Cost Effectiveness of Two Different Strategies to Implement the NVOG Guideline Programme on Subfertility
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 5,200
- Locations
- 16
- Primary Endpoint
- Extent of guideline adherence after approximately one year (measured by a specific set of guideline-derived indicators, formulated beforehand by the research group)
Study Overview
Brief Summary
The purpose of this study is to compare two different strategies to implement the existing Guideline programme on Subfertility, as issued by the Dutch Society of Obstetrics and Gynaecology (NVOG). Therefore, an innovative patient-directed strategy will be compared to a control strategy and effectiveness, costs and feasibility of both strategies will be assessed.
Detailed Description
The Dutch Society of Obstetrics and Gynaecology (NVOG) has developed a guideline programme on Subfertility, including 9 guidelines concerning diagnosis and treatment of subfertility and a national IVF protocol.
However, guidelines in general do not implement themselves; large gaps consists between best evidence (as described in the guidelines) and practice, resulting in a large variation between professionals.
Our study will compare an innovative patient-directed strategy with a (minimal intervention) control strategy, and effectiveness, costs and feasibility of both will be assessed. We eventually aim at the most cost-effective strategy to implement the existing subfertility guideline programme.
Please Note: In our protocol, we consider only 'couples' undergoing fertility treatment; therefore, we aim at gathering information from approximately 5200 records, of both male and female participants. When reporting eventually on their treatment, we will consider them only as couples, resulting in reported numbers of approximately 2600 participating couples.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •each patient, male or female, visiting the OPD for a subfertility related problem or treatment
- •each patient admitted to the hospital with complications of an infertility treatment
Exclusion Criteria
- •patients receiving insemination with donor sperm
- •patients receiving ICSI treatment
- •patients who are non-Dutch speaking or understand too little Dutch to fill out the questionnaires
Arms & Interventions
minimal intervention
professional audit and feedback on current practice
Intervention: professional audit and feedback (guideline adherence) (Behavioral)
maximal intervention
multi-faceted intervention consisting of professional and patient elements
Intervention: patient education (Behavioral)
maximal intervention
multi-faceted intervention consisting of professional and patient elements
Intervention: professional audit and feedback (guideline adherence) (Behavioral)
maximal intervention
multi-faceted intervention consisting of professional and patient elements
Intervention: professional education (communication/shared decision making) (Behavioral)
maximal intervention
multi-faceted intervention consisting of professional and patient elements
Intervention: information tools (Other)
Outcomes
Primary Outcomes
Extent of guideline adherence after approximately one year (measured by a specific set of guideline-derived indicators, formulated beforehand by the research group)
Time Frame: half year after intervention
Costs of both Implementation strategies
Time Frame: half year after intervention
Secondary Outcomes
- Psychosocial patient characteristics after one year: fear, depression, satisfaction(half year after intervention)