Abstract
Background Day care is increasingly being used for complications of pregnancy, but there is little published evidence on its efficacy. We assessed the clinical, psychosocial, and economic effects of day care for three pregnancy complications in a randomised trial of day care versus standard care on an antenatal ward. Methods 395 women were randomly assigned day (263) or ward (132) care in a ratio of two to one, stratified for major diagnostic categories (non-proteinuric hypertension, proteinuric hypertension, and preterm premature rupture of membranes). The research hypothesis was that for these disorders, as an alternative to admission, antenatal day care will reduce specified interventions and investigations, result in no differences in clinical outcome, lead to greater satisfaction and psychological wellbeing, and be more cost-effective. Data were collected through case-note review, self-report questionnaires (response rates 81·0% or higher) and via the hospital's financial system. Analysis was by intention to treat. Findings All participants were included in the analyses. There were no differences between the groups in antenatal tests or investigations or intrapartum interventions. The total duration of antenatal care episodes was shorter in the day-care group than in the ward group (median 17 [IQR 5-9] vs 57 [35-123] h; p=0·001). Overall stay was also significantly shorter in the day-care group (mean 7·22 [SE 0·31] vs 8·53 [0·44]; p=0·014). The median number of care episodes was three (range one to 14) in the day-care group and two (one to nine) in the ward group (p=0·01). There were no statistically or clinically significant differences in maternal or perinatal outcomes. The day-care group reported greater satisfaction, with no evidence of unintended psychosocial sequelae. There was no significant difference in either average cost per patient or average cost per day of care. Interpretation Since clinical outcomes and costs are similar, adoption by maternity services of a policy providing specified women with the choice between admission and day-unit care seems appropriate.
| Original language | English |
|---|---|
| Pages (from-to) | 1104-1109 |
| Number of pages | 6 |
| Journal | Lancet |
| Volume | 363 |
| Issue number | 9415 |
| DOIs | |
| Publication status | Published or Issued - 3 Apr 2004 |
| Externally published | Yes |
ASJC Scopus subject areas
- General Medicine
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In: Lancet, Vol. 363, No. 9415, 03.04.2004, p. 1104-1109.
Research output: Contribution to journal › Article › peer-review
TY - JOUR
T1 - Clinical, psychosocial, and economic effects of antenatal day care for three medical complications of pregnancy
T2 - A randomised controlled trial of 395 women
AU - Turnbull, Deborah A.
AU - Wilkinson, Chris
AU - Gerard, Karen
AU - Shanahan, Marian
AU - Ryan, Philip
AU - Griffith, Elizabeth C.
AU - Kruzins, Gillian
AU - Stamp, Georgina E.
N1 - Funding Information: Antenatal day-care units are common in many tertiary referral hospitals in western Europe and are becoming increasingly popular in Australasia, presumably on the assumption that they will be more cost effective than the traditional model of inpatient care. This premise has until now been largely predicated on limited level-2 evidence, 21 observational research, 6 and opinion. 4 Of particular concern is the fact that the psychosocial effect of day care has thus far been largely neglected. The main limitation of this study is the reduction in power because only two-thirds of the required sample size was recruited (although the width of most of the CI suggests that the estimates are precise). We believe that the low recruitment was related mainly to changes in clinical practice during the course of the trial. We received feedback that, as clinicians observed women with the designated disorders being treated (supposedly) effectively as outpatients, they became progressively more reluctant to refer patients to a trial in which there was a one in three chance of hospital admission. The decision to stop the trial was made by the trial investigators and it was based solely on recruitment rates. The strengths of the trial include the complete enumeration of clinical data, the high questionnaire response rates, and the fact that about 95% of women in both trial groups received the model of care to which they had been assigned, thus minimising any dilution effect. Thus, the use of the Zelen method achieved its goal of ensuring that randomisation was practicable and acceptable to women in the context of a study in which one care option (day care) was likely to be popular. Although concealment of the study group allocation from the research midwife who collected the outcome data from the clinical notes was not possible, two approaches were used to minimise bias, including separation of the roles of the clinical and research midwives and the independent review for inter-rater reliability. The results indicate that day care can offer several benefits to women experiencing mild to moderate hypertension and PPROM late in pregnancy. Notably, it can reduce antenatal and overall stay without sacrificing reassurance or increasing stress. We had hypothesised that this shorter stay in hospital would result in fewer tests and investigations owing to better organisation and use of protocols, as well as reduced opportunities for unnecessary clinical intervention. Although there were no statistically significant reductions in this respect, the direction of effect frequently favoured the day-care group. The study, like most randomised controlled trials in the area of perinatal epidemiology, was not powered to provide definitive findings on rare outcomes such as perinatal mortality. Nevertheless, in relation to safety, we found no significant differences in maternal or perinatal outcomes, with the absolute difference never exceeding 5·5% and 3·5% respectively in the two groups. The cost of an episode of care and cost per day appeared similar across the two groups, which provides evidence that day care is at least as cost effective and possibly more so than standard care, given that all the outcomes were similar or favoured the day-care group. We had expected length of stay to be a major cost driver, but the opportunity within the antenatal period to affect overall resource use was in fact very small, with antenatal care amounting to only about a fifth of the costs of care in both groups. The main components of the largest cost category (postnatal costs) were inpatient care for mother and baby, including special and intensive-care-unit nursery costs, and readmissions and emergency-department visits occurring up to 42 days after delivery. The distribution of cost proportions, including postnatal costs (41·8% vs 36·4%) did not differ significantly between the two models of care. Collection of more definitive empirical evidence from a study designed to detect “equivalence” and with a single primary outcome measure would be worthwhile. 22,23 Future economic assessments should also examine in greater detail personal costs to find out whether the reduction in length of stay is offset by greater commitment of resources by women and their families. We suggest that the results of this trial might be generalisable to other common and slowly progressing medical complications of pregnancy such as diabetes and hyperemesis. Against a backdrop of similar clinical outcomes and costs, adoption by maternity services of a policy providing specified women with the choice between admission and day-unit care seems appropriate. Contributors This study was conceptualised and designed by all the investigators with D Turnbull and C Wilkinson taking the lead role. The economic data were analysed by K Gerard and M Shanahan. The clinical and psychosocial data were analysed by D Turnbull and C Wilkinson. All investigators contributed to the interpretation of the data. The report was prepared and modified by D Turnbull, with all authors contributing to and commenting on drafts. The final version was approved by all the authors. Conflict of interest statement None declared. Acknowledgments This study was funded by the National Health and Medical Research Council of Australia, Project Grant. We thank the women who took part in the study; Steve Brown, Women's and Children's Hospital (provision of costing data); Maria Swan (data collection); Ross Sweet, Women's and Children's Hospital (institutional support); and the midwives and obstetricians who supported the study.
