'SPRING'-Study: Subfertility Guidelines: Patient Related Implementation in the Netherlands Among Gynaecologists

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cost Effectiveness of Two Different Strategies to Implement the NVOG Guideline Programme on Subfertility

Conditions
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Male Infertility, Female Infertility, Ovarian Hyperstimulation Syndrome, Premature Ovarian Failure, Endometriosis

Intervention / Treatment
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* Behavioral: patient education
* Behavioral: professional audit and feedback (guideline adherence)
* Behavioral: professional education (communication/shared decision making)
* Other: information tools


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: minimal intervention<br>professional audit and feedback on current practice | Behavioral: professional audit and feedback (guideline adherence)<br>* feedback on current practice according to quality indicators<br>|
| Active Comparator: maximal intervention<br>multi-faceted intervention consisting of professional and patient elements | Behavioral: patient education<br>* patient leaflets about national guideline contents<br>Behavioral: professional audit and feedback (guideline adherence)<br>* feedback on current practice according to quality indicators<br>Behavioral: professional education (communication/shared decision making)<br>* educational tools for professionals concerning communication and shared decision making<br>Other: information tools<br>* tools and checklists to improve information provision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of guideline adherence after approximately one year (measured by a specific set of guideline-derived indicators, formulated beforehand by the research group) |  | half year after intervention | 
| Costs of both Implementation strategies |  | half year after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychosocial patient characteristics after one year: fear, depression, satisfaction |  | half year after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infertility, guideline, health care implementation, intervention, gynecology