Clinical trial NCT04469894: Health Insurance Literacy and Challenges in Accessing Health Services in Niemann-Pick
Official title: Understanding Health Insurance Literacy and Challenges in Accessing Health Services in Niemann-Pick Disease Through the Eyes of Patients and Families
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Niemann-Pick Diseases
Lead sponsor: National Niemann-Pick Disease Foundation
Sponsor class: OTHER
Collaborators: name: Engage Health Inc.
name: Icahn School of Medicine at Mount Sinai
First posted: 2020-07-14
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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

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)

Eligibility criteria: 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

Primary outcomes:
measure: Health Insurance Literacy
timeFrame: July 2020- September
measure: Health Insurance Coverage
timeFrame: July 2020- September
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: George A Diaz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Niemann-Pick Disease Board Chair
name: Justin Hopkin, MD
role: STUDY_CHAIR
References: