A Decentralized Clinical Trial to Promote Evidence-Based Care for Underserved Patients With Neurofibromatosis 1

Mass General Brigham

Status: Enrolling

Conditions: Neurofibromatosis 1

Treatments: Other: Letters about NF1 Care (Content Type 1); Other: Letters about NF1 Care (Content Type 2)

Study type: Interventional

Funder types: Other

Identifiers

NCT06262113

AD-2022C2-24790 (Other Grant/Funding Number)

2024P000392

Details and patient eligibility

About

The goal of this fully decentralized, randomized controlled trial is to compare the efficacy of two educational interventions for individuals with Neurofibromatosis 1 (NF1). The primary objective of the study is to determine which intervention leads to higher rates of evidenced-based health screenings for NF1 patients in primary care settings.

Adults with NF1 and parents/guardians of children with NF1 from across the U.S. who do not go to a specialized NF clinic and who have an upcoming annual wellness visits (e.g. an annual physical, a well-child visit, etc.) scheduled with a primary care provider (PCP) are eligible to enroll in the study. To see if you might be eligible, fill out a prescreening survey here: https://redcap.link/mynfguide

Full description

Background: The majority of individuals with Neurofibromatosis 1 (NF1) in the United States lack access to specialized NF1 clinics and consequently don't receive care aligned with national recommendations. To address this gap in care, researchers are evaluating two interventions to determine which one helps people get recommended NF1-related health screenings at their annual wellness visit with a primary care provider.

Methods: Participants (adult patients or parents) who enroll in the study will complete baseline survey assessments online before their PCP visit and then be randomized to one of two groups. Both groups will be given letters, one for themselves and one for their clinician, that describe NF1 care recommendations. After attending their annual wellness visit, all participants will be asked to complete an online follow-up survey. A small subsample of participants will also be asked to do a virtual qualitative interview. No visits to Massachusetts General Hospital are required for this study.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Adult Inclusion Criteria:

• Currently lives in the United States (including Puerto Rico and other United States territories)
• Has a clinical diagnosis of neurofibromatosis 1
• Does not attend an NF clinic within the Children's Tumor Foundation NF Clinic Network
• Has an in-person, well-person visit with a primary care provider scheduled within 3 months of their consent
• Speaks English or Spanish

Parent/Guardian of a Child with NF1 Inclusion Criteria:

• Currently lives in the United States (including Puerto Rico and other United States territories)
• Cares for a child (age <18 years) with a clinical diagnosis of neurofibromatosis 1
• Does not attend an NF clinic within the Children's Tumor Foundation NF Clinic Network
• Their child has an in-person, well-person visit with a primary care provider scheduled within 3 months of their consent
• Speaks English or Spanish

Exclusion Criteria:

• Only one person per household may participate in the study
• Unwilling or unable to give informed consent

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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360 participants in 2 patient groups

Intervention Arm

Experimental group

Treatment:

Other: Letters about NF1 Care (Content Type 1)

Enhanced Usual Care Arm

Experimental group

Treatment:

Other: Letters about NF1 Care (Content Type 2)