Medical Record DocumenationSIC-IRNCT00529854
SIC-IR Billing and Documentation
An observational study of Medical Record Documenation and Surgical and Trauma Intensive Care Unit Billing, run by MetroHealth Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medical Record Documenation, Surgical and Trauma Intensive Care Unit Billing
- What is being tested?
- SIC-IR Billing Module
- How many people
- 814 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All surgical and trauma intensive care unit patients addmitted to our reional Level I trauma center
Who may be able to join
- consecutive patients admitted to the surgical and trauma intensive care unit a a single level one trauma center care for by the surgical intensivist
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical and Trauma Intensive Care Unit Documentation and Billing Improvements With Medical Informatics
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.
Read the detailed description
- An observational evaluation will be performed for all STICU patients over a three month time period.
- Data collected will be the outcome measures listed above (Number of ICD-9 codes at discharge, number of CPT codes at discharge, ext)
- In addition the total number of STICU patient-days, ventilator-days, central line-days, confirmed infectious complications, injury severity scores for trauma patients, and antibiotic-days will be collected over the three month period. This will serve as a way to ensure the observational and prospective populations are not different, and only the documentation and billing methods changed.
- The SIC-IR billing module will be released on October 1st, 2007 after attending physician training on its use.
- A prospective evaluation will be performed for all STICU patients over a three month time period
- Data collected will be the outcome measures listed above (Number of ICD-9 codes at discharge, number of CPT codes at discharge, ext)
- In addition the total number of STICU patient-days, ventilator-days, central line-days, confirmed infectious complications, injury severity scores for trauma patients, and antibiotic-days will be collected over the three month period. This will serve as a way to ensure the observational and prospective populations are not different, and only the documentation and billing methods changed.
- After the 3 month prospective evaluation, the attending physicians will be given a survey to document their acceptance or rejection of the billing module.
- The observational and prospective documentation and billing data will be compared.
- Being tested
- SIC-IR Billing Module
- Keywords
- Intensive care unit, medical documentation, medical billing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIC-IR Billing ModuleOther
Medical informatic application designed to help with billing and documentation within the surgical and trauma intensive care unit
| Study group | Role | What they receive |
|---|---|---|
| 1 | Observational evaluation of current billing and documentation practices | |
| 2 | Use of SIC-IR Billing Module Receives: Other: SIC-IR Billing Module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ICD-9 codes at discharge (per patient)
Measured: 6 months
Number of STICU specific ICD-9 codes at discharge (per patient)
Measured: 6 months
Number of CPT codes at discharge (per patient)
Measured: 6 months
Number of STICU specific CPT codes at discharge (per patient)
Measured: 6 months
Number of specific evaluation and management codes used (per patient)
Measured: 6 months
Total STICU charges at discharge (per patient)
Measured: 6 months
Number of denied insurance claims (per month)
Measured: 6 months
Estimated patient survival based on documentation (illness severity) (per patient)
Measured: 6 months
DGR relative weight at discharge (per patient)
Measured: 6 months
Qualitative assessment of attending approval of the SIC-IR module
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Record DocumenationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 814 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Joseph F Golob, MD, Study director, MetroHealth Medical CenterJeffrey A Claridge, MD, Principal investigator, MetroHealth Medical CenterAdam MA Fadlalla, PhD, Study director, Cleveland State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529854
- Sponsor's protocol ID
- IRB07-00922
- Acronym
- SIC-IR
- Status last verified
- Feb 2008
- First submitted
- 13 Sep 2007
- Last updated
- 27 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical and Trauma Intensive Care Unit Documentation and Billing Improvements With Medical Informatics
- ClinicalTrials.gov ID
- NCT00529854
- Acronym / sponsor ID
- SIC-IR / IRB07-00922
- Keywords
- Intensive care unit, medical documentation, medical billing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 814 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 14 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- An observational evaluation will be performed for all STICU patients over a three month time period.
- Data collected will be the outcome measures listed above (Number of ICD-9 codes at discharge, number of CPT codes at discharge, ext)
- In addition the total number of STICU patient-days, ventilator-days, central line-days, confirmed infectious complications, injury severity scores for trauma patients, and antibiotic-days will be collected over the three month period. This will serve as a way to ensure the observational and prospective populations are not different, and only the documentation and billing methods changed.
- The SIC-IR billing module will be released on October 1st, 2007 after attending physician training on its use.
- A prospective evaluation will be performed for all STICU patients over a three month time period
- Data collected will be the outcome measures listed above (Number of ICD-9 codes at discharge, number of CPT codes at discharge, ext)
- In addition the total number of STICU patient-days, ventilator-days, central line-days, confirmed infectious complications, injury severity scores for trauma patients, and antibiotic-days will be collected over the three month period. This will serve as a way to ensure the observational and prospective populations are not different, and only the documentation and billing methods changed.
- After the 3 month prospective evaluation, the attending physicians will be given a survey to document their acceptance or rejection of the billing module.
- The observational and prospective documentation and billing data will be compared.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Observational evaluation of current billing and documentation practices |
| 2 | – | Other: SIC-IR Billing ModuleUse of SIC-IR Billing Module |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All surgical and trauma intensive care unit patients addmitted to our reional Level I trauma center
Key inclusion criteria (1 listed)
- consecutive patients admitted to the surgical and trauma intensive care unit a a single level one trauma center care for by the surgical intensivist
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIC-IR Billing ModuleMedical informatic application designed to help with billing and documentation within the surgical and trauma intensive care unit | Other | 2 |
Primary outcome
Number of ICD-9 codes at discharge (per patient)
Time frame: 6 months
Number of STICU specific ICD-9 codes at discharge (per patient)
Time frame: 6 months
Number of CPT codes at discharge (per patient)
Time frame: 6 months
Number of STICU specific CPT codes at discharge (per patient)
Time frame: 6 months
Number of specific evaluation and management codes used (per patient)
Time frame: 6 months
Total STICU charges at discharge (per patient)
Time frame: 6 months
Number of denied insurance claims (per month)
Time frame: 6 months
Estimated patient survival based on documentation (illness severity) (per patient)
Time frame: 6 months
DGR relative weight at discharge (per patient)
Time frame: 6 months
Qualitative assessment of attending approval of the SIC-IR module
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph F Golob, MD study director
MetroHealth Medical Center
Jeffrey A Claridge, MD principal investigator
MetroHealth Medical Center
Adam MA Fadlalla, PhD study director
Cleveland State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medical Record Documenation and Surgical and Trauma Intensive Care Unit Billing, run by MetroHealth Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ICD-9 codes at discharge (per patient) (time frame: 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2008.