An Emergency Department-To-Home Intervention to Improve Quality of Life and Reduce Hospital Use
3 stycznia 2019 zaktualizowane przez: University of Florida
The purpose of this study is to determine if assigning older, chronically ill patients a healthcare coach after they leave the Emergency Department (ED) improves their quality of life and reduces the need for hospital-based care.
Przegląd badań
Status
Zakończony
Interwencja / Leczenie
Szczegółowy opis
Investigators will review the ED electronic medical record in real-time to determine ED patients' study eligibility. Older, chronically ill ED patients who are eligible and agree to participate in the study will be randomly assigned to a healthcare coach and Care Transition Intervention or usual, post-ED care.
At the time of enrollment, all subjects will be asked to provide informed consent for study investigators to request Medicare Claims to determine how many ED visits, hospital admissions and doctor office visits the subject had at least 30 days after the index ED visit. All research participants will be asked basic personal information such as age, race, sex, employment and marital status. All subjects will be asked to complete a baseline survey about their quality of life.
If the subject is assigned to the Care Transition Intervention, the healthcare coach will visit the subject at home within 3 days of the ED visit. The coach will talk with the subject about following up with a regular, personal doctor and symptoms that indicate a worsening health condition. The coach will help the subject understand their medicines and help the subject make a personal health record (PHR). The coach will tell the subject about the Area Agency on Aging. If the subject receives usual care, they but will be given the usual discharge instructions from the ED nurse and doctor. If the subject receives the Care Transition Intervention, the coach will also call the subject at least 3 times after the ED visit and review the same items listed above.
All enrolled subjects will be asked to complete a phone survey within 31-60 days of the ED visit. This survey will again ask subjects about their quality of life.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
1101
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Florida
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Gainesville, Florida, Stany Zjednoczone, 32608
- UF Health
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Jacksonville, Florida, Stany Zjednoczone, 32209
- UF Health
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
60 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- 60 years of age or older
- Medicare beneficiaries
- Community dwelling
- Reside within defined geographical area (to enable home visits)
- Have a working telephone
- Have at least one of the following conditions documented in their electronic medical record: congestive heart failure, chronic obstructive pulmonary disease, coronary artery disease, diabetes, stroke, pneumonia, medical and surgical back conditions (predominantly spinal stenosis), hip fracture, peripheral vascular disease, cardiac arrhythmias, deep venous thrombosis, pulmonary embolism, peptic ulcer disease or hemorrhage
Exclusion Criteria:
- Current diagnosis of psychosis
- Cancer
- Dialysis
- History of organ transplantation
- Dementia without a live-in caregiver, or
- In hospice care
- Reside outside the defined geographical area
- Reside in a skilled nursing or assisted living facility
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: ED-to-home care transition intervention
The ED-to-home care transition intervention is a coaching intervention.
It is a 4-week program that uses an Area Agency on Aging healthcare coach to conduct a home visit and at least 3 follow-up phone calls to help patients develop the skills needed for self-management and to communicate with healthcare providers.
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The Area Agency on Aging coach's role is to build self-management capabilities for the patient and their caregiver.
During each contact, the coach reviews the four components of the Care Transition Intervention: 1: Follow-up Medical Visit.
2: Knowledge of Red Flag Symptoms.
3: Medication Reconciliation.
4: The Personal Health Record (PHR).
The coach assists patients use the PHR to document and maintain vital information and to communicate with providers.
Inne nazwy:
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Eksperymentalny: Usual Care
Patients randomized to usual care will receive verbal and written discharge instructions from the treating ED physician and nurse as is the standard of care.
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Patients randomized to usual care will receive verbal and written discharge instructions from the treating ED physician and nurse as is the standard of care.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Physical Function Between Baseline and 60 Days Post-ED Visit
Ramy czasowe: Baseline up to 60 days after index ED Visit
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PROMIS Physical Function instruments measure self-reported capability.
Each of 7-items in the physical function instrument used in this study has five response items ranging in value from one to five.
Thus, the minimum score for the Physical Function Instrument used is 7 and the maximum score is 35.
The raw score is translated to a T-score using PROMIS conversion tables.
The T-score rescales the raw score into a standardized score with a mean of 50 and standard deviation of 10.
A higher PROMIS T-score represents more of the concept being measured.
For positively-worded concepts like Physical Function, a T-score of 60 is one SD better than average.
A Physical Function T-score of 40 is one SD worse than average.
Change in Physical Function is the difference between baseline and 60 day T-score.
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Baseline up to 60 days after index ED Visit
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Change in Anxiety Between Baseline and 60 Days Post-ED Visit
Ramy czasowe: Baseline up to 60 days after index ED Visit
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PROMIS Anxiety instruments measure self-reported fear, anxious misery, and hyperarousal.
Each of 8-items in the Anxiety Instrument used in this study has five response items ranging in value from one to five.
Thus, the minimum score for the Anxiety Instrument used is 8 and the maximum score is 40.
The raw score is translated to a T-score using PROMIS conversion tables.
The T-score rescales the raw score into a standardized score with a mean of 50 and standard deviation of 10.
A higher PROMIS T-score represents more of the concept being measured.
For negatively-worded concepts like Anxiety, a T-score of 60 is one SD worse than average and an Anxiety T-score of 40 is one SD better than average.
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Baseline up to 60 days after index ED Visit
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Change in Informational Support Between Baseline and 60 Days Post-ED Visit
Ramy czasowe: Baseline up to 60 days after index ED Visit
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PROMIS Informational Support instruments measure perceived availability of helpful information or advice.
Each of 5-items in the Informational Support Instrument used in this study has five response items ranging in value from one to five.
Thus, the minimum score for the Informational Support Instrument used is 5 and the maximum score is 25.
The raw score is translated to a T-score using PROMIS conversion tables.
The T-score rescales the raw score into a standardized score with a mean of 50 and standard deviation of 10.
A higher PROMIS T-score represents more of the concept being measured.
For positively-worded concepts like Informational Support, a T-score of 60 is one SD better than average and a T-score of 40 is one SD worse than average.
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Baseline up to 60 days after index ED Visit
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Number of Participants With Outpatient Visit Claims
Ramy czasowe: Within 30 days after index ED visit
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This outcome was determined by assessing the number of participants who had one or more Medicare claims for an outpatient visit in the 30 days after the index ED visit.
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Within 30 days after index ED visit
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Number of Participants With ED Visit Claims
Ramy czasowe: Within 30 days after index ED visit
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This outcome was determined by assessing the number of participants who had one or more Medicare claims for an ED visit in the 30 days after the index ED visit.
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Within 30 days after index ED visit
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Number of Participants With In-patient Admission Claims
Ramy czasowe: Within 30 days after index ED visit
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This outcome was determined by assessing the number of participants who had one or more Medicare claims for a hospitalization in the 30 days after the index ED visit.
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Within 30 days after index ED visit
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Donna L Carden, MD, MPH, University of Florida
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
3 maja 2014
Zakończenie podstawowe (Rzeczywisty)
30 listopada 2015
Ukończenie studiów (Rzeczywisty)
10 marca 2017
Daty rejestracji na studia
Pierwszy przesłany
4 marca 2014
Pierwszy przesłany, który spełnia kryteria kontroli jakości
4 marca 2014
Pierwszy wysłany (Oszacować)
6 marca 2014
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
5 kwietnia 2019
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
3 stycznia 2019
Ostatnia weryfikacja
1 stycznia 2019
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- IRB201400005
- PCORI-1306-01451 (Inny numer grantu/finansowania: PCORI)
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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