Abstract
BACKGROUND: Successful implementation and sustainment of interventions is heavily influenced by context. Yet the complexity and dynamic nature of context make it challenging to connect and translate findings across implementation efforts. Existing methods to assess context are typically qualitative, limiting potential replicability and utility. Existing quantitative measures and the siloed nature of implementation efforts limit possibilities for data poolinXg and harmonization. The Inventory of Factors Affecting Successful Implementation and Sustainment (IFASIS) was developed to be a pragmatic, quantitative, organizational-level assessment of contextual factors. The intention is to characterize context with a measure that may enhance replication and reproducibility of findings beyond single implementation case studies. Here, we present the development and validation of the IFASIS. METHODS: A literature review was conducted to identify major concepts of established theories and frameworks to be retained. IFASIS data were examined in relation to implementation outcomes gathered from two studies. Psychometric validation efforts included content and face validity, reliability, internal consistency, and predictive and concurrent validity. Predictive validity was evaluated using generalized estimating equations (GEE) for longitudinal data on three implementation outcomes: reach, effectiveness, and implementation quality. Pragmatic properties were also evaluated. RESULTS: The IFASIS is a 27-item, team-based, instrument that quantitatively operationalizes context. Two rating scales capture current state and importance of each item to an organization. It demonstrated strong reliability, internal consistency, and predictive and concurrent validity. There were significant associations between higher IFASIS scores and improved implementation outcomes. A one-unit increase in total IFASIS score corresponded to a 160% increase in the number of patients receiving a medication (reach). IFASIS domains of factors outside the organization, factors within the organization, and factors about the intervention, and subscales of organizational readiness, community support, and recipient needs and values, were predictive of successful implementation outcomes. IFASIS scores were also significantly associated with measures of implementation quality. CONCLUSIONS: The IFASIS is a psychometrically and pragmatically valid instrument to assess contextual factors in implementation endeavors. Its ability to predict key implementation outcomes and facilitate data pooling across projects suggests it can play an important role in advancing the field.