P. Bittar2, A. Carlson1, A. Mabie3, J. Marcus1, A. C. Allori1 1Duke University Medical Center,Plastic Surgery,Durham, NC, USA 2Duke University School Of Medicine,Durham, NC, USA 3Duke University Medical Center,Otolaryngology & Communication Sciences,Durham, NC, USA
Introduction: Long-term outcomes research for cleft lip and/or palate has been challenging. In 2016, a “standard set” of outcome measures for appraisal of cleft care was proposed by the International Consortium for Health Outcomes Measurement (ICHOM); however, this conceptual framework must be translated into a practical framework customized for specific constraints that exist in each center. Our objective is to describe the process of adapting a conceptual framework into a practical toolkit for one cleft team.
Methods: This is a single-arm implementation study in a single institution. Implementation took place in a mid-sized multidisciplinary team operating a weekly clinic for patients with cleft lip and/or palate from urban/suburban and rural areas across North Carolina and neighboring states. Eligible subjects were patients from English-speaking families with cleft lip and/or palate receiving treatment at our center. Our intervention was the implementation of a prospective data-collection system based on the ICHOM standard set of outcome measures for cleft lip and/or palate. Implementation was accomplished in multiple stages. Patient- and clinician-reported forms and protocols for gathering data were created. Team members were then trained and the system was tested; finally, the system was deployed.
Results: Success of the implementation was appraised using the RE-AIM framework to assess reach, effectiveness, adoption, implementation, and maintenance. 98% of eligible patients and all cleft team members agreed to participate. 94% of required standard set data points 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 email reminders were instituted. Development cost for the system was $7707, and average time cost per clinician was 21 minutes/week.
Conclusion: All conceptual frameworks for outcomes studies must first be tailored to suit the environment; otherwise, they cannot be practically implemented and sustained. In this paper, we present this process for a cleft team using the ICHOM standard set. The process may help other teams in implementing the standard set or other conceptual frameworks within their own hospitals.
