Table 1 The MRC Framework applied for the development and evaluation of a complex intervention in diabetes care.
Phases | |||
|---|---|---|---|
Phase I- Preclinical theory (Why should the intervention work?) | |||
Content | Methods | Results | Publications |
- Collecting evidence on the effectiveness of multifaceted diabetes intervention programs – Identification of evidence on appropriate outcome indicators - Influence of local context | Review of systematic reviews on diabetes care programs in primary care, outpatient, community and hospital settings to identify: conceptual backgrounds of programs, goals, settings, type of program, type of interventions, type of indicators, (cost) effectiveness of programs and interventions | Overview of best choice of interventions and indicators, selection of conceptual model, overview of major confounders, overview of strategic design issues, overview of barriers to high-quality diabetes care at the macro, meso and micro level | [37] |
Phase II- Modeling (How does the intervention work?) | |||
Content | Methods | Results | Publications |
- Understanding of the pathways by which the problem is caused and sustained - Exploration of whether the pathways are amenable to change and, if so, at which points - Quantification of the potential for improvement (estimates of likely effect size) - Program development | - Stakeholder interviews to identify and understand barriers to high-quality diabetes care in the Belgian health care system and multidisciplinary team meetings to discuss program development | - Definition a multifaceted intervention/implementation strategy and outcome-indicators and local adaptation of the treatment protocol | [41] |
Phase III – Exploratory Trials (not performed) | |||
Phase IV – Randomized Controlled Trial | |||
The Diabetes Project Leuven (cluster randomized trial) | |||
Phase V – Long Term Implementation (not performed) | |||