ABSTRACT
OBJECTIVE: Our objective is to describe the process of adapting a conceptual framework into a practical toolkit for one cleft team. DESIGN: This is a single-arm implementation study in a single institution. SETTING: Implementation took place at a mid-sized multidisciplinary clinic for patients with cleft lip and/or palate (CL/P) from urban/suburban and rural areas across North Carolina and neighboring states. PARTICIPANTS: Eligible participants were patients with CL/P from English-speaking families. Sixty patients entered and finished the study. INTERVENTIONS: The implementation of a prospective data collection system based on the International Consortium for Health Outcomes Measurement (ICHOM) standard set of outcome measures for CL/P was accomplished in multiple stages. Patient- and clinician-reported forms and protocols for gathering data were created. Team members were trained and the system was tested; finally, the system was deployed. MAIN OUTCOME MEASURES: Success was appraised using the RE-AIM framework to assess reach, effectiveness, adoption, implementation, and maintenance. RESULTS: Ninety-eight percent of patients and all team members agreed to participate. Ninety-four percent of required data were captured. Adaptations to friction points were made; specifically, visible reminders were affixed to charts, primary clinicians were required to assume data entry responsibility, and e-mail reminders were instituted. Development cost was US$7707; average time cost per clinician was 21 min/wk. CONCLUSIONS: Conceptual frameworks for outcomes studies must be tailored to their environments; otherwise, they cannot be practically implemented and sustained. We present this process for a cleft team using the ICHOM standard set. The process may help other teams implement the standard set or other conceptual frameworks.
