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| Sponsors and Collaborators: |
Radboud University ZonMw: The Netherlands Organisation for Health Research and Development |
|---|---|
| Information provided by: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT00119925 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Male Infertility Female Infertility Ovarian Hyperstimulation Syndrome Premature Ovarian Failure Endometriosis |
Behavioral: patient education Behavioral: professional audit and feedback (guideline adherence) Behavioral: professional education (communication/shared decision making) Other: information tools |
| Study Type: | Interventional |
| Study Design: | Randomized, Double Blind (Subject, Caregiver), Historical Control, Parallel Assignment, Efficacy Study |
| Official Title: | Cost Effectiveness of Two Different Strategies to Implement the NVOG Guideline Programme on Subfertility |
| Estimated Enrollment: | 5200 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | May 2009 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
minimal intervention: Active Comparator
professional audit and feedback on current practice
|
Behavioral: professional audit and feedback (guideline adherence)
feedback on current practice according to quality indicators
|
|
maximal intervention: Active Comparator
multi-faceted intervention consisting of professional and patient elements
|
Behavioral: patient education
patient leaflets about national guideline contents
Behavioral: professional audit and feedback (guideline adherence)
feedback on current practice according to quality indicators
Behavioral: professional education (communication/shared decision making)
educational tools for professionals concerning communication and shared decision making
Other: information tools
tools and checklists to improve information provision
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Selma M Mourad, MD | +31-24-3610590 | s.mourad@kwazo.umcn.nl |
| Contact: Rosella PMG Hermens, MSc, PhD | +31-24-3613129 | R.hermens@kwazo.umcn.nl |
| Netherlands | |
| Radboud University Nijmegen Medical Centre | Recruiting |
| Nijmegen, Netherlands, 6500HB | |
| Contact: Jan AM Kremer, MD, PhD +31-24-3610590 | |
| Rijnstate Ziekenhuis | Recruiting |
| Arnhem, Netherlands | |
| Contact: Alex P Schmoutziguer, MD +31-24-3610590 | |
| Canisius Wilhelmina Ziekenhuis | Recruiting |
| Nijmegen, Netherlands | |
| Contact: Anton Franssen, MD +31-24-3610590 | |
| Bernhoven Ziekenhuis | Recruiting |
| Oss, Netherlands | |
| Contact: Jos Vollebergh, MD +31-243610590 | |
| Bernhoven Ziekenhuis | Recruiting |
| Veghel, Netherlands | |
| Contact: Mirjam van Rozendaal, MD +31-24-3610590 | |
| Rivierenland Ziekenhuis | Recruiting |
| Tiel, Netherlands | |
| Contact: Guido Muijsers, MD +31-24-3610590 | |
| st Antonius Ziekenhuis | Recruiting |
| Nieuwegein, Netherlands | |
| Contact: Jules Schagen van Leeuwen, MD +31-24-3610590 | |
| Maxima Medisch Centrum | Recruiting |
| Veldhoven, Netherlands | |
| Contact: Ben W Mol, MD +31-24-3610590 | |
| Gelre Ziekenhuizen | Recruiting |
| Apeldoorn, Netherlands | |
| Contact: Laurens j van Dam, MD +31-24-3610590 | |
| Streekziekenhuis Zevenaar | Recruiting |
| Zevenaar, Netherlands | |
| Contact: Vincent Blom, MD +31-243610590 | |
| Catharina Ziekenhuis | Recruiting |
| Eindhoven, Netherlands | |
| Contact: Peter A van Dop, MD, PhD +31-243610590 | |
| Jeroen Bosch Ziekenhuis | Recruiting |
| den Bosch, Netherlands | |
| Contact: Carl Hamilton, MD +31-24-3610590 | |
| Slingeland Ziekenhuis | Recruiting |
| Doetinchem, Netherlands | |
| Contact: Eveline Tepe, MD +31-243610590 | |
| ZBC stichting Geertgen | Recruiting |
| de Mortel, Netherlands | |
| Contact: Henk Ruis, MD +31-24-3610590 | |
| Maasziekenhuis Pantein | Recruiting |
| Boxmeer, Netherlands | |
| Contact: Ineke Minkhorst, MD +31-24-3610590 | |
| Ziekenhuis Gelderse Vallei | Recruiting |
| Ede, Netherlands | |
| Contact: Eduard Scheenjes, MD +31-243610590 | |
| Principal Investigator: | 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 |
| Study Chair: | 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 Director: | 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 |
More Information
| Responsible Party: | dept. of Obstetrics and Gynecology ( J.A.M. Kremer ) |
| Study ID Numbers: | SPRING 2005-01, ZonMw grant no. 945-14-116 |
| Study First Received: | July 5, 2005 |
| Last Updated: | October 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00119925 History of Changes |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
infertility guideline health care implementation intervention gynecology |
|
Genital Diseases, Female Infertility Gonadal Disorders Infertility, Female Infertility, Male Ovarian Hyperstimulation Syndrome |
Endocrine System Diseases Ovarian Failure, Premature Endometriosis Endocrinopathy Ovarian Diseases Genital Diseases, Male |
|
Infertility Disease Gonadal Disorders Infertility, Male Endocrine System Diseases Endometriosis Ovarian Failure, Premature Ovarian Diseases |
Genital Diseases, Male Adnexal Diseases Genital Diseases, Female Pathologic Processes Infertility, Female Syndrome Ovarian Hyperstimulation Syndrome |
