Nurse-coordinated multidisciplinary, family-based cardiovascular disease prevention programme (EUROACTION) for patients with coronary heart disease and asympto matic individuals at high risk of cardiovascular disease: a paired, cluster-randomised controlled trial

2009 ◽  
Vol 7 (2) ◽  
pp. 9-10
Author(s):  
Wilma Scholte op Reimer
Keyword(s):  
Cardiovascular Disease ◽  
Coronary Heart Disease ◽  
Heart Disease ◽  
High Risk ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
Family Based ◽  
Randomised Controlled

scholarly journals SMARThealth Pregnancy: Feasibility and Acceptability of a Complex Intervention for High-Risk Pregnant Women in Rural India: Protocol for a Pilot Cluster Randomised Controlled Trial

2021 ◽  
Vol 2 ◽  
Author(s):  
Shobhana Nagraj ◽  
Stephen H. Kennedy ◽  
Vivekananda Jha ◽  
Robyn Norton ◽  
Lisa Hinton ◽  
...  
Keyword(s):  
Decision Support ◽  
Pilot Study ◽  
High Risk ◽  
Randomised Controlled Trial ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Rural India ◽  
Cluster Randomised ◽  
Randomised Controlled

Introduction: India is in the process of a major epidemiological transition towards non-communicable diseases. Cardiovascular disease (CVD) is the leading cause of death in women in India. Predisposing independent risk factors include pregnancy-related conditions, e.g., hypertensive disorders of pregnancy (HDP) and gestational diabetes (GDM) - also associated with significant perinatal mortality and morbidity. Early identification, referral and management of pregnant women at increased risk of future CVD may offer opportunities for prevention. In rural India, Community Health Workers (CHWs) provide most antenatal and postnatal care. Innovative solutions are required to address integrated care for rural women during transitions between antenatal, postnatal and general health services. The George Institute's SMARThealth Programme has shown that CHWs in rural India screening non-pregnant adults for cardiovascular risk, using a decision support system, is feasible. Building on this, we developed a targeted training programme for CHWs and a complex system-level intervention that uses mobile clinical decision support for CHWs and primary care doctors to screen high-risk pregnant women. In addition to addressing HDP and GDM, the intervention also screens for anaemia in pregnancy.Methods/Design: A pilot study will be undertaken in two diverse rural districts of India: Jhajjar (Haryana) and Guntur (Andhra Pradesh). Two Primary Health Centre clusters will be randomised to intervention or control groups at each study site. The primary objective of this pilot study is to explore the feasibility and acceptability of the SMARThealth Pregnancy intervention. Secondary objectives are to estimate: (a) prevalence rates of moderate to severe anaemia, HDPs and GDM at the study sites; (b) referral and follow-up rates, and (c) mean haemoglobin and blood pressure values at the routine 6 week postnatal visit. A process evaluation will be conducted to explore the acceptability of the SMARThealth Pregnancy intervention for pregnant women and healthcare workers using qualitative methods.Discussion: It is anticipated that the findings of this pilot study will help determine the feasibility and acceptability of the SMARThealth Pregnancy intervention, and highlight how the intervention might be further developed for evaluation in a larger, cluster randomised controlled trial.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT03968952.

scholarly journals Safer prescribing and care for the elderly (SPACE): cluster randomised controlled trial in general practice

BJGP Open ◽  
2021 ◽  
pp. BJGPO.2021.0129
Author(s):  
Katharine Ann Wallis ◽  
Carolyn Raina Elley ◽  
Simon A. Moyes ◽  
Arier Lee ◽  
Joanna Frances Hikaka ◽  
...  
Keyword(s):  
General Practice ◽  
High Risk ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
Increased Risk ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Automated Search

BackgroundSafer prescribing in general practice may help to decrease preventable adverse drug events (ADE) and related hospitalisations.AimTo test effect of SPACE on high-risk prescribing of non-steroidal anti-inflammatory drugs (NSAIDs) and/or antiplatelet medicines and related hospitalisations.Design & settingPragmatic cluster randomised controlled trial in general practice. Participants were patients at increased risk of ADEs from NSAIDs and/or antiplatelet medicines at baseline. SPACE comprises automated search to generate for each general practitioner (GP)a list of patients with high-risk prescribing; pharmacist outreach to provide education and one-on-one review of list with GP; and automated letter inviting patients to seek medication review with their GP.MethodPrimary outcome was difference in high-risk prescribing of NSAIDs and/or antiplatelet medicines at 6 months; secondary outcomes included high-risk prescribing for gastrointestinal, renal or cardiac ADEs separately; 12-month outcomes; and related ADE hospitalisations.ResultsWe recruited 39 practices with 205 GPs and 191,593 patients including 21,877 (11.4%) participants, 1,479 (6.8%) with high-risk prescribing. High-risk prescribing improved in both groups at 6 and 12 months compared with baseline. At 6 months, there was no significant difference between groups (OR: 0.99 (0.87, 1.13)) although SPACE improved more for gastrointestinal ADEs (0.81 (0.68, 0.96)). At 12 months, the control group improved more (OR: 1.29 (1.11, 1.49)). There was no significant difference for related hospitalisations.ConclusionFurther work is needed to identify scalable interventions that support safer prescribing in general practice. The use of automated search and feedback plus letter to patient warrants further exploration.

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