Process evaluation of implementing Protected Mealtimes under clinical trial conditions

AIM To evaluate the implementation of Protected Mealtimes and contrast the findings with implementation fidelity. BACKGROUND Protected Mealtimes is a systems approach developed to address the issue of malnutrition in hospitalized patients. Previous studies have used a pre--post study design, with no high-quality trials previously undertaken to measure the effect of the intervention. DESIGN A prospective, stepped-wedge cluster randomized controlled trial was undertaken October-November 2015. This process evaluation was conducted using qualitative and quantitative methods to explain discrepancies between expected and observed clinical trial outcomes. METHODS Qualitative data were collected using focus groups with the healthcare team and contrasted with fidelity data. Quantitative data were collected using attendance lists, audits and observations and analysed descriptively. Concept-driven coding was undertaken using a framework derived from studies citing the Theoretical Domains Framework. FINDINGS Staff training in the trial protocol was viewed positively, however, not all staff attended. Staff were generally enthusiastic about Protected Mealtimes with many programme aspects successfully implemented. Limited staffing resources, particularly of nursing staff, hindered implementation. The presence of trial observers affected staff morale by increasing feelings of stress and anxiety. CONCLUSION Process data allowed challenges for the implementation of Protected Mealtimes under clinical trial conditions to be described. Given our inability to implement the trial protocol fully due to the complexity of the mealtime environment and the lack of efficacy on nutritional intake, alternative approaches should be considered to resolve the problem of hospital malnutrition.