measured at 30 days.
Unscheduled ED Attendance(s)
ED software will be searched to identify ED attendances.
Measured: This will be measured at 180 days.
Unscheduled Hospital Admission(s)
ED and hospital software will be searched to identify admissions.
Measured: This will be measured at 30 days.
Unscheduled Hospital Admission(s)
ED and hospital software will be searched to identify admissions.
Measured: This will be measured at 180 days.
Nursing Home Admission(s)
Hospital software will be searched to identify patients admitted to nursing homes.
Measured: This will be measured at 30 days.
Nursing Home Admission(s)
Hospital software will be searched to identify patients admitted to nursing homes.
Measured: This will be measured at 180 days.
Mortality
Hospital software will be searched to identify patients who pass away.
Measured: This will be measured at 30 days.
Mortality
Hospital software will be searched to identify patients who pass away.
Measured: This will be measured at 180 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study startJan 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Change in study design
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cathryn Ryan, Principal investigator, MidWest Community Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731362
- Sponsor's protocol ID
- 112/2022
- Status last verified
- Nov 2023
- First submitted
- 20 Jan 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Supported Discharge Model of Care for Older Adults Admitted to Hospital: a Protocol for a Descriptive Cohort Study
- ClinicalTrials.gov ID
- NCT05731362
- Acronym / sponsor ID
- 112/2022
- Conditions
- Aging, Hospitalization, Function
- Keywords
- older adults, early supported discharge, cohort study, hospitalised, patient discharge
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Change in study design
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 Feb 2023 (actual)
- 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.
The MidWest multidisciplinary Community Intervention Teams (MD-CIT) comprise of specialist, healthcare teams that provide a rapid and integrated response to a patient with an acute episode of illness who requires enhanced services/acute intervention for a defined short period of time in the MidWest of Ireland. This is provided in the patient's home, thereby facilitating early discharge from the acute hospital setting.
The investigators are performing an evaluation of the MDCIT service provided to older adults admitted to UL Hospitals Group. The investigators will assess patients in hospital, at 30 days and at a six months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Older adults admitted to general medical and surgical wards, trauma/orthopaedic wards and acute medical assessment units and subsequently discharged home with MDCIT support will be included.
Key inclusion criteria (1 listed)
- Older adults ≥ 65 years who are discharged home (community dwelling) from ULHG with a referral to the MDCIT service between December 2022 and June 2023 will be deemed eligible for recruitment
Key exclusion criteria (2 listed)
- Those aged < 65 years discharged home from ULHG and referred to the MDCIT service
- Those deemed to not have decision making capacity to provide informed consent
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 |
|---|---|---|
| MDCIT InterventionThe MidWest Multidisciplinary Community Intervention Teams (MDCIT) comprise of specialist, healthcare teams that provide a rapid and integrated response to a patient with an acute episode of illness who requires enhanced services/acute intervention for a defined short period of time. This is provided in the patient's home after an acute hospital admission, thereby facilitating early discharge. The MDCIT intervention is composed of occupational therapy, physiotherapy, and healthcare assistants, with nursing support as required. The MDCIT therapists aim to make their first visit to patients within 24-48 hours of hospital discharge. Patients receive two-three visits per week, over a period of two to four weeks dependant on the patient's rehabilitation needs. Upon discharge from the MDCIT service, patients can be referred to community services as indicated by therapists. | Other | – |
Primary outcome
Functional Ability
Time frame: This will be measured at baseline.
Function will be measured using the Barthel Index (BI). The BI scores a patient from 0-20, with a higher score indicating greater independence.
Functional Ability
Time frame: This will be measured at 30 days.
Function will be measured using the Barthel Index (BI). The BI scores a patient from 0-20, with a higher score indicating greater independence.
Functional Ability
Time frame: This will be measured at 180 days.
Function will be measured using the Barthel Index (BI). The BI scores a patient from 0-20, with a higher score indicating greater independence.
16 secondary outcomes
Frailty Score
Time frame: This will be measured at baseline.
Frailty Score
Time frame: This will be measured at 30 days.
Frailty Score
Time frame: This will be measured at 180 days.
Patient Quality of Life
Time frame: This will be measured at baseline.
Patient Quality of Life
Time frame: This will be measured at 30 days.
Patient Quality of Life
Time frame: This will be measured at 180 days.
Quality of Care
Time frame: This will be measured at 30 days.
Quality of Care
Time frame: This will be measured at 1800 days.
Unscheduled ED Attendance(s)
Time frame: This will be measured at 30 days.
Unscheduled ED Attendance(s)
Time frame: This will be measured at 180 days.
Unscheduled Hospital Admission(s)
Time frame: This will be measured at 30 days.
Unscheduled Hospital Admission(s)
Time frame: This will be measured at 180 days.
Nursing Home Admission(s)
Time frame: This will be measured at 30 days.
Nursing Home Admission(s)
Time frame: This will be measured at 180 days.
Mortality
Time frame: This will be measured at 30 days.
Mortality
Time frame: This will be measured at 180 days.
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 13 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
Cathryn Ryan principal investigator
MidWest Community Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Hospitalization, run by University of Limerick at 1 site in Ireland.
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 1 inclusion and 2 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 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Functional Ability (time frame: This will be measured at baseline.). The study lists 3 primary outcomes in all. 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 13 Nov 2023.