- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01398761
Development of a Sign-Out Tool to Improve Handoffs in Care
Development and Pilot Testing of a Web-Based, Multi-Disciplinary Sign-Out Tool to Improve Handoffs in Care
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham & Women's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All nurses, residents, PAs, and attendings on the two study services
Exclusion Criteria:
- Clinical staff not on study services within study period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
nurses, residents, PAs, and attendings from the two pilot services
|
Electronic signout tool
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Direct observations
Time Frame: 8 months
|
Time spent preparing and delivering sign-out will be compared before and after implementation of the sign-out using linear regression clustered by user.
|
8 months
|
User satisfaction
Time Frame: 8 months
|
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.
|
8 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2010P002915
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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