Using the Medical Research Council framework for development and evaluation of complex interventions in a low resource setting to develop a theory-based treatment support intervention delivered via SMS text message to improve blood pressure control.

BACKGROUND: Several frameworks now exist to guide intervention development but there remains only limited evidence of their application to health interventions based around use of mobile phones or devices, particularly in a low-resource setting. We aimed to describe our experience of using the Medical Research Council (MRC) Framework on complex interventions to develop and evaluate an adherence support intervention for high blood pressure delivered by SMS text message. We further aimed to describe the developed intervention in line with reporting guidelines for a structured and systematic description. METHODS: We used a non-sequential and flexible approach guided by the 2008 MRC Framework for the development and evaluation of complex interventions. RESULTS: We reviewed published literature and established a multi-disciplinary expert group to guide the development process. We selected health psychology theory and behaviour change techniques that have been shown to be important in adherence and persistence with chronic medications. Semi-structured interviews and focus groups with various stakeholders identified ways in which treatment adherence could be supported and also identified key features of well-regarded messages: polite tone, credible information, contextualised, and endorsed by identifiable member of primary care facility staff. Direct and indirect user testing enabled us to refine the intervention including refining use of language and testing of interactive components. CONCLUSIONS: Our experience shows that using a formal intervention development process is feasible in a low-resource multi-lingual setting. The process enabled us to pre-test assumptions about the intervention and the evaluation process, allowing the improvement of both. Describing how a multi-component intervention was developed including standardised descriptions of content aimed to support behaviour change will enable comparison with other similar interventions and support development of new interventions. Even in low-resource settings, funders and policy-makers should provide researchers with time and resources for intervention development work and encourage evaluation of the entire design and testing process. TRIAL REGISTRATION: The trial of the intervention is registered with South African National Clinical Trials Register number (SANCTR DOH-27-1212-386; 28/12/2012); Pan Africa Trial Register (PACTR201411000724141; 14/12/2013); ClinicalTrials.gov ( NCT02019823 ; 24/12/2013).

Mobile Phone Text Messages to Support Treatment Adherence in Adults With High Blood Pressure (SMS-Text Adherence Support [StAR]): A Single-Blind, Randomized Trial.

BACKGROUND: We assessed the effect of automated treatment adherence support delivered via mobile phone short message system (SMS) text messages on blood pressure. METHODS AND RESULTS: In this pragmatic, single-blind, 3-arm, randomized trial (SMS-Text Adherence Support [StAR]) undertaken in South Africa, patients treated for high blood pressure were randomly allocated in a 1:1:1 ratio to information only, interactive SMS text messaging, or usual care. The primary outcome was change in systolic blood pressure at 12 months from baseline measured with a validated oscillometric device. All trial staff were masked to treatment allocation. Analyses were intention to treat. Between June 26, 2012, and November 23, 2012, 1372 participants were randomized to receive information-only SMS text messages (n=457), interactive SMS text messages (n=458), or usual care (n=457). Primary outcome data were available for 1256 participants (92%). At 12 months, the mean adjusted change in systolic blood pressure compared with usual care was -2.2 mm Hg (95% confidence interval, -4.4 to -0.04) with information-only SMS and -1.6 mm Hg (95% confidence interval, -3.7 to 0.6) with interactive SMS. Odds ratios for the proportion of participants with a blood pressure <140/90 mm Hg were 1.42 (95% confidence interval, 1.03-1.95) for information-only messaging and 1.41 (95% confidence interval, 1.02-1.95) for interactive messaging compared with usual care. CONCLUSIONS: In this randomized trial of an automated adherence support program delivered by SMS text message in a general outpatient population of adults with high blood pressure, we found a small reduction in systolic blood pressure control compared with usual care at 12 months. There was no evidence that an interactive intervention increased this effect. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02019823. South African National Clinical Trials Register, number SANCTR DOH-27-1212-386; Pan Africa Trial Register, number PACTR201411000724141.

Efficacy of a text messaging (SMS) based intervention for adults with hypertension: protocol for the StAR (SMS Text-message Adherence suppoRt trial) randomised controlled trial.

