Table 2 Stages of the intervention
Stage | Purpose | Activities |
|---|---|---|
Stage 0: preclinical: model development | To develop an intervention model based on theoretical understanding and empirical research | In the North Denmark region general practice, a complex strategy for new low back pain guideline implementation will be tested to study behaviour change (professional practice) and clinical results (patient outcomes). |
Stage I: testing and remodelling | Experiments with activities of the intervention in artificial settings | Testing and remodelling structural medical record changes including GP testing of STarT and SOS with patients. Testing and remodelling different questionnaires on volunteers without LBP, GPs, researchers, and patients. Testing and remodelling LBP patient completed questionnaires. Developing electronic generated feedback quality reports for GPs. Testing and remodelling facilitator visits, and feedback procedures on facilitator training sessions. |
Stage II: maximum variation studies | Full package intervention in selected units of the target group with close monitoring | Full package delivery of facilitator visit at a general practice, use of stratifying tools and changes in the medical record. Inviting patients to electronic or paper version questionnaire. Monitor whether data imputed in medical records and patient questionnaires will be stored at DAK-E, delivered to external database provider, and available for data retrieval. |
Stage III: efficacy studies | Cluster RCT with ideal intervention, delivery, randomisation, control group and close monitoring | Randomised controlled trial. Inclusion of provider numbers and patients. Use of guideline facilitator visits. Use of stratifying tools. Use of supervising facilitator contacts and feedback quality reports. Monitoring intervention delivery. Monitoring guideline compliance. Monitoring treatment courses. Monitoring GPs skills and beliefs. Measuring secondary care referral and patient related outcomes. |
Stage IV: effectiveness studies | Routine intervention delivery and ad hoc or routine monitoring | Cost-effectiveness analysis and other health economic analyses are planned and will be described in a separate protocol. |