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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