Clinical trial NCT03330652: Health Disparities in Stroke Patients and Their Families: a Longitudinal Multicenter Study (HDSS)
Official title: Identifying Health Disparities and Health Services Gaps by Following Stroke Patients and Their Family Care-givers to Explore Their Needs and Expectations: A Multi-center Longitudinal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Acute
Keywords: Quality of life
Cognitive function
Mental state
Functional capacity
EQ5D
HADS
Barthel Index
mRS
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Israel National Institute for Health Policy and Health Services Research
First posted: 2017-11-06
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 800 stroke patients/spouces hospitalized at 4 medical centers, and a close family member, will be recruited during one calendar year.

Brief summary: The meeting point of the patient and his/her immediate family with the health care system is complicated and traumatic. While having to deal with medicalization geared towards providing evidence-based and cost-effective medical care, the patient expects comprehensive, holistic care tailored to his/her needs, during hospitalization or in the community. A survey of 800 stroke patients and their caregiver during the 1st year following acute stroke hospitalization will explore their unmet needs.

Detailed description: Background: The meeting point of the patient with the health care system is complicated and traumatic. The patient's autonomy over physical health becomes diminished. The patient and his family need to deal with medicalization geared towards providing evidence-based medical care, while attempting to be cost-efficient. The patient expects comprehensive, holistic care tailored to his/her needs, during hospitalization or in the community.

Objectives: To characterize the patient's and his/her family's needs and expectations from the medical system, following an acute medical event involving hospitalization and community care treatment; to analyze the gaps between these needs and the actual treatment provided.

Working hypotheses: Certain needs and expectations of patients and their families are unrecognized and unmet by the medical system; more deprived population groups can be identified, where the gap between needs and service provided is exceptionally great.

Type of research and methods of data collection: Prospective cohort study. Method(s) of data collection: 800 stroke patients hospitalized at 4 medical centers: Tel Hashomer, Soroka, Asaf-Harofeh, and Naharia, and a close family member (caregiver), will be recruited during one calendar year. These medical centers reflect the heterogeneity of the population, it's ethnic diversity, and the periphery vs. the central areas of the country of Israel. Personal details will be recorded, and informed consent forms signed. The patients will be telephone-interviewed 3-4 months after acute hospitalization, 6-8 months, and after one year, to assess their functionality, coping with bureaucracy, availability and accessibility (financial and cultural), disease management, continuity of treatment, number of caregivers, quality of life, depression, cognitive function, care received by the medical system, "patient at the center" assessment.

Uniqueness and relevance to the National health Insurance Law: Assessment of patient's experience (and his caregivers) in the first year after hospitalization due to stroke, with emphasis on inequality between patients based on socio-economic factors. The assumption is that the gap between expectations and needs of patient and family from the medical system and actual service provided by the system is even bigger among populations who depend more on the system for support.

Among the Ministry of Health's 6 pillars of health is reinforcement of the perception of "patient-centered care" which aims to map out gaps, reasons and challenges in putting this objective into practice. Findings of this research will enable decision makers to efficiently allocate resources and funds to needy populations, thus reducing gaps, lowering use of the medical system and lowering costs incurred by the system.

Eligibility criteria: Inclusion Criteria:

* Acute stroke
* Caregiver of patient who's an immediate family member

Exclusion Criteria:

* Inability to communicate

Primary outcomes:
measure: "patient at the center" assessment
timeFrame: 12 months after acute stroke
Secondary outcomes:
measure: Change over the year of follow up in quality of life
timeFrame: 4, 8, 12 months after acute stroke
measure: Change over the year of follow up in mental health
timeFrame: 4, 8, 12 months after acute stroke
measure: Change over the year of follow up in functional capacity
timeFrame: 4, 8, 12 months after acute stroke
measure: Change over the year of follow up in burden of care
timeFrame: 4, 8, 12 months after acute stroke
Other outcomes:
Locations:
city: Ashkelon
country: Israel
facility: Neurologic Department, Barzilai Medical Center
city: Be'er Sheva
country: Israel
facility: Neurologic Department, Soroka Medical Center
city: Nahariya
country: Israel
facility: Neurologic Department, El Hagalil Medical Center
city: Ramat Gan
country: Israel
facility: Neurologic Department, Sheba Medical Center
Study officials:
affiliation: The Gertner Institute
name: Rachel S Dankner, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: