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Status unknownNCT01481064Updated Jul 23, 2013

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

An interventional study of Multifaceted approach in Patient Centredness, Quality of Life and Risk Factors for Emotional Maladjustment, sponsored by A.G. Huppelschoten. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-07-23.

Sponsored by A.G. Huppelschoten · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jul 2013), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
870
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Patient centredness
  • Quality of life
  • Multifaceted approach
  • Fertility care
03

In context

Lead sponsor

A.G. Huppelschoten is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnant couples
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
870 participants (estimated)

Study arms

  • Active comparator
    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.

    Behavioral: Multifaceted approach

  • No intervention
    Usual care

    After baseline measurement no intervention will occur in these hospitals.

Interventions

  • BehavioralMultifaceted approach

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

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: one year

Secondary outcomes

  1. 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.

    Time frame: 1 year

  2. 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.

    Time frame: 1 year

  3. Cost-effectiveness

    A cost-effectiveness analysis will be performed to evaluate efficiency of the multifaceted approach at different thresholds (cost-effectiveness acceptibility curve)

    Time frame: one year

07

Study locations

1 site
  • Radboud University Radboud Medical Centre
    Nijmegen, Gelderland 6500 HB, Netherlands
08

References and documents

Publications

  • 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. PubMed 25750102 ↗
  • 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. PubMed 23006997 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01481064
Lead sponsor
A.G. Huppelschoten
Responsible party
A.G. Huppelschoten (MD, Principal Investigator, University Medical Center Nijmegen) — Sponsor-investigator
First posted
Nov 29, 2011
Start date
Apr 2011
Primary completion
Jul 2013 (estimated)
Completion
Oct 2013 (estimated)
Last update
Jul 23, 2013

Study contacts

J Kremer, PhD
study chair · Radboud University Medical Center
W Nelen, PhD
study director · Radboud University Medical Center
A Huppelschoten, MD
principal investigator · Radboud University Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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