Diagnosis-Related GroupsNCT04726202
Impact of Semi-automated Proposal and Optimization of Diagnoses and Surgical Procedures for Precoding: a Randomized Controlled Trial
An observational study of Diagnosis-Related Groups and Healthcare Common Procedure Coding System, run by Thomas Steffen at 1 site in Switzerland.
Trial summary
The hypothesis of present study is that the daily monitoring and optimization of DRG coding is associated with higher reimbursement. Therefore, the primary objective is to determine if the daily monitoring and optimization of DRG coding of individual cases leads to better proceeds per day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diagnosis-Related Groups, Healthcare Common Procedure Coding System
- What is being tested?
- Standard procedure and precoding
- How many people
- 1,200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2019to 31 Jan 2020
- 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: patients undergoing inpatient surgery in the fields of General, Visceral, Endocrine or Transplantation Surgery
Who may be able to join
- patients undergoing surgery as inpatients (at least one night stay)
- treated at the Kantonsspital St. Gallen, St. Gallen site
Who cannot join
- surgery as outpatients
- surgery at the Rorschach and Flawil sites
- patients operated on by the Department of Surgery, but hospitalized at another department of the hospital
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Surgery, Cantonal Hospital of St. Gallen
Sankt Gallen, 9007
About this study
The hypothesis of present study is that the daily monitoring and optimization of DRG coding is associated with higher reimbursement. Therefore, the primary objective is to determine if the daily monitoring and optimization of DRG coding of individual cases leads to better proceeds per day.
- Being tested
- Standard procedure, precoding
- Keywords
- DRG, Diagnosis-Related Groups, ICD, reimbursement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard procedureOther
Coding of cases follows the standard procedures established at the hospital
precodingOther
Standard coding will be reviewed by dedicated physicians and corrected or extended if necessary.
Coding will compared to the written OP report for consistency. Dedicated physician visits patients daily (in addition to routine visits). Dedicated physicians review discharge report and will make changes and additions. DRG coding will be adapted to results from visits and discharge report.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | standard procedure of coding at hospital Receives: Other: Standard procedure | |
| Precoding arm | Coding of the standard procedure will be reviewed and corrected Receives: Other: precoding |
What is being measured
The primary outcome is the main question the study is designed to answer.
reimbursement per day at hospital
total reimbursement per arm divided by the total stay of the patients in the arm in days
Measured: 8 months
Secondary outcomes (5)
Length of hospital stay
length of hopital stay in full days including entry and discharge day
Measured: 8 months
Total reimbursement per case
reimbursement in Swiss Francs per case
Measured: 8 months
case mix index per case
Financial department will provide the cost weight/case mix index per case
Measured: 8 months
Severity of perioperative complications
complications during hospitalisation will be graded according to the Clavian-Dindo scale. In case of multiple complications the highest grade will be taken.
Measured: 8 months
readmission rate
Rate of case related readmissions
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Jun 2019
- Primary completion1 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diagnosis-Related GroupsStudies 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Steffen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Steffen, Cantonal Hospital of St. Gallen
- Investigators
- Thomas Steffen, MD, Principal investigator, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726202
- Sponsor's protocol ID
- Chir201902
- Status last verified
- Aug 2021
- First submitted
- 22 Jan 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fillit H, Geldmacher DS, Welter RT, Maslow K, Fraser M. Optimizing coding and reimbursement to improve management of Alzheimer's disease and related dementias. J Am Geriatr Soc. 2002 Nov;50(11):1871-8. doi: 10.1046/j.1532-5415.2002.50519.x.
PubMed 12410910Fetter RB, Freeman JL. Diagnosis related groups: product line management within hospitals. Acad Manage Rev. 1986 Jan;11(1):41-54.
PubMed 10311457Fetter RB. Hospital payment based on diagnosis-related groups. J Soc Health Syst. 1992;3(4):4-15.
PubMed 1288673Freeman JL, Fetter RB, Park H, Schneider KC, Lichtenstein JL, Hughes JS, Bauman WA, Duncan CC, Freeman DH Jr, Palmer GR. Diagnosis-related group refinement with diagnosis- and procedure-specific comorbidities and complications. Med Care. 1995 Aug;33(8):806-27. doi: 10.1097/00005650-199508000-00006.
PubMed 7637403Hughes JS, Lichtenstein J, Fetter RB. Procedure codes: potential modifiers of diagnosis-related groups. Health Care Financ Rev. 1990 Fall;12(1):39-46.
