scholarly journals Can lay health workers support the management of hypertension? Findings of a cluster randomised trial in South Africa

2018 ◽  
Vol 3 (1) ◽  
pp. e000577 ◽  
Author(s):  
Jane Goudge ◽  
Tobias Chirwa ◽  
Sandra Eldridge ◽  
Francesc Xavier F Gómez-Olivé ◽  
Chodziwadziwa Kabudula ◽  
...  
Keyword(s):  
Chronic Care ◽  
Health Workers ◽  
Clinical Care ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Lay Health Workers ◽  
Cross Sectional ◽  
Middle Income ◽  
Cluster Randomised ◽  
Low Middle Income Countries

IntroductionIn low/middle-income countries with substantial HIV and tuberculosis epidemics, health services often neglect other highly prevalent chronic conditions, such as hypertension, which as a result are poorly managed. This paper reports on a study to assess the effect on hypertension management of lay health workers (LHW) working in South African rural primary healthcare clinics to support the provision of integrated chronic care.MethodsA pragmatic cluster randomised trial with a process evaluation in eight rural clinics assessed the effect of adding two LHWs supporting nurses in providing chronic disease care in each intervention clinic over 18 months. Control clinics continued with usual care. The main outcome measure was the change in the difference of percentage of clinic users who had elevated cardiovascular risk associated with high blood pressure (BP) before and after the intervention, as measured by two cross-sectional population surveys.ResultsThere was no improvement in BP control among users of intervention clinics as compared with control clinics. However, the LHWs improved clinic functioning, including overall attendance, and attendance on the correct day. All clinics faced numerous challenges, including rapidly increasing number of users of chronic care, unreliable BP machines and cuffs, intermittent drug shortages and insufficient space.ConclusionLHWs improved the process of providing care but improved BP control required improved clinical care by nurses which was compromised by large and increasing numbers of patients, the dominance of the vertically funded HIV programme and the poor standards of equipment in clinics.Trial registration numberISRCTN12128227.

scholarly journals Effectiveness of delivering integrated COPD care at public healthcare facilities: a cluster randomised trial in Pakistan

BJGP Open ◽  
2019 ◽  
Vol 3 (1) ◽  
pp. bjgpopen18X101634
Author(s):  
Muhammad Amir Khan ◽  
Nida Khan ◽  
John D Walley ◽  
Muhammad Ahmar Khan ◽  
Joseph Hicks ◽  
...  
Keyword(s):  
Public Health ◽  
Primary Outcome ◽  
Clinical Care ◽  
Randomised Trial ◽  
Health Facilities ◽  
Cluster Randomised Trial ◽  
Public Healthcare ◽  
Public Health Facilities ◽  
Cluster Randomised

BackgroundIn Pakistan chronic obstructive pulmonary disease (COPD) prevalence is 2.1% in adults aged >40 years. Despite being a health policy focus, integrated COPD care has remained neglected, with wide variation in practice.AimTo assess whether enhanced care at public health facilities resulted in better control of COPD, treatment adherence, and smoking cessation.Design & settingA two-arm cluster randomised controlled trial was undertaken in 30 public health facilities (23 primary and 7 secondary), across three districts of Punjab, between October 2014–December 2016. Both arms had enhanced diagnosis and patient recording processes. Intervention facilities also had clinical care guides; drugs for COPD; patient education flipcharts; associated staff training; and mobile phone follow-up.MethodFacilities were randomised in a 1:1 ratio (sealed envelope independent lottery method), and 159 intervention and 154 control patients were recruited. The eligibility criteria were as follows: diagnosed with COPD, aged ≥18 years, and living in the catchment area. The primary outcome was change in BODE (Body mass index, airway Obstruction, Dyspnoea, Exercise capacity) index score from baseline to final follow-up visit. Staff and patients were not blinded.ResultsSix-month primary outcomes were available for 147/159 (92.5%) intervention and 141/154 (91.6%) control participants (all clusters). The primary outcome results cluster-level analysis were as follows: mean intervention outcome = -1.67 (95% confidence intervals [CI] = -2.18 to -1.16); mean control outcome = -0.66 (95% CI = -1.09 to -0.22); and covariate-adjusted mean intervention–control difference = -0.96 (95% CI = -1.49 to -0.44; P = 0.001).ConclusionThe findings of this trial and a separate process evaluation study support the scaling of this integrated COPD care package at primary and secondary level public health facilities in Pakistan and similar settings.

