Frailty in Outpatient Digestive Endoscopy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age70-100
SponsorParc de Salut Mar
About this trial
The increase in our society of the proportion of frail people who suffer from disability and dependency forces us to detect modifiable factors and therefore subject to intervention that can adapt health care for frail patients in order to increase the effectiveness and safety of medical treatments and procedures.
A geriatric assessment should be performed on all patients likely to present frailty prior to a digestive endoscopy to assess the risk-benefit of the indication and to improve patient preparation by avoiding adverse effects of endoscopic examinations, increasing the safety and profitability of the tests There are no data in our medium on the prevalence of frailty in patients referred for endoscopy, nor on the incidence in these patients of adverse effects, inadequate preparations, or incomplete examinations, so a frailty study is needed to elaborate multidisciplinary protocols that improve circuits and care in these patients and prevent complications.
The questions we want to try to answer are:
* Prevalence and severity of fragility in digestive endoscopy. * Specific problems related to fragility in digestive endoscopy, mainly the profitability of the examination and the incidence of adverse effects, in order to create protocols for improving care in this group of patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
It will include all patients over 70 years of age who are indicated to undergo an ambulatory upper or lower endoscopy.
Disqualifiers
Age below 70 years
Non-ambulatory endoscopies
Assessment of test contraindications by the endoscopist
Non-acceptance to enter the study
Trial population
Outpatients may be referred from hospital consultations or from out-of-hospital medical centers. Age is the inclusion criterion so that frailty can be assessed in patients over 70 years of age, who are the patients with the highest risk of presenting a frailty condition.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Collection of variables
Other interventionThis is an observational study, so no interventions that are not routine clinical practice are performed. It is only about collecting information on variables that are already collected in normal clinical practice.
Treatment groups
1,474 Participants
are divided into 1 treatment groupGroup A: Outpatients over 70 years of age referred to the Digestive Endoscopy Unit1 intervention
Trial outcomes
Primary outcomes
1
Prevalence of frailty
Valuated frailty questionnaires (CFS and FRAGIL-VIG). Frailty is defined as a CFS rating greater than 4 or a FRAGIL-VIG value greater than 0. The degree of frailty is determined by FRAGIL-VIG score. The frailty questionnaires are completed during nurse telephone contact with the patient, prior to the digestive endoscopy.
Time frame
At the moment of telephone contact with the patientSecondary outcomes
1
Profitability of the endoscopy indication.
The endoscopy indication is defined as unprofitable in the following cases: * The patient does not show up or reschedules the examination * The patient appears but it is not possible to perform the examination due to decompensation of the underlying pathology or for not having been able to comply with the test preparation protocols. * The patient appears and the endoscopic examination is carried out, but it is not possible to give an adequate diagnosis or to carry out a therapeutic under safe conditions. The profitability calculation will be done by calculating the overall percentage of patients in which there are no situations that prevent a diagnosis and/or adequate therapy
Time frame
At the moment of endoscopy.2
Cost of the endoscopy indication
The calculation of the cost of the endoscopy indication is closely related to the concept of profitability. All cases with a lack of profitability conceptually maintain the indication of the test and therefore need repetition of their request, given that the diagnostic-therapeutic objective of the initial indication has not been achieved. The cost of the hypothetical repetition of these scans will be calculated based on the prices established for each type of endoscopy and a cost comparison will be made between the different degrees of fragility.
Time frame
At the moment of endoscopy3
Incidence of relevant complications during the endoscopy process.
A relevant adverse effect is defined in the following cases: * Decompensation of underlying pathology that requires hospital care * Complications related to sedation * Post-colonoscopy bleeding * Post-colonoscopy perforation The patient's medical history will be reviewed 30 days after the endoscopy to collect data on possible relevant complications.
Time frame
30 days after digestive endoscopy.4
Clinical impact of the endoscopy indication
The clinical impact will be measured based on whether the endoscopy performed leads to: * Absence of information in relation to the medical process investigated * A clinical diagnosis in relation to the medical process investigated * A clinical diagnosis not related to the medical process investigated * A therapeutic intervention After the clinical evaluation and medical decision on the result of the endoscopy by the requesting doctor or the endoscopist
Time frame
Up to 2 months after endoscopySponsors and contacts
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Source ClinicalTrials.gov