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The purpose of this study is to evaluate the effects and costs of a multifaceted approach on the patient-centredness of fertility care and the quality of life of fertility patients.
Besides traditional outcomes as (cost)-effectiveness and safety, the Institute of Medicine calls patient-centredness as an independent outcome indicator to evaluate quality of healthcare. Nevertheless, within fertility care there is great variation in the delivery of patient-centred care and room for improvement.
The effects of a multifaceted approach on patient centredness and quality of life will be determined by a baseline and after measurement. Three questionnaires will be used to measure patient centredness (Patient Centredness Questionnaire-Infertility), Quality of Life (FertiQoL) and risk factors of emotional maladjustment(SCREENIVF). The multifaceted approach consists of: 1)audit and feedback, 2) educational outreach visits, and 3) patient-mediated interventions.
During one year the multifaceted approach is performed followed by an after measurement with the same questionnaires. The effects and costs of the multifaceted approach will be determined. Process evaluation will be performed to investigate feasibility and to study wether and to what extend patients and professionals used and appreciated the elements of the multifaceted approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multifaceted approach | Active Comparator | After baseline measurement a multifaceted approach will start for 1 year, including audit and feedback, an educational outreach visit, and patient-mediated interventions. |
|
| Usual care | No Intervention | After baseline measurement no intervention will occur in these hospitals. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multifaceted approach | Behavioral | Audit and feedback, educational outreach visits, and patient-mediated interventions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the level of patient-centredness at one year | Main outcome measure will be the difference in the level of patient-centredness after the multifaceted approach between control and intervention group. The level of patient-centredness will be determined by a patients' questionnaire (PCQ-Infertility). | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in patients' quality of life at one year | Differences in the level of quality of life at after measurement between control and intervention group will be determined. | 1 year |
| Change from baseline in risk factors of emotional maladjustment at one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J Kremer, PhD | Radboud University Medical Center | Study Chair |
| W Nelen, PhD | Radboud University Medical Center | Study Director |
| A Huppelschoten, MD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Radboud Medical Centre | Nijmegen | Gelderland | 6500 HB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25750102 | Derived | Huppelschoten AG, Nelen WL, Westert GP, van Golde RJ, Adang EM, Kremer JA. Improving patient-centredness in partnership with female patients: a cluster RCT in fertility care. Hum Reprod. 2015 May;30(5):1137-45. doi: 10.1093/humrep/dev041. Epub 2015 Mar 6. | |
| 23006997 | Derived | Huppelschoten AG, van Duijnhoven NT, Hermens RP, Verhaak C, Kremer JA, Nelen WL. Improving patient-centeredness of fertility care using a multifaceted approach: study protocol for a randomized controlled trial. Trials. 2012 Sep 24;13:175. doi: 10.1186/1745-6215-13-175. |
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Differences in risk factors of emotional maladjustment at after measurement between control and intervention group will be determined. |
| 1 year |
| Cost-effectiveness | A cost-effectiveness analysis will be performed to evaluate efficiency of the multifaceted approach at different thresholds (cost-effectiveness acceptibility curve) | one year |