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

Endometriosis Clinical Trial

Official title:

Cost Effectiveness of Two Different Strategies to Implement the NVOG Guideline Programme on Subfertility

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00119925
• Other study ID #: SPRING 2005-01
• Secondary ID: ZonMw grant no.
• Status: Recruiting
• Phase: N/A
• First received: July 5, 2005
• Last updated: October 28, 2008
• Start date: October 2005
• Est. completion date: May 2009

Study information

• Verified date: October 2008
• Source: Radboud University
• Contact: Selma M Mourad, MD
• Phone: +31-24-3610590
• Email: s.mourad[@]kwazo.umcn.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5200
• Est. completion date: May 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver)

Related Conditions & MeSH terms

• Endometriosis
• Female Infertility
• Infertility
• Infertility, Female
• Infertility, Male
• Male Infertility
• Menopause, Premature
• Ovarian Hyperstimulation Syndrome
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

Behavioral:
• patient education
patient leaflets about national guideline contents
• professional audit and feedback (guideline adherence)
feedback on current practice according to quality indicators
• 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

Locations

Country	Name	City	State
Netherlands	Gelre Ziekenhuizen	Apeldoorn
Netherlands	Rijnstate Ziekenhuis	Arnhem
Netherlands	Maasziekenhuis Pantein	Boxmeer
Netherlands	ZBC stichting Geertgen	de Mortel
Netherlands	Jeroen Bosch Ziekenhuis	den Bosch
Netherlands	Slingeland Ziekenhuis	Doetinchem
Netherlands	Ziekenhuis Gelderse Vallei	Ede
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	st Antonius Ziekenhuis	Nieuwegein
Netherlands	Canisius Wilhelmina Ziekenhuis	Nijmegen
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen
Netherlands	Bernhoven Ziekenhuis	Oss
Netherlands	Rivierenland Ziekenhuis	Tiel
Netherlands	Bernhoven Ziekenhuis	Veghel
Netherlands	Maxima Medisch Centrum	Veldhoven
Netherlands	Streekziekenhuis Zevenaar	Zevenaar

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Costs of both Implementation strategies		half year after intervention	No
Secondary	Psychosocial patient characteristics after one year: fear, depression, satisfaction		half year after intervention	No

External Links

•   website of the Centre for Quality of Care (WOK)