Hospital ReadmissionsSHHENCT01221532
Support From Hospital to Home for Elders: A Randomized Controlled Study
A study testing SHHE Peridischarge Intervention in people with Hospital Readmissions, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hospital Readmissions
- What is being tested?
- SHHE Peridischarge Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 699 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital
San Francisco, California, 94110
About this 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.
- Conditions
- Hospital Readmissions
- Being tested
- SHHE Peridischarge Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHHE Peridischarge InterventionBehavioural
Support from Hospital to Home (SHHE) Peridischarge Intervention patients will receive Usual care plus
- 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;
- 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;
- 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.
| Study group | Role | What they receive |
|---|---|---|
| SHHE Peridischarge intervention | Experimental | Patients receive the Support from Hospital to Home (SHHE) Peridischarge Intervention plus usual care Receives: Behavioral: SHHE Peridischarge Intervention |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Emergency Department Visits and Inpatient Readmissions
Measured: 30 days after discharge from hospital
Combined Emergency Department Visits and Inpatient Readmissions
Measured: 90 days after discharge from hospital
Combined Emergency Department Visits and Inpatient Readmissions
Measured: 180 days after discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2010 (estimated)
- Study startJul 2010
- Primary completionFeb 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hospital ReadmissionsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 699 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Gordon and Betty Moore Foundation
- Responsible party
- Sponsor
- Investigators
- Jeffrey M Critchfield, MD, Principal investigator, University of California, San FranciscoSue Currin, RN, Principal investigator, San Francisco General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221532
- Sponsor's protocol ID
- SHHE2010
- Acronym
- SHHE
- Status last verified
- Jul 2013
- First submitted
- 13 Jul 2010
- Last updated
- 9 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31126336Chan 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.
PubMed 25986136Goldman 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.
PubMed 25285540
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support From Hospital to Home for Elders: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01221532
- Acronym / sponsor ID
- SHHE / SHHE2010
- Conditions
- Hospital Readmissions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 699 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Gordon and Betty Moore Foundation
- Study start
- Jul 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHHE Peridischarge intervention | Experimental | Behavioral: SHHE Peridischarge InterventionPatients receive the Support from Hospital to Home (SHHE) Peridischarge Intervention plus usual care |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHHE Peridischarge InterventionSupport 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. | Behavioural | SHHE Peridischarge intervention |
Primary outcome
Combined Emergency Department Visits and Inpatient Readmissions
Time frame: 30 days after discharge from hospital
Combined Emergency Department Visits and Inpatient Readmissions
Time frame: 90 days after discharge from hospital
Combined Emergency Department Visits and Inpatient Readmissions
Time frame: 180 days after discharge from hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2013.
- Derived from this study: PubMed 31126336Chan 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.
- Derived from this study: PubMed 25986136Chan 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.
- Derived from this study: PubMed 25285540Goldman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey M Critchfield, MD principal investigator
University of California, San Francisco
Sue Currin, RN principal investigator
San Francisco General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHHE Peridischarge Intervention in people with Hospital Readmissions, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined Emergency Department Visits and Inpatient Readmissions (time frame: 30 days after discharge from hospital). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01221532, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2013.