The role of Lesotho community pharmacists in preventing and controlling cardiovascular diseases: The perceived facilitators and barriers.

BACKGROUND: Cardiovascular diseases are a leading cause of mortality globally. The impact of cardiovascular diseases can be minimized by addressing modifiable risk factors at primary health care level. Community pharmacists are well-positioned to identify patients at risk of cardiovascular diseases for early detection and initiation of treatment. However, the role of Lesotho community pharmacists in preventing and controlling cardiovascular diseases is not well understood. The purpose of this study was to explore the Lesotho community pharmacists' role in preventing and controlling cardiovascular diseases. METHODS: The methodological reporting of this study was guided by the consolidated criteria for reporting qualitative studies. A list of registered community pharmacists was obtained from the Ministry of Health. Pharmacists were selected based on their close proximity to the researcher and invited to participate. Semi-structured interviews were conducted until data saturation was reached. The interviews were audio-recorded, transcribed verbatim, and analysed thematically. RESULTS: Five themes were identified namely: 1) Current roles 2) Future role 3) Facilitators, 4) Barriers, and 5) Community pharmacists' perceptions of their roles. Generally, community pharmacists were involved in medication counselling, health promotion, and referral of patients. Lack of support from government, patients' lack of adherence, poor interprofessional relationship, and lack of clear community pharmacy practice guidelines were identified as barriers. Despite the challenges, community pharmacists are motivated by patients' gratitude for their services. CONCLUSIONS: Lesotho community pharmacists can potentially improve cardiovascular diseases' health outcomes at primary healthcare level through early detection of CVD risk factors, and health promotion.

A systematic review of the role of community pharmacists in the prevention and control of cardiovascular diseases: the perceptions of patients.

BACKGROUND: Cardiovascular diseases are a leading cause of mortality globally. The modifiable risk factors can be measured and identified early at primary healthcare facilities. Community pharmacists present an opportunity for improved management of cardiovascular diseases and health outcomes. The systematic review aims to identify the roles of community pharmacists in preventing and controlling cardiovascular diseases and patients' perceptions towards such functions. METHODS: A systematic review of the literature was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. The team searched MEDLINE, CINAHL via EBSCOhost, and Web of Science from January 2001 to December 2021 with a focus on studies reporting the role of community pharmacists in preventing and controlling cardiovascular diseases, and patients' perceptions of such roles. Search terms included were ''interventions,'' ''community pharmacists,'' ''patients,'' ''cardiovascular diseases,'' ''risk factors,'' and "perceptions". The quality of studies was appraised using the Joanne Briggs Institute checklist. RESULTS: A total of 45 studies met the inclusion criteria: 35 (78%) and 10 (22%) reported community pharmacists' preventive and control roles, respectively. Generally, drug therapy monitoring, medicine and lifestyle counselling, and health education were most common roles, with pharmacist-initiated prescribing and social support least common. A total of 11 (24%) studies reported patients' perceptions of community pharmacists' contribution in preventing (73%, n = 8) and controlling (27%, n = 3) cardiovascular diseases. Patients were satisfied with community pharmacists' services in 10 of 11 studies. CONCLUSIONS: The findings highlight community pharmacists' capability of providing primary healthcare services in preventing and controlling cardiovascular diseases and provide evidence for their inclusion in primary healthcare frameworks. Future research should assess the effectiveness of these roles and provide a comprehensive evaluation of clinical, humanistic, and economic outcomes. SYSTEMATIC REVIEW REGISTRATION: Open Science Framework (OSF) registration https://doi.org/10.17605/OSF.IO/WGFXT .

A collaborative care package for depression comorbid with chronic physical conditions in South Africa.

