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

This study has been completed.
Sponsor:
Collaborator:
Gordon and Betty Moore Foundation
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01221532
First received: July 13, 2010
Last updated: July 5, 2013
Last verified: July 2013

July 13, 2010
July 5, 2013
July 2010
February 2012   (final data collection date for primary outcome measure)
  • Combined Emergency Department Visits and Inpatient Readmissions [ Time Frame: 30 days after discharge from hospital ] [ Designated as safety issue: No ]
  • Combined Emergency Department Visits and Inpatient Readmissions [ Time Frame: 90 days after discharge from hospital ] [ Designated as safety issue: No ]
  • Combined Emergency Department Visits and Inpatient Readmissions [ Time Frame: 180 days after discharge from hospital ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01221532 on ClinicalTrials.gov Archive Site
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Support From Hospital to Home for Elders: A Randomized Controlled Study
Support From Hospital to Home for Elders: A Randomized Controlled Study

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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Hospital Readmissions
Behavioral: SHHE Peridischarge Intervention

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.
  • Experimental: SHHE Peridischarge intervention
    Patients receive the Support from Hospital to Home (SHHE) Peridischarge Intervention plus usual care
    Intervention: Behavioral: SHHE Peridischarge Intervention
  • No Intervention: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
699
July 2013
February 2012   (final data collection date for primary outcome measure)

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.
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01221532
SHHE2010
No
University of California, San Francisco
University of California, San Francisco
Gordon and Betty Moore Foundation
Principal Investigator: Jeffrey M Critchfield, MD University of California, San Francisco
Principal Investigator: Sue Currin, RN San Francisco General Hospital
University of California, San Francisco
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP