Aim and hypotheses
This is a multi-centre randomized controlled trial (RCT), blinded for research team for primary outcome measurement. The primary aim of the RCT is to evaluate the effectiveness of proactive person-centred telephone support provided to breastfeeding mothers of preterm infants for up to 14 days after hospital discharge from NICUs on exclusive breastfeeding. We hypothesize that proactive (health service initiated) telephone support offered to breastfeeding (exclusive or partial) mothers of preterm infants after hospital discharge is more effective than reactive (mother initiated, and defined as usual care) telephone support at increasing the proportion of mothers who are exclusively breastfeeding 8 weeks after discharge.
The secondary aim is to evaluate the effectiveness and cost-effectiveness of proactive telephone support on breastfeeding (exclusive, partial, none and method of feeding), mothers satisfaction with breastfeeding, attachment, parental stress and quality of life in mothers/partners at 8 weeks after hospital discharge and at six months postnatal age. We hypothesize that breastfeeding, maternal satisfaction with breastfeeding and attachment, parental stress, and quality in life will be improved in mothers and partners who receive proactive telephone support. In addition, a qualitative evaluation will be performed, by interviewing mothers and staff on their experiences of receiving and delivering proactive person-centred telephone support respectively.
This intervention has been piloted by Professor Hoddinott and colleagues on a postnatal ward in Scotland [33
]. The implementation, experiences, process evaluation and results from that pilot have provided this planned RCT with important knowledge, crucial for the design. For example, the pilot study reported a 0.23 effect size in breastfeeding 6–8 weeks and that the median telephone call time was 5 minutes.
For the purpose of this trial, we have used the following definitions. Breastfeeding refers to a mother providing any breast milk to her infant, regardless of method. Exclusive breastfeeding refers to only breast milk with no other fluids or solids except for medications and vitamins, given to the infant in the previous 24 hours. Partial breastfeeding refers to breast milk and infant formula, given to the infant in the previous 24 hours.
Person-centred care is defined as building mutual trust and understanding between caregiver and person; treating the person as an individual; respecting the rights of the person, sharing decision-making, providing holistic care and developing therapeutic relationships. The care provider should also engage with and have a sympathetic presence with the person.
The study setting will be four general or referral NICUs level IIIa or IIIb [35
], geographically spread over Sweden. Eligible participants for randomization are mothers with preterm infants (< 37 gestational weeks), admitted to one of the four selected NICUs for at least 48 hours and who breastfeed or express breast milk. Exclusion criteria: serious maternal medical or psychiatric problems at discharge; language problems that cannot be resolved; the infant is transferred to another hospital/unit after discharge; infants that are terminally ill.
Sample size calculation
A priori power analysis has been calculated to determine an adequate sample size for the study. This is a study of independent cases and controls with 1 control per case. Prior data indicate that the exclusive breastfeeding rate at two months of corrected age in preterm infants is 0.53. If the true exclusive breastfeeding rate for intervention mothers is 0.615 (effect size 0.085), we will need to study 531 intervention mothers and 531 control mothers to be able to reject the null hypothesis that the exclusive breastfeeding rates for intervention and control mothers are equal with a probability (power) of 0.8, using the Chi-square test. The Type I error probability associated with this test of the null hypothesis is 0.05. We estimate that the drop-out rate will be 5%, therefore requiring an additional 54 mothers. In total we need a sample size of at least 1116 mothers (I: 558, C: 558). The trial is also powered for the subgroup, low SES mothers. It is estimated that the study period will be 18 months.
Recruitment of the breastfeeding support team
A breastfeeding support team (BST) will be set up in each of the four NICUs (7 staff members/each unit). In the selection of BST members, personal qualities (e.g. warm personality, organizational skills) and willingness to be part of the team are important. The selection will be conducted differently in the NICUs depending on the NICU’s organization, culture in constituting ‘groups’ and feasibility.
Recruitment procedure for participants
The BST members at each NICU will inform eligible mothers and their partners, verbally and in writing, about the study, 1–2 weeks prior to the infant’s potential discharge. Mothers who consent to participate in the study will be randomly allocated immediately after hospital discharge (within 24 h) to one of two groups; intervention (I), or control group (C).
Mothers who meet the inclusion criteria and who provide consent will be randomized to either the proactive (I) or reactive (C) telephone support group. Each mother will be assigned an identification code when they consent to participate, which will be used at randomization and on all questionnaires. The randomization is done by the BST immediately after discharge (within 24 h) by an automated and secure web-based system administrated independent of the research team. A stratified block randomization will be used, with blocks of 25 high SES and 25 low SES mothers at each participating NICU. The randomization takes place after the BST have collected baseline birth, feeding and socio-demographic data so that the BST or mothers will not be biased by knowing the group assignment. The mothers will be informed of their randomization group immediately following randomization by a telephone call or text message. The study outline is presented in Figure .
Flowchart on the progress of the study.
