Effect and Cost Evaluation of a Multifaceted Approach With a Patient-centredness Questionnaire in Fertility Care
Quality of Life
Risk Factors for Emotional Maladjustment
Behavioral: Multifaceted approach
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Effect and Cost Evaluation of a Multifaceted Approach Including Audit and Feedback With a Patient-centredness Questionnaire in Fertility Care.|
- Change from baseline in the level of patient-centredness at one year [ Time Frame: one year ] [ Designated as safety issue: No ]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).
- Change from baseline in patients' quality of life at one year [ Time Frame: 1 year ] [ Designated as safety issue: No ]Differences in the level of quality of life at after measurement between control and intervention group will be determined.
- Change from baseline in risk factors of emotional maladjustment at one year [ Time Frame: 1 year ] [ Designated as safety issue: No ]Differences in risk factors of emotional maladjustment at after measurement between control and intervention group will be determined.
- Cost-effectiveness [ Time Frame: one year ] [ Designated as safety issue: No ]A cost-effectiveness analysis will be performed to evaluate efficiency of the multifaceted approach at different thresholds (cost-effectiveness acceptibility curve)
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Multifaceted approach
After baseline measurement a multifaceted approach will start for 1 year, including audit and feedback, an educational outreach visit, and patient-mediated interventions.
Behavioral: Multifaceted approach
Audit and feedback, educational outreach visits, and patient-mediated interventions.
No Intervention: Usual care
After baseline measurement no intervention will occur in these hospitals.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481064
|Radboud University Radboud Medical Centre|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Study Chair:||J Kremer, PhD||Radboud University|
|Study Director:||W Nelen, PhD||Radboud University|
|Principal Investigator:||A Huppelschoten, MD||Radboud University|