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 |