BACKGROUND: Interventions to support people with hypertension in attending clinics and taking their medication have potential to improve outcomes, but delivery on a wide scale and at low cost is challenging. Some trials evaluating clinical interventions using short message service (SMS) text-messaging systems have shown important outcomes, although evidence is limited. We have developed a novel SMS system integrated with clinical care for use by people with hypertension in a low-resource setting. We aim to test the efficacy of the system in improving blood pressure control and treatment adherence compared to usual care. METHODS/DESIGN: The SMS Text-message Adherence suppoRt trial (StAR) is a pragmatic individually randomised three-arm parallel group trial in adults treated for hypertension at a single primary care centre in Cape Town, South Africa. The intervention is a structured programme of clinic appointment, medication pick-up reminders, medication adherence support and hypertension-related education delivered remotely using an automated system with either informational or interactive SMS text-messages. Usual care is supplemented by infrequent non-hypertension related SMS text-messages. Participants are 1:1:1 individually randomised, to usual care or to one of the two active interventions using minimisation to dynamically adjust for gender, age, baseline systolic blood pressure, years with hypertension, and previous clinic attendance. The primary outcome is the change in mean systolic blood pressure at 12-month follow-up from baseline measured with research staff blinded to trial allocation. Secondary outcomes include the proportion of patients with 80% or more of days medication available, proportion of participants achieving a systolic blood pressure less than 140 mmHg and a diastolic blood pressure less than 90 mmHg, hospital admissions, health status, retention in clinical care, satisfaction with treatment and care, and patient related quality of life. Anonymised demographic data are collected on non-participants. DISCUSSION: The StAR trial uses a novel, low cost system based on widely available mobile phone technology to deliver the SMS-based intervention, manage communication with patients, and measure clinically relevant outcomes. The results will inform implementation and wider use of mobile phone based interventions for health care delivery in a low-resource setting. TRIAL REGISTRATION: NCT02019823.

Clinical audit of diabetes management can improve the quality of care in a resource-limited primary care setting.

OBJECTIVE: To determine whether clinical audit improved the performance of diabetic clinical processes in the health district in which it was implemented. DESIGN: Patient folders were systematically sampled annually for review. SETTING: Primary health-care facilities in the Metro health district of the Western Cape Province in South Africa. PARTICIPANTS: Health-care workers involved in diabetes management. INTERVENTION: Clinical audit and feedback. MAIN OUTCOME MEASURE: The Skillings-Mack test was applied to median values of pooled audit results for nine diabetic clinical processes to measure whether there were statistically significant differences between annual audits performed in 2005, 2007, 2008 and 2009. Descriptive statistics were used to illustrate the order of values per process. RESULTS: A total of 40 community health centres participated in the baseline audit of 2005 that decreased to 30 in 2009. Except for two routine processes, baseline medians for six out of nine processes were below 50%. Pooled audit results showed statistically significant improvements in seven out of nine clinical processes. CONCLUSIONS: The findings indicate an association between the application of clinical audit and quality improvement in resource-limited settings. Co-interventions introduced after the baseline audit are likely to have contributed to improved outcomes. In addition, support from the relevant government health programmes and commitment of managers and frontline staff contributed to the audit's success.

Implementation of Best-Evidence Osteoarthritis Care: Perspectives on Challenges for, and Opportunities From, Low and Middle-Income Countries.

The "Joint Effort Initiative" (JEI) is an international consortium of clinicians, researchers, and consumers under the auspices of the Osteoarthritis Research Society International (OARSI). The JEI was formed with a vision to improve the implementation of coordinated programs of best evidence osteoarthritis care globally. To better understand some of the issues around osteoarthritis care in low- and middle-income countries (LMICs), the JEI invited clinician researcher representatives from South Africa, Brazil, and Nepal to discuss their perspectives on challenges and opportunities to implementing best-evidence osteoarthritis care at the OARSI World Pre-Congress Workshop. We summarize and discuss the main themes of the presentations in this paper. The challenges to implementing evidence-based osteoarthritis care identified in LMICs include health inequities, unaffordability of osteoarthritis management and the failure to recognize osteoarthritis as an important disease. Fragmented healthcare services and a lack of health professional knowledge and skills are also important factors affecting osteoarthritis care in LMICs. We discuss considerations for developing strategies to improve osteoarthritis care in LMICs. Existing opportunities may be leveraged to facilitate the implementation of best-evidence osteoarthritis care. We also discuss strategies to support the implementation, such as the provision of high-quality healthcare professional and consumer education, and systemic healthcare reforms.

A reflective process led by a family physician to develop a renal-protection surveillance tool for HIV patients newly started on dolutegravir.

