Clinical trial NCT06065397: Goal-setting in Stroke: From Guideline Towards Implementation: a Realist Evaluation
Official title: Goal-setting in Stroke: From Guideline Towards Implementation: a Realist Evaluation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Implementation
Realist evaluation
Stroke
Improvement program
Goal setting
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Federal Public Service Health, Food Chain Safety and Environment
First posted: 2023-10-03
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Overall objective: The aim of the project is to integrate the quality improvement programme on goal setting into the current care of people with stroke and to test and refine this programme.

Target group:

1. People after a stroke (treatment in the participating centres); total number 155 people
2. Informal carers (only if the person has had a stroke and has limited opportunities to participate)
3. Professional carer; total number 155 people

What?

The goal-setting programme becomes standard care, it is checked whether the programme has been applied in care by health professionals (review of the patient's medical record), what the effects are on patients (questionnaires) and health professionals (questionnaires) and whether the quality improvement programme needs to be adjusted or refined (interviews with health professionals and the patient group)

When to evaluate?

1. Health professionals: start of the study and end of the study via questionnaires. Interviews/focus group (every 3 months)
2. Review of patient records and observations (every 3 weeks)
3. Patient assessment: Admission and 1 week before discharge or end of study, Interviews/focus group (3 months)

Detailed description: Aim This study aims to evaluate the implementation of a quality improvement program to improve goal-setting in the rehabilitation process after a stroke event (further referred to as goal-setting programme) by means of a realist evaluation.

During this project, following questions will be answered:

What are the different elements and the final form of the initial goal-setting programme? How is goal-setting for the implementation of the goal-setting programme conducted? How is the goal-setting programme implemented? Is the goal-setting programme accepted, is it appropriate and feasible to implement? (review the implementation process).

Are adjustments needed on the goal-setting programme? How are the adjustments in the goal-setting programme being followed up? (review the implementation process) Does the implementation of the goal-setting programme in healthcare have an effect for patient or professional healthcare providers? (patient and healthcare professional outcome: Satisfaction with stroke care, participation, emotional status, empowerment and quality of life and overall feeling on goal-setting in stroke care)

Eligibility criteria: Professional healthcare providers

Inclusion criteria:

* Participants are employed in hospitals, rehabilitation centres and/or private practices/primary healthcare facilities located in the provinces: Province of Flemish Brabant, Brussels, Province of Walloon Brabant, Limburg
* Participants have a social, medical profession/background, work in the management of healthcare services or quality of healthcare
* Participants involved (direct or indirect) in the goal-setting process of the patients
* Participants who master the Flemish or French language
* Adult participants (≥18 years)

Exclusion criteria:

• Not giving informed consent

Patients

Inclusion criteria:

* Participants after a stroke event.
* Residence in one of the four participating sites, in outpatient care or receive treatment in first line zone
* Participants who master the Flemish or French language
* Adult participants (≥18 years)

Exclusion criteria:

* Not giving informed consent
* Other severe comorbidities that interfere with the rehabilitation process or goal-setting process

Informal caregivers

Inclusion criteria:

• Informal caregiver of a stroke patient admitted to one of the four participating sites

Primary outcomes:
measure: Adoption and adherence of goal-setting programme- in acute care setting
timeFrame: Once up to 3 weeks during the hospitalisation period, through study completion, an average of 1 year
measure: Adoption and adherence of goal-setting programme- in rehabilitation setting
timeFrame: Every 3 weeks during the hospitalisation period, through study completion, an average of 1 year
Secondary outcomes:
measure: Evaluation of patient/ informal caregivers: Measuring patient satisfaction with stroke care
timeFrame: Baseline and immediately after the intervention/admission to the healthcare institution
measure: Evaluation of patient/ informal caregivers: Patient Participation
timeFrame: Baseline and immediately after the intervention/admission to the healthcare institution
measure: Evaluation of patient/ informal caregivers, Patient empowerment:
timeFrame: Baseline and immediately after the intervention/admission to the healthcare institution
measure: Evaluation of patient/ informal caregivers, Level of depression:
timeFrame: Baseline and immediately after the intervention/admission to the healthcare institution
measure: Evaluation of patient/ informal caregivers, general Self-Efficacy
timeFrame: Baseline and immediately after the intervention/admission to the healthcare institution
measure: Evaluation of patient/ informal caregivers, stroke self-efficacy:
timeFrame: Baseline and immediately after the intervention/admission to the healthcare institution
measure: Evaluation of professional healthcare providers: Satisfaction of employees in healthcare
timeFrame: Baseline and immediately after the intervention
measure: Evaluation of professional healthcare providers; Self- efficacy
timeFrame: Baseline and immediately after the intervention
measure: Evaluation of professional healthcare providers; Acceptability of Intervention Measure, Intervention Appropriateness Measure, & Feasibility of Intervention Measure questionnaire
timeFrame: 1-2 months after study start, at 4 months after study start and immediately after the intervention
measure: Feedback on the goal setting programme and implementation strategies.
timeFrame: 2-3, 5 and 8 months after study start.
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: UHasselt
state: Limburg
Study officials:
affiliation: UHasselt
name: Annemie Spooren, prof dr
role: PRINCIPAL_INVESTIGATOR
References: