|- candidate number||12262|
|- NTR Number||NTR3405|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-apr-2012|
|- Secondary IDs||80-82315-97-12014 ZonMw|
|- Public Title||Vergelijkend onderzoek naar het effect van een meervoudige strategie op het gebruik van voorspellende modellen en afwachtend beleid bij paren met vruchtbaarheidsproblemen.|
|- Scientific Title||Improving the implementation of tailored expectant management in subfertile couples: A cluster randomised trial.|
|- hypothesis||The aim of this study is to investigate how an increase in the implementation of tailored expectant management in Dutch fertility care can be best achieved. In this study we want to determine the effects of a multifaceted implementation strategy compared to usual care (no strategy) with regard to the number of couples with a good prognosis suitable for tailored expectant management. |
|- Healt Condition(s) or Problem(s) studied||Subfertility, Tailored expectant management, Prognostic models|
|- Inclusion criteria||1. Couples with unexplained subfertility or mild subfertility;|
2. Age between 18 and 38 years;
3. Referred by a general practitioner or on own initiative;
4. No previous fertility treatment in medical history;
5. A prognosis of more than 30 percent chance of natural conception within one year based on the prediction model of Hunault.
|- Exclusion criteria||1. Age 38 years or older;|
2. Fertility treatment in medical history;
3. Referred by another gynaecologist, fertility doctor;
4. Anovulation: Menstrual cycle of less than 24 days or more than 35 days / no menses for over 6 months;
5. Two-sided tubal pathology. Diagnosed by a HCG or laparoscopy;
6. Severe male subfertility. VCM< 3 million (< 3 x 10^6);
7. Couples with a prognosis of less than 30 percent chance of natural conception within one year based on the prediction model of Hunault.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2012|
|- planned closingdate||1-jan-2014|
|- Target number of participants||900|
|- Interventions||In this cluster randomized trial, 25 clinics and their allied general practitioner units are randomized between the intervention and control group. In the intervention group a multifaceted implementation strategy will be implemented for a period of one year while the control group provides care as usual. |
The multifaceted implementation strategy is developed based on the prior barrier and facilitator analysis. The strategy aims to improve the patients’ knowledge and create realistic expectations of treatment and possible benefits and harms, improving communication and counseling skills of the professionals and improving continuity of care. Therefore the implementation strategy will focus on 3 levels:
1. Patient-level: Education material in the form of leaflets, online information and a smartphone App;
2. Professionals-level: Audit and feedback of pre-randomisation data collection, educational outreach visits, communication training and a digital version of the prognostic model as an application for a smartphone;
3. Organisation-level: Local protocol and a local consensus processes.
The effect of the strategy will be evaluated by a pre- and post-randomization data collection and a process evaluation.
|- Primary outcome||The primary outcome is the effect of the strategy on the adherence to tailored expectant management. Measured by the difference in the percentage of couples with unexplained subfertility, with a good prognosis of spontaneous conception within one year (>30%), with tailored expectant management in the year before the intervention and during the intervention period.|
|- Secondary outcome||1. Treatment outcome related measures like ongoing pregnancy and multiple pregnancy rates, time to pregnancy;|
2. Process related measures like percentage transition of patients to another fertility centre and patient related outcome measures like quality of life (FertiQoL) and general experiences with fertility care such as information provision, respect for patients’ values and accessibility of care (Patient Centeredness Questionnaire Infertility);
3. A process related evaluation will assess the intensity of exposure to all the different strategy elements per patient, per clinic and per region. In addition, the feasibility and usefulness of all strategy elements will be evaluated;
4. We will investigate the cost-effectiveness of the multifaceted strategy to implement tailored expectant management. This economic evaluation compares a multifaceted implementation strategy to usual care and is done from a healthcare perspective.
|- Timepoints||The preparation will take 3 months. A pre-randomization data collection will be performed in all participating clinics, this data will be abstracted from medical records and questionnaires. This will take 4 months. The multifaceted strategy will be implemented for a period of nine to twelve months. During this period patients will be treated according to the local protocol. The after measurement will take 3 months and a process evaluation is also performed after the intervention period. The total duration of the study will be two years.|
|- Trial web site||http://www.studies-obsgyn.nl/improvement|
|- CONTACT FOR PUBLIC QUERIES||Drs. F.A.M. Kersten|
|- CONTACT for SCIENTIFIC QUERIES||Drs. F.A.M. Kersten|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Obstetrics and Gynaecology |
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Rationale:|
Prognostic models in reproductive medicine can help to identify subfertile couples that would benefit from fertility treatment. An expectant management in couples with a good chance of a natural conception prevents unnecessary treatment and is recommended in the ‘national network guideline subfertility’ of NVOG and NHG. However, actual implementation is not optimal, leaving a strong potential for improvement. In preparation of the present study, we have performed qualitative and quantitative studies among subfertile couples and professionals, in which we have identified several barriers and facilitators of tailored expectant management (TEM). The results of these studies have been used to develop an implementation strategy.
The main goal is to investigate how an increase in the implementation of tailored expectant management in Dutch fertility care can be best achieved. In this study we want to determine the effects of a multifaceted implementation strategy compared to usual care (no strategy) with regard to the number couples with a good prognosis suitable for tailored expectant management.
In a cluster randomized trial, 25 clinics and their allied general practitioner units will participate. The clinics and their allied general practitioners will be divided in six regions. Randomisation will be stratified for region. There will be randomised between the multifaceted implementation strategy versus usual care The strategy will be implemented for a period of one year. The effect of the strategy will be evaluated by a pre- and post-randomization data collection and a process evaluation.
Couples in primary and secondary care with unexplained subfertility with a good prognosis (>30%) for natural conception within one year based on the prediction model of Hunault.
Professionals who provide care for these couples such as general practitioners, fertility doctors and gynaecologists.
The multifaceted implementation strategy, developed based on the prior barrier and facilitator analysis, will focus on 3 levels:
1. Patient-level: Education materials;
2. Professionals-level: Audit and feedback, educational outreach visits, communication training and a digital version of the prognostic model as an application for a smartphone;
3. Organisation-level: Local protocol and a local consensus processes.
Main study parameters/endpoints:
The primary outcome will be adherence of tailored expectant management measured by percentage of couples with a good prognosis and a tailored expectant management.
Secondary outcomes: treatment outcome related measures, process related measures, patient related measures.
|- Main changes (audit trail)|
|- RECORD||19-apr-2012 - 4-mei-2012|