PY - 2004/4/3
Y1 - 2004/4/3
N2 - Background Day care is increasingly being used for complications of pregnancy, but there is little published evidence on its efficacy. We assessed the clinical, psychosocial, and economic effects of day care for three pregnancy complications in a randomised trial of day care versus standard care on an antenatal ward. Methods 395 women were randomly assigned day (263) or ward (132) care in a ratio of two to one, stratified for major diagnostic categories (non-proteinuric hypertension, proteinuric hypertension, and preterm premature rupture of membranes). The research hypothesis was that for these disorders, as an alternative to admission, antenatal day care will reduce specified interventions and investigations, result in no differences in clinical outcome, lead to greater satisfaction and psychological wellbeing, and be more cost-effective. Data were collected through case-note review, self-report questionnaires (response rates 81·0% or higher) and via the hospital's financial system. Analysis was by intention to treat. Findings All participants were included in the analyses. There were no differences between the groups in antenatal tests or investigations or intrapartum interventions. The total duration of antenatal care episodes was shorter in the day-care group than in the ward group (median 17 [IQR 5-9] vs 57 [35-123] h; p=0·001). Overall stay was also significantly shorter in the day-care group (mean 7·22 [SE 0·31] vs 8·53 [0·44]; p=0·014). The median number of care episodes was three (range one to 14) in the day-care group and two (one to nine) in the ward group (p=0·01). There were no statistically or clinically significant differences in maternal or perinatal outcomes. The day-care group reported greater satisfaction, with no evidence of unintended psychosocial sequelae. There was no significant difference in either average cost per patient or average cost per day of care. Interpretation Since clinical outcomes and costs are similar, adoption by maternity services of a policy providing specified women with the choice between admission and day-unit care seems appropriate.
AB - Background Day care is increasingly being used for complications of pregnancy, but there is little published evidence on its efficacy. We assessed the clinical, psychosocial, and economic effects of day care for three pregnancy complications in a randomised trial of day care versus standard care on an antenatal ward. Methods 395 women were randomly assigned day (263) or ward (132) care in a ratio of two to one, stratified for major diagnostic categories (non-proteinuric hypertension, proteinuric hypertension, and preterm premature rupture of membranes). The research hypothesis was that for these disorders, as an alternative to admission, antenatal day care will reduce specified interventions and investigations, result in no differences in clinical outcome, lead to greater satisfaction and psychological wellbeing, and be more cost-effective. Data were collected through case-note review, self-report questionnaires (response rates 81·0% or higher) and via the hospital's financial system. Analysis was by intention to treat. Findings All participants were included in the analyses. There were no differences between the groups in antenatal tests or investigations or intrapartum interventions. The total duration of antenatal care episodes was shorter in the day-care group than in the ward group (median 17 [IQR 5-9] vs 57 [35-123] h; p=0·001). Overall stay was also significantly shorter in the day-care group (mean 7·22 [SE 0·31] vs 8·53 [0·44]; p=0·014). The median number of care episodes was three (range one to 14) in the day-care group and two (one to nine) in the ward group (p=0·01). There were no statistically or clinically significant differences in maternal or perinatal outcomes. The day-care group reported greater satisfaction, with no evidence of unintended psychosocial sequelae. There was no significant difference in either average cost per patient or average cost per day of care. Interpretation Since clinical outcomes and costs are similar, adoption by maternity services of a policy providing specified women with the choice between admission and day-unit care seems appropriate.
UR - http://www.scopus.com/inward/record.url?scp=1842580945&partnerID=8YFLogxK
U2 - 10.1016/S0140-6736(04)15893-5
DO - 10.1016/S0140-6736(04)15893-5
M3 - Article
C2 - 15064028
AN - SCOPUS:1842580945
SN - 0140-6736
VL - 363
SP - 1104
EP - 1109
JO - Lancet
JF - Lancet
IS - 9415
ER -