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

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ClinicalTrials.gov Identifier: NCT00119925
Recruitment Status : Unknown
Verified October 2008 by Radboud University.
Recruitment status was:  Recruiting
First Posted : July 14, 2005
Last Update Posted : October 29, 2008
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Radboud University

Tracking Information
First Submitted Date  ICMJE July 5, 2005
First Posted Date  ICMJE July 14, 2005
Last Update Posted Date October 29, 2008
Study Start Date  ICMJE October 2005
Estimated Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2008)
  • 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 ]
  • Costs of both Implementation strategies [ Time Frame: half year after intervention ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 7, 2005)
  • Extent of guideline adherence after approximately one year (measured by a specific set of guideline-derived indicators, formulated beforehand by the research group)
  • Costs of both Implementation strategies
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2008)
Psychosocial patient characteristics after one year: fear, depression, satisfaction [ Time Frame: half year after intervention ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2005)
Psychosocial patient characteristics after one year: fear, depression, satisfaction
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 'SPRING'-Study: "Subfertility Guidelines: Patient Related Implementation in the Netherlands Among Gynaecologists"
Official Title  ICMJE Cost Effectiveness of Two Different Strategies to Implement the NVOG Guideline Programme on Subfertility
Brief Summary 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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Condition  ICMJE
  • Male Infertility
  • Female Infertility
  • Ovarian Hyperstimulation Syndrome
  • Premature Ovarian Failure
  • Endometriosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: minimal intervention
    professional audit and feedback on current practice
    Intervention: Behavioral: professional audit and feedback (guideline adherence)
  • Active Comparator: maximal intervention
    multi-faceted intervention consisting of professional and patient elements
    Interventions:
    • Behavioral: patient education
    • Behavioral: professional audit and feedback (guideline adherence)
    • Behavioral: professional education (communication/shared decision making)
    • Other: information tools
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 7, 2005)
5200
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2009
Estimated Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00119925
Other Study ID Numbers  ICMJE SPRING 2005-01
ZonMw grant no. 945-14-116
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party J.A.M. Kremer, dept. of Obstetrics and Gynecology
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE ZonMw: The Netherlands Organisation for Health Research and Development
Investigators  ICMJE
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
PRS Account Radboud University
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP