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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00977678
Other study ID # STHF-1
Secondary ID
Status Completed
Phase N/A
First received May 15, 2009
Last updated December 29, 2009
Start date November 2009
Est. completion date December 2009

Study information

Verified date December 2009
Source Norwegian Department of Health and Social Affairs
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Social Science Data Services
Study type Observational

Clinical 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.

The investigators wish to evaluate:

1. Patient´s satisfaction.

2. General practitioner´s satisfaction.

3. Acceptance by the staff of the clinic.


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.


Recruitment information / eligibility

Status Completed
Enrollment 213
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- all patients from 18 years of age.

Exclusion Criteria:

- age < 18,

- inability or unwillingness to cooperate.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
open access gastroscopy
access to gastroscopy without preceding appointment
Gastroscopy by appointment
Gastroscopy after preceding appointment in a conventional outpatient clinic

Locations

Country Name City State
Norway Department of Gastroenterology Skien Telemark

Sponsors (1)

Lead Sponsor Collaborator
Norwegian Department of Health and Social Affairs

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient´s satisfaction Day of the Gastrocopy No
Secondary General practitioner´satisfaction One month after enrollment of patients No
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