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

NCT ID: NCT01481064

Last Updated: 2013-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

870 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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Patient Centredness Quality of Life Risk Factors for Emotional Maladjustment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Multifaceted approach

Intervention Type BEHAVIORAL

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

Usual care

After baseline measurement no intervention will occur in these hospitals.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Multifaceted approach

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnant couples
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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A.G. Huppelschoten

OTHER

Sponsor Role lead

Responsible Party

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A.G. Huppelschoten

MD, Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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J Kremer, PhD

Role: STUDY_CHAIR

Radboud University Medical Center

W Nelen, PhD

Role: STUDY_DIRECTOR

Radboud University Medical Center

A Huppelschoten, MD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Radboud University Radboud Medical Centre

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 25750102 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23006997 (View on PubMed)

Other Identifiers

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R0000869

Identifier Type: -

Identifier Source: org_study_id

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