Patient Experience of CFS-assessment in the ED

NCT ID: NCT06621290

Last Updated: 2024-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-30

Study Completion Date

2024-11-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

An increasingly common subject of interest among emergency care research is frailty, which is commonly described as a decline in several inter-related physiological systems, in addition to an increased vulnerability to stressors. To increase emergency care staffs ability to intervene appropriately in patients who need interventions to improve their outcomes, geriatric emergency care guidelines include recommendations to identify frailty during the emergency department (ED) visit. However, the patients´ experience of frailty assessment in general is sparsely investigated, and such studies within the ED context are even more limited.

It is conceivable that the patients experience of a frailty assessment may differ depending on several different factors, including which assessment tool is used.

A large number of assessment tools have been developed to help identify frailty, of which the Clinical Frailty Scale (CFS) is one of the most widely used. The CFS has been validated for persons ≥65 years of age and has been evaluated for validity, reliability and feasibility in an ED-setting. The CFS consists of pictograms combined with clinical descriptions of a persons level of functioning in daily life and cognitive status. Hence, to determine the CFS-score, the healthcare staff needs to ask the patient about their physical activity and function level regarding instrumental and personal activities of daily living (eg, banking, shopping, medication management, housekeeping, dressing and hygiene matters).

Since the different questions are often not directly linked to the patients acute illness, but touch on personal subjects like the persons abilities and life situation, it is desirable to understand the patients experience of such an assessment in order to optimise the approach from a patient perspective. To the best of our knowledge, there are no studies that focus on how patients experience being assessed with CFS during their ED-visit.

The aim of this study is therefore to inform a model to guide emergency department staff in assessing frailty with CFS, directed by the perspective from patients along the frailty trajectory. Specifically, our question is:

\- How do older ED-patients experience the frailty assessment with the CFS?

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

With the nature of qualitative data, a definitive sample size cannot be determined in advance. An estimate is that data will need to be collected for 15-25 patients. The analysis is planned to start in parallel with the data collection, and when no further significant findings are made during the progress of the analysis, the data collection will end. To ensure study quality, a reflexive approach and data-/researcher triangulation will be applyed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Frailty in Aging Emergency Department Visit Patient Experience Qualitative Research

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients over the age of 65 visiting the ED

Patients over the age of 65 visiting the ED who is capable of giving informed consent and who are planned to participate in a frailty assessment

Semi-structured interviews

Intervention Type OTHER

Semi-structured interviews on ED-patients experiences of frailty assessment with the CFS

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Semi-structured interviews

Semi-structured interviews on ED-patients experiences of frailty assessment with the CFS

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Qualitative research

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients aged ≥ 65 years attending the ED, and who gives informed consent to participating in the study.
* Emergency department staff will be included if they are to perform a CFS assessment on a patient eligible for the study.

Exclusion Criteria

* Patients who lack cognitive capacity to give informed consent, or have an acute medical condition will be excluded from the study. Exclusion will also apply to patients who do not speak Swedish and where an interpreter cannot be arranged (the patients next of kin will not be used as an interpreter).
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Linkoeping

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Daniel Wilhelms

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Daniel Wilhelms, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Emergency Medicine in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of emergency medicine, Linköping University Hospital, Region Östergötland, Linköping

Linköping, Sweden, Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-03729-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.