Addressing Health Disparities in Normal Pressure Hydrocephalus (NPH) in Maryland (NPH)

Community Interventions to Address Health Disparities in the Care of Normal Pressure Hydrocephalus (NPH) in Maryland

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Normal Pressure Hydrocephalus; Hakim Syndrome
• Intervention / Treatment: Other: patients will receive NPH education; Other: primary care physicians (PCPs) will receive professional NPH education; Other: A community health worker will assist PCP

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 750,000 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 Type: Interventional
• Enrollment (Estimated): 660
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hossein Zare, MS, PhD; Phone Number: 4106147246; Email: hzare1@jhu.edu
• Study Contact Backup: Name: Mark G Luciano, PhD, FACS; Email: markluciano@jhu.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University and Hospital
      • Principal Investigator: Sevil Yasar, MD, PhD
      • Contact: Mark G Luciano, PhD, FACS; Email: markluciano@jhu.edu
      • Contact: Hossein Zare, MS, PhD; Phone Number: 410-614-7246; Email: hzare1@jhu.edu
      • Principal Investigator: Hossein Zare, MS, PhD
      • Principal Investigator: Mark G Luciano, MD, PhD
      • Sub-Investigator: Darrell Gaskin, MS, PhD
      • Sub-Investigator: Taiwo Akindahunsi, MD
      • Sub-Investigator: Michelle Spencer, MS
      • Sub-Investigator: Jiangxia Wang, MA, MS
      • Sub-Investigator: Amanda Garzon, MIA
      • Sub-Investigator: Roger Clark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• People over 65 years old who have completed the Annual Wellness Survey (AWV) survey
• have a clinical profile in the Hopkins Epic data sets
• live in Maryland

Exclusion Criteria:

• People under 65 years old will be excluded if they have not completed the AWV survey
• do not live in Maryland

Community Health Worker (CHW) Inclusion Criteria:

• certified Community Health Workers from Maryland
• completed accredited training by the Maryland Department of Health

Primary Care Physician inclusion criteria:

• must have patients in Johns Hopkins University AWV

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients and the patient's family; All patients and the patient's family will receive NPH-related education.	Other: patients will receive NPH education; Patients will benefit from the Hydrocephalus Association's (HA) educational strategy for idiopathic normal pressure hydrocephalus (iNPH) emphasizes patient collaboration in the development of educational materials specifically for this condition. HA has a library of assets that include PowerPoint presentations, videos, and online and print educational materials. There will be also in-person outreach resulting recruitment, website (the study website and HA website), webform (with a symptom of gait, dementia, and bladder symptoms), YouTube videos. The investigators will also go to the communities like senior centers, health fair, and churches, then we will give a talk about iNPH. These resources will be carefully adjusted to suit low-income demographics, guided by feedback from Baltimore audiences and HA's iNPH volunteers.; Other: primary care physicians (PCPs) will receive professional NPH education; A comprehensive professional development program for PCPs and CHWs, featuring presentations, educational videos, webinars, and tools on iNPH diagnosis, treatment, and care management. Provider Continuing Medical Education (CME) credits will be offered for in-person lectures, aiming to equip PCPs with the skills needed to address iNPH in low-income settings effectively; Other: A community health worker will assist PCP; A community health worker will assist PCP to identify barriers and help overcome these barriers in order for patient to access iNPH care.
Experimental: PCPs Training; Primary Care Provider (PCP) will receive NPH education.	Other: primary care physicians (PCPs) will receive professional NPH education; A comprehensive professional development program for PCPs and CHWs, featuring presentations, educational videos, webinars, and tools on iNPH diagnosis, treatment, and care management. Provider Continuing Medical Education (CME) credits will be offered for in-person lectures, aiming to equip PCPs with the skills needed to address iNPH in low-income settings effectively; Other: A community health worker will assist PCP; A community health worker will assist PCP to identify barriers and help overcome these barriers in order for patient to access iNPH care.
Experimental: CHWs assist PCPs; A community health worker (CHW) will assist PCP.	Other: A community health worker will assist PCP; A community health worker will assist PCP to identify barriers and help overcome these barriers in order for patient to access iNPH care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of referrals	number of referrals for suspicion of NPH to neurologists or neurosurgeons	6 months
number of screenings	number of screenings for shunt surgery	12 months
number of screenings	number of screenings for shunt surgery	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of NPH's consultations	number of patients who have received a consultation	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of referrals	referrals for physical therapy, occupational therapy, psychiatry, neurology - movement disorder specialist, neurology neuropathy specialist, orthopedic surgery, neurosurgery- spine specialist, neuropsychologist	12 months and 24 months

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Investigators: Principal Investigator: Hossein Zare, PhD, Johns Hopkins Bloomberg School of Public Health

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2027
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 30, 2032

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus; Hydrocephalus, Normal Pressure; Health Care Facilities Workforce and Services; Physicians; Health Personnel; Physicians, Primary Care
• Other Study ID Numbers: IRB00028028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol and analytic plan will be freely available. In addition to analytical files, the Stata, Statistical Analysis System (SAS), R codes and programs and data dictionary will be available to researchers approved by one of the study's Principal Investigators to receive data. All papers must include an acknowledgment section that includes the funding source.
• IPD Sharing Time Frame: The investigators will release the data 2 years after finishing up the study on April 2030.
• IPD Sharing Supporting Information Type: SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No