Patient CentrednessNCT01481064
Effect and Cost Evaluation of a Multifaceted Approach With a Patient-centredness Questionnaire in Fertility Care
A study testing Multifaceted approach in people with Patient Centredness and Quality of Life, run by A.G. Huppelschoten at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Centredness, Quality of Life, Risk Factors for Emotional Maladjustment
- What is being tested?
- Multifaceted approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 870 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing MAR-treatment (ovulation induction, intra-uterine inseminations, in vitro fertilization, or intra-cytoplasmic sperm injection).
Who cannot join
- Pregnant couples
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Radboud Medical Centre
Nijmegen, Gelderland, 6500 HB
About this study
Official title: Effect and Cost Evaluation of a Multifaceted Approach Including Audit and Feedback With a Patient-centredness Questionnaire in Fertility Care.
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.
- Being tested
- Multifaceted approach
- Keywords
- Patient centredness, Quality of life, Multifaceted approach, Fertility care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifaceted approachBehavioural
Audit and feedback, educational outreach visits, and patient-mediated interventions.
| Study group | Role | What they receive |
|---|---|---|
| Multifaceted approach | Active comparator | After baseline measurement a multifaceted approach will start for 1 year, including audit and feedback, an educational outreach visit, and patient-mediated interventions. Receives: Behavioral: Multifaceted approach |
| Usual care | No intervention | After baseline measurement no intervention will occur in these hospitals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one year
Secondary outcomes (3)
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.
Measured: 1 year
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.
Measured: 1 year
Cost-effectiveness
A cost-effectiveness analysis will be performed to evaluate efficiency of the multifaceted approach at different thresholds (cost-effectiveness acceptibility curve)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patient CentrednessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 870 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.G. Huppelschoten
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, A.G. Huppelschoten, University Medical Center Nijmegen
- Investigators
- J Kremer, PhD, Study chair, Radboud University Medical CenterW Nelen, PhD, Study director, Radboud University Medical CenterA Huppelschoten, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481064
- Sponsor's protocol ID
- R0000869
- Status last verified
- Jul 2013
- First submitted
- 21 Nov 2011
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
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 25750102Huppelschoten 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Cost Evaluation of a Multifaceted Approach Including Audit and Feedback With a Patient-centredness Questionnaire in Fertility Care.
- ClinicalTrials.gov ID
- NCT01481064
- Acronym / sponsor ID
- R0000869
- Keywords
- Patient centredness, Quality of life, Multifaceted approach, Fertility care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 870 participants (estimated)
- Lead sponsor
- A.G. HuppelschotenUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifaceted approach | Active comparator | Behavioral: Multifaceted approachAfter baseline measurement a multifaceted approach will start for 1 year, including audit and feedback, an educational outreach visit, and patient-mediated interventions. |
| Usual care | No intervention | –After baseline measurement no intervention will occur in these hospitals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing MAR-treatment (ovulation induction, intra-uterine inseminations, in vitro fertilization, or intra-cytoplasmic sperm injection).
Key exclusion criteria (1 listed)
- Pregnant couples
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multifaceted approachAudit and feedback, educational outreach visits, and patient-mediated interventions. | Behavioural | Multifaceted approach |
Primary outcome
Change from baseline in the level of patient-centredness at one year
Time frame: 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).
3 secondary outcomes
Change from baseline in patients' quality of life at one year
Time frame: 1 year
Change from baseline in risk factors of emotional maladjustment at one year
Time frame: 1 year
Cost-effectiveness
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2013.
- Derived from this study: PubMed 25750102Huppelschoten 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.
- Derived from this study: PubMed 23006997Huppelschoten 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifaceted approach in people with Patient Centredness and Quality of Life, run by A.G. Huppelschoten at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the level of patient-centredness at one year (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01481064, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2013.