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Support From Hospital to Home for Elders: A Randomized Controlled Study (SHHE)

5. juli 2013 oppdatert av: University of California, San Francisco

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.

Studieoversikt

Status

Fullført

Studietype

Intervensjonell

Registrering (Faktiske)

699

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • California
      • San Francisco, California, Forente stater, 94110
        • San Francisco General Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

55 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Vanlig omsorg
Eksperimentell: 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

  1. a visit with in-hospital registered nurse, who provides additional patient education, assesses patient's needs post-hospitalization, communicates with the medical team, and develops a personalized discharge plan;
  2. two phone calls from a nurse practitioner(NP)/physician assistant (PA) after discharge, in which adherence to medications, treatment plan, and access to outpatient care, and other issues identified during the hospitalization will be explored;
  3. the provision of a phone support line, on which an NP/PA will call patients back within 24 hours to answer questions and assist transition to outpatient care.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Combined Emergency Department Visits and Inpatient Readmissions
Tidsramme: 30 days after discharge from hospital
30 days after discharge from hospital
Combined Emergency Department Visits and Inpatient Readmissions
Tidsramme: 90 days after discharge from hospital
90 days after discharge from hospital
Combined Emergency Department Visits and Inpatient Readmissions
Tidsramme: 180 days after discharge from hospital
180 days after discharge from hospital

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Jeffrey M Critchfield, MD, University of California, San Francisco
  • Hovedetterforsker: Sue Currin, RN, San Francisco General Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2010

Primær fullføring (Faktiske)

1. februar 2012

Studiet fullført (Faktiske)

1. juli 2013

Datoer for studieregistrering

Først innsendt

13. juli 2010

Først innsendt som oppfylte QC-kriteriene

13. oktober 2010

Først lagt ut (Anslag)

15. oktober 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

9. juli 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. juli 2013

Sist bekreftet

1. juli 2013

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • SHHE2010

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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