Development of a Sign-Out Tool to Improve Handoffs in Care

Continuity of Patient Care Clinical Trial

Official title:

Development and Pilot Testing of a Web-Based, Multi-Disciplinary Sign-Out Tool to Improve Handoffs in Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01398761
• Other study ID #: 2010P002915
• Status: Completed
• Phase: N/A
• First received: July 11, 2011
• Last updated: April 24, 2014
• Start date: January 2011
• Est. completion date: July 2011

Study information

• Verified date: April 2014
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Description:

This study will attempt to answer the following questions:

1. 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)?

2. How can IT support sign-out that facilitates interdisciplinary communication and yet preserves user-specific content among different clinical personnel?

3. 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?

4. What will be the future needs of this tool so that it can fully access data from MetaVision once it is deployed?

5. 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?

6. 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:

1. Clinical and functional specifications for a new web-based sign-out tool

2. A prototype of the sign-out tool tested on 2 active clinical services, one each at MGH and BWH

3. A report of the impact of the tool on clinical care

4. Lessons learned regarding design and implementation that can be applied to more broad-based efforts

5. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 295
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Continuity of Patient Care
• Quality of Signout
• Workflow

Intervention

Other:
• Signout tool
Electronic signout tool

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Partners Siemens Research Council

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of required data elements present	The proportion of required data elements present in written/typed sign-outs during tool implementation.	8 months	No
Secondary	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.	8 months	No
Secondary	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.	8 months	No