Clinical trial NCT00119925: 'SPRING'-Study: "Subfertility Guidelines: Patient Related Implementation in the Netherlands Among Gynaecologists"
Official title: Cost Effectiveness of Two Different Strategies to Implement the NVOG Guideline Programme on Subfertility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Male Infertility
Female Infertility
Ovarian Hyperstimulation Syndrome
Premature Ovarian Failure
Endometriosis
Keywords: infertility
guideline
health care implementation
intervention
gynecology
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2005-07-14
Enrollment: 5200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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

Primary outcomes:
measure: Extent of guideline adherence after approximately one year (measured by a specific set of guideline-derived indicators, formulated beforehand by the research group)
timeFrame: half year after intervention
measure: Costs of both Implementation strategies
timeFrame: half year after intervention
Secondary outcomes:
measure: Psychosocial patient characteristics after one year: fear, depression, satisfaction
timeFrame: half year after intervention
Other outcomes:
Locations:
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuizen
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis
city: Boxmeer
country: Netherlands
facility: Maasziekenhuis Pantein
city: de Mortel
country: Netherlands
facility: ZBC stichting Geertgen
city: den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Doetinchem
country: Netherlands
facility: Slingeland Ziekenhuis
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: st Antonius Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
city: Oss
country: Netherlands
facility: Bernhoven Ziekenhuis
city: Tiel
country: Netherlands
facility: Rivierenland Ziekenhuis
city: Veghel
country: Netherlands
facility: Bernhoven Ziekenhuis
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Zevenaar
country: Netherlands
facility: Streekziekenhuis Zevenaar
Study officials:
affiliation: Centre for Quality of Care Research
name: Rosella PMG Hermens, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Obstetrics and Gynecology, Radboud University Nijmegen Medical Centre
name: Jan AM Kremer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Obstetrics and Gynecology, Radboud University Nijmegen Medical Centre
name: Didi D Braat, Prof. MD PhD
role: STUDY_CHAIR
affiliation: Centre for Quality of Care Research
name: Richard PT Grol, Prof. PhD
role: STUDY_CHAIR
affiliation: Department of Medical Technology Assessment, Radboud University Nijmegen Medical Centre
name: E Adang
role: STUDY_DIRECTOR
affiliation: Dutch Society of Obstetrics and Gynecology
name: J MM van Lith, MD, PhD
role: STUDY_DIRECTOR
affiliation: Department of Epidemiology and Biostatistics, Radboud University Nijmegen Medical Centre
name: G Zielhuis, Prof PhD
role: STUDY_DIRECTOR
References:
citation: 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.