The intervention in this study is proactive telephone support initiated by the BST based at the NICU from which the infant is discharged. Daily phone calls from a member of the BST to the mother will be performed from day 1 until day 14 after discharge. In addition, the mother has the option to call someone in the BST during the same period (reactive telephone support). The telephone support will be conducted with a person-centered approach, as defined earlier and will aim to provide continuity of care. Thus, the mother is enabled to talk about whatever feels important to her and establish a trusting relationship with BST members.
The control group will be offered the opportunity for person-centred reactive telephone support initiated by the mother who can phone the support team from day 1 after discharge until day 14 after discharge, 08.00-16.00 every day. Each NICU will set up a specific telephone number for their telephone support, and schedule BST members to be available. The same level of person-centeredness will be provided for the mothers in the control group (reactive) as mothers in the intervention group (proactive).
The BST members at each site will be educated in a two-day course prior study start provided by the first and last author. The course includes theoretical sessions on becoming a mother in a NICU environment, person centered care and breastfeeding physiology. It also includes a practical session on telephone support (including in how to handle cases when triage to other pathways are needed), and a seminar on research methodology with focus on conducting a RCT. The BST members will receive in-depth information about the study and instructions to procedures for handling informed consent, protocols, log books, baseline questionnaire and telephone systems.
Each unit will keep a Log-book, in which the BST will record data on all infants admitted to the NICU, admission date, gestation week, eligibility for inclusion, date assessed for eligibility, reason for exclusion and whether mothers that decline participation have been asked to voluntarily answer some baseline characteristic questions (i.e. age, parity, gestational age, delivery and maternal educational level). Data on mothers/partners and infants participating in the trial (i.e. name, phone number, address, identification code, and infant’s date of birth) will be recorded in the Log-book prior to hospital discharge. In addition, if any mothers drop out of the trial between informed consent and hospital discharge, the reasons will be recorded. Established data protocols on demographics, infant health and breastfeeding are filled in by a BST member at inclusion and at discharge. All information collected prior hospital discharge, will be forwarded to the researcher in charge, together with data on date of discharge. After hospital discharge, randomization will generate the group allocation which will be entered in to the log book. Only the BST in each unit will know the allocated group for each mother. The identification code will be used to identify all distributed questionnaires and link data to each trial participant. Project coordination and data collection at eight weeks after discharge and six months of infant’s postnatal age will be performed by the first author blind to randomization for the primary outcome. University data protection and quality assurance procedures will be followed. For quality control of data entry, another member of the research team will do a random check of data entry quality in 10% of sample cases.
Baseline socio-demographic and birth data collection
Data collection for participating mothers and partners include: educational level, parity, mode of delivery, ethnicity, and smoking habits. Data collection for participating infants include: gender, single or multiple birth, gestational age (GA) at birth, weight at birth, days on ventilator/ Continuous Positive Airway Pressure (CPAP), length of hospital stay, GA and weight at discharge, neonatal sequelae at discharge, breast milk (exclusive, partial, formula milk) and method (breastfeeding, bottle, cup) at discharge. Table details the time points when baseline data will be collected.
Time schedule for obtaining data on characteristics
Data on feeding status at eight weeks after discharge will be obtained through a telephone call in which mothers are asked if they give their infant breast milk (i.e. exclusive, partial, none), the method of feeding (i.e. breast, bottle, cup, tube) and infant’s weight. If the mothers have ceased breast milk feeding, they are asked at what time they ceased. The person who makes the phone call will be blinded for study group.
Table details the time points when the following outcomes will be collected:
Time schedule for outcome measurements
Parental stress in mothers and partners will be measured through the Swedish Parenthood Stress Questionnaire (SPSQ) [36
], an adapted version of the Parental Stress Index [37
]. It measures perceived stress in parenting in five dimensions (incompetence, role restriction, social isolation, spouse relationship and health problems) and has 34 items.
Quality of life in mothers and partners will be measured through the Short-Form Health Survey (SF-36) [38
]. It measures self reported physical and mental health and has 36 items.
Attachment between the infant and the mother will be measured through the Maternal Postnatal Attachment Scale (MPAS) [39
]. The scale comprises mothers’ emotional response to their infants and dimensions relating to mother-infant attachment and has 19 items.
Mothers satisfaction with breastfeeding will be measured through the Maternal Breastfeeding Evaluation Scale (MBFES) [40
], which measures mothers’ satisfaction with breastfeeding and has 30 items.
Breastfeeding (i.e. exclusive, partial, none and method) and infant’s weight at six months of postnatal age will be measured through questions in the compiled questionnaire (instruments/scales presented above) sent to mothers.
