NCT00529854

Brief Summary

Accurate documentation in the patient medical record is critical to ensure proper diagnosis coding and subsequent hospital reimbursement. Multiple studies have demonstrated that clinicians often omit diagnoses which may result in insurance company denials and significant delays in payment. In addition, omitting diagnoses decreases the severity of patient illness which is often used as a risk adjustment tool to compare institution and physician outcomes. Medical informatics has been used to help improve accurate diagnosis documentation as well as improve billing efficiency. We plan to utilize a medical informatics program called SIC-IR (Surgical Intensive Care - Infection Registry) to improve documentation and attending billing efficiency within the surgical and trauma intensive care unit (STICU). We propose a six month study: a three month observational evaluation of current billing procedures followed by a three month prospective evaluation using a newly created SIC-IR billing module. The outcome measures will include the number of ICD-9 and CPT codes at discharge per patient, severity of patient illness based on documentation, STICU charges, number of insurance company denials, DRG relative weights, as well as a qualitative assessment of attending physician use of the electronic billing module. The observational and prospective patient populations will be compared for total patient-days in the STICU, ventilator-days, antibiotic-days, infectious complications per patient, and injury severity score (trauma patients only) to ensure the populations are similar and only the documentation and billing changes can account for our measured outcomes. We hypothesize that the SIC-IR billing module will increase the number of patient ICD-9 and CPT codes at discharge, increase severity of STICU patient illness via accurate documentation, increase total STICU charges, decrease insurance company denials, and be an efficient and well accepted electronic medical application.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
814

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2007

Completed
17 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

February 27, 2008

Status Verified

February 1, 2008

Enrollment Period

2 months

First QC Date

September 13, 2007

Last Update Submit

February 26, 2008

Conditions

Keywords

Intensive care unitmedical documentationmedical billing

Outcome Measures

Primary Outcomes (10)

  • Number of ICD-9 codes at discharge (per patient)

    6 months

  • Number of STICU specific ICD-9 codes at discharge (per patient)

    6 months

  • Number of CPT codes at discharge (per patient)

    6 months

  • Number of STICU specific CPT codes at discharge (per patient)

    6 months

  • Number of specific evaluation and management codes used (per patient)

    6 months

  • Total STICU charges at discharge (per patient)

    6 months

  • Number of denied insurance claims (per month)

    6 months

  • Estimated patient survival based on documentation (illness severity) (per patient)

    6 months

  • DGR relative weight at discharge (per patient)

    6 months

  • Qualitative assessment of attending approval of the SIC-IR module

    6 months

Study Arms (2)

1

Observational evaluation of current billing and documentation practices

2

Use of SIC-IR Billing Module

Other: SIC-IR Billing Module

Interventions

Medical informatic application designed to help with billing and documentation within the surgical and trauma intensive care unit

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Study Population

All surgical and trauma intensive care unit patients addmitted to our reional Level I trauma center

You may qualify if:

  • consecutive patients admitted to the surgical and trauma intensive care unit a a single level one trauma center care for by the surgical intensivist

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Study Officials

  • Joseph F Golob, MD

    MetroHealth Medical Center

    STUDY DIRECTOR
  • Jeffrey A Claridge, MD

    MetroHealth Medical Center

    PRINCIPAL INVESTIGATOR
  • Adam MA Fadlalla, PhD

    Cleveland State University

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2007

First Posted

September 14, 2007

Study Start

October 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

February 27, 2008

Record last verified: 2008-02

Locations