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Table 3 Intervention fidelity strategies

From: An evidence-based shared decision making programme on the prevention of myocardial infarction in type 2 diabetes: protocol of a randomised-controlled trial

Category [22] Goals [22] Elements of the ISDM study
Design of study • Ensure same treatment dose within conditions. • Curriculum and media are standardised for both study arms
• Ensure equivalent dose across conditions. • Intervention and control-intervention are similar in framing, duration and structure
• Plan for implementation setbacks • For both intervention and control-intervention, two diabetes educators are trained to ensure the completion of the counselling sessions
Training providers • Standardize training • All diabetes educators are trained in standardised train-the-trainer sessions
• Ensure provider skill acquisition
• Minimize “drift” in provider skills • Educational material is standardised
• Optimal patient counselling is demonstrated
• Accommodate provider differences (adequate level of training, skills, experience and professional background) • Providers practise counselling under supervision of a research fellow and subsequent feedback
• Providers assess the patient knowledge questionnaire to ensure skill acquisition
Delivery of intervention • Control for provider differences • Counselling sessions are video-taped, constantly analysed, and fed back by a research fellow
• Reduce differences within treatment • Counselling protocol: deviation from curriculum (duration, material use, content, didactics) is documented
• Ensure adherence to protocol
• Minimize contamination between conditions
Receipt of intervention • Ensure participant knowledge • Questionnaire cards at the end of the counselling session. If there are difficulties in understanding, the diabetes educator discusses and corrects the answer and repeats the information
• Ensure participant ability to use cognitive skills
• Ensure participant ability to perform behavioural skills
Enactment of treatment skills • Ensure participant use of cognitive skills • Patients set individual treatment goals for heart attack prevention
• Ensure participant use of behavioural skills • If patients make treatment decisions that differ from their current treatment goals a physician is consulted for clarification