Eight focus groups (four with participants from the intervention group and four from the control group) with about 8 mothers in each group will be held after the final follow up data from the study has been collected at 6 months, to avoid potential interactions. There will be an option to volunteer for qualitative interview on the questionnaire sent to the mothers 8 weeks after hospital discharge. This enables gaining rich information from women with a maximum diversity sample (i.e. age, SES, parity) for the focus groups. The focus of the group will be on experiences of the received support. Mothers who volunteer but are not selected to participate in a focus group will be given the opportunity to submit their comments through the study Website: http://www.amningsstod.se
In addition, after the study has finished, focus groups will be held with 1) the feeding support team (e.g. experiences of providing care during the trial, the opportunities and challenges, views about the workload and working relationships between the BST and other health service staff) and 2) staff working in the NICU who are not in the feeding teams (e.g. workload and work-organization in the unit) for each NICU, in total 8 groups.
Process evaluation for the study
To evaluate intervention fidelity for person-centered telephone support throughout the study and between intervention and control groups, phone-calls made by each BST member on randomly selected dates, in the beginning, middle and at the end of the study period, will be recorded if the mother consents to it. Recorded phone calls will be analyzed with a thematic coding-scheme. This procedure is important in order to: 1) monitor that support given is person-centered and regardless of group (I or C) and to assess any change in implementation over time (beginning, middle or end of the study period).
In addition, during the study period, members of the research team will observe BST meetings (not when specific mothers are discussed) and NICU staff meetings. Furthermore, interviews with NICU managers will be conducted at the end of the study, with the aim to detect possible major changes (e.g. in care/staff-infant ratio/environment) or problems that have occurred during the study period. Observations and notes will be recorded in a reflective diary, which will contribute to the qualitative data analysis.
All members of the research team will be blind to the group allocation (I, C) throughout the study period and during analyses of primary outcome. Intention-to-treat will be used. This means that analyses will include all randomized mothers in the groups to which they were randomly assigned, regardless of their adherence with the entry criteria, regardless of the treatment they actually received, and regardless of subsequent withdrawal from treatment or deviation from the protocol. To study the differences between intervention group and control group on the primary outcome measure; the proportion of mothers who exclusively breastfeed 8 weeks after discharge, a two-sided Chi - square test will used. The level of significance; p-value is set at p <0.05 in all analyses. The specific statistical analysis used with each outcome variable will be determined by the distribution of the outcome variables. Subgroup analyses will be conducted on SES (low vs. high), parity (primipara vs. multipara), and on GA (very preterm vs. preterm).
Secondary outcomes will potentially be analyzed with a mixed effect model. A mixed effect modeling approach has several advantages when conducting a multicenter study with repeated measurements compared to a conventional analysis. For example, a mixed model, offers an insightful analysis and improved precision by taking into account the different centers in the analysis. In addition, a mixed model does not need complete data from all subjects. The result from a mixed model analysis presents a more accurate estimation of the intervention and standard errors [41
All qualitative interview data from focus groups with mothers will be recorded, transcribed and analyzed; responses to open questions in the questionnaire will be transcribed. Transcripts will be read by two researchers to independently identify categories and key themes according to qualitative content analysis [42
]. The categories and key themes will be discussed at research team meetings and a final version will be agreed. All data from focus groups with staff will be analyzed as with mothers. In addition these will be informed by data from BST meeting and ward observations recorded in a reflective diary. Qualitative data collection and analyses will be performed rigorously and supervised by experienced qualitative researchers.
Health economic evaluation
In the health economic analysis the incremental costs of proactive breastfeeding support will be compared to incremental benefits, in comparison to reactive breastfeeding support [43
]. Three kinds of benefits will be considered in the analysis:
•Changes in breastfeeding rate will be linked to decreased risk of diseases and premature death, using best available data on risks of not breastfeeding. Less risk of disease will be transformed to gained quality adjusted life years (QALYs) for each disease’s impact on health care costs and production losses will also be considered.
•Parents’ quality of life, expressed in QALYs, will be measured until 6 months postnatal age, SF-6D based on SF-36 [38
•Use of health care resources of the infant, during the follow up time (6 months) will be measured through questions of the infants’ health and wellbeing, illnesses, visits to health care facilities, apart from normal follow-up visits, in the questionnaire sent to mothers at 8 weeks after discharge and at 6 months PNA.
Costs are measured by the recorded number and duration of telephone calls in both study groups. Number and duration of calls are recorded by the BST in the log book. Cost-effectiveness will be analyzed using a cost-utility analysis. Cost-effectiveness ratio will be expressed as costs per gained QALY [43
The study has no obvious risks; in the pilot study mothers expressed their appreciation that somebody called. All eligible mothers and their partners who agree to participate in the study will sign a written consent. The mothers and the partners will be informed that participation in the study is voluntary and that they can withdraw at any time and that the questionnaires, answers and results are all anonymous and cannot be linked or influence the medical care they receive any way. The trial is conducted and monitored to minimize harm, if the mother wishes not to be called every day; the mothers have the option to decide when to be called. Log book, questionnaires, and recorded telephone calls are stored in a locked area, not accessible to unauthorized individuals. This study has been approved by the Regional Ethical Review Board, Uppsala 2012-08-15 Dnr: 2012/292.