A group of Vanguard Community Health Centre doctors embarked on a Health System's Improvement (HSI) project with the aim of reducing harm to renal function in patients who were either commenced on or switched to a dolutegravir (DTG)-based antiretroviral therapy (ART) regimen since 2019, when the usual monitoring and evaluation of ART-regimen switches were disrupted by the coronavirus disease 2019 (COVID-19) pandemic. This intended harm-reduction exercise, involving a reflective process that was facilitated by the family physician, led to the development of a Vanguard Renal Protection Surveillance tool, which is now used at Vanguard to detect and prevent renal decline.

Amitriptyline prescribing in public sector healthcare facilities in the Western Cape, South Africa.

BACKGROUND: Inappropriate medication use is a major patient safety concern, especially for the elderly population. Amitriptyline is widely used in primary care in South Africa and a cross-sectional study found that amitriptyline was prescribed potentially inappropriately in 6.5% of elderly patients. An analysis of prescriptions from the Chronic Dispensing Unit in the Western Cape revealed that amitriptyline was one of the most common medicines prescribed without a suitable diagnosis listed on the prescription. OBJECTIVE: The main objective of the medicine use evaluation (MUE) was to determine whether amitriptyline was prescribed in accordance with recommendations from standard treatment guidelines (STG) and essential medicines lists (EML) endorsed by the National Department of Health, South Africa. METHODS: A retrospective, cross-sectional, multicentre review of patients' clinical notes was conducted. The study population was selected by systematic random sampling from adult outpatients who were prescribed amitriptyline for longer than three months. Criteria for evaluation included amitriptyline indication and total daily dose prescribed. RESULTS: Of the sample of 2237 patient medical records reviewed, 1732 (77.4%) included amitriptyline prescriptions that were according to the approved STG indications. For the approved STG indications, amitriptyline was prescribed mainly for osteoarthritis (25.8%), neuropathies (18.5%) and chronic non-cancer pain (17.9%). Major depressive disorders constituted only 8.6% of the patient records reviewed; however, doses were atypically low. The main inappropriate indication for amitriptyline was sleep disorders (16%). CONCLUSION: This MUE has highlighted the need to improve the use of amitriptyline in specific patient populations, e.g. the elderly and patients with sleeping disorders.

Older persons' experience with health care at two primary level clinics in Cape Town, South Africa: a qualitative assessment.

BACKGROUND: Efficient methods of assessing older persons' healthcare needs are required in busy public sector primary healthcare clinics in South Africa. These clinics are the main points of entry into the healthcare system. This study was part of a larger study to test the local applicability and adaptability of the World Health Organization's (WHO) Age Friendly Primary Care Toolkit for assessing and managing chronic diseases and common geriatric syndromes. AIM: To assess how older persons experience healthcare delivery at two primary healthcare clinics, and identify perceived gaps in health care to older people. DESIGN & SETTING: A qualitative study at two primary healthcare sites in the suburbs of Cape Town, South Africa. METHOD: Focus group discussions (two at each facility) using an interview guide. RESULTS: Analysed data were categorised into five themes: 'despite the challenges, there is overall good care'; 'communication gaps and the frustration of feeling unheard'; 'the health service is experienced as being unreliable, stretched, and is difficult to access'; 'there is a perception of pervasive structural ageism in the clinics'; and 'there is a perception that the quality of care received is related to the profession of the healthcare provider'. CONCLUSION: Challenges of access and care for older clients at primary care clinics are linked to their age-specific holistic needs, which are not fully met by the current age-friendly arrangements. Measures should be taken at the clinics to complement the perceived good clinical care received, by improving access to care, making care appropriate to the need, reducing waiting times, and creating opportunities for older persons to feel respected and heard.

Family medicine internship support during the COVID-19 pandemic in Cape Town, South Africa - A narrative report.

The health-service redesign that came with the preparation for the surge of COVID-19 had a potential of disrupting the Family Medicine internship programme like it did to many other health and academic programmes. A team of Cape-Town based Community Health Centre (CHC) doctors mitigated this challenge by designing an innovative tool that facilitated ongoing supervision of the interns in order to achieve the outcomes of the Health Professions Council of South Africa (HPCSA).

Development and validation of a tool to measure patient experience in chronic disease care.

