Primary:To evaluate the superiority of a patient-centred, education based, clinical strategy to reduce the volume of endoscopies for dyspepsia in patients over 18 years of age without alarm symptoms, referred for OGD through open-access endoscopy…
ID
Source
Brief title
Condition
- Gastrointestinal disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the difference between the two study arms in
proportion of patients receiving direct OGD after the initial visit to the
endoscopy clinic, out of the total number of patients referred for open-access
endoscopy. OGDs performed at any time in the study after initial successful
intervention , will still be considered successful intervention
(intention-to-treat).
Secondary outcome
The difference between the change scores of the two study arms on the following
three parameters: Health-related anxiety, severity of upper GI symptoms and
quality of life. These will be assessed using a questionnaire at the initial
visit to the endoscopy clinic and after 8 weeks
The proportion of patients that received the e-learning and nevertheless
received OGD in the 8 weeks after the initial visit, out of the total number of
patients receiving the e-learning
Educational value of the e-learning. This will be tested through a knowledge
test integrated in the e-learning and administered before and after the
e-learning
Background summary
Upper gastrointestinal (GI) symptoms, such as dyspepsia without alarm symptoms,
are highly prevalent in the general population. Lifestyle modifications and
medication can reduce symptoms in most patients. Guidelines state that
oesophagogastroduodenoscopy (OGD) is only indicated in a selected high risk
group. In spite of these guidelines, OGD referrals for dyspepsia without alarm
symptoms are still substantial, subjecting patients to unnecessary risks and
causing a burden on healthcare costs. Therefore a strategy is needed to reduce
the volume of OGDs in dyspepsia without alarm symptoms.
Study objective
Primary:
To evaluate the superiority of a patient-centred, education based, clinical
strategy to reduce the volume of endoscopies for dyspepsia in patients over 18
years of age without alarm symptoms, referred for OGD through open-access
endoscopy compared to usual care
Secondary:
1. To determine whether a reserved policy on OGDs combined with a strategy to
increase patient knowledge and self-care is non-inferior to early OGD in terms
of health-related anxiety, severity of upper GI symptoms and quality of life
2. To evaluate the percentage of patients receiving OGD in spite of the
education, in the 12 weeks after the initial visit.
3. To determine whether patients will be able to answer questions about the
recognition and management of dyspeptic symptoms more correctly after
completion of the e-learning, compared to before the e-learning.the educational
value of the e-learning
Study design
General
The proposed study is a multicentre, randomised (see chapter 5.2), controlled
superiority trial, consisting of two parallel groups and a primary endpoint of
the proportion of patients receiving OGD. The two groups will comprise an
intervention arm and control arm. Superiority of the primary endpoint will be
tested.
Study setting
Four hospitals in the Netherlands will be included; the Canisius-Wilhelmina
Ziekenhuis (Nijmegen), VieCuri Medisch Centrum (Venlo), Jeroen Bosch Ziekenhuis
(JBZ) and Ziekenhuis Gelderse Vallei (Ede), all with open-access endoscopy
option available. The population referred to these hospitals is representative
for the general Dutch population in terms of employment rate and marital
status, have a slightly lower perception of health, percentage of nicotine
abuse and income and slightly higher percentage of alcohol intake, obesity and
contact with GP(14)
Baseline measurement
A baseline measurement will be done for each participating centre over the 12
months prior to study commencement. The number of OGD referrals and procedures
will be determined through a retrospective assessment.
Intervention
Patients in the intervention arm will receive oral and written information
about the study. They will be informed about the limited asset of OGD in
dyspepsia and the possibilities of lifestyle modifications. They will then be
offered a web-based e-learning module instead of OGD. The e-learning module
will contain educational material and questionnaires. Questionnaire data will
be extracted from the e-learning module. For more detailed information see
chapter on *investigational product* (Chapter 5). Patients will be advised to
return to the GP if symptoms persist and the GP will receive advice about
management and treatment optimalisation of each individual patient.
Control
Patients in the control arm will receive oral and written information about the
study and *care as usual*, i.e. OGD. They will also receive the same
questionnaires as the intervention group.
Post-intervention and control measurements
Post-intervention, the difference (%) between the number of patients referred
for OGD and those that received OGD in both groups will be determined.
Follow-up
Eight weeks after intervention we will administer questionnaires. Literature
suggests that antisecretory drugs should be tried for 1-2 months(15) and a
delay in diagnosis when no alarm symptoms exist, has been shown not to effect
outcome(9) justifying an eight week follow-up.
After either intervention or OGD, patients will directly return to the
standard of care of the general practitioner.
Intervention
Patients will be offered e-learning instead of endoscopy. The e-learning will
contain educational material and questionnaires. Questionnaire data will be
extracted from the e-learning.
Study burden and risks
Benefits of specific education of patients on upper GI symptoms and treatment
are possibly a reduced amount of inappropriate OGDs. This consequently results
in reduced exposure to the risk of serious adverse events and reduced costs.
The potential harm of a reserved policy on upper GI endoscopies is a possible
persisting feeling of fear or uncertainness which might otherwise have been
taken away by a OGD. This could result in more frequent visits to the primary
healthcare centre. It has however been stated before that OGD does not reassure
patients long term. Also, however inappropriate, incidentally a clinically
significant endoscopic finding can be done during such endoscopies. These
incidental findings might not be found when OGD is averted. In addition,
completing the e-learning and questionnaires will consume time of patients.
Oudlaan 4
Utrecht 3515GA
NL
Oudlaan 4
Utrecht 3515GA
NL
Listed location countries
Age
Inclusion criteria
Patients are eligible for inclusion when they meet the following criteria at randomisation:
- Age *18 years
- Reported upper gastrointestinal symptoms in the past 6 months
- Referred for OGD
- Guidelines for referral not met
- Signed informed consent
Exclusion criteria
Patient who fulfil the criteria for OGD acoording to the Dutch college of General Practitioners (NHG) guidelines ('Maagklachten') and NICE guidelines on *Upper gastrointestinal tract cancers*.;- Family history of gastric- or oesophageal cancer (at least one first or second grade family member with a malignancy at the age of 50 or younger)
- Diseases or circumstances that will most likely impair understanding of the e-learning
- Any argument provided by a patient*s own GP stating the urge of OGD, notwithstanding the guidelines
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60056.091.17 |