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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01481064
Enrollment
870
Registered
2011-11-29
Start date
2011-04-30
Completion date
2013-10-31
Last updated
2013-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Patient centredness, Quality of life, Multifaceted approach, Fertility 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.

Interventions

BEHAVIORALMultifaceted approach

Audit and feedback, educational outreach visits, and patient-mediated interventions.

Sponsors

A.G. Huppelschoten
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Pregnant couples

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in the level of patient-centredness at one yearone yearMain 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

MeasureTime frameDescription
Change from baseline in patients' quality of life at one year1 yearDifferences 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 year1 yearDifferences in risk factors of emotional maladjustment at after measurement between control and intervention group will be determined.
Cost-effectivenessone yearA cost-effectiveness analysis will be performed to evaluate efficiency of the multifaceted approach at different thresholds (cost-effectiveness acceptibility curve)

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026