Transitions of CarePREDICTNCT05232656
PREventing Adverse Events Post-Discharge Through Proactive Identification, Multidisciplinary Communication, and Technology
A study testing Pre-Discharge Checklist and Patient Safety Dashboard in people with Transitions of Care and General Medicine, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The goal of this study is to expand the use of previously developed patient safety dashboards and patient-centered discharge checklists to three general medicine units in an affiliated community hospital. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transitions of Care, General Medicine, Discharge Checklist
- What is being tested?
- Pre-Discharge Checklist and Patient Safety Dashboard
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 30 Sep 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, >18 years of age, English-speaking
- Caregivers >18 years of age designated by patient or patient's healthcare proxy
- Two or more patient safety risk factors
Who cannot join
- Non-English speaking patients for whom we cannot identify an English-speaking healthcare proxy
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Impact of an Epic-integrated Safety Dashboard and Interactive Pre-discharge Checklist on Post-discharge Adverse Events
The goal of this study is to expand the use of previously developed patient safety dashboards and patient-centered discharge checklists to three general medicine units in an affiliated community hospital. The safety dashboard and interactive pre-discharge checklist are cognitive aids for clinicians and patients, respectively, that serve to facilitate early detection of patients at risk for preventable harm, including suboptimal discharge preparation. The aims of this study are to:
- Enhance the safety dashboard and interactive pre-discharge checklist to include "smart" notifications for hospital-based clinicians when patients are at high risk for adverse events or have identified specific concerns related to discharge based on their checklist responses.
- Expand intervention to general medical units at our community hospital-affiliate, BWFH.
- Evaluate impact on post-discharge AEs for patients discharged from BWFH who are at risk for preventable harm and hospital readmission.
Read the detailed description
Our project proposes to address gaps in functionality of commercially available EHR systems through evaluation of novel, EHR-integrated HIT tools. We previously designed, developed, and implemented the patient safety dashboard and interactive pre-discharge checklist to engage clinicians and patients in systematically addressing safety threats in each of several domains. By integrating clinical data of several different types, these tools serve to reduce cognitive load and improve decision-making for clinicians. In this way, these tools represent a preventative intervention that mitigates risk in each domain by suggesting corrective action corresponding to institutional safety guidelines.
Studying the effectiveness of these tools on post-discharge outcomes will improve knowledge, technical capability, and clinical practice related to patient safety during transitions of care. Specifically, our project will advance scientific knowledge by quantifying the post-discharge impact of an intervention that changes clinical practice by enabling hospital-based clinicians to proactively institute corrective action for "at risk" patients who may require additional surveillance and supportive services during transitions. Also, we will establish the technical feasibility of spreading customized, third-party digital health applications that fill critical safety gaps in commercially available EHRs; expanding to a community hospital has clear implications for adoption and validation of this technology in different practice settings.
- Being tested
- Pre-Discharge Checklist and Patient Safety Dashboard
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Discharge Checklist and Patient Safety DashboardBehavioural
Pre-discharge preparation checklist for patients to assess discharge readiness. Patient safety dashboard for clinicians to proactively identify at-risk patients.
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention | No intervention | Usual care on three general medicine units. Patients/caregivers do no have access to the discharge preparation checklist. Providers do not have access to the safety dashboard. |
| Post-intervention | Experimental | Patients/caregivers have access to the pre-discharge preparation checklist. Providers have access to patient safety dashboard. Receives: Behavioral: Pre-Discharge Checklist and Patient Safety Dashboard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Potential Post-Discharge Adverse Events
Potential post-discharge adverse events will be measured as the number of new or worsening symptoms or signs per patient
Measured: 24 months
Secondary outcomes (2)
Actual Post-Discharge Adverse Events
Actual post-discharge adverse events will be measured as the number of adverse events per patient
Measured: 24 months
Preventable Post-Discharge Adverse Events
Actual post-discharge adverse events related to preventable harm will be measured as the number of post-discharge adverse events per patient related to a specific safety risk domain identified during index hospitalization
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Sep 2018
- Primary completion20 Mar 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transitions of CareStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Crico
- Responsible party
- Principal investigator, Anuj K. Dalal, MD, Brigham and Women's Hospital
- Investigators
- Anuj K Dalal, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232656
- Sponsor's protocol ID
- 2018P001137
- Acronym
- PREDICT
- Status last verified
- Jan 2022
- First submitted
- 31 Jan 2022
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vasudevan A, Plombon S, Piniella N, Garber A, Malik M, O'Fallon E, Goyal A, Gershanik E, Kumar V, Fiskio J, Yoon C, Lipsitz SR, Schnipper JL, Dalal AK. Effect of digital tools to promote hospital quality and safety on adverse events after discharge. J Am Med Inform Assoc. 2024 Oct 1;31(10):2304-2314. doi: 10.1093/jamia/ocae176.
