Global Approach to Faint and Falls (F2)

Guideline-based Global Approach to the Management of Faints and Falls in a Dedicated Outpatient Facility

Syncope is the most frequent cause of transient loss of consciousness. Falls are very common in older people. If the falls are unexplained and not accidental, it is likely that the patient had a syncope event and showed a lack of awareness for loss of consciousness. The management of unexplained falls is the same as that of syncope. There is a gap between the best available scientific evidence provided by the guidelines and the need to disseminate these concepts in clinical practice. The absence of a systematic comprehensive approach to fainting and falls results in higher health and social costs, unnecessary hospitalizations and diagnostic procedures, prolonged hospital stays, lower diagnostic rates, and higher rates of misdiagnosis and symptomatic recurrence.

Aim of the study The aim of the study is to assess the efficacy (adherence) of a diagnostic protocol and the costs of a comprehensive guideline-based approach to the management of fainting and falls in a population of consecutive patients referred to a dedicated multidisciplinary outpatient facility.

Primary endpoint:

1. Prevalence rate of patients with unexplained fall undergoing diagnostic investigations for syncope among those initially subjected to a diagnostic evaluation for falls.

Secondary endpoints:

1. Comparison between patients initially assigned to syncope and those assigned to unexplained fall in terms of diagnostic tests and final diagnosis.
2. Comparison between patients initially assigned to syncope and those assigned to unexplained fall in terms of adherence to guideline recommendations.
3. Analysis of costs per patient of fall and syncope protocols
4. All previous analyses will be performed according to the following age groups: ≥75, 74-65 and 64-40 years.

Inclusion criteria

1. Consecutive patients >40 years of age, belonging to the Cwithin Fainting and Falls for the evaluation of an episode of syncope or fall.
2. Fragile patients at risk of falling.

Exclusion criteria:

1. Patients aged <40 years
2. Patients with dental falls
3. Patients with a known diagnosis of syncope
4. Patients in whom syncope and fall are secondary symptoms of severe underlying comorbidities

Study Overview

• Status: Recruiting
• Conditions: Syncope; Fall
• Intervention / Treatment: Diagnostic test: Diagnostic pathway

Detailed Description

1. Background. Syncope is the most frequent cause of transient loss of consciousness. Falls are very common in older people. If the falls are unexplained and not accidental, it is likely that the patient had a syncope event and showed a lack of awareness for loss of consciousness. The management of unexplained falls is the same as that of syncope. There is a gap between the best available scientific evidence provided by the guidelines and the need to disseminate these concepts in clinical practice. The absence of a systematic comprehensive approach to fainting and falls results in higher health and social costs, unnecessary hospitalizations and diagnostic procedures, prolonged hospital stays, lower diagnostic rates, and higher rates of misdiagnosis and symptomatic recurrence.

2. Aims of the study.

   To assess the effectiveness (adherence) of a patient flow pathway and cost of a guideline-based global approach to the management of faints and falls in patients referred to dedicated multidisciplinary outpatient facilities. We will considerer the following endpoints:

   Primary-endpoint:

   I. Point and interval prevalence estimation of patients with unexplained falls among those who underwent fall diagnostic assessment at initial presentation and then moved to faint pathway for prosecution of diagnostic assessment and its determinants.

   Secondary endpoints:

   I. Point and interval estimate of the agree proportion between initial presentation and final diagnosis in patients initially assigned to faint and those with unexplained falls.

   II. Descriptive comparison between patients initially assigned to faint and those with unexplained falls in terms of diagnostic assessment and adherence rate to the recommendations of the guidelines

   III. Descriptive cost analysis of the faint and fall protocol (costs of investigations per patient).

   Moreover, all previous analysis will be performed also for predefined age subgroups (≥75, 74-65 and 64-40 years).

3. Study design Prospective observational study

Inclusion criteria

- Consecutive patients aged ≥40 years referred to the Faint & Fall Clinics for assessment of an episode of faint or fall. The patients will be recruited from the second half of 2020 and the recruitment will continue until to the achievement of the sample size

Exclusion criteria:

• Patients with age <40 years
• Patients with incidental fall
• Patients with an established diagnosis of syncope
• Patients in whom syncope and fall are secondary symptoms of severe underlying comorbidities (e.g: acute myocardial infarction, pulmonary embolism, acute haemorrage)

Patients' flow Each included patient will undergo to the faint and fall protocol, to assess the effectiveness of a patients' flow pathways (shown in the figure 1) developed in accordance with the most recent guidelines on syncope of the European Society of cardiology (1) and of guidelines on falls of the American and British Geriatrics Societies (2). The detailed flow pathway is described in the Appendix.

• Study Type: Observational
• Enrollment (Anticipated): 340

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 16149
      • Recruiting
      • IRCCS Istituto Auxologico Italiano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with faint or fall referred to a Syncope Unit for diagnosis and therapy

Description

Inclusion Criteria:

• Consecutive patients aged ≥40 years referred to the Faint & Fall Clinics for assessment of an episode of faint or fall.

Exclusion Criteria:

• Patients with age <40 years
• Patients with incidental fall
• Patients with an established diagnosis of syncope
• Patients in whom syncope and fall are secondary symptoms of severe underlying comorbidities (e.g: acute myocardial infarction, pulmonary embolism, acute haemorrage)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Syncope and fall; Consecutive patients aged ≥40 years referred to the Faint & Fall Clinics for assessment of an episode of faint or fall.	Diagnostic test: Diagnostic pathway; Each included patient will undergo to the faint and fall protocol, to assess the effectiveness of a patients' flow pathways developed in accordance with the most recent guidelines on syncope of the European Society of cardiology and of guidelines on falls of the American and British Geriatrics Societies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unexplained falls	Point and interval prevalence estimation of patients with unexplained falls, among those who underwent fall diagnostic assessment at initial presentation and then moved to faint pathway for prosecution of diagnostic assessment and its determinants.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Final diagnosis	Point and interval estimate of the agree proportion between initial presentation and final diagnosis in patients initially assigned to faint and those with unexplained falls.	1 year
Comparison	Descriptive comparison between patients initially assigned to faint and those with unexplained falls in terms of diagnostic assessment and adherence rate to the recommendations of the guidelines	1 year
Costs	Descriptive cost analysis of the faint and fall protocol (costs of investigations per patient).	1 year

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano
• Investigators: Principal Investigator: Michele Brignole, Istituto Auxologico Italiano

Publications and helpful links

General Publications

• Panel on Prevention of Falls in Older Persons, American Geriatrics Society and British Geriatrics Society. Summary of the Updated American Geriatrics Society/British Geriatrics Society clinical practice guideline for prevention of falls in older persons. J Am Geriatr Soc. 2011 Jan;59(1):148-57. doi: 10.1111/j.1532-5415.2010.03234.x.
• Brignole M, Moya A, de Lange FJ, Deharo JC, Elliott PM, Fanciulli A, Fedorowski A, Furlan R, Kenny RA, Martin A, Probst V, Reed MJ, Rice CP, Sutton R, Ungar A, van Dijk JG; ESC Scientific Document Group. 2018 ESC Guidelines for the diagnosis and management of syncope. Eur Heart J. 2018 Jun 1;39(21):1883-1948. doi: 10.1093/eurheartj/ehy037. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Anticipated): December 31, 2026
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Treatment; Diagnosis; Syncope; Ambulatory blood pressure monitoring; Fall; Tilt table test; implantable loop recorder; carotid sinus massage
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Unconsciousness; Consciousness Disorders; Syncope
• Other Study ID Numbers: 09C021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No