'SPRING'-Study: "Subfertility Guidelines: Patient Related Implementation in the Netherlands Among Gynaecologists"
Cost Effectiveness of Two Different Strategies to Implement the NVOG Guideline Programme on Subfertility
2 other identifiers
interventional
5,200
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2005
Longer than P75 for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2005
CompletedFirst Posted
Study publicly available on registry
July 14, 2005
CompletedStudy Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedOctober 29, 2008
October 1, 2008
3.3 years
July 5, 2005
October 28, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (1)
Psychosocial patient characteristics after one year: fear, depression, satisfaction
half year after intervention
Study Arms (2)
minimal intervention
ACTIVE COMPARATORprofessional audit and feedback on current practice
maximal intervention
ACTIVE COMPARATORmulti-faceted intervention consisting of professional and patient elements
Interventions
feedback on current practice according to quality indicators
educational tools for professionals concerning communication and shared decision making
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Gelre Ziekenhuizen
Apeldoorn, Netherlands
Rijnstate Ziekenhuis
Arnhem, Netherlands
Maasziekenhuis Pantein
Boxmeer, Netherlands
ZBC stichting Geertgen
De Mortel, Netherlands
Slingeland Ziekenhuis
Doetinchem, Netherlands
Ziekenhuis Gelderse Vallei
Ede, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
st Antonius Ziekenhuis
Nieuwegein, Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, 6500HB, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Bernhoven Ziekenhuis
Oss, Netherlands
Rivierenland Ziekenhuis
Tiel, Netherlands
Bernhoven Ziekenhuis
Veghel, Netherlands
Maxima Medisch Centrum
Veldhoven, Netherlands
Streekziekenhuis Zevenaar
Zevenaar, Netherlands
Related Publications (1)
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.
PMID: 21134950DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 5, 2005
First Posted
July 14, 2005
Study Start
October 1, 2005
Primary Completion
February 1, 2009
Study Completion
May 1, 2009
Last Updated
October 29, 2008
Record last verified: 2008-10