Continuity of Patient CareNCT01398761
Development of a Sign-Out Tool to Improve Handoffs in Care
A study testing Signout tool in people with Continuity of Patient Care and Workflow, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this grant is to fund the research necessary to fully understand the impact of this sign-out tool on clinician workflow, quality of sign-out, and continuity of care. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Continuity of Patient Care, Workflow, Quality of Signout
- What is being tested?
- Signout tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jul 2011
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All nurses, residents, PAs, and attendings on the two study services
Who cannot join
- Clinical staff not on study services within study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham & Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Development and Pilot Testing of a Web-Based, Multi-Disciplinary Sign-Out Tool to Improve Handoffs in Care
The purpose of this grant is to fund the research necessary to fully understand the impact of this sign-out tool on clinician workflow, quality of sign-out, and continuity of care. This information will inform exactly how Partners will move ahead with tools to improve handoffs in care (i.e., whether the prototype will be adapted further, adopted Partners wide, or abandoned in favor of other solutions). The investigators hypothesize that a web-based handoff tool improves provider satisfaction, the quality of written sign-outs, and measures of continuity of care compared with current handoff tools.
Read the detailed description
This study will attempt to answer the following questions:
- What are the specific needs for clinical content among various clinical personnel (nurses, residents, and attendings) on different services at two different hospitals (MGH, BWH)?
- How can IT support sign-out that facilitates interdisciplinary communication and yet preserves user-specific content among different clinical personnel?
- Can a sign-out tool currently deployed at MGH be transferred to BWH using existing IT services and a minimum amount of local IS effort?
- What will be the future needs of this tool so that it can fully access data from MetaVision once it is deployed?
- How should the tool be further improved such that it optimizes user adoption, provider satisfaction and workflow, the quality of sign-out, and continuity of care?
- Is it feasible for a future, refined version of this tool to be adopted across Partners acute care hospitals?
The study design is an observational, before-after pilot study. A multi-disciplinary steering committee and working group will be assembled to determine requirements and guide design in conjunction with HPM leadership, research staff, a Partners IS analyst, and MGH LCS personnel. The intervention will then be implemented on two services. Before and during implementation, several outcomes will be measured, including provider satisfaction and workflow, continuity of care, and quality of sign-out.
Deliverables will include the following:
- Clinical and functional specifications for a new web-based sign-out tool
- A prototype of the sign-out tool tested on 2 active clinical services, one each at MGH and BWH
- A report of the impact of the tool on clinical care
- Lessons learned regarding design and implementation that can be applied to more broad-based efforts
- An update to the Sign-out White Paper with recommendations for action based on the results of this study The lessons learned will be applicable not only to Partners, but to other institutions (nationwide and worldwide) wishing to improve patient safety during handoffs in care.
- Conditions
- Continuity of Patient Care, Workflow, Quality of Signout
- Being tested
- Signout tool
- Keywords
- Continuity of patient care, Workflow, Quality of signout, Web based, Handoffs, Multi disciplinary, Written signout, Information science
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Signout toolOther
Electronic signout tool
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | nurses, residents, PAs, and attendings from the two pilot services Receives: Other: Signout tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of required data elements present
The proportion of required data elements present in written/typed sign-outs during tool implementation.
Measured: 8 months
Secondary outcomes (2)
Direct observations
Time spent preparing and delivering sign-out will be compared before and after implementation of the sign-out using linear regression clustered by user.
Measured: 8 months
User satisfaction
Individual questions from the user satisfaction survey will be presented as medians with interquartile ranges on Likert-type questions and compared using the Wilcoxon rank sum test. A global satisfaction score will be derived by calculating the proportion of questions for which users were satisfied or very satisfied, and compared using linear regression. Results of the continuity of care survey will be analyzed similarly.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuity of Patient 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Partners Siemens Research Council
- Responsible party
- Principal investigator, Jeffrey L. Schnipper, MD.,MPH., Brigham and Women's Hospital
- Investigators
- Jeffrey L Schnipper, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398761
- Sponsor's protocol ID
- 2010P002915
- Status last verified
- Apr 2014
- First submitted
- 11 Jul 2011
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Testing of a Web-Based, Multi-Disciplinary Sign-Out Tool to Improve Handoffs in Care
- ClinicalTrials.gov ID
- NCT01398761
- Acronym / sponsor ID
- 2010P002915
- Conditions
- Continuity of Patient Care, Workflow, Quality of Signout
- Keywords
- Continuity of patient care, Workflow, Quality of signout, Web based, Handoffs, Multi disciplinary, Written signout, Information science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Partners Siemens Research Council
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 21 Jul 2011 (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 purpose of this grant is to fund the research necessary to fully understand the impact of this sign-out tool on clinician workflow, quality of sign-out, and continuity of care. This information will inform exactly how Partners will move ahead with tools to improve handoffs in care (i.e., whether the prototype will be adapted further, adopted Partners wide, or abandoned in favor of other solutions). The investigators hypothesize that a web-based handoff tool improves provider satisfaction, the quality of written sign-outs, and measures of continuity of care compared with current handoff tools.
Detailed description
This study will attempt to answer the following questions:
- What are the specific needs for clinical content among various clinical personnel (nurses, residents, and attendings) on different services at two different hospitals (MGH, BWH)?
- How can IT support sign-out that facilitates interdisciplinary communication and yet preserves user-specific content among different clinical personnel?
- Can a sign-out tool currently deployed at MGH be transferred to BWH using existing IT services and a minimum amount of local IS effort?
- What will be the future needs of this tool so that it can fully access data from MetaVision once it is deployed?
- How should the tool be further improved such that it optimizes user adoption, provider satisfaction and workflow, the quality of sign-out, and continuity of care?
- Is it feasible for a future, refined version of this tool to be adopted across Partners acute care hospitals?
The study design is an observational, before-after pilot study. A multi-disciplinary steering committee and working group will be assembled to determine requirements and guide design in conjunction with HPM leadership, research staff, a Partners IS analyst, and MGH LCS personnel. The intervention will then be implemented on two services. Before and during implementation, several outcomes will be measured, including provider satisfaction and workflow, continuity of care, and quality of sign-out.
Deliverables will include the following:
- Clinical and functional specifications for a new web-based sign-out tool
- A prototype of the sign-out tool tested on 2 active clinical services, one each at MGH and BWH
- A report of the impact of the tool on clinical care
- Lessons learned regarding design and implementation that can be applied to more broad-based efforts
- An update to the Sign-out White Paper with recommendations for action based on the results of this study The lessons learned will be applicable not only to Partners, but to other institutions (nationwide and worldwide) wishing to improve patient safety during handoffs in care.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Signout toolnurses, residents, PAs, and attendings from the two pilot services |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All nurses, residents, PAs, and attendings on the two study services
Key exclusion criteria (1 listed)
- Clinical staff not on study services within study period
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 |
|---|---|---|
| Signout toolElectronic signout tool | Other | Intervention |
Primary outcome
Proportion of required data elements present
Time frame: 8 months
The proportion of required data elements present in written/typed sign-outs during tool implementation.
2 secondary outcomes
Direct observations
Time frame: 8 months
User satisfaction
Time frame: 8 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 28 Apr 2014.
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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 L Schnipper, MD, MPH 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 Signout tool in people with Continuity of Patient Care and Workflow, 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 1 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 28 Apr 2014. 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?
Proportion of required data elements present (time frame: 8 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 28 Apr 2014.