Improving patient-centredness in partnership with female patients: a cluster RCT in fertility care.
OBJECTIVE
What is the effect of a multifaceted intervention with participation of patients on improvement of patient-centredness in fertility care?


CONCLUSIONS
A multifaceted intervention with participation of patients did not improve total patient-centredness scores provided by women in fertility care.


BACKGROUND
We should provide care that takes into account the preferences and needs of patients, i.e. patient-centred care. Especially infertile patients who suffer from a high emotional burden of treatment could benefit from a more patient-centred approach in healthcare. However, the improvement of patient-centred care is still needed, because effective strategies to come to improvement are lacking.


METHODS
A cluster RCT was performed within 32 Dutch fertility clinics, covering about one-third of all Dutch hospitals. After randomization, 16 clinics in the intervention group were exposed to a multifaceted improvement strategy for patient-centred fertility care for 1 year. This strategy comprised audit and feedback, educational outreach visits and patient-mediated interventions. The remaining 16 clinics in the control group performed care as usual.


METHODS
The clinics' levels of patient-centredness were measured, using the validated Patient-centredness Questionnaire-Infertility (PCQ-Infertility). At baseline measurement, a total of 1620 women in couples undergoing fertility care (this included both male, female, mixed infertility and infertility of unknown cause) in one of the participating clinics were randomly selected to participate in the study and complete the questionnaire. For the after measurement, we randomly selected a comparable sample of 1565 women in infertile couples. Both women who had already started their treatment before the start of the study (67%) and women who started their treatment after the start of this study (33%) were included. To avoid bias, we only included the responses of non-pregnant respondents.


RESULTS
The final analysis involved 30 clinics. A total of 946 women (response 58.4%) completed their questionnaire at baseline measurement and also a total of 946 women (response 60.4%) at after measurement. After excluding the pregnant patients, respectively 696 and 730 questionnaires were eligible for analysis at baseline and after measurement. The total score of case-mix adjusted PCQ-Infertility at after measurement did not differ significantly between the intervention and control group (B = 0.06; 95% confidence interval (CI) = -0.04-0.15; P = 0.25). However, scores on the continuity of care subscale were significantly higher in the intervention group compared with the control group (B = 0.20; 95% CI = 0.00-0.40; P < 0.05). The addition of three interaction terms to the model had a significant impact: (i) being younger than 36 years, (ii) beginning treatment after the study had started and (iii) using complementary and alternative medicine. If women met all three conditions, the scores in the intervention group were on average 0.31 points higher compared with the control group (95% CI = 0.14-0.48; P = <0.001).


CONCLUSIONS
Our response rates are sufficient, but the responses of many women are still lacking which might have biased our results. Furthermore, the PCQ-Infertility scores at baseline measurement were already reasonably high, which could have limited the effect of the multifaceted improvement strategy. Because we only included women in infertile couples in our study, we cannot draw conclusions on the effect of an improvement strategy for patient-centred fertility care for partners.


CONCLUSIONS
A multifaceted intervention with participation of patients did not improve total patient-centredness scores, although some effect could be observed in specific groups of women and in specific dimensions of patient-centredness. These results can guide future research, in which we should focus more on personalized strategies and outcome measures.


BACKGROUND
This work was supported by Merck Sharp & Dohme (MSD), The Netherlands. There are no competing interests.


BACKGROUND
Clinical Trials NCT01481064.
Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB Nijmegen, The Netherlands dana.huppelschoten@radboudumc.nl.
Aleida G
AG
Huppelschoten
Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB Nijmegen, The Netherlands.
Willianne L D M
WL
Nelen
IQ Healthcare, Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB Nijmegen, The Netherlands.
Gert P
GP
Westert
Department of Obstetrics and Gynaecology, Maastricht University Medical Centre, Maastricht, PO Box 5800, 6202 AZ Maastricht, The Netherlands.
Ron J T
RJ
van Golde
Department of Epidemiology, Biostatistics and HTA, Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB Nijmegen, The Netherlands.
Eddy M M
EM
Adang
Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB Nijmegen, The Netherlands IQ Healthcare, Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB Nijmegen, The Netherlands.
Jan A M
JA
Kremer
D000328:Adult; D003625:Data Collection; D005260:Female; D006801:Humans; D007246:Infertility / Q000628:therapy*; D009426:Netherlands; D018802:Patient-Centered Care; D011247:Pregnancy; D011256:Pregnancy Outcome; D027724:Reproductive Techniques, Assisted; D012107:Research Design; D018401:Sample Size; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
RCTs; audit and feedback; improvement strategy; multifaceted approach; patient-centredness