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

October 28, 2008 updated by: Radboud University Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

5200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Apeldoorn, Netherlands
        • Recruiting
        • Gelre Ziekenhuizen
        • Contact:
          • Laurens j van Dam, MD
          • Phone Number: +31-24-3610590
      • Arnhem, Netherlands
        • Recruiting
        • Rijnstate Ziekenhuis
        • Contact:
          • Alex P Schmoutziguer, MD
          • Phone Number: +31-24-3610590
      • Boxmeer, Netherlands
        • Recruiting
        • Maasziekenhuis Pantein
        • Contact:
          • Ineke Minkhorst, MD
          • Phone Number: +31-24-3610590
      • Doetinchem, Netherlands
        • Recruiting
        • Slingeland Ziekenhuis
        • Contact:
          • Eveline Tepe, MD
          • Phone Number: +31-243610590
      • Ede, Netherlands
        • Recruiting
        • Ziekenhuis Gelderse Vallei
        • Contact:
          • Eduard Scheenjes, MD
          • Phone Number: +31-243610590
      • Eindhoven, Netherlands
        • Recruiting
        • Catharina Ziekenhuis
        • Contact:
          • Peter A van Dop, MD, PhD
          • Phone Number: +31-243610590
      • Nieuwegein, Netherlands
        • Recruiting
        • St Antonius Ziekenhuis
        • Contact:
          • Jules Schagen van Leeuwen, MD
          • Phone Number: +31-24-3610590
      • Nijmegen, Netherlands
        • Recruiting
        • Canisius Wilhelmina Ziekenhuis
        • Contact:
          • Anton Franssen, MD
          • Phone Number: +31-24-3610590
      • Nijmegen, Netherlands, 6500HB
        • Recruiting
        • Radboud University Nijmegen Medical Centre
        • Contact:
          • Jan AM Kremer, MD, PhD
          • Phone Number: +31-24-3610590
      • Oss, Netherlands
        • Recruiting
        • Bernhoven Ziekenhuis
        • Contact:
          • Jos Vollebergh, MD
          • Phone Number: +31-243610590
      • Tiel, Netherlands
        • Recruiting
        • Rivierenland Ziekenhuis
        • Contact:
          • Guido Muijsers, MD
          • Phone Number: +31-24-3610590
      • Veghel, Netherlands
        • Recruiting
        • Bernhoven Ziekenhuis
        • Contact:
          • Mirjam van Rozendaal, MD
          • Phone Number: +31-24-3610590
      • Veldhoven, Netherlands
        • Recruiting
        • Máxima Medisch Centrum
        • Contact:
          • Ben W Mol, MD
          • Phone Number: +31-24-3610590
      • Zevenaar, Netherlands
        • Recruiting
        • Streekziekenhuis Zevenaar
        • Contact:
          • Vincent Blom, MD
          • Phone Number: +31-243610590
      • de Mortel, Netherlands
        • Recruiting
        • ZBC stichting Geertgen
        • Contact:
          • Henk Ruis, MD
          • Phone Number: +31-24-3610590
      • den Bosch, Netherlands
        • Recruiting
        • Jeroen Bosch Ziekenhuis
        • Contact:
          • Carl Hamilton, MD
          • Phone Number: +31-24-3610590

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: professional audit and feedback (guideline adherence)
feedback on current practice according to quality indicators
Behavioral: patient education
patient leaflets about national guideline contents
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
half year after intervention
Costs of both Implementation strategies
Time Frame: half year after intervention
half year after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Psychosocial patient characteristics after one year: fear, depression, satisfaction
Time Frame: half year after intervention
half year after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Anticipated)

February 1, 2009

Study Completion (Anticipated)

May 1, 2009

Study Registration Dates

First Submitted

July 5, 2005

First Submitted That Met QC Criteria

July 7, 2005

First Posted (Estimate)

July 14, 2005

Study Record Updates

Last Update Posted (Estimate)

October 29, 2008

Last Update Submitted That Met QC Criteria

October 28, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPRING 2005-01
  • ZonMw grant no. 945-14-116

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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