Drop in Gastroscopy - Experience After 9 Months

This study has been completed.
Sponsor:
Information provided by:
Norwegian Department of Health and Social Affairs
ClinicalTrials.gov Identifier:
NCT00977678
First received: May 15, 2009
Last updated: December 29, 2009
Last verified: December 2009
  Purpose

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.

Condition Intervention
Esophageal Diseases
Peptic Ulcer
Stomach Diseases
Other: open access gastroscopy
Other: Gastroscopy by appointment

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Drop in Gastroscopy - Experience After 9 Months

Resource links provided by NLM:


Further study details as provided by Norwegian Department of Health and Social Affairs:

Primary Outcome Measures:
  • Patient´s satisfaction [ Time Frame: Day of the Gastrocopy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • General practitioner´satisfaction [ Time Frame: One month after enrollment of patients ] [ Designated as safety issue: No ]

Enrollment: 213
Study Start Date: November 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Open access gastroscopy
Patients referred to open access gastroscopy
Other: open access gastroscopy
access to gastroscopy without preceding appointment
Conventional outpatient gastroscopy
Gastroscopy after preceding appointment
Other: Gastroscopy by appointment
Gastroscopy after preceding appointment in a conventional outpatient clinic

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Current patients referred to our outpatient gastroscopy clinic

Criteria

Inclusion Criteria:

  • all patients from 18 years of age.

Exclusion Criteria:

  • age < 18,
  • inability or unwillingness to cooperate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00977678

Locations
Norway
Department of Gastroenterology
Skien, Telemark, Norway, 3728
Sponsors and Collaborators
Norwegian Department of Health and Social Affairs
Investigators
Principal Investigator: Gert Huppertz-Hauss, MD Telemark Hospital, Department of internal medicin, Skien, Norway
  More Information

No publications provided

Responsible Party: Gert Huppertz-Hauss, Telemark Hospital, N-3710 Skien, Norway
ClinicalTrials.gov Identifier: NCT00977678     History of Changes
Other Study ID Numbers: STHF-1
Study First Received: May 15, 2009
Last Updated: December 29, 2009
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian Department of Health and Social Affairs:
open access gastroscopy

Additional relevant MeSH terms:
Esophageal Diseases
Peptic Ulcer
Stomach Diseases
Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Duodenal Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014