Substudy 12 Executive Summary
Substudy 12: The Cost-Effectiveness of Home Versus Hospital Management of Feeding Difficulties in Preterm Infants
by Bonnie Stevens
The purpose of this study was to compare the cost, safety, and efficacy of supporting breast feeding in the hospital and home setting for term and preterm neonates. The overall goal was to determine the incremental costs and consequences to society associated with home-based compared to hospital-based support of breast feeding in term and preterm neonates in the first week of life. Data to support safe and efficacious management of these infants were collected.
This study has provided data about (a) the cost-effectiveness of managing breast feeding of term and preterm neonates in the first week of life, (b) the efficacy and safety of home care for these infants and mothers, (c) the mothers' satisfaction about hospital and home-based supportive nursing care and (d) the resources utilized by mothers of neonates while in the hospital and community settings. This work has provided insight into determining the most appropriate site for managing breast feeding problems for term and preterm neonates that may be used to establish evidence for practice (best practices). Eventually these data may contribute to the development of standards of care for these neonates and their mothers and influence the decisions of policy makers. Therefore, the target audience is broad and includes the consumer (mothers), the clinician (health care professionals), administrator (in the hospital and community), and policy makers at institutional and governmental levels.
A randomized control trial (RCT) design with prognostic stratification for gestational age (GA) at birth was used to study the problem. Eligible mother-infant pairs were stratified as term (> 37 weeks GA at birth) or preterm (35-37 weeks GA at birth) and randomly allocated to the experimental (EXP) or standard care (SC) group. Mother/ infants in the SC group were cared for in the hospital and were discharged using existing hospital discharge criteria at approximately 48-60 hours postpartum. Mother/infants in the EXP group were assessed at 24-36 hours postpartum and discharged home if they met the same discharge criteria. Each mother/infant pair in the EXP group was also scheduled to receive a minimum of 3 home visits from the community nurses (who were qualified as lactation consultants). Mothers in both groups were encouraged to use a preexisting 24-hour telephone help line and outpatient community breast feeding clinic. Economic and clinical (safety and efficacy) outcomes were measured at study entry (prior to randomization), at hospital discharge and at a seven-day follow-up session. Both quantitative and qualitative methods for data collection and analysis were employed.
The findings for the term and preterm infants were analyzed independently and therefore will be discussed separately.
The sample for the term group consisted of 101 mother-infant dyads, of whom 53 (52.5%) were in the EXP group and 48 (47.5%) were in the SC group. Direct family costs (i.e., the amount by which the family and their friends paid out of pocket) and indirect family costs (i.e., time missed from work in the labour market, from leisure, or from household work) were determined. Health care system costs including hospital delivery costs (i.e., costs of the hospital stay, including physician fees, overhead costs, labs), post-discharge systems costs (i.e., other costs to the system such as nursing visits, visits to the community physicians, lab tests, readmission costs, etc.), total system costs (i.e., costs of the hospital delivery plus post-discharge system costs). Societal costs (i.e., costs include total system costs plus direct and indirect family costs) were assessed. The SC and EXP groups only differed significantly in their post-discharge system costs (p<0.0001) (with greater costs to the EXP group). There was a trend towards significance in the direct family costs (p=0.1085) (with greater costs to the SC group). The groups did not differ significantly in their indirect family costs, hospital delivery costs, or total system costs.
Regarding clinical outcomes, the two groups differed significantly with respect to the proportion of infants who were exclusively breast fed at the follow-up visit (<0.0446) and the number of feeds that were exclusively breast feeding within the past 24 hours (p<0.0278), with the EXP group being breast fed more exclusively than the SC group on both accounts. In relation to maternal satisfaction, the mothers who were in the EXP group, were satisfied with early discharge and the quality of the home care that they received by the community nursing agency. They identified the following advantages: they were at home in a familiar and comfortable setting; they received specialized support for breast feeding and for infant care; they could be at home with other family members and they had faster recovery. Over 50% said there were no limitations with early discharge. Others said they were fearful of leaving the hospital too soon and were concerned about their own and their baby's health, there was a lack of support at home and not enough coverage from the visiting nurse on the weekends.
The mothers in the SC group stated that the benefits were that the hospital support was accessible and the environment was controlled. They also said they had parental preparation time and breast-feeding support. On the other hand, most mothers stated that the limitations of staying in the hospital environment was that the conditions in hospital were not conducive to adequate sleep and recovery and that the hospital staff were not supportive to their or their infant's needs.
The sample for the preterm group consisted of 37 mother-infant dyads, of whom 19 (51.4%) were in the experimental (EXP) group and 18 (48.7%) were in the standard care (SC) group. The SC and EXP groups did not differ on direct costs, indirect costs, hospital delivery costs, systems costs, total systems costs or societal costs. This is most likely reflective of the lack of a significant difference in duration of hospital stay between the two groups (as the infants did not meet the predetermined discharge criteria) and the small sample size. There were no statistically significant differences in any of the clinical outcomes, although similar to the term group, the EXP group had a higher proportion of infants who were exclusively breast fed. In relation to maternal satisfaction, the analyses of the qualitative data for the preterm group did not differ significantly from the term group, except that those mothers who were discharged early thought that the number and frequency of community nursing agency visits may not be sufficient.