Health Care QualityNCT01855646
Improved Patient Handoffs to Prevent Sentinel Events
A study testing Structured Sign Out Form in people with Health Care Quality and Access and Evaluation, run by Duke University at 1 site in United States.
Trial summary
The overall aim of this project is to improve the quality of the handoffs between hospitalists on the general medicine service at Durham Regional Hospital with the intent of improving transitions of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Care Quality, Access and Evaluation
- What is being tested?
- Structured Sign Out Form
- How many people
- 4,344 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Jan 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients age >18 years
- admitted to the non-resident hospital medicine general medicine service at Durham Regional Hospital (DRH). (This would include transfers from outside hospital, the Emergency Room, intensive care units, and the Durham Rehab Institute.)
- Additionally, hospital medicine faculty who round on the non-resident general medicine service at DRH will be included for the purposes of completion of perception surveys.
Who cannot join
- Patients presenting for consults, rapid responses handled by surgical services and rapid responses as reason for transfer from Durham Rehabilitation Institute.
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham Regional Hospital
Durham, North Carolina, 27704
About this study
Official title: Patient Acuity Score With Improved Patient Handoffs to Prevent Sentinel Events
The overall aim of this project is to improve the quality of the handoffs between hospitalists on the general medicine service at Durham Regional Hospital with the intent of improving transitions of care. The intervention will be an improved and more structured face to face sign-out process using a standardized admission sign-out sheet, which is not part of the official medical record. Daytime admitting physicians will assign an acuity score to their patients in which the severity of illness will be scored from 1-7, with 7 being the most sick / likely to have rapid response team (RRT) or adverse event. The assignment of this score would be based off of the clinician's judgment in the patient's overall assessment. All patients, age >18 years, admitted to the non-resident hospital medicine general medicine service at DRH will be study eligible. Data analysis will examine aggregate hospitalist perception of sign-out practice before and after intervention, total number of RRTs, unplanned transfers, and rapid responses pre and post intervention, percentage of hospitalist based patients of overall rapid responses pre and post intervention, percentage of hospitalists using acuity scores, and average and mean severity score of patients with rapid responses compared with those admitted. Patients have a risk of loss of confidentiality.
- Conditions
- Health Care Quality, Access and Evaluation
- Being tested
- Structured Sign Out Form
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Sign Out FormOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of RRT's and unplanned transfers pre and post intervention matching aggregate numbers month to month
Measured: End of Study, Approximately 6 months
Secondary outcomes (1)
Physician attitudes towards sign-out process pre and post intervention
Measured: End of Study, Approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care QualityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855646
- Sponsor's protocol ID
- Pro00044212
- Status last verified
- Apr 2014
- First submitted
- 14 May 2013
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Acuity Score With Improved Patient Handoffs to Prevent Sentinel Events
- ClinicalTrials.gov ID
- NCT01855646
- Acronym / sponsor ID
- Pro00044212
- Conditions
- Health Care Quality, Access and Evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,344 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 16 May 2013 (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 overall aim of this project is to improve the quality of the handoffs between hospitalists on the general medicine service at Durham Regional Hospital with the intent of improving transitions of care. The intervention will be an improved and more structured face to face sign-out process using a standardized admission sign-out sheet, which is not part of the official medical record. Daytime admitting physicians will assign an acuity score to their patients in which the severity of illness will be scored from 1-7, with 7 being the most sick / likely to have rapid response team (RRT) or adverse event. The assignment of this score would be based off of the clinician's judgment in the patient's overall assessment. All patients, age >18 years, admitted to the non-resident hospital medicine general medicine service at DRH will be study eligible. Data analysis will examine aggregate hospitalist perception of sign-out practice before and after intervention, total number of RRTs, unplanned transfers, and rapid responses pre and post intervention, percentage of hospitalist based patients of overall rapid responses pre and post intervention, percentage of hospitalists using acuity scores, and average and mean severity score of patients with rapid responses compared with those admitted. Patients have a risk of loss of confidentiality.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients age >18 years
- admitted to the non-resident hospital medicine general medicine service at Durham Regional Hospital (DRH). (This would include transfers from outside hospital, the Emergency Room, intensive care units, and the Durham Rehab Institute.)
- Additionally, hospital medicine faculty who round on the non-resident general medicine service at DRH will be included for the purposes of completion of perception surveys.
Key exclusion criteria (1 listed)
- Patients presenting for consults, rapid responses handled by surgical services and rapid responses as reason for transfer from Durham Rehabilitation Institute.
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 |
|---|---|---|
| Structured Sign Out Form | Other | – |
Primary outcome
Comparison of RRT's and unplanned transfers pre and post intervention matching aggregate numbers month to month
Time frame: End of Study, Approximately 6 months
1 secondary outcome
Physician attitudes towards sign-out process pre and post intervention
Time frame: End of Study, Approximately 6 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 25 Nov 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Sign Out Form in people with Health Care Quality and Access and Evaluation, run by Duke 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 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 25 Nov 2016. 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?
Comparison of RRT's and unplanned transfers pre and post intervention matching aggregate numbers month to month (time frame: End of Study, Approximately 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2016.