Mixed-method study to assess the feasibility, acceptability and early effectiveness of the Hospital to Home programme for follow-up of high-risk newborns in a rural district of Central Uganda: A study protocol

Introduction A follow-up programme designed for high-risk newborns discharged from inpatient newborn units in low-resource settings is imperative to ensure these newborns receive the healthiest possible start to life. We aim to assess the feasibility, acceptability and early outcomes of a discharge and follow-up programme, called Hospital to Home (H2H), in a neonatal unit in central Uganda. Methods and analysis We will use a mixed-methods study design comparing a historical cohort and an intervention cohort of newborns and their caregivers admitted to a neonatal unit in Uganda. The study design includes two main components. The first component includes qualitative interviews (n=60 or until reaching saturation) with caregivers, community health workers called Village Health Team (VHT) members and neonatal unit staff. The second component assesses and compares outcomes between a prospective intervention cohort (n=100, born between July 2019 and September 2019) and a historical cohort (n=100, born between July 2018 and September 2018) of infants. The historical cohort will receive standard care while the intervention cohort will receive standard care plus the H2H intervention. The H2H intervention comprises training for healthcare workers on lactation, breast feeding and neurodevelopmentally supportive care, including cue-based feeding, and training to caregivers on recognition of danger signs and care of their high-risk infants. Infants and their families receive home visits until 6 months of age, or longer if necessary, by specially trained VHTs. Quantitative data will be analysed using descriptive statistics and regression analysis. All results will be stratified by cohort group. Qualitative data will be analysed guided by Braun and Clarke’s thematic analysis technique. Ethics and dissemination This study protocol was approved by the relevant Ugandan ethics committees. All participants will provide written informed consent. We will disseminate through peer-reviewed publications and key stakeholders and public engagement. Trial registration number ISRCTN51636372; Pre-result. We will use a mixed-method study design. Objective 1 will be assessed using an observational descriptive design and Objective 2 will be assessed with a post-test only design16 (figure 1). H2H study flow chart. *Or until saturation has been reached. H2H, Hospital to Home; KH, Kiwoko Hospital; NU, neonatal unit, VHTs, Village Health Teams. Uganda is ranked 159 of 189 in the 2019 Human Development Index.17 Subsistence farming is the major source of income for the majority of people and more than a quarter live below the poverty line.18 Uganda is still grappling with high maternal (336 per 100 000 live births) and neonatal (27 per 1000 live births) mortality rates.19 Neonatal deaths account for 42% of the under-five deaths and over 60% of the total infant deaths in the country.20 It is estimated that Uganda has nearly 7% preterm birth rate, which amounts to 108 000 babies born too soon each year; 9800 direct preterm deaths and 5700 impaired preterm survivors per year.21 The H2H intervention will take place at Kiwoko Hospital (KH) based in the Nakaseke district and in two surrounding districts—Luwero and Nakasongola (figure 2). Socio-economically, there are no marked differences across these three districts; they represent rural Uganda and a region with relatively poor socio-economic circumstances. These districts are inhabited by people of two major tribes—Baganda and Banyakore who are mostly farmers and pastoralists by their occupation. KH is a rural faith-based hospital located in the Nakaseke district of Central Uganda. The 250-bed hospital sees over 40 000 patients a year and serves a catchment area of approximately 1 million people. For the past 22 years, the study implementer, Adara Development, has worked alongside KH to develop maternal, newborn and child health services, including the establishment of a neonatal unit that now provides care to over 1200 newborns a year.22 Of the 1311 newborns admitted to the unit in 2019, 52% are low birth weight (<2.5 kg), 14% very low birth weight (<1.5 kg) and 3% extremely low birth weight (<1 kg).22 Map showing Hospital to Home study districts. The KH neonatal unit provides thermal care, kangaroo care, assisted feeding, intravenous therapy, oxygen therapy, phototherapy, bubble continuous positive airway pressure, seizure management and management of infections, among other services. In the community, KH runs community-based healthcare programmes which include safe motherhood outreach clinics providing antenatal and postnatal care, mother and child immunisations, health education and family planning services. The clinics are supported by a network of VHTs who provide health education and mobilise the community to attend clinics. The study population will be selected from high-risk newborns and their caregivers discharged from the neonatal unit at KH and who live in Luwero, Nakaseke or Nakasongola districts. We will use the following inclusion and exclusion criteria to recruit infants for the historical and