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Post-Acute Physician Home Visit Program

9. august 2019 oppdatert av: Jeffrey L. Schnipper, MD.,MPH., Brigham and Women's Hospital

Post-Acute Physician Home Visits: A Randomized Controlled Trial

New or worsening symptoms following discharge from the hospital likely leads to unplanned readmission. These rates are higher than desired and costly to patients, payers, and providers. Many interventions have unsuccessfully attempted to reduce readmissions, but few have provided in-home personnel to patients transitioning from acute care back to ambulatory care. Still fewer have involved a physician in the home. We therefore will test the effect of a physician home visit to a patient's home who was discharged in the last 4 days.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

51

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, Forente stater, 02130
        • Brigham and Women's Faulkner 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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Resides within either a 5-mile or 20-minute driving radius of Brigham and Women's Hospital (BWH) or Brigham and Women's Faulkner Hospital (BWFH) emergency room
  • Has capacity to consent to study
  • >=18 years old

Exclusion Criteria:

  • Undomiciled
  • In police custody
  • Domestic violence screen positive

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Home visit
A participant in this arm will receive a home visit after discharge from the hospital.
Annen: Home visit

The visit will be entirely patient tailored, last approximately one hour, and at a minimum will entail:

  • Medical assessment
  • Psychosocial assessment
  • Medication reconciliation
  • Follow-up of inpatient primary team's specific recommendations
  • Follow-up, as needed, with primary care team or inpatient team
Ingen inngripen: Usual Care
A participant in this arm will not receive a home visit after discharge from the hospital.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
New or worsening symptoms
Tidsramme: 30 days after discharge from hospital

"Since you got home from the hospital, have you had any symptoms at all?" If no, stop. If yes, continue.

"I'm going to read off a list of symptoms, and I want you to tell me if that symptom is new or has gotten worse since you left the hospital. Please don't include symptoms that have stayed the same since you were in the hospital." For each affirmative, double check if the symptom is new or has gotten worse since getting out of the hospital. Only if new or worse, mark yes.
30 days after discharge from hospital

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
3-element Care Transition Mål, skår
Tidsramme: 30 dager etter utskrivning
30 dager etter utskrivning
Total cost, 30-days post discharge
Tidsramme: Day of discharge to 30 days later
Day of discharge to 30 days later
Total reimbursement, 30-days post discharge
Tidsramme: Day of discharge to 30 days later
Day of discharge to 30 days later
Primary care provider follow-up within 14 days, y/n
Tidsramme: Day of discharge to 14 days later
Day of discharge to 14 days later
Ability to carry out the discharge plan, score
Tidsramme: 30 days after discharge
I would like to ask you about some more problems that you might have faced after you left the hospital one month ago. I will read some statements and ask if you agree or disagree.
30 days after discharge
Change in medication list due to home visit, y/n
Tidsramme: Day of home visit
Physician-initiated medication change during home visit
Day of home visit
Receipt of prescribed medicines following discharge, y/n
Tidsramme: 30 days after discharge
Pharmacy confirmation
30 days after discharge
Unplanned 30-day readmission(s) after index hospitalization, y/n
Tidsramme: 30 days after discharge
30 days after discharge
Unplanned 30-day readmission(s) after index hospitalization, #
Tidsramme: 30 days after discharge
30 days after discharge

