Viewing Study NCT06426004



Ignite Creation Date: 2024-06-16 @ 11:48 AM
Last Modification Date: 2024-10-26 @ 3:30 PM
Study NCT ID: NCT06426004
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-05-30
First Post: 2024-05-15

Brief Title: Addressing Health Disparities in Normal Pressure Hydrocephalus NPH in Maryland
Sponsor: Johns Hopkins Bloomberg School of Public Health
Organization: Johns Hopkins Bloomberg School of Public Health

Study Overview

Official Title: Community Interventions to Address Health Disparities in the Care of Normal Pressure Hydrocephalus NPH in Maryland
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: NPH
Brief Summary: The study aims to estimate Normal Pressure Hydrocephalus NPH prevalence and evaluate health equity gaps in Baltimore and Maryland based on zip codes and race with a focus on the Black community Interventions will include educational elements about NPH and three layers targeting patients Primary Care Providers and community health workers to enhance care access Short-term outcomes will measure referrals to specialists while long-term outcomes will assess healthcare utilization The study aims to identify and reduce racial disparities in NPH care access informing intervention strategies for NPH and other surgical areas
Detailed Description: This proposal responds to an established need for developing an evidence-based and community-informed approach to address health disparities in specialty surgical clinics where barriers to accessing care are multiplied along each level of the referral pathway The study will focus on Normal Pressure Hydrocephalus NPH related care - a clinical syndrome characterized excess cerebrospinal fluid CSF in the brain resulting in symptoms of falls dementia and urinary incontinence that is treated surgically by shunting to remove excess fluid from the brain This disorder afflicts an estimated about 750000 Americans and prevalence increases with age Limited information regarding racial and socioeconomic contributing factors associated with diagnosis and treatment is available

Studies show NPH goes underdiagnosed in the USA In the first part of the study the investigators will estimate NPH prevalence the health equity gap in Baltimore and greater Maryland MD the health equity gap based on Zip Code as a marker of sociodemographic community status and the health equity gap based on race looking at the Black community which comprises over 60 of the Baltimore and 30 in MD population In the second part of the study the investigators will develop three layers of interventions that involve educational elements about NPH and evaluate which provides the most benefit including referrals to NPH related care 1 Patients identified from the first part of the study with possible NPH symptoms will receive intervention 2 Patients and the Primary Care Providers PCPs receive intervention and 3 patients and PCP receive intervention and with additional community health workers CHWs assisting providers with managing the patient care including referrals addressing socioeconomic barriers transportation to receive care

The success of these interventions will be evaluated by short-term outcomes such as referrals to specialists including neurologists and neurosurgeons every 6 months and long-term outcomes such as healthcare utilization including screening for shunt surgery within 12 months This study aims to identify racial disparities in access to NPH care and intervention outcomes will evaluate the effect of different interventions on reducing racial disparities and to help developing a referral system to address the needs of most vulnerable population and Zip Codes in Baltimore and greater MD Using the results of this study will help to identify gaps understand the best intervention and develop intervention strategies not only for NPH but potentially other surgical areas

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None