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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
A.G. Huppelschoten, University Medical Center Nijmegen
ClinicalTrials.gov Identifier:
NCT01481064
First received: November 21, 2011
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Patient Centredness
Quality of Life
Risk Factors for Emotional Maladjustment
Behavioral: Multifaceted approach

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effect and Cost Evaluation of a Multifaceted Approach Including Audit and Feedback With a Patient-centredness Questionnaire in Fertility Care.

Further study details as provided by University Medical Center Nijmegen:

Primary Outcome Measures:
  • Change from baseline in the level of patient-centredness at one year [ Time Frame: one year ] [ Designated as safety issue: No ]
    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:
  • Change from baseline in patients' quality of life at one year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Differences in risk factors of emotional maladjustment at after measurement between control and intervention group will be determined.

  • Cost-effectiveness [ Time Frame: one year ] [ Designated as safety issue: No ]
    A cost-effectiveness analysis will be performed to evaluate efficiency of the multifaceted approach at different thresholds (cost-effectiveness acceptibility curve)


Estimated Enrollment: 870
Study Start Date: April 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Audit and feedback, educational outreach visits, and patient-mediated interventions.
No Intervention: Usual care
After baseline measurement no intervention will occur in these hospitals.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant couples
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481064

Locations
Netherlands
Radboud University Radboud Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
A.G. Huppelschoten
Investigators
Study Chair: J Kremer, PhD Radboud University
Study Director: W Nelen, PhD Radboud University
Principal Investigator: A Huppelschoten, MD Radboud University
  More Information

No publications provided by University Medical Center Nijmegen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: A.G. Huppelschoten, MD, Principal Investigator, University Medical Center Nijmegen
ClinicalTrials.gov Identifier: NCT01481064     History of Changes
Other Study ID Numbers: R0000869
Study First Received: November 21, 2011
Last Updated: July 22, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by University Medical Center Nijmegen:
Patient centredness
Quality of life
Multifaceted approach
Fertility care

ClinicalTrials.gov processed this record on August 21, 2014