INTRODUCTION: A task-sharing collaborative care model for integrated depression care for South Africa's burgeoning primary health care population with chronic conditions was developed and tested through two pragmatic cluster randomized controlled trials. One trial focused on patients with hypertension and was located in one district where a collaborative care model was co-designed with district stakeholders. The other trial, focused on patients on antiretroviral treatment, was located in the same district site, with the addition of a second neighbouring district, without adaptation of the original model. This paper describes the package used to implement this model, and implementation outcomes across the two sites, and summarises lessons and challenges. METHODS: The Template for Intervention Description and Replication (TIDieR) framework, adapted for complex health systems interventions, was used to describe components of the package. Additional elements of 'modifications made' and 'actual implementation' introduced in the 'Getting messier with TIDieR' framework, were used to describe implementation outcomes in terms of reach, adoption and implementation across the two trial districts. RESULTS: In the absence of a co-design process to adapt the model to the context of the second site, there was less system level support for the model. Consequently, more project employed human resources were deployed to support training of primary care nurses in identification and referral of patients with depression; and supervise co-located lay counsellors. Referrals to co-located lay counselling services were more than double in the second site. However, uptake of counselling sessions was greater in the first site. This was attributed to greater in-vivo supervision and support from existing mental health specialists in the system. There was greater reliance on online supervision and support in the second site where geographical distances between clinics were larger. CONCLUSION: The need for in-country co-designed collaborative care models, and 'implementation heavy' implementation research to understand adaptations required to accommodate varying in-country health system contexts is highlighted.

A systematic review of impact of person-centred interventions for serious physical illness in terms of outcomes and costs.

BACKGROUND: Person-centred care (PCC) is being internationally recognised as a critical attribute of high-quality healthcare. The International Alliance of Patients Organisations defines PCC as care that is focused and organised around people, rather than disease. Focusing on delivery, we aimed to review and evaluate the evidence from interventions that aimed to deliver PCC for people with serious physical illness and identify models of PCC interventions. METHODS: Systematic review of literature using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We searched AMED, CINAHL, Cochrane Library, Embase, Medline, PsycINFO, using the following key concepts: patient/person-centred care, family centred care, family based care, individualised care, holistic care, serious illness, chronic illness, long-term conditions from inception to April 2022. Due to heterogeneity of interventions and populations studied, narrative synthesis was conducted. Study quality was appraised using the Joanna Briggs checklist. RESULTS: We screened n=6156 papers. Seventy-two papers (reporting n=55 different studies) were retained in the review. Most of these studies (n=47) were randomised controlled trials. Our search yielded two main types of interventions: (1) studies with self-management components and (2) technology-based interventions. We synthesised findings across these two models:Self-management component: the interventions consisted of training of patients and/or caregivers or staff. Some studies reported that interventions had effect in reduction hospital admissions, improving quality of life and reducing costs of care.Technology-based interventions: consisted of mobile phone, mobile app, tablet/computer and video. Although some interventions showed improvements for self-efficacy, hospitalisations and length of stay, quality of life did not improve across most studies. DISCUSSION: PCC interventions using self-management have some effects in reducing costs of care and improving quality of life. Technology-based interventions improves self-efficacy but has no effect on quality of life. However, very few studies used self-management and technology approaches. Further work is needed to identify how self-management and technology approaches can be used to manage serious illness. PROSPERO REGISTRATION NUMBER: CRD42018108302.

HeAlth System StrEngThening in four sub-Saharan African countries (ASSET) to achieve high-quality, evidence-informed surgical, maternal and newborn, and primary care: protocol for pre-implementation phase studies.

To achieve universal health coverage, health system strengthening (HSS) is required to support the of delivery of high-quality care. The aim of the National Institute for Health Research Global Research Unit on HeAlth System StrEngThening in Sub-Saharan Africa (ASSET) is to address this need in a four-year programme, with three healthcare platforms involving eight work-packages. Key to effective health system strengthening (HSS) is the pre-implementation phase of research where efforts focus on applying participatory methods to embed the research programme within the existing health system. To conceptualise the approach, we provide an overview of the key methods applied across work-package to address this important phase of research conducted between 2017 and 2021.Work-packages are being undertaken in publicly funded health systems in rural and urban areas in Ethiopia, Sierra Leone, South Africa, and Zimbabwe. Stakeholders including patients and their caregivers, community representatives, clinicians, managers, administrators, and policymakers are the main research participants.In each work-package, initial activities engage stakeholders and build relationships to ensure co-production and ownership of HSSIs. A mixed-methods approach is then applied to understand and address determinants of high-quality care delivery. Methods such as situation analysis, cross-sectional surveys, interviews and focus group discussions are adopted to each work-package aim and context. At the end of the pre-implementation phase, findings are disseminated using focus group discussions and participatory Theory of Change workshops where stakeholders from each work package use findings to select HSSIs and develop a programme theory.ASSET places a strong emphasis of the pre-implementation phase in order to provide an in-depth and systematic diagnosis of the existing heath system functioning, needs for strengthening and stakeholder engagement. This common approach will inform the design and evaluation of the HSSIs to increase effectiveness across work packages and contexts, to better understand what works, for whom, and how.

