Health Disparities in Stroke Patients and Their Families: a Longitudinal Multicenter Study (HDSS) (HDSS)
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|ClinicalTrials.gov Identifier: NCT03330652|
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : August 31, 2020
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||800 participants|
|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|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||October 31, 2021|
- "patient at the center" assessment [ Time Frame: 12 months after acute stroke ]coping with bureaucracy, availability and accessibility (financial and cultural), disease management, continuity of treatment
- Change over the year of follow up in quality of life [ Time Frame: 4, 8, 12 months after acute stroke ]Quality of life will be measured using the European Quality of life 5 Dimention (EQ5D) questionnaire. Scores range from 0-15 where 15 is the worst score
- Change over the year of follow up in mental health [ Time Frame: 4, 8, 12 months after acute stroke ]Mental health will be evaluated for anxiety and depression using the Hospital and Anxiety Disease Scale (HADS). Score range 0-21 for each anxiety and depression subscales. 21 means worst score.
- Change over the year of follow up in functional capacity [ Time Frame: 4, 8, 12 months after acute stroke ]Functional capacity of the stroke patient will be measured using the Barthel index. Scores range 0-100 where 0 means worst dissability.
- Change over the year of follow up in burden of care [ Time Frame: 4, 8, 12 months after acute stroke ]Burden of care as it is experienced by the caregiver of the stroke patient will be evaluated by the Zarit questionnaire. A scale of 0-88 where 88 means the most severe burden
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330652
|Contact: Rachel S Dankner, MD, MPHfirstname.lastname@example.org|
|Contact: Angela Chetrit, MBAemail@example.com|
|Neurologic Department, Barzilai Medical Center||Recruiting|
|Contact: Ron Milo, MD firstname.lastname@example.org|
|Contact: Nir Michal email@example.com|
|Neurologic Department, Soroka Medical Center||Terminated|
|Be'er Sheva, Israel|
|Neurologic Department, El Hagalil Medical Center||Terminated|
|Neurologic Department, Sheba Medical Center||Completed|
|Ramat Gan, Israel, 52621|
|Principal Investigator:||Rachel S Dankner, MD, MPH||The Gertner Institute|