NCT01221532

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
699

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 15, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 9, 2013

Status Verified

July 1, 2013

Enrollment Period

1.6 years

First QC Date

July 13, 2010

Last Update Submit

July 5, 2013

Conditions

Outcome Measures

Primary Outcomes (3)

  • Combined Emergency Department Visits and Inpatient Readmissions

    30 days after discharge from hospital

  • Combined Emergency Department Visits and Inpatient Readmissions

    90 days after discharge from hospital

  • Combined Emergency Department Visits and Inpatient Readmissions

    180 days after discharge from hospital

Study Arms (2)

SHHE Peridischarge intervention

EXPERIMENTAL

Patients receive the Support from Hospital to Home (SHHE) Peridischarge Intervention plus usual care

Behavioral: SHHE Peridischarge Intervention

Usual Care

NO INTERVENTION

Interventions

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.

SHHE Peridischarge intervention

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (3)

  • Chan B, Goldman LE, Sarkar U, Guzman D, Critchfield J, Saha S, Kushel M. High perceived social support and hospital readmissions in an older multi-ethnic, limited English proficiency, safety-net population. BMC Health Serv Res. 2019 May 24;19(1):334. doi: 10.1186/s12913-019-4162-6.

  • Chan B, Goldman LE, Sarkar U, Schneidermann M, Kessell E, Guzman D, Critchfield J, Kushel M. The Effect of a Care Transition Intervention on the Patient Experience of Older Multi-Lingual Adults in the Safety Net: Results of a Randomized Controlled Trial. J Gen Intern Med. 2015 Dec;30(12):1788-94. doi: 10.1007/s11606-015-3362-y.

  • Goldman LE, Sarkar U, Kessell E, Guzman D, Schneidermann M, Pierluissi E, Walter B, Vittinghoff E, Critchfield J, Kushel M. Support from hospital to home for elders: a randomized trial. Ann Intern Med. 2014 Oct 7;161(7):472-81. doi: 10.7326/M14-0094.

Study Officials

  • Jeffrey M Critchfield, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
  • Sue Currin, RN

    San Francisco General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2010

First Posted

October 15, 2010

Study Start

July 1, 2010

Primary Completion

February 1, 2012

Study Completion

July 1, 2013

Last Updated

July 9, 2013

Record last verified: 2013-07

Locations