Clinical trial NCT01820039: FertiScreen: an Online Application to Improve the Quality of Fertility Care
Official title: FertiScreen: an Online Application to Improve the Quality of Fertility Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Unexplained Subfertile Couples With a Good Prognosis.
Keywords: e-health intervention
infertility
primary care
referral rate
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2013-03-28
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness of the application: adherence to tailored expectant management
timeFrame: Two years
Secondary outcomes:
measure: experiences with FertiScreen
timeFrame: two years
Other outcomes:
measure: effects on quality of care
timeFrame: two years
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
state: PO Box 9101
Study officials:
affiliation: IQ Healthcare, UMC St Radboud, Nijmegen, The Netherlands
name: Jan AM Kremer, MD, PhD
role: STUDY_DIRECTOR
References: