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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

699

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Francisco, California, United States, 94110
        • San Francisco General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Combined Emergency Department Visits and Inpatient Readmissions
Time Frame: 30 days after discharge from hospital
30 days after discharge from hospital
Combined Emergency Department Visits and Inpatient Readmissions
Time Frame: 90 days after discharge from hospital
90 days after discharge from hospital
Combined Emergency Department Visits and Inpatient Readmissions
Time Frame: 180 days after discharge from hospital
180 days after discharge from hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

July 13, 2010

First Submitted That Met QC Criteria

October 13, 2010

First Posted (Estimate)

October 15, 2010

Study Record Updates

Last Update Posted (Estimate)

July 9, 2013

Last Update Submitted That Met QC Criteria

July 5, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • SHHE2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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