Implementation evaluation of a pharmacist-led complex intervention: A mixed-methods analysis embedded within the ASPIRE randomized controlled trial

Background

Geriatric patients with multimorbidity and polypharmacy are at high risk for medication-related harm. Complex interventions including medication reconciliation and medication review can improve outcomes, though their effectiveness in older patients remains unclear due to implementation failure in recent trials. The ASPIRE (The effect of a trAnSitional Pharmacist Intervention in geRiatric inpatients on hospital visits after dischargE) project evaluates a complex intervention aimed at reducing unplanned hospital revisits in geriatric patients while simultaneously maximizing intervention implementation.

Objectives

To perform an implementation evaluation by describing the implementation strategies, evaluating fidelity, feasibility, and acceptability and documenting process outcomes of the ASPIRE intervention.

Methods

A convergent parallel mixed-methods design was used with quantitative data from all intervention patients and qualitative data from semi-structured interviews and one focus group. The implementation strategies were designed based on the Expert Recommendations for Implementing Change guidelines. Fidelity to each intervention component was quantitatively measured for all intervention patients, using an 80% threshold to define successful implementation. Feasibility and acceptability were qualitatively assessed using Flottorp's contextual analysis framework. Intervention duration and process outcomes were reported descriptively.

Results

The ASPIRE trial enrolled 415 intervention participants aged 85.9 (±5.78) years. The complex intervention was successfully implemented with 87% of patients receiving all intervention components and considered feasible and acceptable by the majority of stakeholders. Key factors for successful implementation with the greatest impact on fidelity, feasibility, and acceptability included adequate time and workforce allocation, additional training, established working relationships, a shared information system and a detailed intervention guide. Median intervention duration was 77.3 (interquartile range (IQR) 65.8-93.5) minutes and 64.5 (IQR 54.2-78.8) minutes for patients discharged home or to a nursing home, respectively.

Conclusion

The ASPIRE intervention was successfully implemented and considered feasible and acceptable by the stakeholders, highlighting its potential to improve care for geriatric patients. The high level of implementation provide a strong basis for the further evaluation of its effectiveness.