scholarly journals Saving babies’ lives (SBL) – a programme to reduce neonatal mortality in rural Cambodia: study protocol for a stepped-wedge cluster-randomised trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Kaajal Patel ◽  
Sopheakneary Say ◽  
Daly Leng ◽  
Manila Prak ◽  
Koung Lo ◽  
...  
Keyword(s):  
Data Collection ◽  
Neonatal Mortality ◽  
Rural Areas ◽  
Health Workers ◽  
Randomised Trial ◽  
Scale Up ◽  
Cluster Randomised Trial ◽  
Stepped Wedge ◽  
Cluster Randomised ◽  
The Continuum

Abstract Background Neonatal mortality remains unacceptably high. Many studies successful at reducing neonatal mortality have failed to realise similar gains at scale. Effective implementation and scale-up of interventions designed to tackle neonatal mortality is a global health priority. Multifaceted programmes targeting the continuum of neonatal care, with sustainability and scalability built into the design, can provide practical insights to solve this challenge. Cambodia has amongst the highest neonatal mortality rates in South-East Asia, with rural areas particularly affected. The primary objective of this study is the design, implementation, and assessment of the Saving Babies’ Lives programme, a package of interventions designed to reduce neonatal mortality in rural Cambodia. Methods This study is a five-year stepped-wedge cluster-randomised trial conducted in a rural Cambodian province with an estimated annual delivery rate of 6615. The study is designed to implement and evaluate the Saving Babies’ Lives programme, which is the intervention. The Saving Babies’ Lives programme is an iterative package of neonatal interventions spanning the continuum of care and integrating into the existing health system. The Saving Babies’ Lives programme comprises two major components: participatory learning and action with community health workers, and capacity building of primary care facilities involving facility-based mentorship. Standard government service continues in control arms. Data collection covering the whole study area includes surveillance of all pregnancies, verbal and social autopsies, and quality of care surveys. Mixed methods data collection supports iteration of the complex intervention, and facilitates impact, outcome, process and economic evaluation. Discussion Our study uses a robust study design to evaluate and develop a holistic, innovative, contextually relevant and sustainable programme that can be scaled-up to reduce neonatal mortality. Trial registration ClinicalTrials.gov: NCT04663620. Registered on 11th December 2020, retrospectively registered.

scholarly journals Action leveraging evidence to reduce perinatal mortality and morbidity (ALERT): study protocol for a stepped-wedge cluster-randomised trial in Benin, Malawi, Tanzania and Uganda

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Joseph Akuze ◽  
Kristi Sidney Annerstedt ◽  
Lenka Benova ◽  
Effie Chipeta ◽  
Jean-Paul Dossou ◽  
...  
Keyword(s):  
Perinatal Mortality ◽  
Process Evaluation ◽  
Study Protocol ◽  
Health Workers ◽  
Randomised Trial ◽  
User Participation ◽  
Cluster Randomised Trial ◽  
Evidence Based ◽  
Stepped Wedge ◽  
Cluster Randomised

Abstract Background Insufficient reductions in maternal and neonatal deaths and stillbirths in the past decade are a deterrence to achieving the Sustainable Development Goal 3. The majority of deaths occur during the intrapartum and immediate postnatal period. Overcoming the knowledge-do-gap to ensure implementation of known evidence-based interventions during this period has the potential to avert at least 2.5 million deaths in mothers and their offspring annually. This paper describes a study protocol for implementing and evaluating a multi-faceted health care system intervention to strengthen the implementation of evidence-based interventions and responsive care during this crucial period. Methods This is a cluster randomised stepped-wedge trial with a nested realist process evaluation across 16 hospitals in Benin, Malawi, Tanzania and Uganda. The ALERT intervention will include four main components: i) end-user participation through narratives of women, families and midwifery providers to ensure co-design of the intervention; ii) competency-based training; iii) quality improvement supported by data from a clinical perinatal e-registry and iv) empowerment and leadership mentoring of maternity unit leaders complemented by district based bi-annual coordination and accountability meetings. The trial’s primary outcome is in-facility perinatal (stillbirths and early neonatal) mortality, in which we expect a 25% reduction. A perinatal e-registry will be implemented to monitor the trial. Our nested realist process evaluation will help to understand what works, for whom, and under which conditions. We will apply a gender lens to explore constraints to the provision of evidence-based care by health workers providing maternity services. An economic evaluation will assess the scalability and cost-effectiveness of ALERT intervention. Discussion There is evidence that each of the ALERT intervention components improves health providers’ practices and has modest to moderate effects. We aim to test if the innovative packaging, including addressing specific health systems constraints in these settings, will have a synergistic effect and produce more considerable perinatal mortality reductions. Trial registration Pan African Clinical Trial Registry (www.pactr.org): PACTR202006793783148. Registered on 17th June 2020.

scholarly journals Enhanced hypertension care through private clinics in Pakistan: a cluster randomised trial

BJGP Open ◽  
2019 ◽  
Vol 3 (1) ◽  
pp. bjgpopen18X101617 ◽  
Author(s):  
Muhammad Amir Khan ◽  
Nida Khan ◽  
John D Walley ◽  
Shaheer Ellahi Khan ◽  
Joseph Hicks ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Urban Areas ◽  
Controlled Trial ◽  
Clinical Care ◽  
Randomised Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised Trial ◽  
Cvd Risk ◽  
Cluster Randomised

BackgroundHypertension in Pakistan affects 33% of people aged ≥45 years, and in urban areas around 70% of basic health care occurs in private facilities.AimTo assess whether enhanced care at urban private clinics resulted in better control of hypertension, cardiovascular disease (CVD) risk factors, and treatment adherence.Design & settingA two-arm cluster randomised controlled trial was conducted at 26 private clinics (in three districts of Punjab) between January 2015–September 2016. Both arms had enhanced screening and diagnosis of hypertension and related conditions, and patient recording processes. Intervention facilities also had a clinical care guide, additional drugs for hypertension, a patient lifestyle education flipchart, associated training, and mobile phone follow-up.MethodClinics were randomised in a 1:1 ratio (sealed envelope lottery method). A total of 574 intervention and 564 control patients in 13 clusters in each arm were recruited (male and female, aged ≥25 years, systolic blood pressure [SBP] >140 mmHg, and/or diastolic blood pressure [DBP] >90 mmHg). The primary outcome was change in SBP from baseline to 9-month follow-up.Staff and patients were not blinded, but outcome assessors were blinded.ResultsNine-month primary outcomes were available for 522/574 (90.9%) intervention and 484/564 (85.8%) control participants (all clusters). The unadjusted cluster-level analysis results were as follows: mean intervention outcome was -25.2 mmHg (95% confidence intervals [CI] = -29.9 to-20.6); mean control outcome was -9.4 mmHg (95% CI = 21.2 to 2.2); and mean control–intervention difference was 15.8 (95% CI = 3.6 to 28.0; P = 0.01).ConclusionThe findings and separate process evaluation support the scaling of an integrated CVD–hypertension care intervention in urban private clinics in areas lacking public primary care in Pakistan.

scholarly journals Effect of a mass radio campaign on family behaviours and child survival in Burkina Faso: a repeated cross-sectional, cluster-randomised trial

