Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507527
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-18
Brief Title:
Frailty in Outpatient Digestive Endoscopy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
ASSESSMENT OF THE ADEQUACY IN CARE OF THE FRAGILE PATIENT IN A DIGESTIVE ENDOSCOPY UNIT FRIEND Study FRailty In ENDoscopy Estudi FRIEND FRailty In ENDoscopy
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FRIEND
Brief Summary:
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
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
Detailed Description:
This is a prospective observational study
In all patients older than 70 years referred for an ambulatory endoscopy the presence of frailty and its degree will be assessed through validated questionnaires commonly used in the preparation of the patient for digestive endoscopy A nurse trained by the Geriatrics Service of our hospital carries out a telephone contact with the patient or the patients caregiver to fill out the questionnaires
The formation of subgroups of patients will be assessed for the statistical analysis in relation to the degree of frailty and the type of endoscopy upper or lower digestive endoscopy
A random sample of 1474 individuals is sufficient to estimate with 95 confidence and an accuracy of - 25 percentage units a prevalence of frailty in the study population that is expected to be around 40 Given that at this stage it is a cross-sectional study no follow-up losses are expected
Since the main aim of the study is cross-sectional it is necessary to estimate the prevalence of frailty and a 95 confidence interval calculated using an exact method Clopper-Pearson method
The analysis of the profitability of the indication and of the adverse effects as outcomes of interest in the achievement of the secondary objectives will be analyzed according to the degree of frailty main factor of the study Likewise the effect of potentially confounding variables will be studied on the degree of fragility and also on each of the outcomes taken into consideration Finally a multivariate analysis for each outcome will be used to evaluate the possible causal association with the degree of frailty adjusting in each analysis for potentially confounding variables
For the analyzes the statistical package STATA 151 and R will be used in the version that is updated at the time of the statistical analysis
Basic patient demographic data age sex will be collected The presence of multipathology will be assessed using the CIRSG-Charlson questionnaire Data related to the patients frailty will be collected using the CFS and FRAGIL-VIG questionnaires
Information about the endoscopic procedure will be collected with data recorded in the medical history The cleaning agent and the degree of compliance with the colon cleaning protocol diet fasting volume ingested fractionation of the cleaning agent will be noted in the clinical history as well as the incidents that occurred in relation to the preparation for endoscopy
In the endoscopic report data on the preparation of the colon and intra-trial complications will be recorded
Information on post-test complications will be collected with the data recorded in the clinical record Only relevant adverse effects that require medical attention will be recorded not considering minor adverse effects because they are not relevant to our study since they do not provide information that helps to improve the care of the fragile patient in the field of endoscopy
Frailty is defined as a CFS rating greater than 4 or a FRAGIL-VIG value greater than 0
Adequate preparation is defined as a Boston Cleansing Classification rating of 2 or 3 in each and every segment of the colon
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 cost-effectiveness calculation will be done by calculating the overall percentage of patients in which there are no situations that prevent an adequate diagnosis andor therapy and the causes of lack of cost-effectiveness will be calculated based on the assumptions explained in the textThe 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
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
In all patients older than 70 years referred for an ambulatory endoscopy the presence of frailty and its degree will be assessed through validated questionnaires commonly used in the preparation of the patient for digestive endoscopy A nurse trained by the Geriatrics Service of our hospital carries out a telephone contact with the patient or the patients caregiver to fill out the questionnaires
The formation of subgroups of patients will be assessed for the statistical analysis in relation to the degree of frailty and the type of endoscopy upper or lower digestive endoscopy
A random sample of 1474 individuals is sufficient to estimate with 95 confidence and an accuracy of - 25 percentage units a prevalence of frailty in the study population that is expected to be around 40 Given that at this stage it is a cross-sectional study no follow-up losses are expected
Since the main aim of the study is cross-sectional it is necessary to estimate the prevalence of frailty and a 95 confidence interval calculated using an exact method Clopper-Pearson method
The analysis of the profitability of the indication and of the adverse effects as outcomes of interest in the achievement of the secondary objectives will be analyzed according to the degree of frailty main factor of the study Likewise the effect of potentially confounding variables will be studied on the degree of fragility and also on each of the outcomes taken into consideration Finally a multivariate analysis for each outcome will be used to evaluate the possible causal association with the degree of frailty adjusting in each analysis for potentially confounding variables
For the analyzes the statistical package STATA 151 and R will be used in the version that is updated at the time of the statistical analysis
Basic patient demographic data age sex will be collected The presence of multipathology will be assessed using the CIRSG-Charlson questionnaire Data related to the patients frailty will be collected using the CFS and FRAGIL-VIG questionnaires
Information about the endoscopic procedure will be collected with data recorded in the medical history The cleaning agent and the degree of compliance with the colon cleaning protocol diet fasting volume ingested fractionation of the cleaning agent will be noted in the clinical history as well as the incidents that occurred in relation to the preparation for endoscopy
In the endoscopic report data on the preparation of the colon and intra-trial complications will be recorded
Information on post-test complications will be collected with the data recorded in the clinical record Only relevant adverse effects that require medical attention will be recorded not considering minor adverse effects because they are not relevant to our study since they do not provide information that helps to improve the care of the fragile patient in the field of endoscopy
Frailty is defined as a CFS rating greater than 4 or a FRAGIL-VIG value greater than 0
Adequate preparation is defined as a Boston Cleansing Classification rating of 2 or 3 in each and every segment of the colon
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 cost-effectiveness calculation will be done by calculating the overall percentage of patients in which there are no situations that prevent an adequate diagnosis andor therapy and the causes of lack of cost-effectiveness will be calculated based on the assumptions explained in the textThe 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None