'SPRING'-Study: "Subfertility Guidelines: Patient Related Implementation in the Netherlands Among Gynaecologists"
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Radboud University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Radboud University
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00119925
First received: July 5, 2005
Last updated: October 28, 2008
Last verified: October 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) |
| Official Title: | Cost Effectiveness of Two Different Strategies to Implement the NVOG Guideline Programme on Subfertility |
Resource links provided by NLM:
Genetics Home Reference related topics:
CATSPER1-related nonsyndromic male infertility
sensorineural deafness and male infertility
Turner syndrome
Y chromosome infertility
MedlinePlus related topics:
Endometriosis
Female Infertility
Infertility
Male Infertility
Premature Ovarian Failure
U.S. FDA Resources
Further study details as provided by Radboud University:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Costs of both Implementation strategies [ Time Frame: half year after intervention ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Psychosocial patient characteristics after one year: fear, depression, satisfaction [ Time Frame: half year after intervention ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Active Comparator: minimal intervention
professional audit and feedback on current practice
|
Behavioral: professional audit and feedback (guideline adherence)
feedback on current practice according to quality indicators
|
|
Active Comparator: maximal intervention
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00119925
Contacts
| 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 |
Locations
| Netherlands | |
| Gelre Ziekenhuizen | Recruiting |
| Apeldoorn, Netherlands | |
| Contact: Laurens j van Dam, MD +31-24-3610590 | |
| Rijnstate Ziekenhuis | Recruiting |
| Arnhem, Netherlands | |
| Contact: Alex P Schmoutziguer, MD +31-24-3610590 | |
| Maasziekenhuis Pantein | Recruiting |
| Boxmeer, Netherlands | |
| Contact: Ineke Minkhorst, MD +31-24-3610590 | |
| ZBC stichting Geertgen | Recruiting |
| de Mortel, Netherlands | |
| Contact: Henk Ruis, MD +31-24-3610590 | |
| 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 | |
| Ziekenhuis Gelderse Vallei | Recruiting |
| Ede, Netherlands | |
| Contact: Eduard Scheenjes, MD +31-243610590 | |
| Catharina Ziekenhuis | Recruiting |
| Eindhoven, Netherlands | |
| Contact: Peter A van Dop, MD, PhD +31-243610590 | |
| st Antonius Ziekenhuis | Recruiting |
| Nieuwegein, Netherlands | |
| Contact: Jules Schagen van Leeuwen, MD +31-24-3610590 | |
| Radboud University Nijmegen Medical Centre | Recruiting |
| Nijmegen, Netherlands, 6500HB | |
| Contact: Jan AM Kremer, MD, PhD +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 | |
| Rivierenland Ziekenhuis | Recruiting |
| Tiel, Netherlands | |
| Contact: Guido Muijsers, MD +31-24-3610590 | |
| Bernhoven Ziekenhuis | Recruiting |
| Veghel, Netherlands | |
| Contact: Mirjam van Rozendaal, MD +31-24-3610590 | |
| Maxima Medisch Centrum | Recruiting |
| Veldhoven, Netherlands | |
| Contact: Ben W Mol, MD +31-24-3610590 | |
| Streekziekenhuis Zevenaar | Recruiting |
| Zevenaar, Netherlands | |
| Contact: Vincent Blom, MD +31-243610590 | |
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
| 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
Additional Information:
No publications provided by Radboud University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | J.A.M. Kremer, dept. of Obstetrics and Gynecology |
| ClinicalTrials.gov Identifier: | NCT00119925 History of Changes |
| Other Study ID Numbers: | SPRING 2005-01, ZonMw grant no. 945-14-116 |
| Study First Received: | July 5, 2005 |
| Last Updated: | October 28, 2008 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
infertility guideline health care implementation intervention gynecology |
Additional relevant MeSH terms:
|
Infertility, Male Endometriosis Infertility Infertility, Female Menopause, Premature Primary Ovarian Insufficiency Ovarian Hyperstimulation Syndrome |
Genital Diseases, Female Genital Diseases, Male Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013