Clinical trial NCT05909657: Enablers and Barriers to Hydroxyurea Use for Sickle Cell Disease Jamaica
Official title: Access to Care for SCD Management in Jamaica: Enablers and Barriers to Hydroxyurea Utilization
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sickle Cell Disease
Keywords: hydroxyurea
access to care
Jamaica
Lead sponsor: The University of The West Indies
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruitment Patients and caregivers of children (ages \< 18 years) with SCD will be recruited islandwide- specifically from the Sickle Cell Unit (SCU) located at the University of the West Indies (UWI) campus and from all four regional health authorities. Patients will be recruited when in a well state. Similarly healthcare providers - Physicians, Registered Nurses, and Pharmacists- will be recruited from each region. For the desk review there would be interviews conducted with the Director of logistics and the Director of individual benefits - NHF, Policy Director or designee at MOHW, NCD director - MOHW and the Health Service Director - MOHW.

Brief summary: Sickle cell disease (SCD) is associated with a lifetime of medical and socio-behavioural complications that require coordination of care from multidisciplinary teams. Access to adequate care for SCD is important as inadequate access can contribute to increased acute care utilization, disjointed care delivery, and earlier mortality for many SCD patients. Hydroxyurea (HU) is the first drug approved for the treatment of SCD and improves many adverse outcomes of SCD and yet its use remains sub-optimal. This mixed-methods study aims to identify the barriers and enablers that SCD patients, caregivers of children (under age 18 years), and health care providers (including physicians, nurses and pharmacists) identify for health care access and HU utilization. The findings may guide development and implementation of strategies to improve access to SCD healthcare and HU uptake which may result in significant benefits to patients, families and the healthcare system including possible reduction in healthcare utilization. Participants will be recruited from the Sickle Cell Unit, Kingston and from all four Jamaican regional health authorities. Questionnaires and interview guides for provider and patient/caregiver assessments are adapted, with permission, from the Sickle Cell Disease Implementation Consortium tools. The study will also examine data on HU usage from the National Health Fund of Jamaica since its addition of SCD to its list of chronic illnesses in 2015. All data collected will be de-identified and maintained in a secure database, with access limited to key personnel. There is minimal risk to participants. Participants will be selected only because of the specific problem under investigation, and not because of easy availability, diminished autonomy, or social bias.


Eligibility criteria: Inclusion Criteria:

* SCD Patients (ages 18 and over)
* Adult Caregivers of SCD Children/Adolescents under 18 years
* Healthcare Providers: Physicians, Nurses and Pharmacists who treat and interact with sickle cell patients

Exclusion Criteria:

* SCD patients below age 18 years
* SCD patients who are acutely ill

Primary outcomes:
measure: surveys to determine patient and caregiver access to HU and perceived barriers to HU use for SCD in Jamaica
timeFrame: 18 months
measure: in-depth interviews to determine patient and caregiver access to HU and perceived barriers to HU use for SCD in Jamaica
timeFrame: 18 months
measure: surveys to asses patients and caregivers experience using HU for SCD in Jamaica
timeFrame: 18 Months
measure: in-depth interviews to asses patients and caregivers experience using HU for SCD in Jamaica
timeFrame: 18 Months
measure: examine healthcare providers knowledge and attitudes toward providing HU for SCD in Jamaica using surveys
timeFrame: 18 months
measure: In-depth interviews to examine healthcare providers knowledge and attitudes toward providing HU for SCD in Jamaica
timeFrame: 18 months
measure: Desk review of supply and benefits used for HU will be conducted in the study with the aim to identify potential gaps in the health care service delivery that may reduce the uptake of hydroxyurea by persons with sickle cell disease
timeFrame: 18 months
measure: A desk review assessment of the cost to patients in the health care system to deliver HU for patients living with Sickle Cell Disease in Jamaica
timeFrame: 10 months
measure: Assessment of the health care system to deliver HU for patients living with Sickle Cell Disease in Jamaica by doing a desk review and defining where (pharmacies - private, government, or hospital) HU is made available in Jamaica.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Jamaica
facility: Sickle Cell Unit - Caribbean Institute for Health Research
state: Saint Andrew
Study officials:
References: