Back to resultsGoal-setting in Stroke: From Guideline Towards Implementation: a Realist Evaluation
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Goal setting improvement program
Sponsored by
About this trial
This is an interventional health services research trial for Stroke focused on measuring Implementation, Realist evaluation, Stroke, Improvement program, Goal setting
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
Sites / Locations
- UHasseltRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
People after a stroke event
Healthcare professionals
Close relatives of people after a stroke
Arm Description
Implementation of improvement program
Implementation of improvement program
Implementation of improvement program
Outcomes
Primary Outcome Measures
Adoption and adherence of goal-setting programme- in acute care setting
The medical record screens whether all points of the predetermined goal setting programme are carried out and noted in the medical record.
Adoption and adherence of goal-setting programme- in rehabilitation setting
The medical record screens whether all points of the predetermined goal setting programme are carried out and noted in the medical record.
Secondary Outcome Measures
Evaluation of patient/ informal caregivers: Measuring patient satisfaction with stroke care
• Measuring patient satisfaction with stroke care: Satisfaction with stroke care questionnaire, In this evaluation, patients are asked to evaluate the care and treatment in the health facility using a 4-point Likert scale, ranging from strongly disagree to strongly agree. On the other hand, the preparation for discharge from hospital and the subsequent period are also surveyed. The latter is conducted only in patients transferred from a participating center or in those going home after admission to rehabilitation. The higher the outcome score the higher the stroke patients' and informal caregivers' satisfaction is with hospital stroke care.
Evaluation of patient/ informal caregivers: Patient Participation
• Patient Participation: Via the Patient Participation in Rehabilitation Questionnaire, patients' experiences of participation in their rehabilitation will be assessed. This evaluation will be evaluated as an optional scale. Only for participants who are able to fulfill this questionnaire based on cognition or on level of load ability. The Patient Participation in Rehabilitation Questionnaire contains 20 items, scoring is based on a five point-likert scale varying from always agree to never agree. The higher the score the higher according to the patient/informal caregiver wishes the involved in their care is.
Evaluation of patient/ informal caregivers, Patient empowerment:
• Patient empowerment: Through the Health Care Empowerment Inventory, patients or informal caregivers are asked about their engagement with the patient about their healthcare. Using eight statements, the patient or informal caregiver must indicate the extent to which they agree or disagree with each of the following statements. The higher the score the higher the patient/informal caregiver wishes to be involved in their healthcare.
Evaluation of patient/ informal caregivers, Level of depression:
• Level of depression: Via the Patient Health Questionnaire-9 (PHQ-9) the mental functioning is evaluated. The PHQ-9 is the depression module, which scores each of the 9 Diagnostic Statistical Manual of Mental Disorders-IV criteria as "0" (not at all) to "3" (nearly every day). The lower the score, the lower the change of a depression are.
Evaluation of patient/ informal caregivers, general Self-Efficacy
• Level of helplessness/self-efficacy scale The first questionnaire evaluated the level of self-efficiency through the General Self-Efficacy Scale. This questionnaire is a mandatory questionnaire. The General Self-Efficacy Scale concerns a unidimensional questionnaire that measures how a person generally copes with stressors/difficult situations in life. It involves ten statements (optimistic 'self-beliefs') that ask about how one thinks and acts in general. The scale consists of 10 statements. For each statement, responders must answer on a 4-point likert scale, ranging from completely incorrect to completely correct. The higher the score, the more confident the patient/informal caregiver is that his or her actions are responsible for successful outcomes.
Evaluation of patient/ informal caregivers, stroke self-efficacy:
• Level of helplessness/self-efficacy scale The second questionnaire evaluated the level of self-efficiency through the Stroke self-efficacy questionnaire. This questionnaire is an optional questionnaire. The Stroke self-efficacy questionnaire is a 13-item self-report scale measuring self-efficacy judgements in specific domains of functioning post stroke. Individuals rate their belief in their ability to achieve each of the 13 items on a 10-point scale, where 0 = not at all confident to 10 = very confident. The higher the score the higher the patient/informal caregiver's self-confidence in functional performance.
Evaluation of professional healthcare providers: Satisfaction of employees in healthcare
• Satisfaction of employees in healthcare survey Through the Satisfaction of employees in healthcare survey, 20 statements are shown to healthcare professionals. For each statement, healthcare professionals have to score the statement using a 4 point likert scale, ranging from strongly disagree to strongly agree. A higher score indicated on the statement corresponds to a higher level of satisfaction with their work setting.
