Nurse-based counselling on thirst in patients with advanced chronic heart failure : Study protocol for a pilot before-after study and process evaluation.

BACKGROUND: Many patients with chronic heart failure (CHF) are critically ill and experience increased thirst. Study aims are to develop and evaluate a nurse-based counselling intervention to promote self-care competencies related to thirst in hospitalised patients with advanced CHF eligible or listed for heart transplantation. METHODS: A mixed-methods approach will be adapted with three study phases: (1) development of the nurse-based counselling intervention, (2) feasibility testing and training of nurses, and (3) implementation of the intervention and, evaluation of initial effects and process measures. In phase (1), interviews with hospitalised patients with advanced CHF listed for heart transplantation (n = 10), focus groups (n = 2) and a Germany-wide survey with nurses will be performed. In phase (2), experts experienced with caring for patients with advanced CHF and patients with advanced CHF will be consulted for content validation and pretest of the counselling intervention. The training concept for nurses will be evaluated using questionnaires. In phase (3), a pilot before-after study will be conducted (n = 60). Primary patient-related outcome for the pilot study is thirst intensity using a numeric rating scale. Furthermore, a process evaluation (interviews with patients [n = 10], survey with nurses and physicians) will be performed. Quantitative data will be analysed descriptively, and qualitative data will be analysed using content analysis. Mean values of thirst intensity of the individual measurement points will be evaluated as interrupted time-series analysis using regression analyses. CONCLUSION: The development and implementation of a counselling intervention is influenced by various factors. Therefore, it is important to consider all factors throughout the process from development to evaluation.