Fuzzy-set qualitative comparative analysis of implementation outcomes in an integrated mental healthcare trial in South Africa.

BACKGROUND: Integrating mental health services into primary healthcare platforms is an established health systems strategy in low-to-middle-income countries. In South Africa, this was pursued through the Programme for Improving Mental Health Care (PRIME), a multi-country initiative that relied on task-sharing as a principle implementation strategy. Towards better describing the implementation processes, qualitative comparative analysis was adopted to explore causal pathways in the intervention. OBJECTIVE: This study aimed to explore factors that could have influenced key outcomes of an integrated mental healthcare intervention in South Africa. METHODS: Drawing from an embedded multiple case study design, the analysis used qualitative comparative analysis. Focusing on nine PHC clinics in the Dr Kenneth Kaunda District as cases, with depression reduction scores set as outcome measures, trial data variables were modelled in a hypothetical causal process. A fuzzy-set qualitative comparative analysis was performed by 1) developing the research questions, 2) developing the fuzzy set, 3) testing necessity and 4) testing sufficiency. These steps were undertaken collaboratively among the research team. RESULTS: The data were calibrated during several meetings among team members to gain a degree of consensus. Necessity analyses suggested that none of the causal conditions exceeded the threshold of necessity and triviality, and confirmed the inclusion of relevant variables in line with the proposed models. Sufficiency analyses produced two configurations, which were subjected to standard and specific analyses. Ultimately, the results suggested that none of the causal conditions were necessary for a reduction in depression scores to occur, while programme fidelity was identified as a sufficient condition for a reduction in scores to occur. CONCLUSIONS: The study highlights the importance of understanding implementation pathways to enable better integration of mental health services within primary healthcare in low-to-middle-income settings. It underlines the importance of programme fidelity in achieving the goals of implementation.

Effectiveness of a task-sharing collaborative care model for identification and management of depressive symptoms in patients with hypertension attending public sector primary care clinics in South Africa: pragmatic parallel cluster randomised controlled trial.

BACKGROUND: We tested the real-world effectiveness of a collaborative task-sharing model on depressive symptom reduction in hypertensive Primary Health Care (PHC) patients in South Africa. METHOD: A pragmatic parallel cluster randomised trial in 20 clinics in the Dr Kenneth Kaunda district, North West province. PHC clinics were stratified by sub-district and randomised in a 1:1 ratio. Control clinics received care as usual (CAU), involving referral to PHC doctors and/or mental health specialists. Intervention clinics received CAU plus enhanced mental health training and a lay counselling referral service. Participant inclusion criteria were ≥ 18 years old, Patient Health Questionnaire-9 (PHQ-9) score ≥ 9 and receiving hypertension medication. Primary superiority outcome was ≥ 50% reduction in PHQ-9 score at 6 months. Statistical analyses comprised mixed effects regression models and a non-inferiority analysis. TRIAL REGISTRATION NUMBER: NCT02425124. RESULTS: Between April 2015 and October 2015, 1043 participants were enrolled (504 intervention and 539 control); 82% were women; half were ≥ 55 years. At 6 and 12 months follow-up, 91% and 89% of participants were interviewed respectively. One control group participant committed suicide. There was no significant difference in the primary outcome between intervention (N=256/456) and control (N=232/492) groups (55.9% versus 50.9%; adjusted risk difference = -0.04 ([95% CI = -0.19; 0.11], p = 0.6). The difference in PHQ-9 scores was within the defined equivalence limits at 6 and 12 months for the non-inferiority analysis. LIMITATIONS: The trial was limited by low exposure to depression treatment by trial participants and by observed co-intervention in control clinics CONCLUSIONS: Incorporating lay counselling services within collaborative care models does not produce superior nor inferior outcomes to models with specialist only counselling services. FUNDING: This work was supported by the UK Department for International Development [201446] as well as the National Institute of Mental Health, United States of America, grant number 1R01MH100470-01. Graham Thornicroft is supported by the National Institute for Health Research (NIHR) Applied Research Collaboration (ARC) South London at King's College London and King's College Hospital NHS Foundation Trust.

