scholarly journals Process evaluation of complex cardiovascular interventions: How to interpret the results of my trial?

2020 ◽  
Vol 19 (3) ◽  
pp. 269-274
Author(s):  
Markus Saarijärvi ◽  
Lars Wallin ◽  
Ewa-Lena Bratt

Complex interventions of varying degrees of complexity are commonly used and evaluated in cardiovascular nursing and allied professions. Such interventions are increasingly tested using randomized trial designs. However, process evaluations are seldom used to better understand the results of these trials. Process evaluation aims to understand how complex interventions create change by evaluating implementation, mechanisms of impact, and the surrounding context when delivering an intervention. As such, this method can illuminate important mechanisms and clarify variation in results. In this article, process evaluation is described according to the Medical Research Council guidance and its use exemplified through a randomized controlled trial evaluating the effectiveness of a transition program for adolescents with chronic conditions.

Evaluation ◽  
2018 ◽  
Vol 25 (2) ◽  
pp. 149-170 ◽  
Author(s):  
Sarah Louise Brand ◽  
Cath Quinn ◽  
Mark Pearson ◽  
Charlotte Lennox ◽  
Christabel Owens ◽  
...  

Medical Research Council guidelines recognise the need to optimise complex interventions prior to full trial through greater understanding of underlying theory and formative process evaluation, yet there are few examples. A realist approach to formative process evaluation makes a unique contribution through a focus on theory formalisation and abstraction. The success of an intervention is dependent on the extent to which it gels or jars with existing provision and can be successfully transferred to new contexts. Interventions with underlying programme theory about how they work, for whom, and under which circumstances will be better able to adapt to work with (rather than against) different services, individuals, and settings. In this methodological article, we describe and illustrate how a realist approach to formative process evaluation develops contextualised intervention theory that can underpin more adaptable and scalable interventions. We discuss challenges and benefits of this approach.


BMJ ◽  
2015 ◽  
Vol 350 (mar19 6) ◽  
pp. h1258-h1258 ◽  
Author(s):  
G. F. Moore ◽  
S. Audrey ◽  
M. Barker ◽  
L. Bond ◽  
C. Bonell ◽  
...  

2021 ◽  
Author(s):  
Patrick Ware ◽  
Amika Shah ◽  
Heather Joan Ross ◽  
Alexander Gordon Logan ◽  
Phillip Segal ◽  
...  

BACKGROUND Despite the growing prevalence of people with complex conditions and evidence of the positive impact of telemonitoring for single conditions, little research exists on the use of telemonitoring in this population, particularly those with multiple chronic conditions (MCCs). OBJECTIVE This randomized controlled trial (RCT) and embedded qualitative study aimed to evaluate the impact and experiences of patients and healthcare providers (HCPs) using a telemonitoring system with decision support to manage complex patients, including those with MCCs, compared to the standard of care. METHODS A pragmatic 6-month RCT sought to recruit 146 patients with a diagnosis of heart failure (HF), uncontrolled hypertension (HT), and/or insulin requiring diabetes (DM) from outpatient specialty settings in Toronto, Canada. Participants were randomized into the control and telemonitoring groups with the latter being instructed to take readings relevant to their condition(s). The telemonitoring system contained an algorithm that generated decision support in the form of actionable self-care directives to patients and alerts to HCPs. The primary outcome was health status as measured by the SF-36. Secondary outcomes included anxiety and depression, self-efficacy in chronic disease management, and self-reported healthcare utilization. HF-related quality of life and self-care measures were also collected from patients followed for HF. Within- and between-group change scores were analyzed for statistical significance (P<.05). A convenience sample of HCPs and patients in the intervention group were interviewed about their experiences RESULTS A total of 96 patients were recruited and randomized. Recruitment was terminated early due to implementation challenges and the onset of COVID-19. No significant within- and between-group differences were found for the main primary and secondary outcomes. However, a within-group analysis of HF patients found improvements in self-care maintenance (P=.036) and physical quality of life (P= .046). Opinions expressed by the 5 HCPs and 13 patients interviewed differed based on the condition(s) monitored. Although HF patients reported benefitting from actionable self-care guidance and meaningful interactions with their HCPs, patient and HCP users of the DM and HT modules did not think telemonitoring improved the clinical management of those conditions to the same degree. These differing experiences were largely attributed to the siloed nature of specialty care, and the design of the decision support whereby it was indicated that fluctuations in HT and DM patient status typically required less urgent intervention compared to HF. CONCLUSIONS Consistent with previous studies, we recommend that future research conceive telemonitoring as a program and that self-management and clinical decision support are necessary, but not sufficient components of such programs for complex patients with lower acuity. We conclude that a multidisciplinary model of care that includes care coordination must accompany telemonitoring systems which may best be operationalized through novel models of care, such as nurse-led models. CLINICALTRIAL ClinicalTrials.gov NCT03127852, ISRCTN (41238563) INTERNATIONAL REGISTERED REPORT RR2-10.2196/resprot.8367


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