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

Completed

• Conditions: Niemann-Pick Diseases

• Registration Number: NCT04469894
• Lead Sponsor: National Niemann-Pick Disease Foundation

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)

Study Timeline

• Study Start: 2020-06-15
• Study First Submitted: 2020-07-10
• Study First Submitted QC: 2020-07-10
• Study First Posted: 2020-07-14
• Primary Completion: 2020-09-21
• Study Completion: 2020-09-21
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health Insurance Coverage	July 2020- September	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
Health Insurance Literacy	July 2020- September	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

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States