The empirical evidence underpinning the concept and practice of person-centred care for serious illness: a systematic review.

INTRODUCTION: Person-centred care has become internationally recognised as a critical attribute of high-quality healthcare. However, the concept has been criticised for being poorly theorised and operationalised. Serious illness is especially aligned with the need for person-centredness, usually necessitating involvement of significant others, management of clinical uncertainty, high-quality communication and joint decision-making to deliver care concordant with patient preferences. This review aimed to identify and appraise the empirical evidence underpinning conceptualisations of 'person-centredness' for serious illness. METHODS: Search strategy conducted in May 2020. Databases: CINAHL, Embase, PubMed, Ovid Global Health, MEDLINE and PsycINFO. Free text search terms related to (1) person-centredness, (2) serious illness and (3) concept/practice. Tabulation, textual description and narrative synthesis were performed, and quality appraisal conducted using QualSyst tools. Santana et al's person-centred care model (2018) was used to structure analysis. RESULTS: PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flow data: n=12,446 studies screened by title/abstract, n=144 full articles assessed for eligibility, n=18 studies retained. All studies (n=18) are from high-income countries, and are largely of high quality (median score 0.82). The findings suggest that person-centred care encompasses the patient and family being respected, given complete information, involved in decision-making and supported in their physical, psychological, social and existential needs. The studies highlight the importance of involving and supporting family/friends, promoting continuation of normality and self-identity, and structuring service organisation to enable care continuity. CONCLUSION: Person-centred healthcare must value the social network of patients, promote quality of life and reform structurally to improve patients' experience interacting with the healthcare system. Staff must be supported to flexibly adapt skills, communication, routines or environments for individual patients. There remains a need for primary data investigating the meaning and practice of PCC in a greater diversity of diagnostic groups and settings, and a need to ground potential components of PCC within broader universal values and ethical theory.

Evaluating the integration of chronic care elements in primary health care for people with mental illness: a longitudinal study in Nepal conducted among primary health care workers.

BACKGROUND: Despite many important developments in the global mental health arena in the past decade, many people with mental health problems still do not have access to good quality mental health care. The aim of this study was to evaluate the perceived impact of a mental health care package (MHCP) in integrating chronic care elements in primary health care for people with mental illness. METHODS: A controlled pre-post study design was used in 20 primary health care facilities in Chitwan, Nepal. We compared 10 health facilities that had implemented a MHCP (intervention group), with 10 health facilities that had not implemented the MHCP (comparative control group) but provided regular physical health services. We administered the Assessment of Chronic Illness Care (ACIC) tool on a group basis within all 20 health facilities among 37 health workers. Data was collected at three time points; at baseline, midline (at 13 months from baseline) and end line (at 25 months from baseline). RESULTS: From baseline to end line, we see a notable shift in the level of support reported by the intervention health facilities compared to those in the comparative control group. While at baseline 10% of the intervention health facilities had basic support for the implementation of chronic illness care, at the end line, 90% of the intervention group reported having reasonable support with the remaining 10% of the intervention facilities reporting that they had full support. In contrast, 20% of the health facilities in the comparative control group at end line still reported having limited support for the implementation of chronic illness care, with the remaining 80% only managing to shift to the next level which is basic support. CONCLUSIONS: These findings suggest that training and supervision of primary health care workers in the implementation of MHCP interventions can lead to strengthening of the system to better address the needs of patients with chronic mental health problems. However, substantial financial and coordination inputs are needed to implement the MHCP. The comparative control group also demonstrated improvements, possibly due to the administration of the ACIC tool and components of counselling services for family planning and HIV/AIDS services.