BACKGROUND:  There is a global increase in the prevalence of non-communicable diseases and a growing understanding that patients need to be involved in their care. Patient experience should be assessed and the information used to improve on the planning and delivery of health services. AIM:  This study described the development and validation of a patient-reported experience measure (PREM) tool which is appropriate for the South African context, to assess self-reported patient experience of chronic care. SETTING:  The study was conducted at four primary health care facilities in the Cape Town Metropole. METHODS:  This was a validity and reliability study with multiple phases to develop and determine the psychometric properties of a novel tool. It consisted of three phases, namely: Phase 1 - Consensus Validity; Phase 2 - Face Validity; Phase 3 - Reliability. Phase 1 consisted of an expert panel reaching consensus on a draft tool. Phase 2a consisted of qualitative semi-structured interviews and cognitive interviews. Phase 3 tested the internal consistency of the tool, the time necessary to complete, as well as floor and ceiling effects with 200 questionnaires. RESULTS:  The process described resulted in a final questionnaire with n = 10 items in three languages that was easily understood by patients. Internal consistency was determined with the overall Cronbach's alpha 0.86. This PREM has been named Chronic Care Assessment of Patient Experience. CONCLUSION:  Using best practice guidance in tool construction and validation, we delivered a PREM with the potential to improve the quality of care from the perspective of patients. Implementation studies are now required to determine how best to use this tool in routine practice.

The effect of phlebotomy training on blood sample rejection and phlebotomy knowledge of primary health care providers in Cape Town: A quasi-experimental study.

BACKGROUND: There is an increasing amount of blood sample rejection at primary health care facilities (PHCFs), impacting negatively the staff, facility, patient and laboratory costs. AIM: The primary objective was to determine the rejection rate and reasons for blood sample rejection at four PHCFs before and after a phlebotomy training programme. The secondary objective was to determine whether phlebotomy training improved knowledge among primary health care providers (HCPs) and to develop a tool for blood sample acceptability. STUDY SETTING: Two community health centres (CHCs) and two community day centres (CDCs) in Cape Town. METHODS: A quasi-experimental study design (before and after a phlebotomy training programme). RESULTS: The sample rejection rate was 0.79% (n = 60) at CHC A, 1.13% (n = 45) at CHC B, 1.64% (n = 38) at CDC C and 1.36% (n = 8) at CDC D pre-training. The rejection rate remained approximately the same post-training (p > 0.05). The same phlebotomy questionnaire was administered pre- and post-training to HCPs. The average score increased from 63% (95% CI 6.97‒17.03) to 96% (95% CI 16.91‒20.09) at CHC A (p = 0.039), 58% (95% CI 9.09‒14.91) to 93% (95% CI 17.64‒18.76) at CHC B (p = 0.006), 60% (95% CI 8.84‒13.13) to 97% (95% CI 16.14‒19.29) at CDC C (p = 0.001) and 63% (95% CI 9.81‒13.33) to 97% (95% CI 18.08‒19.07) at CDC D (p = 0.001). CONCLUSION: There is no statistically significant improvement in the rejection rate of blood samples (p > 0.05) post-training despite knowledge improving in all HCPs (p < 0.05).

Auditing chronic disease care: Does it make a difference?

BACKGROUND: An integrated audit tool was developed for five chronic diseases, namely diabetes, hypertension, asthma, chronic obstructive pulmonary disease and epilepsy. Annual audits have been done in the Western Cape Metro district since 2009. The year 2012 was the first year that all six districts in South Africa's Western Cape Province participated in the audit process. AIM: To determine whether clinical audits improve chronic disease care in health districts over time. SETTING: Western Cape Province, South Africa. METHODS: Internal audits were conducted of primary healthcare facility processes and equipment availability as well as a folder review of 10 folders per chronic condition per facility. Random systematic sampling was used to select the 10 folders for the folder review. Combined data for all facilities gave a provincial overview and allowed for comparison between districts. Analysis was done comparing districts that have been participating in the audit process from 2009 to 2010 ('2012 old') to districts that started auditing recently ('2012 new'). RESULTS: The number of facilities audited has steadily increased from 29 in 2009 to 129 in 2012. Improvements between different years have been modest, and the overall provincial average seemed worse in 2012 compared to 2011. However, there was an improvement in the '2012 old' districts compared to the '2012 new' districts for both the facility audit and the folder review, including for eight clinical indicators, with '2012 new' districts being less likely to record clinical processes (OR 0.25, 95% CI 0.21-0.31). CONCLUSION: These findings are an indication of the value of audits to improve care processes over the long term. It is hoped that this improvement will lead to improved patient outcomes.