Using the consolidated framework for implementation research to guide a pilot of implementing an institution level patient informed consent process for clinical research at an outpatient setting
Authors: Lin Xuling , Yuen Joanne Yong Ern , Chan Wei Quan Jeremy , Divakar Tushar Gosavi , Keong Nicole Chwee Har , Lee Lester Chee How , Kumar Sumeet , Tan Chew Seah , Soon Kim Chin Pauline , Chew Yee Pheng Amy , Yazid Heriati Mohd , Saleh Farah Julieanna Mohd , Cai Fenglong , Chai Fui Chih , Azwan Nur Fakhirah Mohamed , Faizal Nurhidayah Mohamad , Lou Siew Choo , Tan Siew Sin Priscilla , Jarimin Cut Marini , Stanley Gowri Michael , Hussien Khadijah , Sanmwan Nurhazah , Amran Nur Hidayah , Ramli Nurliana , Neo Shermyn Xiu Min , Tan Louis Chew Seng , Tan Eng King , Lum Elaine 
Published: January 2023

Abstract
Background
In Singapore, research teams seek informed patient consent on an ad hoc basis for specific clinical studies and there is typically a role separation between operational and research staff. With the enactment of the Human Biomedical Research Act, there is increased emphasis on compliance with consent-taking processes and research documentation. To optimize resource use and facilitate long-term research sustainability at our institution, this study aimed to design and pilot an institution level informed consent workflow (the “intervention”) that is integrated with clinic operations.

Methods
We used the Consolidated Framework for Implementation Research (CFIR) as the underpinning theoretical framework and conducted the study in three stages: Stage 1, CFIR constructs were used to systematically identify barriers and facilitators of intervention implementation, and a simple time-and-motion study of the patient journey was used to inform the design of the intervention; Stage 2, implementation strategies were selected and mapped to the Expert Recommendations for Implementing Change (ERIC) taxonomy; Stage 3, we piloted and adapted the implementation process at two outpatient clinics and evaluated implementation effectiveness through patient participation rates.

Results
We identified 15 relevant CFIR constructs. Implementation strategies selected to address these constructs were targeted at three groups of stakeholders: institution leadership (develop relationships, involve executive boards, identify and prepare champions), clinic management team (develop relationships, identify and prepare champions, obtain support and commitment, educate stakeholders), and clinic operations staff (develop relationships, assess readiness, conduct training, cyclical tests of change, model and simulate change, capture and share local knowledge, obtain and use feedback). Time-and-motion study in clinics identified the pre-consultation timepoint as the most appropriate for the intervention. The implementation process was adapted according to clinic operations staff and service needs. At the conclusion of the pilot, 78.3% of eligible patients provided institution level informed consent via the integrated workflow implemented.

Conclusions
Our findings support the feasibility of implementing an institution level informed consent workflow that integrates with service operations at the outpatient setting to optimize healthcare resources for research. The CFIR provided a useful framework to identify barriers and facilitators in the design of the intervention and its implementation process.