TABLE 1.
Learning objectives.
| Learning objectives | |
|---|---|
| Scenario 1: Parents do not see the need for the study or find the requirements too rigorous | Establish a setting for the communication that is quiet, friendly and not associated with previous “bad news” experiences of the parents |
| Identify and eliminate risks like emotional states that prevent information transfer and subsequently successful communication | |
| Communicate the expected benefits of the mini tablets (IMP) over the currently used formulation of enalapril (e.g., facilitated by demonstrating the mini tablets) and the expected burden and risks involved in study participation in a language that meets the parents’ needs | |
| Detect motives for a rejection of research in general or the proposed study in particular and provide relevant information in a patient-centred and empathic way | |
| Scenario 2: Parents are not able to follow the informed consent discussion | Learning objectives 1‐3 plus |
| Identify barriers to comprehension and use supportive material like picture card etc. | |
| Facilitate parental questions and expression of concerns | |
| Prioritize on key information with highest importance for parents | |
| Schedule a follow-up appointment, if needed | |
| Scenario 3. Lack of a trustful relationship with the parents | Learning objectives 1‐3, 6 plus |
| Identify barriers to trust | |
| Use confidence-building body language and positive vocabulary (e.g., “research” instead of “clinical trial”) | |
| Actively involve study nurse, referring physician with lower barriers or pre-existing strong relationship to parents | |
| Scenario 4: Fear of invasive medical procedures | Learning objectives 1‐3, 6 plus |
| Identify reasons for fear without downplaying or concealing risks and burdens | |
| Explain how risks and burdens are kept to a minimum | |
| Point out that the study protocol has been approved by the ethics committee. | |
| Scenario 5: Uncooperative clinical staff | Learning objectives 1‐3 |
| Identify causes of negative reactions and address each single concern in a respectful way | |
| Define benefits and justify risks and burdens for participants and efforts for clinical and study staff | |
| Explain how risks, burdens and efforts are kept to a minimum | |
| Apply conflict management methods | |
| Scenario 6: Lack of confidence in the process by members of the study staff | Learning objectives 1‐3 |
| Identify the exact cause behind the lack of confidence | |
| Evaluate the need for information and provide it in respectful way | |
| Make own personal beliefs about the study transparent | |
| Use self-confident and positive wording and body language |