AllNCT00252057
Testing the Re-Engineered Hospital Discharge
A study testing Re-Engineered Hospital Discharge in people with All, run by Boston University at 1 site in United States.
Trial summary
The purpose of this study is to determine if the "Re-Engineered Discharge" will decrease rehospitalization rates and adverse events of patients leaving Boston Medical Center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- All
- What is being tested?
- Re-Engineered Hospital Discharge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 749 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Oct 2007
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The Project Director will meet with the subject to determine if the patient meets inclusion or exclusion criteria.
- are over 18 years old;
- are to be discharged to a community, non-institutionalized setting;
- report that they desire to be hospitalized in the future if there is a clinical need; and
- are admitted to Firm B of the BMC Inpatient Service.
Who cannot join
- admitted to non-general Medical services at BMC (e.g., orthopedic surgery, obstetrics and gynecology, otolaryngology, general surgery, or psychiatry);
- requiring hospice, nursing home or other institutional settings upon discharge,
- who die during the admission,
- subjects who speak languages other than English;
- those who indicate that they have no access to a telephone or unable to give a contact telephone number; and
- those not competent to sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if the "Re-Engineered Discharge" will decrease rehospitalization rates and adverse events of patients leaving Boston Medical Center.
Read the detailed description
This project responds to the problems of non-standardized care and discontinuity at hospital discharge. Post-discharge adverse events are common and have been well documented. However, to date, there are no studies demonstrating the effectiveness of any procedures or tools designed to reduce them. This work builds on our "Safe Practices Implementation Challenge Grant" in which we developed the "Reengineered Hospital Discharge" tool, a set of 10 discrete, mutually reinforcing components. Hypotheses: The newly designed "Re-engineered Hospital Discharge" intervention will (1) reduce the percentage of patients experiencing a post-discharge adverse event, and (2) reduce subsequent hospital utilization (emergency department visits and rehospitalization) within 30 days following hospital discharge. Population Studied: Patients from a network of Community Health Centers discharged from a general medical service at an urban hospital. The subjects studied represent a low-income, ethnically diverse urban population. This study meets AHRQ guidelines for the inclusion of priority populations in research. Methods: 432 adult patients admitted to the general medical service of Boston Medical Center will be enrolled and randomized to (1) those receiving routine discharge as defined by our "Process Map" (Control Group); and (2) those receiving our "Re-engineered Hospital Discharge" intervention, a set of 10 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist (Intervention Group). Outcome Measures: The primary patient centered outcomes are: the combined 30-day subsequent hospital utilization (readmission and emergency department use), and health status as measured by the SF-12. Process outcomes include the number and severity of the adverse events related to the discharge 30 days after discharge. Although not a primary outcome, an economic analysis will be completed. Expected Results: This project will provide valuable information about whether the "Re-Engineered Discharge" will reduce adverse events related to discharge and decrease subsequent hospital utilization. Deliverables/Dissemination: An advisory committee of senior Boston Medical Center leaders will oversee the project and, if proven effective, will implement the intervention throughout our Academic Medical Center. The "Re-engineered Hospital Discharge" tool will be widely generalizable and widely disseminated.
- Conditions
- All
- Being tested
- Re-Engineered Hospital Discharge
- Keywords
- rehospitalization, readmission, adverse events, discharge
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-Engineered Hospital DischargeBehavioural
Also called RED
The "Re-engineered Hospital Discharge" (Project RED) intervention provides a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call after discharge by a clinical pharmacist.
| Study group | Role | What they receive |
|---|---|---|
| Re-engineered hospital discharge | Experimental | Participants received the "Re-Engineered Hospital Discharge", a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist. Receives: Behavioral: Re-Engineered Hospital Discharge |
| Standard hospital discharge | No intervention | Participants received the routine, standard hospital discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Rehospitalizations (Emergency Department Visits Plus Hospital Admissions) in the 30 Days After Discharge.
The total number of rehospitalizations (emergency department visits plus hospital admissions) in the 30 days after discharge, compared across study arms. Participants could have more than one rehospitalization in this period; all rehospitalizations for each were counted, making the unit of measure the rehospitalizations and not the participants.
Measured: 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2005 (estimated)
- Study startDec 2005
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AllStudies of the same condition, open and under way.
- 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
- 749 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Jack, Boston University
- Investigators
- Brian Jack, MD, Principal investigator, Boston Medical Center - Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00252057
- Sponsor's protocol ID
- H-24858
- Status last verified
- Feb 2017
- First submitted
- 10 Nov 2005
- Last updated
- 28 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Woz S, Mitchell S, Hesko C, Paasche-Orlow M, Greenwald J, Chetty VK, O'Donnell J, Jack B. Gender as risk factor for 30 days post-discharge hospital utilisation: a secondary data analysis. BMJ Open. 2012 Apr 18;2(2):e000428. doi: 10.1136/bmjopen-2011-000428. Print 2012.
PubMed 22514241Mitchell SE, Paasche-Orlow MK, Forsythe SR, Chetty VK, O'Donnell JK, Greenwald JL, Culpepper L, Jack BW. Post-discharge hospital utilization among adult medical inpatients with depressive symptoms. J Hosp Med. 2010 Sep;5(7):378-84. doi: 10.1002/jhm.673.
PubMed 20577971Jack BW, Chetty VK, Anthony D, Greenwald JL, Sanchez GM, Johnson AE, Forsythe SR, O'Donnell JK, Paasche-Orlow MK, Manasseh C, Martin S, Culpepper L. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009 Feb 3;150(3):178-87. doi: 10.7326/0003-4819-150-3-200902030-00007.
