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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01398761
Recruitment Status : Completed
First Posted : July 21, 2011
Last Update Posted : April 28, 2014
Partners Siemens Research Council
Information provided by (Responsible Party):
Jeffrey L. Schnipper, MD.,MPH., Brigham and Women's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Continuity of Patient Care Workflow Quality of Signout Other: Signout tool Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 295 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Development and Pilot Testing of a Web-Based, Multi-Disciplinary Sign-Out Tool to Improve Handoffs in Care
Study Start Date : January 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Arm Intervention/treatment
Experimental: Intervention
nurses, residents, PAs, and attendings from the two pilot services
Other: Signout tool
Electronic signout tool

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • All nurses, residents, PAs, and attendings on the two study services

Exclusion Criteria:

  • Clinical staff not on study services within study period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01398761

United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Partners Siemens Research Council
Principal Investigator: Jeffrey L Schnipper, MD, MPH Brigham and Women's Hospital

Responsible Party: Jeffrey L. Schnipper, MD.,MPH., Associate Professor of Medicine, Brigham and Women's Hospital Identifier: NCT01398761     History of Changes
Other Study ID Numbers: 2010P002915
First Posted: July 21, 2011    Key Record Dates
Last Update Posted: April 28, 2014
Last Verified: April 2014

Keywords provided by Jeffrey L. Schnipper, MD.,MPH., Brigham and Women's Hospital:
Continuity of patient care
Quality of signout
Web based
Multi disciplinary
Written signout
Information science