Determining trustworthiness and safety of remote consulting during the COVID-19 pandemic in primary healthcare for chronic disease populations in Nigeria and Tanzania

ABSTRACT

ConditionChronic disease, type 2 diabetes, hypertension, chronic obstructive pulmonary disease, coronary heart disease
Not Applicable

InterventionCurrent intervention as of 12/06/2023
The intervention involves REaCH training for healthcare workers to deliver remote consulting via mobile phone to patients and will be compared to care as usual. The study will take place in Nigeria (urban/MIC/West Africa) and Tanzania (rural/LIC/East Africa). In each country, 20 primary care facility clusters (each cluster is made up of one or more clinic/facility, which between them has =10 healthcare workers) will be recruited. Tier 1 trainees are healthcare workers with a higher diploma or degree who speak, read and write in English; Tier 2 trainees are other cadres e.g. community health workers, pharmacy assistants, and medical assistants who may communicate in English or in local languages. The tier 1 and tier 2 trainees work as a team within the facility. Health workers will be in the trial for between one and six months depending upon when they receive REaCH training and whether they take part in the process evaluation.

At the beginning of the intervention, all clusters are randomised into groups of two (a sequence) and allocated a monthly timeslot to receive REaCH training over a ten-month period. This will be done by generating a random number for each cluster and then clusters assigned to each sequence in ascending order of the generated number. The randomisation will be conducted by the trial statistician who will be blinded to cluster name. The intervention implementers and clinics will not be blinded to allocation sequence as this is impractical given the need to plan and prepare training. In each local trial delivery team, one investigator and 1 research assistant will remain blinded to the month during which REaCH training was delivered to each cluster. Each facility is given a unique identification number consisti

Primary outcome:1. Patient trust in healthcare provider measured using the Physician Humanistic Behaviour Questionnaire (PHBQ) at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months
2. Face to face consultation rate defined as the number of visits per month for the eligible patient population where the patient is seen in person by the consulting health worker measured from the open cohort data at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months
3. Remote consultation rate defined as the number of visits per month for the eligible patient population conducted using a telephone measured from the open cohort data at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months
4. Prescribing rate defined as the number of prescriptions issued and collected to the eligible patient population per month. This outcome is a proxy for patient safety as a change in this outcome is an indicator of changes in safety and confidence measured from the open cohort data at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months

CriteriaInclusion criteria 1. Receiving healthcare from participating primary care facilities
2. Able to speak, read and write in English or local language
3. Give consent to participate in the study
4. Aged =18 years
5. Receiving treatment and/or monitoring for =1 of the following conditions
5.1. Type 2 diabetes
5.2. Hypertension
5.3. Chronic obstructive pulmonary disease
5.4. Coronary heart disease
6. Contact with health facility =3 times per year

Exclusion criteria 1. No access to a mobile phone or fixed phone in the community
2. Identified by health workers as nearing the end of life or currently severely ill
3. Carers consulting on another person’s behalf
4. Unable to provide informed consent