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Post-Acute Physician Home Visit Program

9 augusti 2019 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

51

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, Förenta staterna, 02130
        • Brigham and Women's Faulkner Hospital

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:

  • 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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Home visit
A participant in this arm will receive a home visit after discharge from the hospital.
Övrig: 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
Inget ingripande: Usual Care
A participant in this arm will not receive a home visit after discharge from the hospital.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
New or worsening symptoms
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
3-post Care Transition Mått, poäng
Tidsram: 30 dagar efter utskrivning
30 dagar efter utskrivning
Total cost, 30-days post discharge
Tidsram: Day of discharge to 30 days later
Day of discharge to 30 days later
Total reimbursement, 30-days post discharge
Tidsram: Day of discharge to 30 days later
Day of discharge to 30 days later
Primary care provider follow-up within 14 days, y/n
Tidsram: Day of discharge to 14 days later
Day of discharge to 14 days later
Ability to carry out the discharge plan, score
Tidsram: 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
Tidsram: Day of home visit
Physician-initiated medication change during home visit
Day of home visit
Receipt of prescribed medicines following discharge, y/n
Tidsram: 30 days after discharge
Pharmacy confirmation
30 days after discharge
Unplanned 30-day readmission(s) after index hospitalization, y/n
Tidsram: 30 days after discharge
30 days after discharge
Unplanned 30-day readmission(s) after index hospitalization, #
Tidsram: 30 days after discharge
30 days after discharge

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Global satisfaction with care, score
Tidsram: 30 days after discharge
Exploratory
30 days after discharge
Days at home since discharge, #
Tidsram: 30 days after discharge
Exploratory
30 days after discharge
All-cause 30-day readmission(s) after index hospitalization, y/n
Tidsram: 30 days after discharge
Exploratory
30 days after discharge
All-cause 30-day readmission(s) after index hospitalization, #
Tidsram: 30 days after discharge
Exploratory
30 days after discharge
Emergency Department (ED) observation stay(s) after index hospitalization, y/n
Tidsram: 30 days after discharge
Exploratory
30 days after discharge
Emergency Department (ED) observation stay(s) after index hospitalization, #
Tidsram: 30 days after discharge
Exploratory
30 days after discharge
Emergency Department (ED) visit(s) after index hospitalization, #
Tidsram: 30 days after discharge
Exploratory
30 days after discharge
Emergency Department (ED) visit(s) after index hospitalization, y/n
Tidsram: 30 days after discharge
Exploratory
30 days after discharge
Imaging, #
Tidsram: 30 days after discharge
Exploratory
30 days after discharge
Imaging, y/n
Tidsram: 30 days after discharge
Exploratory
30 days after discharge
Lab orders, #
Tidsram: 30 days after discharge
Exploratory
30 days after discharge
Lab orders, y/n
Tidsram: 30 days after discharge
Exploratory
30 days after discharge
Physician visits, y/n
Tidsram: 30 days after discharge
Exploratory
30 days after discharge
Physician visits, #
Tidsram: 30 days after discharge
Exploratory
30 days after discharge
Home health utilization, days
Tidsram: 30 days after discharge
Exploratory
30 days after discharge
Home health utilization, y/n
Tidsram: 30 days after discharge
Exploratory
30 days after discharge
All cause 30-day mortality, y/n
Tidsram: 30 days after discharge
Exploratory
30 days after discharge
Unplanned 30-day mortality, y/n
Tidsram: 30 days after discharge
Exploratory
30 days after discharge
Change in medication list due to error at discharge, y/n
Tidsram: Visit date
Exploratory
Visit date
Pneumococcal vaccination if appropriate, y/n
Tidsram: 30 days after discharge
Exploratory
30 days after discharge
Influenza vaccination if appropriate, y/n
Tidsram: 30 days after discharge
Exploratory
30 days after discharge
Smoking cessation counseling if appropriate, y/n
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 30 days after discharge
Heart failure patients only; Exploratory
30 days after discharge
Smoking status post-discharge
Tidsram: 30 days after discharge
Heart failure patients only; Exploratory
30 days after discharge
Use of inappropriate medications in the elderly, y/n
Tidsram: 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
Tidsram: Date of home visit
Exploratory
Date of home visit
Duration of physician visit, minutes
Tidsram: Date of home visit
Exploratory
Date of home visit

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Brigham and Women's Hospital

Utredare

  • Huvudutredare: Jeffrey Schnipper, MD MPH, Brigham and Women's Hospital

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

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 (Faktisk)

6 juni 2017

Primärt slutförande (Faktisk)

20 januari 2018

Avslutad studie (Faktisk)

20 januari 2018

Studieregistreringsdatum

Först inskickad

5 juni 2017

Först inskickad som uppfyllde QC-kriterierna

5 juni 2017

Första postat (Faktisk)

7 juni 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 augusti 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 augusti 2019

Senast verifierad

1 augusti 2019

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • P000719

Plan för individuella deltagardata (IPD)

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NEJ

Läkemedels- och apparatinformation, studiedokument

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