RESUMO
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.
RESUMO
This paper describes the development and validation of the Case Management Quality Scale (CMQS) to measure the quality of care provided by case managers in an early intervention service for clients with first episode psychosis. A total of 300 client participants from the Singapore Early Psychosis Programme completed a self-administered survey comprising 52 items measuring case management, the Client Satisfaction Questionnaire 8-item version (CSQ-8), Recovery Self-Assessment - person in recovery version (RSA-R), and Working Alliance Inventory - long form client version (WAI-C), and Recovering Quality of Life 10-item version (ReQoL-10). Exploratory factor analysis was conducted on the 52-item scale and the items were reduced using criterion validity. Psychometric properties of the 25-item CMQS were tested using internal consistency and concurrent validity. A 2-factor structure of the CMQS was established comprising two subscales - Therapeutic alliance and Care and empowerment. The test of normality for CMQS and subscales was largely found to be within the acceptable range. The Cronbach's alpha for the CMQS scale was high (0.97) and in terms of convergent validity, the CMQS and the two subscales had a moderate correlation with the CSQ-8, RSA-R, and WAI-C (r ranging from 0.596-0.711) and a mild correlation with the ReQoL-10. In conclusion, the CMQS is a user-friendly, and psychometrically sound instrument that is potentially useful for measuring case manager-client therapeutic alliance, and the level of care and empowerment in a case management service.
