Health Insurance Literacy and Challenges in Accessing Health Services in Niemann-Pick

Understanding Health Insurance Literacy and Challenges in Accessing Health Services in Niemann-Pick Disease Through the Eyes of Patients and Families

This study is a US based qualitative PRO research study to document the health insurance literacy as well as the patient experience in Niemann-Pick as it relates to accessing desired care, services and medications for patients.

The outcome of this research will be used to inform various other workstreams as NNPDF works to assist families.

The core research objectives are to understand the following from Niemann-Pick patients and their families in the US

Study Overview

• Status: Completed
• Conditions: Niemann-Pick Diseases

Detailed Description

This study is a US based qualitative PRO research study to document the health insurance literacy as well as the patient experience in Niemann-Pick as it relates to accessing desired care, services and medications for patients.

The outcome of this research will be used to inform various other workstreams as NNPDF works to assist families.

The core research objectives are to understand the following from Niemann-Pick patients and their families in the US;

• Level of health insurance literacy through assessment of health insurance terminology, and self-reported insights regarding information seeking, document literacy and cognitive skills
• If they have healthcare insurance, and if not, why not
• Types (including name) of insurance by which Niemann-Pick families are covered
• Information regarding Medicaid Waivers

• Attributes of insurance plans including, but not limited to;

  • Deductible amounts for individual and family
  • Out of pocket maximums for individual and family
  • Insurance premiums
  • Associated Health Savings Accounts
  • Associated Cost Sharing requirements
  • Services, drugs and assistive devices covered
• What the perceived out-of-pocket costs are for Niemann-Pick families (annually)
• When out-of-pocket maximums are perceived to be met for Niemann-Pick families

• Patient and HCP experience in terms of challenges with accessing desired care and coverage

  • Where are families experiencing challenges with accessing desired care and coverage? (drugs, assistive devices, services) Is it different for the different phenotypes of the disease?
  • What is the challenge? (financial, time, stress, others)
  • What is the life impact of that challenge? (work and educational impact, lack or delay of treatment, others)

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Within the United States, patients or the parent/caregiver of patients who have been diagnosed with any of the 7 known subtypes of Niemann-Pick disease

Description

Inclusion Criteria:

• Participant must be a person with Niemann-Pick disease who is 18 years or older or The parent/legal guardian of a person with Niemann-Pick disease. Please note: Parents whose child has passed on are able to participate in the RSVP. Parents whose child has passed on in the last two years are also able to participate in the interview. Please note that only one family member will be eligible to complete the RSVP and interview for one family.
• Confirmed diagnosis of Niemann-Pick disease, confirmed by membership in the NNPDF or by provision of a proof of disease form
• Able to read, write and communicate in English
• Able to grant informed consent
• Willing to complete a survey and RSVP, and to participate in a 30-minute telephone interview
• Ability to view or receive a document from the interviewer before or during the interview (web browser, ability to receive a text, fax or document by mail)

Exclusion Criteria:

- Inability to meet any of the above 6 criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort
Niemann-Pick Type A; Also referred to as Infantile Neurovisceral ASMD
Niemann-Pick Type A/B; Also referred to as Intermediate form or Chronic Neurovisceral ASMD
Niemann-Pick Type B; Also referred to as Chronic Visceral ASMD
Niemann-Pick Type C (Early Infantile); Onset at less than 2 years of age
Niemann-Pick Type C (Late Infantile); Neurodegenerative form (late-infantile) onset at 2-6 years of age
Niemann-Pick Type C (Juvenile); Neurodegenerative form (juvenile) onset at 6-15 years of age
Niemann-Pick Type C (Adult); Psychiatric neurodegenerative form (adult) onset at greater than 15 years of age

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Insurance Literacy	Health insurance literacy will be measured by a score on a brief quiz regarding health insurance key terms as well as self-ratings regarding various aspects of the participants' ability to navigate and understand insurance	July 2020- September
Health Insurance Coverage	Health insurance coverage will be measured by the different multiple choice and open-ended questions based on the services available under the participants' insurance plan as well as their reported difficulty with navigating their plan and obtaining what they need for Niemann-Pick	July 2020- September

Collaborators and Investigators

• Sponsor: National Niemann-Pick Disease Foundation
• Collaborators: Icahn School of Medicine at Mount Sinai; Engage Health Inc.
• Investigators: Principal Investigator: George A Diaz, MD, PhD, Icahn School of Medicine at Mount Sinai; Study Chair: Justin Hopkin, MD, National Niemann-Pick Disease Board Chair

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Actual): September 21, 2020
• Study Completion (Actual): September 21, 2020

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Lymphatic Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Genetic Diseases, Inborn; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolism, Inborn Errors; Lysosomal Storage Diseases; Lipid Metabolism Disorders; Dementia; Brain Diseases, Metabolic; Brain Diseases, Metabolic, Inborn; Language Disorders; Communication Disorders; Sphingolipidoses; Lysosomal Storage Diseases, Nervous System; Lipidoses; Lipid Metabolism, Inborn Errors; Speech Disorders; Frontotemporal Lobar Degeneration; Aphasia; Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Niemann-Pick Diseases; Niemann-Pick Disease, Type A; Niemann-Pick Disease, Type C
• Other Study ID Numbers: NNPDF-BUR001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The data for each question in the study will be analyzed and reported by Engage Health using descriptive statistics as appropriate for the nature of the data collected-frequency distributions, cross tabulations and measures of central tendency and dispersion.
• IPD Sharing Time Frame: September 2020
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Analytic Code

Drug and device information, study documents

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