- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00252057
Testing the Re-Engineered Hospital Discharge
27 februari 2017 uppdaterad av: Brian Jack, Boston University
The purpose of this study is to determine if the "Re-Engineered Discharge" will decrease rehospitalization rates and adverse events of patients leaving Boston Medical Center.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This project responds to the problems of non-standardized care and discontinuity at hospital discharge.
Post-discharge adverse events are common and have been well documented.
However, to date, there are no studies demonstrating the effectiveness of any procedures or tools designed to reduce them.
This work builds on our "Safe Practices Implementation Challenge Grant" in which we developed the "Reengineered Hospital Discharge" tool, a set of 10 discrete, mutually reinforcing components.
Hypotheses: The newly designed "Re-engineered Hospital Discharge" intervention will (1) reduce the percentage of patients experiencing a post-discharge adverse event, and (2) reduce subsequent hospital utilization (emergency department visits and rehospitalization) within 30 days following hospital discharge.
Population Studied: Patients from a network of Community Health Centers discharged from a general medical service at an urban hospital.
The subjects studied represent a low-income, ethnically diverse urban population.
This study meets AHRQ guidelines for the inclusion of priority populations in research.
Methods: 432 adult patients admitted to the general medical service of Boston Medical Center will be enrolled and randomized to (1) those receiving routine discharge as defined by our "Process Map" (Control Group); and (2) those receiving our "Re-engineered Hospital Discharge" intervention, a set of 10 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist (Intervention Group).
Outcome Measures: The primary patient centered outcomes are: the combined 30-day subsequent hospital utilization (readmission and emergency department use), and health status as measured by the SF-12.
Process outcomes include the number and severity of the adverse events related to the discharge 30 days after discharge.
Although not a primary outcome, an economic analysis will be completed.
Expected Results: This project will provide valuable information about whether the "Re-Engineered Discharge" will reduce adverse events related to discharge and decrease subsequent hospital utilization.
Deliverables/Dissemination: An advisory committee of senior Boston Medical Center leaders will oversee the project and, if proven effective, will implement the intervention throughout our Academic Medical Center.
The "Re-engineered Hospital Discharge" tool will be widely generalizable and widely disseminated.
Studietyp
Interventionell
Inskrivning (Faktisk)
749
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Massachusetts
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Boston, Massachusetts, Förenta staterna, 02118
- Boston Medical Center
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
The Project Director will meet with the subject to determine if the patient meets inclusion or exclusion criteria.
Inclusion criteria include are patients who:
- are over 18 years old;
- are to be discharged to a community, non-institutionalized setting;
- report that they desire to be hospitalized in the future if there is a clinical need; and
- are admitted to Firm B of the BMC Inpatient Service.
Exclusion Criteria:
- admitted to non-general Medical services at BMC (e.g., orthopedic surgery, obstetrics and gynecology, otolaryngology, general surgery, or psychiatry);
- requiring hospice, nursing home or other institutional settings upon discharge,
- who die during the admission,
- subjects who speak languages other than English;
- those who indicate that they have no access to a telephone or unable to give a contact telephone number; and
- those not competent to sign informed consent.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Re-engineered hospital discharge
Participants received the "Re-Engineered Hospital Discharge", a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist.
|
The "Re-engineered Hospital Discharge" (Project RED) intervention provides a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call after discharge by a clinical pharmacist.
Andra namn:
|
Inget ingripande: Standard hospital discharge
Participants received the routine, standard hospital discharge.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Total Number of Rehospitalizations (Emergency Department Visits Plus Hospital Admissions) in the 30 Days After Discharge.
Tidsram: 30 days after discharge
|
The total number of rehospitalizations (emergency department visits plus hospital admissions) in the 30 days after discharge, compared across study arms.
Participants could have more than one rehospitalization in this period; all rehospitalizations for each were counted, making the unit of measure the rehospitalizations and not the participants.
|
30 days after discharge
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Brian Jack, MD, Boston Medical Center - Family Medicine
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Woz S, Mitchell S, Hesko C, Paasche-Orlow M, Greenwald J, Chetty VK, O'Donnell J, Jack B. Gender as risk factor for 30 days post-discharge hospital utilisation: a secondary data analysis. BMJ Open. 2012 Apr 18;2(2):e000428. doi: 10.1136/bmjopen-2011-000428. Print 2012.
- Mitchell SE, Paasche-Orlow MK, Forsythe SR, Chetty VK, O'Donnell JK, Greenwald JL, Culpepper L, Jack BW. Post-discharge hospital utilization among adult medical inpatients with depressive symptoms. J Hosp Med. 2010 Sep;5(7):378-84. doi: 10.1002/jhm.673.
- Jack BW, Chetty VK, Anthony D, Greenwald JL, Sanchez GM, Johnson AE, Forsythe SR, O'Donnell JK, Paasche-Orlow MK, Manasseh C, Martin S, Culpepper L. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009 Feb 3;150(3):178-87. doi: 10.7326/0003-4819-150-3-200902030-00007.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 december 2005
Primärt slutförande (Faktisk)
1 oktober 2007
Avslutad studie (Faktisk)
1 oktober 2007
Studieregistreringsdatum
Först inskickad
10 november 2005
Först inskickad som uppfyllde QC-kriterierna
10 november 2005
Första postat (Uppskatta)
11 november 2005
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 mars 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 februari 2017
Senast verifierad
1 februari 2017
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- H-24858
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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