This trial is active, not recruiting.

Conditions patient centredness, quality of life, risk factors for emotional maladjustment
Treatment multifaceted approach
Sponsor A.G. Huppelschoten
Start date April 2011
End date July 2013
Trial size 870 participants
Trial identifier NCT01481064, R0000869


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
(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.
multifaceted approach
Audit and feedback, educational outreach visits, and patient-mediated interventions.
(No Intervention)
After baseline measurement no intervention will occur in these hospitals.

Primary Outcomes

Change from baseline in the level of patient-centredness at one year
time frame: one year

Secondary Outcomes

Change from baseline in patients' quality of life at one year
time frame: 1 year
Change from baseline in risk factors of emotional maladjustment at one year
time frame: 1 year
time frame: one year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients undergoing MAR-treatment (ovulation induction, intra-uterine inseminations, in vitro fertilization, or intra-cytoplasmic sperm injection). Exclusion Criteria: - Pregnant couples

Additional Information

Official title Effect and Cost Evaluation of a Multifaceted Approach Including Audit and Feedback With a Patient-centredness Questionnaire in Fertility Care.
Principal investigator A Huppelschoten, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by University Medical Center Nijmegen.