PubMed 39013194
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Epic-integrated Safety Dashboard and Interactive Pre-discharge Checklist on Post-discharge Adverse Events
- ClinicalTrials.gov ID
- NCT05232656
- Acronym / sponsor ID
- PREDICT / 2018P001137
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Crico
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 10 Feb 2022 (actual)
- 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 goal of this study is to expand the use of previously developed patient safety dashboards and patient-centered discharge checklists to three general medicine units in an affiliated community hospital. The safety dashboard and interactive pre-discharge checklist are cognitive aids for clinicians and patients, respectively, that serve to facilitate early detection of patients at risk for preventable harm, including suboptimal discharge preparation. The aims of this study are to:
- Enhance the safety dashboard and interactive pre-discharge checklist to include "smart" notifications for hospital-based clinicians when patients are at high risk for adverse events or have identified specific concerns related to discharge based on their checklist responses.
- Expand intervention to general medical units at our community hospital-affiliate, BWFH.
- Evaluate impact on post-discharge AEs for patients discharged from BWFH who are at risk for preventable harm and hospital readmission.
Detailed description
Our project proposes to address gaps in functionality of commercially available EHR systems through evaluation of novel, EHR-integrated HIT tools. We previously designed, developed, and implemented the patient safety dashboard and interactive pre-discharge checklist to engage clinicians and patients in systematically addressing safety threats in each of several domains. By integrating clinical data of several different types, these tools serve to reduce cognitive load and improve decision-making for clinicians. In this way, these tools represent a preventative intervention that mitigates risk in each domain by suggesting corrective action corresponding to institutional safety guidelines.
Studying the effectiveness of these tools on post-discharge outcomes will improve knowledge, technical capability, and clinical practice related to patient safety during transitions of care. Specifically, our project will advance scientific knowledge by quantifying the post-discharge impact of an intervention that changes clinical practice by enabling hospital-based clinicians to proactively institute corrective action for "at risk" patients who may require additional surveillance and supportive services during transitions. Also, we will establish the technical feasibility of spreading customized, third-party digital health applications that fill critical safety gaps in commercially available EHRs; expanding to a community hospital has clear implications for adoption and validation of this technology in different practice settings.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention | No intervention | –Usual care on three general medicine units. Patients/caregivers do no have access to the discharge preparation checklist. Providers do not have access to the safety dashboard. |
| Post-intervention | Experimental | Behavioral: Pre-Discharge Checklist and Patient Safety DashboardPatients/caregivers have access to the pre-discharge preparation checklist. Providers have access to patient safety dashboard. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, >18 years of age, English-speaking
- Caregivers >18 years of age designated by patient or patient's healthcare proxy
- Two or more patient safety risk factors
Key exclusion criteria (1 listed)
- Non-English speaking patients for whom we cannot identify an English-speaking healthcare proxy
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 |
|---|---|---|
| Pre-Discharge Checklist and Patient Safety DashboardPre-discharge preparation checklist for patients to assess discharge readiness. Patient safety dashboard for clinicians to proactively identify at-risk patients. | Behavioural | Post-intervention |
Primary outcome
Potential Post-Discharge Adverse Events
Time frame: 24 months
Potential post-discharge adverse events will be measured as the number of new or worsening symptoms or signs per patient
2 secondary outcomes
Actual Post-Discharge Adverse Events
Time frame: 24 months
Preventable Post-Discharge Adverse Events
Time frame: 24 months
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 10 Feb 2022.
- Derived from this study: PubMed 39013194Vasudevan A, Plombon S, Piniella N, Garber A, Malik M, O'Fallon E, Goyal A, Gershanik E, Kumar V, Fiskio J, Yoon C, Lipsitz SR, Schnipper JL, Dalal AK. Effect of digital tools to promote hospital quality and safety on adverse events after discharge. J Am Med Inform Assoc. 2024 Oct 1;31(10):2304-2314. doi: 10.1093/jamia/ocae176.
- 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.
Anuj K Dalal, MD principal investigator
Brigham and Women's 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 Pre-Discharge Checklist and Patient Safety Dashboard in people with Transitions of Care and General Medicine, run by Brigham and Women's Hospital 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 3 inclusion and 1 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 10 Feb 2022. 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?
Potential Post-Discharge Adverse Events (time frame: 24 months). 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 NCT05232656, which also lists 1 linked publication.
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 10 Feb 2022.