The Cardiac Care Bridge Randomized Trial in High-risk Older Cardiac Patients: A Mixed-methods Process Evaluation

Aim: To evaluate healthcare professionals' performance and treatment fidelity in the Cardiac Care Bridge (CCB) nurse-coordinated transitional care intervention in older cardiac patients to understand and interpret the study results.

Design: A mixed-methods process evaluation based on the Medical Research Council Process Evaluation framework.

Methods: Quantitative data on intervention key elements were collected from 153 logbooks of all intervention patients. Qualitative data were collected using semi-structured interviews with 19 CCB professionals (cardiac nurses, community nurses and primary care physical therapists), from June 2017 until October 2018. Qualitative data-analysis is based on thematic analysis and integrated with quantitative key element outcomes. The analysis was blinded to trial outcomes. Fidelity was defined as the level of intervention adherence.

Results: The overall intervention fidelity was 67%, ranging from severely low fidelity in the consultation of in-hospital geriatric teams (17%) to maximum fidelity in the comprehensive geriatric assessment (100%). Main themes of influence in the intervention performance that emerged from the interviews are interdisciplinary collaboration, organizational preconditions, confidence in the programme, time management and patient characteristics. In addition to practical issues, the patient's frailty status and limited motivation were barriers to the intervention.

Conclusion: Although involved healthcare professionals expressed their confidence in the intervention, the fidelity rate was suboptimal. This could have influenced the non-significant effect of the CCB intervention on the primary composite outcome of readmission and mortality 6 months after randomization. Feasibility of intervention key elements should be reconsidered in relation to experienced barriers and the population.

Impact: In addition to insight in effectiveness, insight in intervention fidelity and performance is necessary to understand the mechanism of impact. This study demonstrates that the suboptimal fidelity was subject to a complex interplay of organizational, professionals' and patients' issues. The results support intervention redesign and inform future development of transitional care interventions in older cardiac patients.