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Global satisfaction with care, score
Tidsramme: 30 days after discharge
Exploratory
30 days after discharge
Days at home since discharge, #
Tidsramme: 30 days after discharge
Exploratory
30 days after discharge
All-cause 30-day readmission(s) after index hospitalization, y/n
Tidsramme: 30 days after discharge
Exploratory
30 days after discharge
All-cause 30-day readmission(s) after index hospitalization, #
Tidsramme: 30 days after discharge
Exploratory
30 days after discharge
Emergency Department (ED) observation stay(s) after index hospitalization, y/n
Tidsramme: 30 days after discharge
Exploratory
30 days after discharge
Emergency Department (ED) observation stay(s) after index hospitalization, #
Tidsramme: 30 days after discharge
Exploratory
30 days after discharge
Emergency Department (ED) visit(s) after index hospitalization, #
Tidsramme: 30 days after discharge
Exploratory
30 days after discharge
Emergency Department (ED) visit(s) after index hospitalization, y/n
Tidsramme: 30 days after discharge
Exploratory
30 days after discharge
Imaging, #
Tidsramme: 30 days after discharge
Exploratory
30 days after discharge
Imaging, y/n
Tidsramme: 30 days after discharge
Exploratory
30 days after discharge
Lab orders, #
Tidsramme: 30 days after discharge
Exploratory
30 days after discharge
Lab orders, y/n
Tidsramme: 30 days after discharge
Exploratory
30 days after discharge
Physician visits, y/n
Tidsramme: 30 days after discharge
Exploratory
30 days after discharge
Physician visits, #
Tidsramme: 30 days after discharge
Exploratory
30 days after discharge
Home health utilization, days
Tidsramme: 30 days after discharge
Exploratory
30 days after discharge
Home health utilization, y/n
Tidsramme: 30 days after discharge
Exploratory
30 days after discharge
All cause 30-day mortality, y/n
Tidsramme: 30 days after discharge
Exploratory
30 days after discharge
Unplanned 30-day mortality, y/n
Tidsramme: 30 days after discharge
Exploratory
30 days after discharge
Change in medication list due to error at discharge, y/n
Tidsramme: Visit date
Exploratory
Visit date
Pneumococcal vaccination if appropriate, y/n
Tidsramme: 30 days after discharge
Exploratory
30 days after discharge
Influenza vaccination if appropriate, y/n
Tidsramme: 30 days after discharge
Exploratory
30 days after discharge
Smoking cessation counseling if appropriate, y/n
Tidsramme: 30 days after discharge
Exploratory
30 days after discharge
Evaluation of ejection fraction as assessed by echocardiogram or other appropriate study, scheduled or completed, if not done within 1 year; y/n
Tidsramme: 30 days after discharge
Heart failure patients only; Exploratory; appropriate studies include cardiac magnetic resonance imaging, radionuclide ventriculography, single photon emission computed tomography myocardial perfusion imaging, or left ventriculography
30 days after discharge
Angiotensin converting enzyme inhibitor or angiotensin receptor blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
Tidsramme: 30 days after discharge
Heart failure patients only; Exploratory
30 days after discharge
Beta blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
Tidsramme: 30 days after discharge
Heart failure patients only; Exploratory
30 days after discharge
Aldosterone antagonist for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
Tidsramme: 30 days after discharge
Heart failure patients only; Exploratory
30 days after discharge
Lipid lowering for coronary artery disease, peripheral vascular disease, cerebrovascular accident, or diabetes, y/n
Tidsramme: 30 days after discharge
Heart failure patients only; Exploratory
30 days after discharge
Smoking status post-discharge
Tidsramme: 30 days after discharge
Heart failure patients only; Exploratory
30 days after discharge
Use of inappropriate medications in the elderly, y/n
Tidsramme: 30 days after discharge
Exploratory; using Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) and Beers criteria
30 days after discharge
Time between discharge and visit, days
Tidsramme: Date of home visit
Exploratory
Date of home visit
Duration of physician visit, minutes
Tidsramme: Date of home visit
Exploratory
Date of home visit

Samarbeidspartnere og etterforskere

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

Sponsor

Brigham and Women's Hospital

Etterforskere

  • Hovedetterforsker: Jeffrey Schnipper, MD MPH, Brigham and Women's 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.

Generelle publikasjoner

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 (Faktiske)

6. juni 2017

Primær fullføring (Faktiske)

20. januar 2018

Studiet fullført (Faktiske)

20. januar 2018

Datoer for studieregistrering

Først innsendt

5. juni 2017

Først innsendt som oppfylte QC-kriteriene

5. juni 2017

Først lagt ut (Faktiske)

7. juni 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. august 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. august 2019

Sist bekreftet

1. august 2019

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • P000719

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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