Neurofibromatosis 1
Conditions
Keywords
Neurofibromatosis, NF1, Guideline, Healthcare, PCP, Parent, Pediatric, Primary Care, Annual Care, Physical Exam, Well-Child
Brief summary
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
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 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.
Interventions
OTHERLetters 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
OTHERLetters 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
Sponsors
Massachusetts General Hospital
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Receipt of Recommended NF1 Health Screenings | 2 weeks after PCP visit | Number of AAP and ACMG recommended health screenings received by the person with NF1 at the annual wellness visit with their PCP, as assessed by patient/parent self-report |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Activation Measure® | At baseline and 2 weeks after PCP visit | The Patient Activation Measure will be used to assess patient's and parent's self-efficacy managing their or their child's care. The patient form has 13 items and the parent form has 10 items. The measure has scores ranging from 0-100, where higher scores indicate higher patient/parent activation (e.g. self-efficacy in managing your own or your child's healthcare). |
| Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Clinician and Group Survey Version 4.0 (Beta): Rating of the Visit | 2 weeks after PCP visit | The CAHPS® Rating of the Visit will be used to assess patient/parent satisfaction with the visit. This rating is a single item scored from 0 to 10, where higher scores indicated a better visit. |
| Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Clinician and Group Survey Version 4.0 (Beta): How Well Providers Communicate With Patients Subscale | 2 weeks after PCP visit | The subscale will be used to assess How Well Providers Communicate With Patients. This scale will be scored from 0 to 100, where higher scores indicated better communication with patients. |
| Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Clinician and Group Survey Version 4.0 (Beta): Providers' Use of Information to Coordinate Patient Care Subscale | 2 weeks after PCP visit | The subscale will be used to assess Providers' Use of Information to Coordinate Patient Care. This scale will be scored from 0 to 100, where higher scores indicate better use of information to coordinate care. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVanessa Merker, PhD
Massachusetts General Hospital
PRINCIPAL_INVESTIGATORScott Plotkin, MD, PhD
Massachusetts General Hospital
Outcome results
None listed