2018 ◽  
Vol 6 (3) ◽  
pp. e330-e341 ◽  
Author(s):  
Sophie Sarrassat ◽  
Nicolas Meda ◽  
Hermann Badolo ◽  
Moctar Ouedraogo ◽  
Henri Some ◽  
...  
Keyword(s):  
Burkina Faso ◽  
Child Survival ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Cross Sectional ◽  
Cluster Randomised ◽  
Radio Campaign

scholarly journals The effect of mobile phone text-message reminders on Kenyan health workers' adherence to malaria treatment guidelines: a cluster randomised trial

The Lancet ◽  
2011 ◽  
Vol 378 (9793) ◽  
pp. 795-803 ◽  
Author(s):  
Dejan Zurovac ◽  
Raymond K Sudoi ◽  
Willis S Akhwale ◽  
Moses Ndiritu ◽  
Davidson H Hamer ◽  
...  
Keyword(s):  
Mobile Phone ◽  
Treatment Guidelines ◽  
Health Workers ◽  
Randomised Trial ◽  
Text Message ◽  
Malaria Treatment ◽  
Cluster Randomised Trial ◽  
Cluster Randomised

scholarly journals Cross-sectional study evaluating data quality of the National Cancer Registration and Analysis Service (NCRAS) prostate cancer registry data using the Cluster randomised trial of PSA testing for Prostate cancer (CAP)

BMJ Open ◽  
2017 ◽  
Vol 7 (11) ◽  
pp. e015994 ◽  
Author(s):  
Samuel William David Merriel ◽  
Emma L Turner ◽  
Eleanor Walsh ◽  
Grace J Young ◽  
Chris Metcalfe ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Randomised Trial ◽  
Tnm Stage ◽  
Cancer Registration ◽  
Cluster Randomised Trial ◽  
Gleason Grade ◽  
Cross Sectional ◽  
Cancer Data ◽  
Psa Testing ◽  
Cluster Randomised

ObjectivesTo compare the completeness and agreement of prostate cancer data recorded by the National Cancer Registration and Analysis Service (NCRAS) with research-level data specifically abstracted from medical records from the Cluster randomised triAl of prostate specific antigen (PSA) testing for Prostate cancer (CAP) trial.DesignCross-sectional comparison study.ParticipantsWe included 1356 men from the CAP trial cohort who were linked to the NCRAS registry.Primary and secondary outcome measuresCompleteness of prostate cancer data in NCRAS and CAP and agreement for tumour, node, metastases (TNM) stage (T1/T2; T3; T4/N1/M1) and Gleason grade (4–6; 7; 8–10), measured by differences in proportions and Cohen’s kappa statistic. Data were also stratified by year and pre-2010 versus post-2010, when NCRAS reporting standards changed.ResultsCompared with CAP, completeness was lower in NCRAS for Gleason grade (41.2% vs 76.7%, difference 35.5, 95% CI 32.1 to 39.0) and TNM stage (29.9% vs 67.6%, difference 37.6, 95% CI 34.1 to 41.1). NCRAS completeness for Gleason grade (pre-2010 vs post-2010 31.69% vs 64%; difference 32.31, 95% CI 26.76 to 37.87) and TNM stage (19.31% vs 55.50%; difference 36.19, 95% CI 30.72 to 41.67) improved over time. Agreement for Gleason grade was high (Cohen’s kappa, κ=0.90, 95% CI 0.88 to 0.93), but lower for TNM stage (κ=0.41, 95% CI 0.37 to 0.51) overall. There was a trend towards improved agreement on Gleason grade, but not TNM stage, when comparing pre-2010 and post-2010 data.ConclusionNCRAS case identification was very high; however, data on prostate cancer grade was less complete than CAP, and agreement for TNM stage was modest. Although the completeness of NCRAS data has improved since 2010, the higher completeness rate in CAP demonstrates that gains could potentially be achieved in routine registry data. This study’s findings highlight a need for improved recording of stage and grade data in the source medical records.

Sign in / Sign up

Export Citation Format

Share Document