intervention cohorts (box 1) as well as for the in-depth interview participants (box 2): To address hypothesis 1, in-depth interviews (IDI) will be conducted with caregivers or parents (n=15 or until reaching saturation) from each cohorts, H2H VHTs (n=15 or until reaching saturation) and staff working in the KH neonatal unit (n=15 or until reaching saturation). Sample sizes have been determined based on an estimate of the number of subjects required to achieve saturation. Sample sizes will vary, depending on when saturation is reached.23 No further interviews will be conducted when the research team finds additional interviews adding no new ideas on the aspects of feasibility and acceptability of the H2H programme. To address hypothesis 2, the study will recruit 100 babies in each cohort. The sample size is based on a pragmatic approach and is not powered to detect programme outcomes but will provide important preliminary data and inform an appropriate effect size and sample size for future studies. A historical cohort of infants will be selected prior to establishment of H2H at KH. We will use a random number generator to randomly select 100 infants who were born between July 2018 and September 2018, who received standard care in the KH neonatal unit and met eligibility criteria as outlined in the study flow chart (see figure 1). For the H2H intervention cohort, we will use a random number generator to select 100 infants who were born between July 2019 and September 2019 and who received standard care plus H2H intervention in the KH neonatal unit. Data from infants in both cohorts will be collected when they reach 6 months corrected age. The study team will identify all eligible newborns from a database of patients admitted to the KH neonatal unit. Those meeting initial eligibility criteria will be entered into a screening log. When an infant on the screening log reaches 5½ to 6 months corrected age, study staff will contact caregivers of the infant over the phone to introduce them to the research study. They will be invited to come to KH with their infant when the infant is 6 months corrected age to attend the H2H study clinic. Caregivers interested to participate in the research will be provided travel incentive to reach up to the KH H2H clinic. When infants and their caregivers come to the H2H study clinic, the caregiver will go through the informed consent process with a trained staff member. Once a caregiver has provided consent for their participation in the study, study assessments will take place. H2H is a family-centred programme of facility-based care and at-home follow-up of high-risk newborns discharged from the KH Neonatal Unit. Caregivers and their infants admitted to the KH Neonatal Unit will receive the H2H facility-based component during their hospital stay and before being discharged home. Discharge planning begins early on admission into the neonatal unit by educating and preparing the family to be able to care for their infant safely at home. When the discharge date nears, the neonatal unit team coordinates with a VHT working within the family’s geographical area. This VHT will be assigned to the family to provide in-home follow-up care and support after discharge. To improve programme adherence in the community component of the intervention, VHTs will be regularly supervised by a research community midwife, provided monetary (travel and airtime) incentive and non-monetary incentives including a bicycle and supplies for their follow-up visits. To improve programme adherence in the facility component of intervention, ongoing education will be provided to staff and experts will be available to answer questions via a messaging application and email. The programme is described in box 3. bmjopen-2020-043773supp001.pdf bmjopen-2020-043773supp002.pdf Feasibility and acceptability of the H2H programme will be evaluated with a mixed-method approach using quantitative data collected in the hospital and during at-home visits, and qualitative data from IDIs. Preliminary evidence of impact will be evaluated quantitatively using data from the historical comparison and intervention cohorts. Infants in each cohort will be assessed at the study clinic when they are 6 months corrected age and assessments will be conducted by trained study staff through observation and anthropometric assessments on infants, and structured interview questionnaires with caregivers. The key outcome measures of the study will be: bmjopen-2020-043773supp003.pdf bmjopen-2020-043773supp004.pdf bmjopen-2020-043773supp005.pdf Other outcomes of interest: bmjopen-2020-043773supp006.pdf bmjopen-2020-043773supp007.pdf bmjopen-2020-043773supp008.pdf bmjopen-2020-043773supp009.pdf IDIs will be conducted with three different populations: KH neonatal unit staff, VHTs and caregivers of newborns from the historical and intervention cohorts (online supplemental additional file 10). IDIs with KH staff and VHTs will be conducted 12–18 months after H2H programme implementation. They will include questions related to feasibility and acceptability of delivering the H2H programme in the hospital and at home; appropriateness of the programme; and perceived challenges of the programme. IDIs with caregivers of infants in each cohort will be conducted after the infants’ assessment at 6 months corrected age. These interviews will include questions related to their experience during their hospital stay and caring for their infant after discharge. Caregivers in the intervention cohort will be asked additional questions related to their acceptance of the H2H programme. bmjopen-2020-043773supp010.pdf Interviews will be audio-recorded and transcribed. Those conducted in the local language, Luganda, will be transcribed and translated into English by a trained transcriptionist and translator. Transcripts will be uploaded and managed in NVivo V.12.00. The interviews will be conducted by trained study staff who have experience in qualitative research. Operational programmatic data from the H2H facility component will be collected by KH neonatal unit staff as part of standard H2H inpatient process. Operational programmatic data from the H2H community component will be collected by H2H VHTs as part of at-home visits, and by the community midwife. Data from IDIs and interviews will be collected in the form of audiotape and field notes. Data from the historical comparison and intervention cohorts will be collected with infants that are 6 months corrected age, by trained study staff. Data will be collected by hand on paper data collection forms and entered electronically by a trained data entry team into a REDCap cloud-based electronic database. Paper forms will be stored in a locked cabinet at the site. The database will be maintained on a secure server and regularly backed up. Access to the locked cabinet and electronic database will be limited to essential individuals. Data entry will be overseen by the monitoring and evaluation officer. Study data will be de-identified whenever possible. No names of participants will be published or made publicly available. The H2H intervention, design and conduct were shaped after consultation with service providers from the neonatal unit and the Community Based Health Care Department of Kiwoko Hospital. The study team orally presented the H2H pilot programme concept to the Uganda Ministry of Health and the Uganda National Newborn Steering Committee. Our plan to disseminate findings will engage local and national key stakeholders, including parents, VHTs, KH staff and local district health offices. The first outcome, feasibility of the H2H facility component, will be assessed by summarising the percentage of infants during the intervention period who met the discharge criteria and percentage of infants whose caregiver received the discharge teaching topics. Feasibility will be demonstrated if 70% of infants meet discharge criteria and 70% of parents receive the discharge teaching topics. The second outcome, feasibility of the H2H community component, will be assessed by summarising the number of at-home follow-up visits completed per infant. Mean, median, range and IQR will be calculated. Feasibility will be demonstrated if the infants receive 60% of the recommended at-home follow-up visits. The schedule for home follow-up visits is determined by the infants’ level of risk and weight at discharge and is further guided by an ongoing assessment of risk and weight gain until they reach 6 months corrected age. Feasibility of the H2H community component will also be demonstrated if 60% of infants sought medical care at a health facility if referred by a VHT. The third outcome, acceptability of the H2H programme, will be assessed by summarising the percentage of caregivers that refuse the community component of the intervention. Acceptability will be demonstrated if 15% or fewer caregivers refuse the community component of the intervention. The fourth outcome, preliminary evidence of impact on growth, and secondary outcomes 5–8, will be assessed by comparing outcomes between the historical and intervention cohorts. Infants in each cohort will be assessed when they are 6 months corrected age. We will summarise outcome measures by cohort group. These outcome data will be analysed by descriptive statistics and linear regression. Quantitative data collected in a REDCap database will be analysed in Excel, SPSS V.26.00, Stata 15.00 and R. Outcomes 9 and 10 will be analysed by summarising mean knowledge and skill scores and percentage of VHTs who score 80% or more on both knowledge and skills domains. Composite scores on knowledge and skills will be computed by summing up all knowledge and skill items as outlined in the assessment form. Outcome 11 will be analysed by summarising the average length of stay for infants in both historical and intervention cohort. Qualitative aspects of feasibility and acceptability, including operational challenges in programme implementation and caregivers’ and staff’s comment on intervention satisfaction, will complement quantitative markers of feasibility and acceptability. Qualitative data will be analysed following a thematic analysis approach, using a comprehensive coding process as guided by Braun and Clarke’s thematic analysis technique.26 Themes will be based on the study objectives and those emerging from the data. Social scientists (three people) will agree the coding frame and undertake analysis collaboratively to ensure agreement on the coding approach. Thematic summaries will be developed and shared with the wider team for discussion.