Clinical trial NCT06096831: Living With Stroke - Sustainable Utilization of Healthcare Services
Official title: Living With Stroke - Sustainable Utilization of Healthcare Services
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stroke
Cerebrovascular Disorders
Cerebrovascular Accident
Healthcare Utilization
Keywords: Post-stroke
Healthcare utilization
Continuity of care
Rehabilitation
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Ben-Gurion University of the Negev
name: Clalit Health Services
name: Carmel Medical Center
First posted: 2023-10-24
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Post-stroke patients living in the community. At least one year after the stroke occurred. An estimated number of approximately 40,000 patients nationwide (Part 1) and 240 patients hospitalized at the 'Carmel' Medical Center (Part 2\&3).

Brief summary: The proposed study will generate a national mapping of healthcare utilization patterns in people post-stroke in the chronic phase living in the community; examine the associations between individual-level characteristics, health outcomes and healthcare utilization; and will describe patients' perspectives on their needs for health services and their experiences of using them.

The study will use mixed-methods methodology (quantitative and qualitative) and will proceed in three parts. In part 1, data will be extracted retrospectively from electronic medical records of of Clalit Health Services, covering all patients with a stroke diagnosis. In part 2, a sub-sample of 240 patients will be asked to answer standardized questionnaires. In part 3, a sub-sample of 20 participants will participate in in-depth, semi-structured interviews.

Detailed description: Stroke is the leading cause of long-term disability worldwide. Although healthcare services can have a crucial role in mitigating the long-term multidimensional disabilities caused by stroke, most medical and rehabilitative services are currently directed towards the acute phase of the disease up to six months after its occurrence. Healthcare services in the chronic phase are inadequately structured, and stroke survivors in the community report lack of continuity of care and a sense of abandonment. Long-term utilization patterns of healthcare service by post-stroke persons are unknown.

Based on data to be collected from people in the chronic post-stroke phase living in the community, the study goals are to (1) generate a national mapping of patterns of healthcare utilization; (2) examine associations between individual-level characteristics and healthcare utilization; and (3) describe patients' perspectives on their needs for health services and their experience of using them.

A 'Mixed methods' research combining qualitative and quantitative methods will be conducted.The research will include 3 parts: Part 1 of the study is retrospective study based on data extracting from electronic medical records of Clalit Health Services on healthcare utilization of people post-stroke (app. 40,000 people); Part 2 is a cross-sectional study based on a sub-group of 240 people post-stroke that will be asked to answer standardized questionnaires on face to face meeting aimed to capture individual determinants of healthcare utilization; Part 3 will include in-depth interviews with 20 people post-stroke to capture patients' perspectives on their post-stroke healthcare needs and their experience of using healthcare services.

Eligibility criteria: Inclusion Criteria for the retrospective study (Part 1):

* People diagnosed with stroke (First stroke occurred between 2010-2022)
* At least one year after the event
* Living in the community
* Aged 18 and above
* Insured by HMO (Clalit health services)

Exclusion Criteria for the retrospective study (Part 1):

* Stroke chronicity of less than a year
* Diagnosis of TIA (Transient Ischemic Attack)

Inclusion Criteria for the cross-sectional and qualitative study (Parts 2\&3):

* People diagnosed with stroke
* Hospitalized for a first stroke at the 'Carmel' Medical Center between 2010-2022
* Understand Hebrew/ Arabic/ Russian in a way that allows them to understand the consent form and answer the survey questions.

Exclusion Criteria for the cross-sectional and qualitative study (Parts 2\&3):

* Stroke chronicity of less than a year the study
* Transient ischemic attack (TIA)
* Patients who have a guardian, a nursing condition as a result of diseases other than stroke or other serious background diseases that impair function, people with communication difficulties that do not allow answering questionnaires or to be interviewed.

Primary outcomes:
measure: Visits to a neurologist
timeFrame: 1 year
measure: Use of physical therapy services
timeFrame: 1 year
measure: Stroke impact Scale - SIS 3.0
timeFrame: 1 hour
measure: Visits to the emergency medicine center and urgent hospitalization data from Clalit's electronic medical records (EMR) of all insured patients who had a stroke. An estimated number of 40,000 patients post-stroke.
timeFrame: 1 year
Secondary outcomes:
measure: Use of occupational therapy services
timeFrame: 1 year
measure: Use of speech-language therapy services
timeFrame: 1 year
measure: Recurrent stroke
timeFrame: 1 year
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: University of Haifa
Study officials:
affiliation: University of Haifa
name: Michal Kafri, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carmel Medical Center
name: Sivan Bloch, M.D
role: PRINCIPAL_INVESTIGATOR
References: