Collaborative care for the detection and management of depression among adults with hypertension in South Africa: study protocol for the PRIME-SA randomised controlled trial

Abstract

BackgroundThe high co-morbidity of mental disorders, particularly depression, with non-communicable diseases (NCDs) such as cardiovascular disease (CVD), is concerning given the rising burden of NCDs globally, and the role depression plays in confounding prevention and treatment of NCDs. The objective of this randomised control trial (RCT) is to determine the real-world effectiveness of strengthened depression identification and management on depression outcomes in hypertensive patients attending primary health care (PHC) facilities in South Africa (SA).Methods/designThe study design is a pragmatic, two-arm, parallel-cluster RCT, the unit of randomisation being the clinics, with outcomes being measured for individual participants. The 20 largest eligible clinics from one district in the North West Province are enrolled in the trial. Equal numbers of hypertensive patients (n = 50) identified as having depression using the Patient Health Questionnaire (PHQ-9) are enrolled from each clinic, making up a total of 1000 participants with 500 in each arm. The nurse clinicians in the control facilities receive the standard training in Primary Care 101 (PC101), a clinical decision support tool for integrated chronic care that includes guidelines for hypertension and depression care. Referral pathways available include referrals to PHC physicians, clinical or counselling psychologists and outpatient psychiatric and psychological services. In the intervention clinics, this training is supplemented with strengthened training in the depression components of PC101 as well as training in clinical communication skills for nurse-led chronic care. Referral pathways are strengthened through the introduction of a facility-based behavioural health counsellor, trained to provide structured manualised counselling for depression and adherence counselling for all chronic conditions. The primary outcome is defined as at least 50% reduction in PHQ-9 score measured at 6 months.DiscussionThis trial should provide evidence of the real world effectiveness of strengtheneddepression identification and collaborative management on health outcomes of hypertensive patients withcomorbid depression attending PHC facilities in South Africa.Trial registrationSouth African National Clinical Trial Register: SANCTR (http://www.sanctr.gov.za/SAClinicalTrials) (DOH-27-0916-5051). Registered on 9 April 2015. ClinicalTrials.gov: ID: NCT02425124. Registered on 22 April 2015.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2518-6) contains supplementary material, which is available to authorized users.

Empowering frontline providers to deliver universal primary healthcare using the Practical Approach to care kit

“…Absolute effect sizes are in line with implementation science literature, and effects extend to health outcomes and economic benefits, including fewer and shorter hospital admissions 21 23. A further four trials involving almost 50 000 patients from 88 clinics are underway, with components evaluating mental health24 25 and non-communicable diseases,26 as well as preliminary work for a trial of PACK Child 27…”

Using a mentorship model to localise the Practical Approach to Care Kit (PACK): from South Africa to Ethiopia

“…Training cases were selected to emphasise areas where it was anticipated that the PHC professionals would have low levels of previous experience, for example, in the areas of non-communicable diseases and mental health, as well as priority programmes (eg, antenatal care). Ethiopia also opted to include training cases that integrated communication skills that are being implemented in South Africa24: ‘PRY’ (Prepare, Relationship-building and find out whY the patient has come to consult) and ‘ICE’ (Ideas, Concerns and Expectations). This emphasis on clinical communication skills was in support of the Health Sector Transformation Plan agenda to promote compassionate, respectful clinicians.…”

Mental health, disability and cardiovascular risks in South African adults with hypertension: structural equation models of causal pathways

“…The study design is a cross sectional and cohort study within a randomised trial. As part of an international programme to increase treatment of mental disorders in LMICs [21], the PRIME-SA cluster randomised controlled trial was conducted in the Dr Kenneth Kaunda district of the North West province of South Africa from 2015 to 2016 [20]. The largest 20 public sector primary care clinics in the district were included in the trial, with 10 clinics randomly allocated to continue with usual care and 10 to receive the intervention.…”

“…The planned sample size of 1000 (50 participants per clinic) was intended to provide 90% power to detect a 17% difference between arms in the primary outcome (≥ 50% reduction in PHQ-9 score after 6 months), assuming 15% loss to follow-up, intra-cluster correlation of 0.04, and 5% significance level [20].…”

“…The present study goes on to investigate causal pathways linking physical multimorbidity, depression, stress, disability and cardiovascular risk factors in South African adults with hypertension. Data were collected during a randomised trial of a health system intervention intended to improve diagnosis and treatment of depression in patients with hypertension, and thereby also to improve blood pressure control, in public primary care facilities [20]. We analysed these longitudinal and cross-sectional data with the objectives of : 1) constructing structural equation models (SEMs) representing potential causal paths linking sociodemographic factors, multimorbidity, depression symptoms, stress scores, disability and cardiovascular risk factors;…”