Viewing Study NCT04564820


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Study NCT ID: NCT04564820
Status: COMPLETED
Last Update Posted: 2022-02-08
First Post: 2020-09-21
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Strengthening the Interdisciplinary and Inter Sectoral Collaboration in Stroke Rehabilitation Through Application of FIM
Sponsor: Neurorehabilitering - Kbh, City of Copenhagen
Organization:

Study Overview

Official Title: Application of the Functional Independence MeasureĀ® (FIM) With the Aim of Strengthening the Interdisciplinary and Inter Sectoral Collaboration in Stroke Rehabilitation - a Mixed Methods Multicenter Study
Status: COMPLETED
Status Verified Date: 2022-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study seeks to explore ways to strengthening the interdisciplinary and inter sectoral collaboration in stroke rehabilitation through the application of Functional Independence MeasureĀ® (FIM) and common interdisciplinary patient related tasks. The study will be evaluated through interviews with staff, participant observation and quantitative patient data.
Detailed Description: Bispebjerg Hospital is considering implementing the FIM instrument in the Neurological Department. Before decisions making a more thorough examination is needed to see if the extra resources used to apply the FIM measurement is offset by improvement in the clinic. At Neurorehabilitering Copenhagen FIM measurement has recently been implemented in a trial period of 2 years hence an exploration of the application of FIM is needed.

The study seeks to explore experiences with application of the FIM instrument combined with structured interdisciplinary tasks related to the patient's everyday routines.

Aims:

1. To explore behavior, reaction and experiences in multidisciplinary staff members when applying the FIM instrument combined with interdisciplinary collaboration related to common patient tasks.

Including:
* the exploration of practical settings.
* the staffs experiences both pros and cons with the application of the FIM instrument.
* the staffs experiences of the interdisciplinary and inter sectoral collaboration.
2. To nuance the findings in the qualitative part of the study with quantitative data from the FIM including data on change in FIM score on the short term (2-3 weeks) and long term (approx. 4 months).
3. To evaluate on practicalities when applying the FIM instrument including the feasibility of scoring within 72 hours within admittance to and before discharge from the departments and the change in score between the 2 sectors.
4. To compare FIM to baseline characteristics such as National Institutes of Health Stroke Scale (NIHSS), Functional oral intake Scale (FOIS), and Pre-Stroke Modified Rankin Score.

Hypotheses:

1. It is expected that the application of the FIM instrument combined with interdisciplinary tasks will contribute to a development of a common language between the interdisciplinary staff members and to stimulate a more holistic goalsetting when engaging with the patient. Hereby it is expected to contribute to the interdisciplinary collaboration. A more multidisciplinary approach is expected to be experienced by the application of FIM hereby probably giving less attention to their professional background and more focus on the patient. It is expected that the staff will experience that FIM contributes to a more united use of language between the sectors and hereby linking the whole process of the patient.
2. It is expected that the patients will have a moderate to severe disability measured by FIM and a change in score is expected in both sectors.
3. Approx. half of the scores are expected to be within the 72 hours of planned timing.
4. A moderate correlation is expected between the FIM score and baseline measurements as National Institutes of Health Stroke Scale (NIHSS), Functional oral intake Scale (FOIS) and weak to moderate with Pre-Stroke Modified Rankin Score.

This Mixed Methods Multicenter Study consists of 5 elements divided into a quantitative and a qualitative part. The quantitative part is an observational cohort study with 15-20 stroke patients consecutively recruited. The qualitative part includes 8 participant observations, 4 focus group interviews, approx. 10 individual interviews and data on goalsetting from hospital charts from the 15-20 patients.

The setting is at the Neurological Ward at Bispebjerg Hospital in the Capital Region of Denmark and at Neurorehabilitering Copenhagen, a center which specializes in neurological rehabilitation in the Municipality of Copenhagen.

In the qualitative study, staff in a project group experimenting with the use of the FIM instrument combined with interdisciplinary tasks will participate in focus group interviews and some of them will participate in individual interviews using strategic sampling with maximal variation on profession, years of experience and sector. Participant observation of the FIM scorings will be performed as videorecordings beeing analysed. All qualitative data will be analysed with both investigator and data triangulation.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: