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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01481064
• Other study ID #: R0000869
• Status: Active, not recruiting
• Phase: N/A
• First received: November 21, 2011
• Last updated: July 22, 2013
• Start date: April 2011
• Est. completion date: October 2013

Study information

• Verified date: July 2013
• Source: University Medical Center Nijmegen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 870
• Est. completion date: October 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Patient Centredness
• Quality of Life
• Risk Factors for Emotional Maladjustment

Intervention

Behavioral:
• Multifaceted approach
Audit and feedback, educational outreach visits, and patient-mediated interventions.

Locations

Country	Name	City	State
Netherlands	Radboud University Radboud Medical Centre	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
A.G. Huppelschoten

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Change from baseline in risk factors of emotional maladjustment at one year	Differences in risk factors of emotional maladjustment at after measurement between control and intervention group will be determined.	1 year	No
Secondary	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	No