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.
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
- Conditions the study is for
- Esophageal Diseases, Peptic Ulcer, Stomach Diseases
- 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.
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:
- Patient´s satisfaction.
- General practitioner´s satisfaction.
- 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.
- Conditions
- Esophageal Diseases, Peptic Ulcer, Stomach Diseases
- 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 group | Role | What they receive |
|---|---|---|
| Open access gastroscopy | Patients referred to open access gastroscopy Receives: Other: open access gastroscopy | |
| Conventional outpatient gastroscopy | Gastroscopy 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.
Patient´s satisfaction
Measured: Day of the Gastrocopy
Secondary outcomes (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.
- First posted16 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal DiseasesStudies 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
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Department of Health and Social Affairs
- Sponsor type
- Other government
- Investigators
- Gert Huppertz-Hauss, MD, Principal investigator, Telemark Hospital, Department of internal medicin, Skien, Norway
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drop in Gastroscopy - Experience After 9 Months
- ClinicalTrials.gov ID
- NCT00977678
- Acronym / sponsor ID
- STHF-1
- Conditions
- Esophageal Diseases, Peptic Ulcer, Stomach Diseases
- Keywords
- open access gastroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Norwegian Department of Health and Social AffairsOther government
- Study start
- Nov 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 Sep 2009 (estimated)
- 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 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:
- Patient´s satisfaction.
- General practitioner´s satisfaction.
- Acceptance by the staff of the 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open access gastroscopy | – | Other: open access gastroscopyPatients referred to open access gastroscopy |
| Conventional outpatient gastroscopy | – | Other: Gastroscopy by appointmentGastroscopy after preceding appointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Current patients referred to our outpatient gastroscopy clinic
Key inclusion criteria (1 listed)
- all patients from 18 years of age.
Key exclusion criteria (2 listed)
- age < 18,
- inability or unwillingness to cooperate.
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 |
|---|---|---|
| open access gastroscopyaccess to gastroscopy without preceding appointment | Other | Open access gastroscopy |
| Gastroscopy by appointmentGastroscopy after preceding appointment in a conventional outpatient clinic | Other | Conventional outpatient gastroscopy |
Primary outcome
Patient´s satisfaction
Time frame: Day of the Gastrocopy
1 secondary outcome
General practitioner´satisfaction
Time frame: One month after enrollment of patients
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 30 Dec 2009.
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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.
Gert Huppertz-Hauss, MD principal investigator
Telemark Hospital, Department of internal medicin, Skien, Norway
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 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.