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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intervention Arm |
|
|
|
Experimental Enhanced Usual Care Arm |
|
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
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.