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Esophageal DiseasesNCT00977678

Drop in Gastroscopy - Experience After 9 Months

An observational study of Esophageal Diseases and Peptic Ulcer, run by Norwegian Department of Health and Social Affairs at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The capacity for endoscopical procedures in the Norwegian health system is low in comparison to demands from patients and family practitioners. The studies aim is to evaluate the acceptance of a new concept: an open access gastroscopy clinic where patients can attend without a preceding appointment. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
open access gastroscopy and Gastroscopy by appointment
How many people
213 participants
Where
1 siteNorway
Study dates
Nov 2009to Dec 2009
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: Current patients referred to our outpatient gastroscopy clinic

Who may be able to join

  • all patients from 18 years of age.

Who cannot join

  • age < 18,
  • inability or unwillingness to cooperate.

Trial locations and contacts

1 site in 1 country.

Norway1 site
  • Department of Gastroenterology

    Skien, Telemark, 3728

Other trials in Norway

About this study

The capacity for endoscopical procedures in the Norwegian health system is low in comparison to demands from patients and family practitioners.

The studies aim is to evaluate the acceptance of a new concept: an open access gastroscopy clinic where patients can attend without a preceding appointment.

The investigators wish to evaluate:

  1. Patient´s satisfaction.
  2. General practitioner´s satisfaction.
  3. Acceptance by the staff of the clinic.
Read the detailed description

The fact that access to specialized norwegian health care is characterized by a mismatch between system´s capacity and patient´s and refering physician´s demands, leads to delay of diagnostic investigations such as for example gastroscopies. Patients referred to gastroscopies have to wait 4 to 12 weeks to get an appointment. Consequence might be a delay in diagnosing of significant diseases such as ulcers or even malignancies. In addition the general practitioner is frequently forced to start a therapy by suspicion, and the patient has in numerable cases to stay off work.

In September 2008, the investigators started an open-access gastroscopy outpatient clinic, which allows the family practitioners in a defined area of the Telemark county to refer their patients to a gastroscopy without a preceding appointment. Patients from the other parts of the county and those, who need special service as i.e. interpreter, endocarditis prophylaxis etc. are referred conventionally and need an appointment.

Aim of the study is to evaluate the acceptance of both forms of outpatient clinics by both patients and general practitioners. In addition to that, the investigators will evaluate the acceptance of the open access clinic by the staff. Of special concern is the fear, that easier access might lead to a number of unnecessary procedures.

All patients from open access clinic and from the conventional clinic are asked to fill in a questionaire without any kind of personal identifying data such as name, age, date of the procedure etc., but with questions about their satisfaction with the procedure, the time from their first contact with their family practitioner to the procedure, the information prior and after the procedure. They will be asked if they did consume drugs against "ulcer-disease" or not.

In addition the referring practitioners are asked to fill in a questionnaire about their acceptance of the open access clinic, and to give the investigators some ideas about advantages and disadvantages from their point of view.

The staff is asked to give their experience especially according to the not calculable number of patients that attend to the clinic each day.

If the present study shows high acceptance of the open-access-offer by patients and health workers, the plan is to extend it to other patient groups and to perform studies to investigate the effects on the grade of diseases at the time of diagnosis and possible consequences for treatment and health economy.

Being tested
open access gastroscopy, Gastroscopy by appointment
Keywords
open access gastroscopy
Medical subject headings
Esophageal Diseases, Peptic Ulcer, Stomach Diseases

What participants receive

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

  • open access gastroscopyOther

    access to gastroscopy without preceding appointment

  • Gastroscopy by appointmentOther

    Gastroscopy after preceding appointment in a conventional outpatient clinic

Study groups in NCT00977678
Study groupRoleWhat they receive
Open access gastroscopyPatients referred to open access gastroscopy
Receives: Other: open access gastroscopy
Conventional outpatient gastroscopyGastroscopy after preceding appointment
Receives: Other: Gastroscopy by appointment

What is being measured

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

  1. Patient´s satisfaction

    Measured: Day of the Gastrocopy

Secondary outcomes (1)
  1. General practitioner´satisfaction

    Measured: One month after enrollment of patients

Timeline

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

  1. First posted16 Sep 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionDec 2009
  4. Study completionDec 2009

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
Case-control
Time perspective
Prospective
Enrolment
213 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00977678
Sponsor's protocol ID
STHF-1
Status last verified
Dec 2009
First submitted
15 May 2009
Last updated
30 Dec 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Esophageal Diseases and Peptic Ulcer, run by Norwegian Department of Health and Social Affairs at 1 site in Norway.

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 2 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 30 Dec 2009. 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 Norway. 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?

Patient´s satisfaction (time frame: Day of the Gastrocopy). 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 30 Dec 2009.

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