Clinical trial NCT01481064: Effect and Cost Evaluation of a Multifaceted Approach With a Patient-centredness Questionnaire in Fertility Care
Official title: Effect and Cost Evaluation of a Multifaceted Approach Including Audit and Feedback With a Patient-centredness Questionnaire in Fertility Care.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient Centredness
Quality of Life
Risk Factors for Emotional Maladjustment
Keywords: Patient centredness
Quality of life
Multifaceted approach
Fertility care
Lead sponsor: University Medical Center Nijmegen
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 870
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing MAR-treatment (ovulation induction, intra-uterine inseminations, in vitro fertilization, or intra-cytoplasmic sperm injection).

Exclusion Criteria:

* Pregnant couples

Primary outcomes:
measure: Change from baseline in the level of patient-centredness at one year
timeFrame: one year
Secondary outcomes:
measure: Change from baseline in patients' quality of life at one year
timeFrame: 1 year
measure: Change from baseline in risk factors of emotional maladjustment at one year
timeFrame: 1 year
measure: Cost-effectiveness
timeFrame: one year
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Radboud Medical Centre
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: J Kremer, PhD
role: STUDY_CHAIR
affiliation: Radboud University Medical Center
name: W Nelen, PhD
role: STUDY_DIRECTOR
affiliation: Radboud University Medical Center
name: A Huppelschoten, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.