Scaling up integrated primary mental health in six low- and middle-income countries: obstacles, synergies and implications for systems reform.

BACKGROUND: There is a global drive to improve access to mental healthcare by scaling up integrated mental health into primary healthcare (PHC) systems in low- and middle-income countries (LMICs). AIMS: To investigate systems-level implications of efforts to scale-up integrated mental healthcare into PHC in districts in six LMICs. METHOD: Semi-structured interviews were conducted with 121 managers and service providers. Transcribed interviews were analysed using framework analysis guided by the Consolidated Framework for Implementation Research and World Health Organization basic building blocks. RESULTS: Ensuring that interventions are synergistic with existing health system features and strengthening of the healthcare system building blocks to support integrated chronic care and task-sharing were identified as aiding integration efforts. The latter includes (a) strengthening governance to include technical support for integration efforts as well as multisectoral collaborations; (b) ring-fencing mental health budgets at district level; (c) a critical mass of mental health specialists to support task-sharing; (d) including key mental health indicators in the health information system; (e) psychotropic medication included on free essential drug lists and (f) enabling collaborative and community- oriented PHC-service delivery platforms and continuous quality improvement to aid service delivery challenges in implementation. CONCLUSIONS: Scaling up integrated mental healthcare in PHC in LMICs is more complex than training general healthcare providers. Leveraging existing health system processes that are synergistic with chronic care services and strengthening healthcare system building blocks to provide a more enabling context for integration are important. DECLARATION OF INTEREST: None.

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.

BACKGROUND: The 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/DESIGN: The 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. DISCUSSION: This 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 REGISTRATION: South 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.

Collaborative care for the detection and management of depression among adults receiving antiretroviral therapy in South Africa: study protocol for the CobALT randomised controlled trial.

BACKGROUND: The scale-up of antiretroviral treatment (ART) programmes has seen HIV/AIDS transition to a chronic condition characterised by high rates of comorbidity with tuberculosis, non-communicable diseases (NCDs) and mental health disorders. Depression is one such disorder that is associated with higher rates of non-adherence, progression to AIDS and greater mortality. Detection and treatment of comorbid depression is critical to achieve viral load suppression in more than 90% of those on ART and is in line with the recent 90-90-90 Joint United Nations Programme on HIV/AIDS (UNAIDS) targets. The CobALT trial aims to provide evidence on the effectiveness and cost-effectiveness of scalable interventions to reduce the treatment gap posed by the growing burden of depression among adults on lifelong ART. METHODS: The study design is a pragmatic, parallel group, stratified, cluster randomised trial in 40 clinics across two rural districts of the North West Province of South Africa. The unit of randomisation is the clinic, with outcomes measured among 2000 patients on ART who screen positive for depression using the Patient Health Questionnaire (PHQ-9). Control group clinics are implementing the South African Department of Health's Integrated Clinical Services Management model, which aims to reduce fragmentation of care in the context of rising multimorbidity, and which includes training in the Primary Care 101 (PC101) guide covering communicable diseases, NCDs, women's health and mental disorders. In intervention clinics, we supplemented this with training specifically in the mental health components of PC101 and clinical communications skills training to support nurse-led chronic care. We strengthened the referral pathways through the introduction of a clinic-based behavioural health counsellor equipped to provide manualised depression counselling (eight sessions, individual or group), as well as adherence counselling sessions (one session, individual). The co-primary patient outcomes are a reduction in PHQ-9 scores of at least 50% from baseline and viral load suppression rates measured at 6 and 12 months, respectively. DISCUSSION: The trial will provide real-world effectiveness of case detection and collaborative care for depression including facility-based counselling on the mental and physical outcomes for people on lifelong ART in resource-constrained settings. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT02407691 ) registered on 19 March 2015; Pan African Clinical Trials Registry ( 201504001078347 ) registered on 19/03/2015; South African National Clinical Trials Register (SANCTR) ( DOH-27-0515-5048 ) NHREC number 4048 issued on 21/04/2015.