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

Purpose

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 scheduled with a primary care provider (PCP) are eligible to enroll in the study.

Condition

  • Neurofibromatosis 1

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
Double (Participant, Care Provider)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Intervention Arm
  • Other: Letters about NF1 Care (Content Type 1)
    Participants will receive two letters about NF1 care, one for themselves and one for their primary care clinician, to read in advance of the patient's annual wellness visit
Experimental
Enhanced Usual Care Arm
  • Other: Letters about NF1 Care (Content Type 2)
    Participants will receive two letters about NF1 care, one for themselves and one for their primary care clinician, to read in advance of the patient's annual wellness visit

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Paulina Arias Hernandez, MSW
617-724-5321
pahernandez@mgb.org

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Paulina Arias Hernandez, MSW
6177245321
pahernandez@mgb.org

Detailed 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 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 a follow-up survey. A small subsample of participants will also be asked to do a qualitative interview.