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CompletedNCT01855646Updated Nov 25, 2016

Improved Patient Handoffs to Prevent Sentinel Events

An interventional study of Structured Sign Out Form in Health Care Quality and Access and Evaluation, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-25.

Sponsored by Duke University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
4,344
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Health Care Quality
  • Access and Evaluation
03

In context

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Patients presenting for consults, rapid responses handled by surgical services and rapid responses as reason for transfer from Durham Rehabilitation Institute.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4,344 participants (actual)

Interventions

  • OtherStructured Sign Out Form
06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Physician attitudes towards sign-out process pre and post intervention

    Time frame: End of Study, Approximately 6 months

Other outcomes

  1. Compliance rate monthly with sign-out sheet completion; will use simple descriptive statistics

    Time frame: End of Study, Approximately 6 months

07

Study locations

1 site
  • Durham Regional Hospital
    Durham, North Carolina 27704, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01855646
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
May 16, 2013
Primary completion
Jan 2014
Completion
Jan 2014
Last update
Nov 25, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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