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An Emergency Department-To-Home Intervention to Improve Quality of Life and Reduce Hospital Use

3 januari 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

1101

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Florida
      • Gainesville, Florida, Verenigde Staten, 32608
        • UF Health
      • Jacksonville, Florida, Verenigde Staten, 32209
        • UF Health

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

60 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: ED-to-home care transition intervention
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.
Andere namen:
  • Care Transition Intervention
Experimenteel: 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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Physical Function Between Baseline and 60 Days Post-ED Visit
Tijdsspanne: Baseline up to 60 days after index ED Visit
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.
Baseline up to 60 days after index ED Visit
Change in Anxiety Between Baseline and 60 Days Post-ED Visit
Tijdsspanne: Baseline up to 60 days after index ED Visit
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.
Baseline up to 60 days after index ED Visit
Change in Informational Support Between Baseline and 60 Days Post-ED Visit
Tijdsspanne: Baseline up to 60 days after index ED Visit
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.
Baseline up to 60 days after index ED Visit
Number of Participants With Outpatient Visit Claims
Tijdsspanne: Within 30 days after index ED visit
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.
Within 30 days after index ED visit
Number of Participants With ED Visit Claims
Tijdsspanne: Within 30 days after index ED visit
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.
Within 30 days after index ED visit
Number of Participants With In-patient Admission Claims
Tijdsspanne: Within 30 days after index ED visit
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.
Within 30 days after index ED visit

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Florida

Medewerkers

Patient-Centered Outcomes Research Institute

Onderzoekers

  • Hoofdonderzoeker: Donna L Carden, MD, MPH, University of Florida

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

3 mei 2014

Primaire voltooiing (Werkelijk)

30 november 2015

Studie voltooiing (Werkelijk)

10 maart 2017

Studieregistratiedata

Eerst ingediend

4 maart 2014

Eerst ingediend dat voldeed aan de QC-criteria

4 maart 2014

Eerst geplaatst (Schatting)

6 maart 2014

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 april 2019

Laatste update ingediend die voldeed aan QC-criteria

3 januari 2019

Laatst geverifieerd

1 januari 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB201400005
  • PCORI-1306-01451 (Ander subsidie-/financieringsnummer: PCORI)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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