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Irritable Bowel SyndromeNCT05144594

Direct Medical Costs Associated With Negative Diagnosis of IBS.

An observational study of Irritable Bowel Syndrome, run by Region Örebro County.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to calculate the unnecessary costs that are associated with a negative IBS diagnosis. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Irritable Bowel Syndrome
How many people
3,000 participants
Where
No sites listed yet
Study dates
29 Nov 2021to 31 May 2025
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 to 65 years
  • All sexes
  • Adult, Older adult

Study population: Patients diagnosed with IBS within primary care of Region Örebro County 2013-2017.

Who may be able to join

  • All adult patients (both sexes) who were diagnosed with IBS according to ICD-10 within primary care of Region Örebro County 2013-2017.

Who cannot join

  • Patients < 18 years or > 65 years

Trial locations and contacts

No sites are listed yet.

About this study

Official title: Assessment of Direct Medical Costs Associated With Making a Negative Diagnosis of IBS.

The purpose of this study is to calculate the unnecessary costs that are associated with a negative IBS diagnosis.

Read the detailed description

In Örebro Region there are 29 public general health centers. Approximately 300.000 inhabitants are listed within these health centers. Approximately 150 doctors are currently working within the primary health care of Örebro Region. The electronic patient register in Örebro Region allows to search for the International Statistical Classification of Diseases (ICD-10) for IBS (K58.9 and K58.0) This allows retrospective research regarding diagnosis of IBS.

A study planned ahead of this study by the same research group will focus on adherence to guidelines of making a positive diagnosis of IBS. This data will be used for this study as well.

Data will be collected retrospectively over the period 2013-2017 using the the electronic patient register in Örebro Region. Patients diagnosed with IBS will be identified by ICD-code K.58. By evaluating their patient register it will be determined how the GP has made the IBS diagnosis. Patients will fall into three categories: those who received a positive IBS diagnosis using the Rome criteria, those who received a negative IBS diagnosis and those whose patient record is lacking sufficient information.

A detailed analysis of the collected data will focus on the proportion of patients who received a negative diagnosis. We will only include patients with age >40 years without "red flags", since in these patients additional diagnostics are seldom warranted and generally not useful. Red flags are, for example, blood in the stool, fever, anemia or involuntary weight loss. In patients over 40 years, certain additional diagnostics may be important. For example, changes in bowel habits may be caused by colorectal cancer and for this reason these patients are routinely referred for a colonoscopy according to the guidelines for the "standardized care chain".

For each patient, data regarding the used diagnostic tools will be collected and at the end the costs of these diagnostic tools will be calculated. If a patient is referred to a specialist, the costs for the associated diagnostics will be calculated as well.

The results of the diagnostic tests will be evaluated as well, in order to confirm that these tests were not indicated, as one may expect. If a patient was referred to a specialist, the costs for the associated diagnostics will be calculated as well. Diagnostic tools include gastroscopy, colonoscopy, abdominal ultrasound, vaginal ultrasound, abdominal x-ray and abdominal MRI. Laboratory testing includes liver tests, tests for lactose intolerance, stool samples, food allergy tests and autoimmune serology.

The two groups (positive vs negative diagnosis) will be compared regarding the costs of diagnostic tools and laboratory testing, in order to establish the total amount of costs that are associated with making a negative IBS diagnosis.

Descriptive statistical analysis of the economic costs for IBS patients receiving a positive diagnosis will be compared to those receiving a negative diagnosis. The total cost of all diagnostic procedures will be analyzed, as well as various cost components. A separate analysis will be performed to confirm the expected negative results of the additional diagnostic tests, associated with a negative IBS diagnosis.

Keywords
Irritable bowel syndrome, Rome IV, Functional gastrointestinal disorders
Medical subject headings
Irritable Bowel Syndrome, Gastrointestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05144594
Study groupRoleWhat they receive
Patients diagnosed with IBSPatients diagnosed with IBS within primary care in Region Örebro County between 2013-2017, identified by ICD-code K.58.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Direct medical costs of diagnostic tools associated with a negative diagnosis of IBS.

    Unnecessary costs of diagnostic tools, e.g. endoscopy and radiology in SEK that are associated with a negative IBS diagnosis

    Measured: 2013-2017

  2. Direct medical costs of laboratory tests associated with a negative diagnosis of IBS.

    Unnecessary costs of laboratory tests, e.g. liver tests, tests for lactose intolerance, stool samples, food allergy tests and autoimmune serology, in SEK that are associated with a negative IBS diagnosis

    Measured: 2013-2017

  3. Direct medical costs of referrals to specialists associated with a negative diagnosis of IBS.

    Unncessary costs of referrals to specialist care. If a patient was referred to a specialist, the costs for the associated diagnostics will be calculated as well.

    Measured: 2013-2017

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2021
  2. Study start29 Nov 2021 (estimated)
  3. Primary completion31 May 2024 (estimated)
  4. Study completion31 May 2025 (estimated)

Resources

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
Other
Time perspective
Retrospective
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05144594
Sponsor's protocol ID
277075
Status last verified
Nov 2021
First submitted
22 Nov 2021
Last updated
3 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Irritable Bowel Syndrome, run by Region Örebro County.

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: status not confirmed, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jussi Rauma, M.D. (+460702484167, jussi.rauma@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Direct medical costs of diagnostic tools associated with a negative diagnosis of IBS. (time frame: 2013-2017). The study lists 3 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 3 Dec 2021.

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