Feasibility of the PANDA e-health system as a tool to increase antenatal contacts and improve perinatal outcomes in Tanzania

1. Recruitment and retention of women in the study:
1.1. Women who fulfil the eligibility criteria, women who are invited to participate in the study, those recruited and any participants who leave the study before completion, recorded in a participant log at the following time points:
1.1.1. Control group: 80 pregnant women recruited at their first antenatal visit or in subsequent visits (November 2022)
1.1.2. Control group follow-up: 80 pregnant women followed up two weeks post-partum (Dec 22 – March 23)
1.1.3. Intervention group: 80 pregnant women recruited at their first or subsequent visits (April 23)
1.1.4. Control group follow-up: 80 pregnant women follow up two weeks post-partum (May – September 23)

1.2. Reasons for non-recruitment (e.g. refusal to participate, or do not consent to take part, language barrier) when approached at their first or subsequent antenatal visit at the facilities and recorded in the screening log. Permission will be sought to collect data on reasons for non-participation from women and health workers who have provided contact details but declined to take part.

1.3. Reasons for withdrawal and loss to follow-up documented in participant log during the course of the study

1. Usual care (baseline – 6 months) demographic and clinical data routinely collected in the ANC register, at the first antenatal appointment, including age, civil status, address, education, obstetric data including last normal menstrual period, number of previous pregnancies and their outcomes, previous obstetric complications, medical conditions (including chronic and hereditary diseases), vaccination (including tetanus Toxoid), screening for Syphilis and HIV, records of blood pressure, haemoglobin level, fundal height, albumin in the urine (urine dipstick) and physical examination.
80 electronic case reports (one per participant) will be created in REDCap following enrolment into the study. Demographic, obstetric and medical details and screening results from the ANC register for first and subsequent visits and birth outcomes of all recruited women will be extracted from the register.

2. PANDA: (Implementation period: April – September 2023)
80 PANDA medical records (one per participant enrolled) will be created following enrolment into the study.
Demographics and obstetric details will be automatically collected through PANDA which creates an electronic medical record for each woman visited. The application includes 4 modules: personal information, medical history, screening and education. Personal information includes age, ethnicity, spoken language, address/location of the visit, marital status and education. Medical history includes details about previous and index pregnancy, including place of birth, vaccinations, the onset of labour, mode of birth, maternal and infant outcomes, and antenatal and postnatal complications. The screening section includes measurement values (height, weight, blood pressure and pulse, temperature, fundal height), screening for UTI, other infections, respiratory problems and TB, and rapid-test results for HIV, syphilis, malaria, gestational diabetes, and anemia. It also includes monitoring of the baby, including fundal height measurement, and recording of fetal movements. The education section is meant to give advice to the woman on hygiene, malaria prevention, danger signs during pregnancy, childbirth planning, breastfeeding, family planning and subsequent visits. Additional data, including COVID (testing, vaccination) have been added during the adaptation phase. Data will be collected at recruitment, and for each subsequent visit scheduled with the woman. A de-identified dataset of all women who consent to share their data will be extracted from the Medical Unit for analysis. During the implementation of PANDA, healthcare workers will input women’s obstetric history and details of current pregnancy, including data of screening (height, blood pressure, weight etc) and diagnosis (HIV, malaria, syphilis) into PANDA. The same data will be recorded in the existing register held at the dispensary to prevent gaps in the data routinely collected.

3. Anonymised routinely collected clinical data for all women attending ANC in the included facilities during the study period will be extracted from the ANC and birth registers, using an electronic Case Report Form, created in REDCap. This will include maternal age, county of residence, occupation classification, medical and obstetric history (previous pregnancies, mode of birth) and index pregnancy data including HIV status, syphilis, malaria, anemia and tetanus vaccination, n. of ANC visits, and referrals. This will permit the assessment of the feasibility of comparison and assessment of the potential for selection bias in the sample taking part in the research. The number of anonymised records of all women booked for ANC in the included facilities between November 22 to September 23.

4. Acceptability of study processes and the intervention (phase 2) captured by questionnaires and semi-structured face-to-face (or telephone) interviews conducted two weeks postnatally with:
4.1. Women participating in the study during phase 2 (N up to 80; up to 40 per facility)
4.2. Healthcare workers using PANDA to deliver antenatal care (up to 10) at the end of phase 2 (August – September 2023)

5. Uptake and the additional impact of the intervention on the practice and environment of care captured between April/September 2023 by:
5.1. An intervention log completed by healthcare providers delivering PANDA and the one managing the Medical Unit / or extract from PANDA after each antenatal care visit conducted with enrolled women, will summarise all study-related activities to determine what was done, when and by whom. For HCP using the PANDA app and Point of Care, this will include the number of visits conducted and sent to the server, the average length of visits, and the number of referrals. For HCP managing the Medical Unit, this will include record review, action taken on women with complications etc.
5.2. A short questionnaire survey of health workers providing antenatal care but not directly involved in delivering the intervention (using PANDA) will be completed at the end of phase 2 (August – September 2023)
5.3. Environment, provision of information, interaction, screening and diagnosis and communication between the woman and provider measured using the Quality of Prenatal Care Questionnaire, a 46-item tool will be used to measure women's rating of the quality of antenatal care at the following time points:
5.3.1. Control group follow-up: number of women completing the QPCQ two weeks postnatally (Dec 22 to April 23)
5.3.2. Intervention group follow-up number of women completing the QPCQ two weeks postnatally (May – September 23)
5.4. The Person Centre Prenatal Care Scale, a 34-item tool will be used to assess the respectful care components including the provision of dignified care, adequate communication and trust between woman and provider at the following time points:
5.4.1. Control group follow-up: number of women completing the PCPCS two weeks postnatally (Dec 22 to April 23)
5.4.2. Intervention group follow-up: number of women completing the PCPCS two weeks postnatally (May – September 23)
5.5. A short questionnaire asking women to rate their experience to take part in the study, including engagement with the PANDA e-health system will be conducted at the following time points:
5.5.1. Control group follow-up: number of women completing the short questionnaire two weeks postnatally (Dec 22 to April 23)
5.5.2. Intervention group follow-up: number of women completing the short questionnaire two weeks postnatally (May – September 23)

6. Health economics: data will be captured to identify the key resources associated with the intervention including:
6.1. Human resources: the intervention log as described above will be used to identify persons and time spent attending training and conducting visits.
6.2. healthcare providers who implement the PANDA system will be asked to complete a survey to capture their perspective on the impact of the system on the time it takes to deliver antenatal care, any increases in staff provision required, and whether they think using the system is manageable in current workloads.
Number of healthcare workers using PANDA, completing the survey by the end of phase 2 (August – September 2023)