- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01221532
Support From Hospital to Home for Elders: A Randomized Controlled Study (SHHE)
The investigators will randomize 700 non-psychiatric, non-obstetric, non-surgical patients aged 55 years and older at San Francisco General Hospital (SFGH) to usual care (ten days of prescription medication, discharge summary sent to primary care provider (PCP), and outpatient appt made for patient, and patient's nurse reviews discharge plan,) or usual care plus a peridischarge intervention (a visit with specialized in-hospital discharge nurse, development of personalized discharge plan, two phone calls from a nurse practitioner(NP)/physician assistant (PA) after discharge and availability of additional calls back from NP/PA, upon patient request, to help answer questions and assist patient's transition to outpatient care, and communication with primary care/subspecialty providers). The usual care and usual care plus intervention groups will be assessed for differences in mortality and rates of rehospitalization and emergency department use 30, 90 and 180 days following discharge from the hospital.
The discharge process from the hospital to home is frequently marked by poor quality and high risk of adverse events and readmissions. It has been hypothesized that better coordinated care, personalized patient education, and follow-up calls to identify potential sources of adverse events, such as medical complications and medication errors can reduce rehospitalization and emergency room visits following discharge from the hospital. Although these interventions have been shown to reduce combined hospital readmissions and emergency department visits in English-speaking patients, none has focused on elderly patients in a diverse urban public hospital setting that includes non-English-speakers, who might benefit more than other populations from enhanced services during and after discharge from the hospital. Further, these labor-intensive interventions are costly to implement, and it is unknown whether opportunity cost of providing additional services in a limited-resource environment such as San Francisco General Hospital (SFGH) outweighs the unknown clinical benefits.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
California
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San Francisco, California, Stati Uniti, 94110
- San Francisco General Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- patients age 55 and older
- admitted to the general medicine, family medicine, cardiology, and neurology services at San Francisco General Hospital,
- able to communicate in either English, Spanish, Mandarin or Cantonese,
- attending physicians agree to the patient's participation.
- Patients must be able to demonstrate an understanding of the study's goals through a set of teach back questions included in the consent process.
Exclusion Criteria:
- transferred from an outside hospital;
- admitted for a planned hospitalization (e.g. chemotherapy, a planned surgery)
- requiring hospice, nursing home, rehab or other institutional settings (i.e. expected by the physician team to be discharged to skilled nursing facilities) - those unable to independently consent (i.e. severely cognitively impaired, delirious, deaf, or involuntarily hospitalized because of severe mental illness)
- unable to understand English, Spanish or Cantonese (as reported by medical teams or unable to complete the consent teach-back process)
- less than age 55
- aphasic
- otherwise excluded by the medical team
- participated in the pilot project of this intervention.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: Solita cura
|
|
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Sperimentale: SHHE Peridischarge intervention
Patients receive the Support from Hospital to Home (SHHE) Peridischarge Intervention plus usual care
|
Support from Hospital to Home (SHHE) Peridischarge Intervention patients will receive Usual care plus
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Combined Emergency Department Visits and Inpatient Readmissions
Lasso di tempo: 30 days after discharge from hospital
|
30 days after discharge from hospital
|
|
Combined Emergency Department Visits and Inpatient Readmissions
Lasso di tempo: 90 days after discharge from hospital
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90 days after discharge from hospital
|
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Combined Emergency Department Visits and Inpatient Readmissions
Lasso di tempo: 180 days after discharge from hospital
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180 days after discharge from hospital
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Jeffrey M Critchfield, MD, University of California, San Francisco
- Investigatore principale: Sue Currin, RN, San Francisco General Hospital
Pubblicazioni e link utili
Pubblicazioni generali
- Chan B, Goldman LE, Sarkar U, Guzman D, Critchfield J, Saha S, Kushel M. High perceived social support and hospital readmissions in an older multi-ethnic, limited English proficiency, safety-net population. BMC Health Serv Res. 2019 May 24;19(1):334. doi: 10.1186/s12913-019-4162-6.
- Chan B, Goldman LE, Sarkar U, Schneidermann M, Kessell E, Guzman D, Critchfield J, Kushel M. The Effect of a Care Transition Intervention on the Patient Experience of Older Multi-Lingual Adults in the Safety Net: Results of a Randomized Controlled Trial. J Gen Intern Med. 2015 Dec;30(12):1788-94. doi: 10.1007/s11606-015-3362-y.
- Goldman LE, Sarkar U, Kessell E, Guzman D, Schneidermann M, Pierluissi E, Walter B, Vittinghoff E, Critchfield J, Kushel M. Support from hospital to home for elders: a randomized trial. Ann Intern Med. 2014 Oct 7;161(7):472-81. doi: 10.7326/M14-0094.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- SHHE2010
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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