Effect and Cost Evaluation of a Multifaceted Approach With a Patient-centredness Questionnaire in Fertility Care

Not Applicable

• Conditions: Patient Centredness; Quality of Life; Risk Factors for Emotional Maladjustment
• Interventions: Behavioral: Multifaceted approach

• Registration Number: NCT01481064
• Lead Sponsor: A.G. Huppelschoten

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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-11-21
• Study First Submitted QC: 2011-11-24
• Study First Posted: 2011-11-29
• Status Verified: 2013-07
• Primary Completion: 2013-07
• Last Update Submitted: 2013-07-22
• Last Update Posted: 2013-07-23
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 870

Inclusion Criteria

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

Exclusion Criteria

• Pregnant couples

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multifaceted approach	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in the level of patient-centredness at one year	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).

Secondary Outcome Measures

Name	Time	Method
Change from baseline in patients' quality of life at one year	1 year	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	1 year	Differences in risk factors of emotional maladjustment at after measurement between control and intervention group will be determined.
Cost-effectiveness	one year	A cost-effectiveness analysis will be performed to evaluate efficiency of the multifaceted approach at different thresholds (cost-effectiveness acceptibility curve)

Trial Locations

Locations (1)

Radboud University Radboud Medical Centre; 🇳🇱 Nijmegen, Gelderland, Netherlands