- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00611091
Improving Posthospital Medication Management of Older Adults Through Health IT
12. september 2013 opdateret af: Jerry Gurwitz, University of Massachusetts, Worcester
The incidence of drug-induced injury is high in the ambulatory geriatric population and is increased for elders upon transition from the hospital to the ambulatory setting.
In this application, we describe an effort to build on our extensive experience in medication safety and HIT-based medication management to respond to the AHRQ RFA entitled Ambulatory Safety and Quality Program: Improving Quality through Clinician Use of Health IT (RFA-HS-07-006).
In this study, we propose to develop and evaluate the value of an enhanced, HIT-based transitional care intervention superimposed on the ambulatory electronic medical record (EMR) to improve the quality and safety of medication management, focusing particularly on the transition from the inpatient to the ambulatory setting for older adults with multiple comorbid conditions who are prescribed high risk medications.
We propose a randomized controlled trial of a HIT-based transitional care intervention with enhanced medication and therapeutic monitoring alerts to improve the quality and safety of patient monitoring and medication management.
We postulate that the efficient and coordinated delivery of actionable health information to the clinician via use of HIT in the ambulatory setting can improve medication safety for the growing geriatric population.
The specific aims for this study are to evaluate, among a population of older adults discharged from the hospital, the impact of an enhanced discharge information system initiated upon transition to the ambulatory setting: (1) on the rate of follow-up by an outpatient provider within 14 days of hospital discharge; (2) on the prevalence of appropriate monitoring for selected high risk medications at 30 days from the time of hospital discharge; (3) on the incidence of adverse drug events (ADEs) 30 days after discharge; and (4) on the rate of emergency department visits and hospital readmission within 30 days of discharge.
A secondary aim for this study is to determine costs directly related to the development and installation of the HIT-based transitional care intervention.
This research allows for the examination of an integrated HIT intervention on the quality of follow-up, outpatient clinician workflow, occurrence of ADEs, and health care utilization to gain insights into the effective use of clinical alerts and coordinated delivery of actionable information to outpatient clinicians in the management of ambulatory elderly patients subsequent to hospital discharge.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
5077
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Massachusetts
-
Worcester, Massachusetts, Forenede Stater, 01608
- St Vincent's Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
65 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 65+ years old, member of the study site health plan, hospitalized at the study site hospital, discharged to an outpatient provider at the study site health plan clinic
Exclusion Criteria:
- does not meet inclusion criteria
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: I
Intervention Group - (receive intervention) randomized at patient level - includes all health plan members, aged 65+, hospitalized at the study site hospital and discharged to an outpatient health plan clinic provider.
|
Follow-up appointment needs/plans
Andre navne:
Laboratory follow-up needs
Andre navne:
New medications
Andre navne:
|
|
Ingen indgriben: C
Control Group - (do not receive intervention) randomized at patient level - includes all health plan members, aged 65+, hospitalized at the study site hospital and discharged to an outpatient health plan clinic provider.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
rate of follow-up to an outpatient provider within 14 days of hospital discharge.
Tidsramme: 1 year 3 months
|
1 year 3 months
|
|
prevalence of appropriate monitoring for selected high risk medications at 30 days from the time of hospital discharge.
Tidsramme: 1 year 3 months
|
1 year 3 months
|
|
incidence of adverse drug events (ADEs) 45 days after discharge.
Tidsramme: 1 year 3 months
|
1 year 3 months
|
|
rate of hospital readmission and emergency department (ED) within 30 days of discharge.
Tidsramme: 1 year 3 months
|
1 year 3 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
assess whether a HIT-based transitional care intervention is more effective in subgroups of patients (by level of comorbidity, number of medications, and use of specific high risk medications)
Tidsramme: 1 year 3 months
|
1 year 3 months
|
|
determine costs directly related to the development and installation of the HIT-based transitional care intervention.
Tidsramme: 3 years
|
3 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Jerry H Gurwitz, MD, Meyers Primary Care Institute/University of Massachusetts Medical School
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2010
Primær færdiggørelse (Faktiske)
1. juni 2012
Studieafslutning (Faktiske)
1. september 2013
Datoer for studieregistrering
Først indsendt
25. januar 2008
Først indsendt, der opfyldte QC-kriterier
7. februar 2008
Først opslået (Skøn)
8. februar 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
16. september 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. september 2013
Sidst verificeret
1. september 2013
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 12603
- 1R18HS017203 (U.S.A. AHRQ bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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