Chronic Recurrent Multifocal Osteomyelitis
Conditions
Brief summary
This project aims to quantify and evaluate rates of non-adherence and barriers to medication adherence in pediatric patients with CRMO followed at Seattle Children's Hospital's robust CRMO program, which is the only clinical program in the Washington, Wyoming, Alaska, Montana, Idaho (WWAMI) region. This will be a stepped-wedge cluster-randomized trial, in which participants will be randomly assigned to one of two groups -- one which receives educational materials at the end of their first clinic visit, and the other which receives educational materials at the end of their second clinic visit. All participants will be given baseline surveys at the start of their first clinic visit, as well as follow-up surveys at the start of their second and third clinic visits. These surveys aim to evaluate rates of non-adherence and qualitative barriers to adherence, as well as efficacy of educational interventions in improving adherence rates.
Interventions
OTHEREducation of medication management
Video and handout materials will be provided
Sponsors
University of Washington
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of CRMO * Receives clinical care at Seattle Children's Hospital * On one or more scheduled prescription medications
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication possession ratio (MPR) | 6 to 9 months | The MPR is reported as a percentage calculated as: (total prescription days of supply/ (last prescription date - the first prescription date)). For example, if a patient only filled a one-month prescription twice during 6 months, so only had 60 days of medications available during the 6 months, the MPR would be 33%. A MPR of ≥0.8 is generally accepted as good compliance. The MPR data will be calculated for T0 and T1. In order to capture adequate data to calculate the MPR, refill data was acquired for 3 months prior to the beginning of the study (MPR T0) and for 3 months after T1 (MPR T1). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Barriers to adherence | 6-9 months | A survey will be conducted to determine the barriers predefined and any other barriers |
Countries
United States
Outcome results
None listed