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.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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PO Box 9101
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Nijmegen、PO Box 9101、オランダ、6500 HB
- 募集
- Radboud University Nijmegen Medical Centre
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:ヘルスサービス研究
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:FertiScreen
all patients between 18 and 38 years, consulting their general practitioner for infertility will be asked to use FertiScreen.
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FertiScreen is an online application to assess whether referral is necessary or expectant management is indicated.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Effectiveness of the application: adherence to tailored expectant management
時間枠:Two years
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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.
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Two years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
experiences with FertiScreen
時間枠:two years
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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.
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two years
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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effects on quality of care
時間枠:two years
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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
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協力者と研究者
捜査官
- スタディディレクター:Jan AM Kremer, MD, PhD、IQ Healthcare, UMC St Radboud, Nijmegen, The Netherlands
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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