Evaluation of professional healthcare providers; Self- efficacy
• Self- efficacy in patient centeredness questionnaire A 27-statement questionnaire asks healthcare professionals about how doctors and caregivers interact and communicate with patients. Participants can answer using a 5-point likert scale ranging from the answer option very little to very much. This questionnaire contains 3 main topics; 1) exploring the patient perspective, 2) sharing information and power and 3) Dealing with communicative challenges. A higher score corresponds to more confidence in dealing with patients.
Evaluation of professional healthcare providers; Acceptability of Intervention Measure, Intervention Appropriateness Measure, & Feasibility of Intervention Measure questionnaire
Through a questionnaire (Acceptability of Intervention Measure, Intervention Appropriateness Measure, & Feasibility of Intervention Measure questionnaire) professional healthcare professionals are asked if they can assess whether the programme is appropriate and feasible and whether they accept the programme. A total of 12 statements are presented to participants where for each statement the participant has to indicate via a 5-point likert scale (ranging from Completely disagree to Completely agree) to what extent they agree or disagree with the statement.
Feedback on the goal setting programme and implementation strategies.
Through a semi-structured interview or focus group, both professional caregivers and patients/ informal caregivers are asked for their feedback on the programme and the implementation strategies used.
Full Information
NCT ID
NCT06065397
First Posted
February 28, 2023
Last Updated
October 2, 2023
Sponsor
Hasselt University
Collaborators
Federal Public Service Health, Food Chain Safety and Environment
1. Study Identification
Unique Protocol Identification Number
NCT06065397
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2023 (Actual)
Primary Completion Date
September 23, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Federal Public Service Health, Food Chain Safety and Environment
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
People after a stroke (treatment in the participating centres); total number 155 people
Informal carers (only if the person has had a stroke and has limited opportunities to participate)
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?
Health professionals: start of the study and end of the study via questionnaires. Interviews/focus group (every 3 months)
Review of patient records and observations (every 3 weeks)
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Implementation, Realist evaluation, Stroke, Improvement program, Goal setting
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
People after a stroke event
Arm Type
Experimental
Arm Description
Implementation of improvement program
Arm Title
Healthcare professionals
Arm Type
Experimental
Arm Description
Implementation of improvement program
Arm Title
Close relatives of people after a stroke
Arm Type
Experimental
Arm Description
Implementation of improvement program
Intervention Type
Procedure
Intervention Name(s)
Goal setting improvement program
Intervention Description
A improvement program how to optimalize patient-centered goal setting in rehab care is being implemented.
Primary Outcome Measure Information:
Title
Adoption and adherence of goal-setting programme- in acute care setting
Description
The medical record screens whether all points of the predetermined goal setting programme are carried out and noted in the medical record.
Time Frame
Once up to 3 weeks during the hospitalisation period, through study completion, an average of 1 year
Title
Adoption and adherence of goal-setting programme- in rehabilitation setting
Description
The medical record screens whether all points of the predetermined goal setting programme are carried out and noted in the medical record.
Time Frame
Every 3 weeks during the hospitalisation period, through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Evaluation of patient/ informal caregivers: Measuring patient satisfaction with stroke care
Description
• Measuring patient satisfaction with stroke care: Satisfaction with stroke care questionnaire, In this evaluation, patients are asked to evaluate the care and treatment in the health facility using a 4-point Likert scale, ranging from strongly disagree to strongly agree. On the other hand, the preparation for discharge from hospital and the subsequent period are also surveyed. The latter is conducted only in patients transferred from a participating center or in those going home after admission to rehabilitation. The higher the outcome score the higher the stroke patients' and informal caregivers' satisfaction is with hospital stroke care.
Time Frame
Baseline and immediately after the intervention/admission to the healthcare institution
Title
Evaluation of patient/ informal caregivers: Patient Participation
Description
• Patient Participation: Via the Patient Participation in Rehabilitation Questionnaire, patients' experiences of participation in their rehabilitation will be assessed. This evaluation will be evaluated as an optional scale. Only for participants who are able to fulfill this questionnaire based on cognition or on level of load ability. The Patient Participation in Rehabilitation Questionnaire contains 20 items, scoring is based on a five point-likert scale varying from always agree to never agree. The higher the score the higher according to the patient/informal caregiver wishes the involved in their care is.
Time Frame
Baseline and immediately after the intervention/admission to the healthcare institution
Title
Evaluation of patient/ informal caregivers, Patient empowerment:
Description
• Patient empowerment: Through the Health Care Empowerment Inventory, patients or informal caregivers are asked about their engagement with the patient about their healthcare. Using eight statements, the patient or informal caregiver must indicate the extent to which they agree or disagree with each of the following statements. The higher the score the higher the patient/informal caregiver wishes to be involved in their healthcare.
Time Frame
Baseline and immediately after the intervention/admission to the healthcare institution
Title
Evaluation of patient/ informal caregivers, Level of depression:
Description
• Level of depression: Via the Patient Health Questionnaire-9 (PHQ-9) the mental functioning is evaluated. The PHQ-9 is the depression module, which scores each of the 9 Diagnostic Statistical Manual of Mental Disorders-IV criteria as "0" (not at all) to "3" (nearly every day). The lower the score, the lower the change of a depression are.
Time Frame
Baseline and immediately after the intervention/admission to the healthcare institution
Title
Evaluation of patient/ informal caregivers, general Self-Efficacy
Description
• Level of helplessness/self-efficacy scale The first questionnaire evaluated the level of self-efficiency through the General Self-Efficacy Scale. This questionnaire is a mandatory questionnaire. The General Self-Efficacy Scale concerns a unidimensional questionnaire that measures how a person generally copes with stressors/difficult situations in life. It involves ten statements (optimistic 'self-beliefs') that ask about how one thinks and acts in general. The scale consists of 10 statements. For each statement, responders must answer on a 4-point likert scale, ranging from completely incorrect to completely correct. The higher the score, the more confident the patient/informal caregiver is that his or her actions are responsible for successful outcomes.
Time Frame
Baseline and immediately after the intervention/admission to the healthcare institution
Title
Evaluation of patient/ informal caregivers, stroke self-efficacy:
Description
• Level of helplessness/self-efficacy scale The second questionnaire evaluated the level of self-efficiency through the Stroke self-efficacy questionnaire. This questionnaire is an optional questionnaire. The Stroke self-efficacy questionnaire is a 13-item self-report scale measuring self-efficacy judgements in specific domains of functioning post stroke. Individuals rate their belief in their ability to achieve each of the 13 items on a 10-point scale, where 0 = not at all confident to 10 = very confident. The higher the score the higher the patient/informal caregiver's self-confidence in functional performance.
Time Frame
Baseline and immediately after the intervention/admission to the healthcare institution
Title
Evaluation of professional healthcare providers: Satisfaction of employees in healthcare
Description
• Satisfaction of employees in healthcare survey Through the Satisfaction of employees in healthcare survey, 20 statements are shown to healthcare professionals. For each statement, healthcare professionals have to score the statement using a 4 point likert scale, ranging from strongly disagree to strongly agree. A higher score indicated on the statement corresponds to a higher level of satisfaction with their work setting.
Time Frame
Baseline and immediately after the intervention
Title
Evaluation of professional healthcare providers; Self- efficacy
Description
• Self- efficacy in patient centeredness questionnaire A 27-statement questionnaire asks healthcare professionals about how doctors and caregivers interact and communicate with patients. Participants can answer using a 5-point likert scale ranging from the answer option very little to very much. This questionnaire contains 3 main topics; 1) exploring the patient perspective, 2) sharing information and power and 3) Dealing with communicative challenges. A higher score corresponds to more confidence in dealing with patients.
Time Frame
Baseline and immediately after the intervention
Title
Evaluation of professional healthcare providers; Acceptability of Intervention Measure, Intervention Appropriateness Measure, & Feasibility of Intervention Measure questionnaire
Description
Through a questionnaire (Acceptability of Intervention Measure, Intervention Appropriateness Measure, & Feasibility of Intervention Measure questionnaire) professional healthcare professionals are asked if they can assess whether the programme is appropriate and feasible and whether they accept the programme. A total of 12 statements are presented to participants where for each statement the participant has to indicate via a 5-point likert scale (ranging from Completely disagree to Completely agree) to what extent they agree or disagree with the statement.
Time Frame
1-2 months after study start, at 4 months after study start and immediately after the intervention
Title
Feedback on the goal setting programme and implementation strategies.
Description
Through a semi-structured interview or focus group, both professional caregivers and patients/ informal caregivers are asked for their feedback on the programme and the implementation strategies used.
Time Frame
2-3, 5 and 8 months after study start.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annemie Spooren, prof dr
Phone
+3211269332
Email
annemie.spooren@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annemie Spooren, prof dr
Organizational Affiliation
UHasselt
Official's Role
Principal Investigator
Facility Information:
Facility Name
UHasselt
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liselot Thijs, Phd
Phone
003222862653
Email
liselot.thijs@uhasselt.be
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Goal-setting in Stroke: From Guideline Towards Implementation: a Realist Evaluation
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