The Cardiac Care Bridge randomized trial in high‐risk older cardiac patients: A mixed‐methods process evaluation

Abstract

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.

Experiences of frail older cardiac patients with a nurse-coordinated transitional care intervention - a qualitative study

“…This is in line with the experiences of community nurses within this TCI who reported that they contributed to the prevention of complications by early signalling health deteriorations (e.g. heart failure decompensation) [ 24 ]. In addition, one of the community nurses experienced that patients thought that they were able to recognize their heart failure deterioration early.…”

“…In both groups, 50% of patients reached the composite outcome of unplanned hospital readmission or mortality at 6 months follow-up. In addition, caregivers in our TCI reported that the levels of frailty of the population influenced the performance of the intervention, for example due to comorbidities that impeded patients in physical rehabilitation [ 24 ]. This is comparable with the results that we found in the theme varying experiences with recovery.…”

“…Furthermore, data about the intervention delivery was registered in medical hospital files and logbooks which were filled out by the participating healthcare providers during the intervention. A process evaluation of the intervention delivery is reported [ 24 ].…”

“…To prevent potential bias, the qualitative data on participants’ perspectives were analysed before the study results on effectiveness of the TCI were known. However, the researchers were involved in the data collection on the intervention delivery in the large process evaluation [ 24 ] and therefore aware of a suboptimal intervention fidelity. This information was taken into account into the data analysis of participants’ experiences in order to understand the findings.…”

The Cardiac Care Bridge transitional care program for the management of older high-risk cardiac patients: An economic evaluation alongside a randomized controlled trial

“…Baseline variables that were used as predictor variables for multiple imputation were carefully selected, based on their association with missingness or the outcome. Last, from the CCB process evaluation, it is known that the mean intervention fidelity rate was only 67%, which could have influenced the effect on the composite outcome and intervention costs [ 37 ]. However, we calculated the intervention costs from a standardized intervention cost price instead of a fidelity-based cost price based per individual which could have resulted in a slight overestimation of the actual intervention costs.…”