PubMed 19189907
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Re-Engineered Hospital Discharge
- ClinicalTrials.gov ID
- NCT00252057
- Acronym / sponsor ID
- H-24858
- Conditions
- All
- Keywords
- rehospitalization, readmission, adverse events, discharge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 749 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 11 Nov 2005 (estimated)
- Results
- Posted 13 Apr 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the "Re-Engineered Discharge" will decrease rehospitalization rates and adverse events of patients leaving Boston Medical Center.
Detailed description
This project responds to the problems of non-standardized care and discontinuity at hospital discharge. Post-discharge adverse events are common and have been well documented. However, to date, there are no studies demonstrating the effectiveness of any procedures or tools designed to reduce them. This work builds on our "Safe Practices Implementation Challenge Grant" in which we developed the "Reengineered Hospital Discharge" tool, a set of 10 discrete, mutually reinforcing components. Hypotheses: The newly designed "Re-engineered Hospital Discharge" intervention will (1) reduce the percentage of patients experiencing a post-discharge adverse event, and (2) reduce subsequent hospital utilization (emergency department visits and rehospitalization) within 30 days following hospital discharge. Population Studied: Patients from a network of Community Health Centers discharged from a general medical service at an urban hospital. The subjects studied represent a low-income, ethnically diverse urban population. This study meets AHRQ guidelines for the inclusion of priority populations in research. Methods: 432 adult patients admitted to the general medical service of Boston Medical Center will be enrolled and randomized to (1) those receiving routine discharge as defined by our "Process Map" (Control Group); and (2) those receiving our "Re-engineered Hospital Discharge" intervention, a set of 10 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist (Intervention Group). Outcome Measures: The primary patient centered outcomes are: the combined 30-day subsequent hospital utilization (readmission and emergency department use), and health status as measured by the SF-12. Process outcomes include the number and severity of the adverse events related to the discharge 30 days after discharge. Although not a primary outcome, an economic analysis will be completed. Expected Results: This project will provide valuable information about whether the "Re-Engineered Discharge" will reduce adverse events related to discharge and decrease subsequent hospital utilization. Deliverables/Dissemination: An advisory committee of senior Boston Medical Center leaders will oversee the project and, if proven effective, will implement the intervention throughout our Academic Medical Center. The "Re-engineered Hospital Discharge" tool will be widely generalizable and widely disseminated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Re-engineered hospital discharge | Experimental | Behavioral: Re-Engineered Hospital DischargeParticipants received the "Re-Engineered Hospital Discharge", a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist. |
| Standard hospital discharge | No intervention | –Participants received the routine, standard hospital discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The Project Director will meet with the subject to determine if the patient meets inclusion or exclusion criteria.
- are over 18 years old;
- are to be discharged to a community, non-institutionalized setting;
- report that they desire to be hospitalized in the future if there is a clinical need; and
- are admitted to Firm B of the BMC Inpatient Service.
Key exclusion criteria (6 listed)
- admitted to non-general Medical services at BMC (e.g., orthopedic surgery, obstetrics and gynecology, otolaryngology, general surgery, or psychiatry);
- requiring hospice, nursing home or other institutional settings upon discharge,
- who die during the admission,
- subjects who speak languages other than English;
- those who indicate that they have no access to a telephone or unable to give a contact telephone number; and
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 |
|---|---|---|
| Re-Engineered Hospital DischargeAlso: REDThe "Re-engineered Hospital Discharge" (Project RED) intervention provides a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call after discharge by a clinical pharmacist. | Behavioural | Re-engineered hospital discharge |
Primary outcome
Total Number of Rehospitalizations (Emergency Department Visits Plus Hospital Admissions) in the 30 Days After Discharge.
Time frame: 30 days after discharge
The total number of rehospitalizations (emergency department visits plus hospital admissions) in the 30 days after discharge, compared across study arms. Participants could have more than one rehospitalization in this period; all rehospitalizations for each were counted, making the unit of measure the rehospitalizations and not the participants.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22514241Woz S, Mitchell S, Hesko C, Paasche-Orlow M, Greenwald J, Chetty VK, O'Donnell J, Jack B. Gender as risk factor for 30 days post-discharge hospital utilisation: a secondary data analysis. BMJ Open. 2012 Apr 18;2(2):e000428. doi: 10.1136/bmjopen-2011-000428. Print 2012.
- Derived from this study: PubMed 20577971Mitchell SE, Paasche-Orlow MK, Forsythe SR, Chetty VK, O'Donnell JK, Greenwald JL, Culpepper L, Jack BW. Post-discharge hospital utilization among adult medical inpatients with depressive symptoms. J Hosp Med. 2010 Sep;5(7):378-84. doi: 10.1002/jhm.673.
- Derived from this study: PubMed 19189907Jack BW, Chetty VK, Anthony D, Greenwald JL, Sanchez GM, Johnson AE, Forsythe SR, O'Donnell JK, Paasche-Orlow MK, Manasseh C, Martin S, Culpepper L. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009 Feb 3;150(3):178-87. doi: 10.7326/0003-4819-150-3-200902030-00007.
- Boston Medical CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Brian Jack, MD principal investigator
Boston Medical Center - Family Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Re-Engineered Hospital Discharge in people with All, run by Boston University 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 6 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 28 Mar 2017. 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?
Yes. Results are posted in the registry (first posted 13 Apr 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Number of Rehospitalizations (Emergency Department Visits Plus Hospital Admissions) in the 30 Days After Discharge. (time frame: 30 days after discharge). 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 NCT00252057, 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 28 Mar 2017; AzTrials last refreshed its copy on 28 Oct 2026.