'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
Sponsor:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014