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| ID | Type | Description | Link |
|---|---|---|---|
| ZonMw grant no. 945-14-116 |
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| minimal intervention | Active Comparator | professional audit and feedback on current practice |
|
| maximal intervention | Active Comparator | multi-faceted intervention consisting of professional and patient elements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| patient education | Behavioral | patient leaflets about national guideline contents |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Psychosocial patient characteristics after one year: fear, depression, satisfaction | half year after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Selma M Mourad, MD | Contact | +31-24-3610590 | s.mourad@kwazo.umcn.nl | |
| Rosella PMG Hermens, MSc, PhD | Contact | +31-24-3613129 | R.hermens@kwazo.umcn.nl |
| Name | Affiliation | Role |
|---|---|---|
| Rosella PMG Hermens, MSc, PhD | Centre for Quality of Care Research | Principal Investigator |
| Jan AM Kremer, MD, PhD | Department of Obstetrics and Gynecology, Radboud University Nijmegen Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeroen Bosch Ziekenhuis | Recruiting | 's-Hertogenbosch | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21134950 | Derived | Mourad SM, Hermens RP, Liefers J, Akkermans RP, Zielhuis GA, Adang E, Grol RP, Nelen WL, Kremer JA. A multi-faceted strategy to improve the use of national fertility guidelines; a cluster-randomized controlled trial. Hum Reprod. 2011 Apr;26(4):817-26. doi: 10.1093/humrep/deq299. Epub 2010 Dec 6. |
| Label | URL |
|---|---|
| website of the Centre for Quality of Care (WOK) | View source |
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| professional audit and feedback (guideline adherence) |
| Behavioral |
feedback on current practice according to quality indicators |
|
| professional education (communication/shared decision making) | Behavioral | educational tools for professionals concerning communication and shared decision making |
|
| information tools | Other | tools and checklists to improve information provision |
|
| Didi D Braat, Prof. MD PhD | Department of Obstetrics and Gynecology, Radboud University Nijmegen Medical Centre | Study Chair |
| Richard PT Grol, Prof. PhD | Centre for Quality of Care Research | Study Chair |
| E Adang | Department of Medical Technology Assessment, Radboud University Nijmegen Medical Centre | Study Director |
| J MM van Lith, MD, PhD | Dutch Society of Obstetrics and Gynecology | Study Director |
| G Zielhuis, Prof PhD | Department of Epidemiology and Biostatistics, Radboud University Nijmegen Medical Centre | Study Director |
| Gelre Ziekenhuizen | Recruiting | Apeldoorn | Netherlands |
|
| Rijnstate Ziekenhuis | Recruiting | Arnhem | Netherlands |
|
| Maasziekenhuis Pantein | Recruiting | Boxmeer | Netherlands |
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| ZBC stichting Geertgen | Recruiting | De Mortel | Netherlands |
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| Slingeland Ziekenhuis | Recruiting | Doetinchem | Netherlands |
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| Ziekenhuis Gelderse Vallei | Recruiting | Ede | Netherlands |
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| Catharina Ziekenhuis | Recruiting | Eindhoven | Netherlands |
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| st Antonius Ziekenhuis | Recruiting | Nieuwegein | Netherlands |
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| Radboud University Nijmegen Medical Centre | Recruiting | Nijmegen | 6500HB | Netherlands |
|
| Canisius Wilhelmina Ziekenhuis | Recruiting | Nijmegen | Netherlands |
|
| Bernhoven Ziekenhuis | Recruiting | Oss | Netherlands |
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| Rivierenland Ziekenhuis | Recruiting | Tiel | Netherlands |
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| Bernhoven Ziekenhuis | Recruiting | Veghel | Netherlands |
|
| Maxima Medisch Centrum | Recruiting | Veldhoven | Netherlands |
|
| Streekziekenhuis Zevenaar | Recruiting | Zevenaar | Netherlands |
|
| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| D007247 | Infertility, Female |
| D016471 | Ovarian Hyperstimulation Syndrome |
| D016649 | Primary Ovarian Insufficiency |
| D004715 | Endometriosis |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| D019983 | Guideline Adherence |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017531 | Health Care Evaluation Mechanisms |
| D017530 | Health Care Quality, Access, and Evaluation |
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