PubMed 10113461Geuss S, Jungmeister A, Baumgart A, Seelos R, Ockert S. [Prospective DRG coding : Improvement in cost-effectiveness and documentation quality of in-patient hospital care]. Chirurg. 2018 Feb;89(2):138-145. doi: 10.1007/s00104-017-0555-4. German.
PubMed 29188352Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
PubMed 19638912
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Semi-automated Proposal and Optimization of Diagnoses and Surgical Procedures for Precoding: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04726202
- Acronym / sponsor ID
- Chir201902
- Keywords
- DRG, Diagnosis-Related Groups, ICD, reimbursement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Thomas SteffenUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 27 Jan 2021 (actual)
- 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.
The hypothesis of present study is that the daily monitoring and optimization of DRG coding is associated with higher reimbursement. Therefore, the primary objective is to determine if the daily monitoring and optimization of DRG coding of individual cases leads to better proceeds per day.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | – | Other: Standard procedurestandard procedure of coding at hospital |
| Precoding arm | – | Other: precodingCoding of the standard procedure will be reviewed and corrected |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing inpatient surgery in the fields of General, Visceral, Endocrine or Transplantation Surgery
Key inclusion criteria (2 listed)
- patients undergoing surgery as inpatients (at least one night stay)
- treated at the Kantonsspital St. Gallen, St. Gallen site
Key exclusion criteria (3 listed)
- surgery as outpatients
- surgery at the Rorschach and Flawil sites
- patients operated on by the Department of Surgery, but hospitalized at another department of the hospital
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 |
|---|---|---|
| Standard procedureCoding of cases follows the standard procedures established at the hospital | Other | Control arm |
| precodingStandard coding will be reviewed by dedicated physicians and corrected or extended if necessary. Coding will compared to the written OP report for consistency. Dedicated physician visits patients daily (in addition to routine visits). Dedicated physicians review discharge report and will make changes and additions. DRG coding will be adapted to results from visits and discharge report. | Other | Precoding arm |
Primary outcome
reimbursement per day at hospital
Time frame: 8 months
total reimbursement per arm divided by the total stay of the patients in the arm in days
5 secondary outcomes
Length of hospital stay
Time frame: 8 months
Total reimbursement per case
Time frame: 8 months
case mix index per case
Time frame: 8 months
Severity of perioperative complications
Time frame: 8 months
readmission rate
Time frame: 8 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 4 Aug 2021.
- Background: PubMed 12410910Fillit H, Geldmacher DS, Welter RT, Maslow K, Fraser M. Optimizing coding and reimbursement to improve management of Alzheimer's disease and related dementias. J Am Geriatr Soc. 2002 Nov;50(11):1871-8. doi: 10.1046/j.1532-5415.2002.50519.x.
- Background: PubMed 10311457Fetter RB, Freeman JL. Diagnosis related groups: product line management within hospitals. Acad Manage Rev. 1986 Jan;11(1):41-54.
- Background: PubMed 1288673Fetter RB. Hospital payment based on diagnosis-related groups. J Soc Health Syst. 1992;3(4):4-15.
- Background: PubMed 7637403Freeman JL, Fetter RB, Park H, Schneider KC, Lichtenstein JL, Hughes JS, Bauman WA, Duncan CC, Freeman DH Jr, Palmer GR. Diagnosis-related group refinement with diagnosis- and procedure-specific comorbidities and complications. Med Care. 1995 Aug;33(8):806-27. doi: 10.1097/00005650-199508000-00006.
- Background: PubMed 10113461Hughes JS, Lichtenstein J, Fetter RB. Procedure codes: potential modifiers of diagnosis-related groups. Health Care Financ Rev. 1990 Fall;12(1):39-46.
- Background: PubMed 29188352Geuss S, Jungmeister A, Baumgart A, Seelos R, Ockert S. [Prospective DRG coding : Improvement in cost-effectiveness and documentation quality of in-patient hospital care]. Chirurg. 2018 Feb;89(2):138-145. doi: 10.1007/s00104-017-0555-4. German.
- Background: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Background: PubMed 19638912Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
- OnlineGrouperLink provided by the sponsor.
- Common Terminology Criteria for Adverse Events (CTCAE)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Thomas Steffen, MD principal investigator
Cantonal Hospital of St. Gallen
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 Diagnosis-Related Groups and Healthcare Common Procedure Coding System, run by Thomas Steffen at 1 site in Switzerland.
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 2 inclusion and 3 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 4 Aug 2021. 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 Switzerland. 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?
reimbursement per day at hospital (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04726202, which also lists 8 linked publications.
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 4 Aug 2021.