FertiScreen: an Online Application to Improve the Quality of Fertility Care

Objectives The investigators present an online application to empower and inform patients and improve guideline adherence in unexplained subfertility. Thereby the investigators expect to reduce overtreatment in fertility care with higher quality of care.

Methods The investigators conduct a prospective cohort study including couples with a diagnosis of unexplained subfertility. Couples consulting their general practitioner with an unfulfilled child wish will be offered to use FertiScreen. FertiScreen is an online application, in which patients are asked questions about their fertility problem (ie menstrual cycle, age, duration of child wish and the results of the Chlamydia Trachomatis antibody titre and semen analysis). FertiScreen then uses the validated prediction model of Hunault to calculate couples' chance of natural conception during the next twelve months. In addition, patients can find links to extra information concerning subfertility. Couples can then initiate an online consultation with their general practitioner and a gynaecologist, in order to discuss their results and prognosis. When the calculated prognosis of spontaneous conception within one year is >30%, tailored expectant management for 6-12 months will be advised, as no benefit can be expected from fertility treatment.

Questionnaires will be sent to patients as well as to their caregivers (general practitioner, gynaecologist). These questionnaires will focus on the use of FertiScreen (System Usability Scale) and the different domains of quality of care (effectiveness, cost-effectiveness, safety, patient-centredness). For the latter, the investigators use the Hospital Anxiety and Depression Scale and the Patient Centredness Questionnaire for Infertility.

In order to be able to draw conclusions, the investigators will conduct a baseline measurement among couples with unexplained subfertility who have been referred to a fertility clinic. Their data will be abstracted from their medical records and they will receive the aforementioned questionnaires as well (except for the System Usability Scale).

The investigators will recruit couples presenting to general practitioners in the Nijmegen area (which for second line treatment consists of one general hospital and one academic hospital). To detect an increase in guideline adherence of the current 60% to 75% with a power of 80% (P<0,05), the investigators need to include 152 couples in the before as well as in the after measurement.

Study Overview

• Status: Unknown
• Conditions: Unexplained Subfertile Couples With a Good Prognosis.
• Intervention / Treatment: Other: FertiScreen

• Study Type: Interventional
• Enrollment (Anticipated): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • PO Box 9101
    • Nijmegen, PO Box 9101, Netherlands, 6500 HB
      • Recruiting
      • Radboud University Nijmegen Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 37 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• couple consulting their general practitioner with subfertility
• women >18 years and <38 years
• one of the partners Dutch speaking
• access to the Internet
• residing in the Netherlands
• unfulfilled childwish for at least 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FertiScreen; all patients between 18 and 38 years, consulting their general practitioner for infertility will be asked to use FertiScreen.	Other: FertiScreen; FertiScreen is an online application to assess whether referral is necessary or expectant management is indicated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of the application: adherence to tailored expectant management	The adherence to tailored expectant management: measured by the percentage of patients with unexplained infertility with a good prognosis of spontaneous conception within one year (>30%) with tailored expectant management.	Two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
experiences with FertiScreen	Among the patients the focus will be on ease of use, speed of use, sense of privacy, the extent to which the experience meet previous expectations and the recognisability of the given advise. Among health care providers, the evaluation will focus on the experienced changes in the daily care.	two years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
effects on quality of care	Efficiency: economic analysis (number of consultations in the second line and the number of diagnostic tests carried out. Safety: we will measure complaints of anxiety and depression and quality of life at a patient level. Future implications: we will give advises for implementation strategy to optimize use of FertiScreen.	two years

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Study Director: Jan AM Kremer, MD, PhD, IQ Healthcare, UMC St Radboud, Nijmegen, The Netherlands

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): May 1, 2015
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: March 14, 2013
• First Submitted That Met QC Criteria: March 25, 2013
• First Posted (Estimate): March 28, 2013

Study Record Updates

• Last Update Posted (Estimate): December 16, 2013
• Last Update Submitted That Met QC Criteria: December 13, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: infertility; primary care; e-health intervention; referral rate
• Other Study ID Numbers: FertiScreen

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No