Dataset Information

Mixed methods evaluation of targeted case finding for cardiovascular disease prevention using a stepped wedged cluster RCT.

ABSTRACT:

Background

A pilot project cardiovascular prevention was implemented in Sandwell (West Midlands, UK). This used electronic primary care records to identify untreated patients at high risk of cardiovascular disease then invited these high risk patients for assessment by a nurse in their own general practice. Those found to be eligible for treatment were offered treatment. During the pilot a higher proportion of high risk patients were started on treatment in the intervention practices than in control practices. Following the apparent success of the prevention project, it was intended to extend the service to all practices across the Sandwell area. However the pilot project was not a robust evaluation. There was a need for an efficient evaluation that would not disrupt the planned rollout of the project.

Methods/design

Project nurses will sequentially implement targeted cardiovascular case finding in a phased way across all general practices, with the sequence of general practices determined randomly. This is a stepped wedge randomised controlled trial design. The target population is patients aged 35 to 74, without diabetes or cardiovascular disease whose ten-year cardiovascular risk, (determined from data in their electronic records) is ? 20%. The primary outcome is the number of high risk patients started on treatment, because these data could be efficiently obtained from electronic primary care records. From this we can determine the effects of the case finding programme on the proportion of high risk patients started on treatment in practices before and after implementation of targeted case finding. Cost-effectiveness will be modelled from the predicted effects of treatments on cardiovascular events and associated health service costs. Alongside the implementation it is intended to interview clinical staff and patients who participated in the programme in order to determine acceptability to patients and clinicians. Practical considerations meant that 26 practices in Sandwell could be randomised, including about 6,250 patients at high risk of cardiovascular disease. This gives sufficient power for evaluation.

Discussion

It is possible to design a stepped wedge randomised controlled trial using routine data to determine the primary outcome to evaluate implementation of a cardiovascular prevention programme.

SUBMITTER: Marshall T

PROVIDER: S-EPMC3505746 | biostudies-literature | 2012 Oct

REPOSITORIES: biostudies-literature

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Publications

Mixed methods evaluation of targeted case finding for cardiovascular disease prevention using a stepped wedged cluster RCT.

Marshall Tom T Caley Michael M Hemming Karla K Gill Paramjit P Gale Nicola N Jolly Kate K

BMC public health 20121026

<h4>Background</h4>A pilot project cardiovascular prevention was implemented in Sandwell (West Midlands, UK). This used electronic primary care records to identify untreated patients at high risk of cardiovascular disease then invited these high risk patients for assessment by a nurse in their own general practice. Those found to be eligible for treatment were offered treatment. During the pilot a higher proportion of high risk patients were started on treatment in the intervention practices tha ...[more]

PMID: 23101763

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Project description:BackgroundThe primary prevention of cardiovascular (CV) events is often less intense in persons at higher CV risk and vice versa. Clinical practice guidelines recommend that clinicians and patients use shared decision making (SDM) to arrive at an effective and feasible prevention plan that is congruent with each person's CV risk and informed preferences. However, SDM does not routinely happen in practice. This study aims to integrate into routine care an SDM decision tool (CV PREVENTION CHOICE) at three diverse healthcare systems in the USA and study strategies that foster its adoption and routine use.MethodsThis is a mixed method, hybrid type III stepped wedge cluster randomized study to estimate (a) the effectiveness of implementation strategies on SDM uptake and utilization and (b) the extent to which SDM results in prevention plans that are risk-congruent. Formative evaluation methods, including clinician and stakeholder interviews and surveys, will identify factors likely to impact feasibility, acceptability, and adoption of CV PREVENTION CHOICE as well as normalization of CV PREVENTION CHOICE in routine care. Implementation facilitation will be used to tailor implementation strategies to local needs, and implementation strategies will be systematically adjusted and tracked for assessment and refinement. Electronic health record data will be used to assess implementation and effectiveness outcomes, including CV PREVENTION CHOICE reach, adoption, implementation, maintenance, and effectiveness (measured as risk-concordant care plans). A sample of video-recorded clinical encounters and patient surveys will be used to assess fidelity. The study employs three theoretical approaches: a determinant framework that calls attention to categories of factors that may foster or inhibit implementation outcomes (the Consolidated Framework for Implementation Research), an implementation theory that guides explanation or understanding of causal influences on implementation outcomes (Normalization Process Theory), and an evaluation framework (RE-AIM).DiscussionBy the project's end, we expect to have (a) identified the most effective implementation strategies to embed SDM in routine practice and (b) estimated the effectiveness of SDM to achieve feasible and risk-concordant CV prevention in primary care.Trial registrationClinicalTrials.gov, NCT04450914 . Posted June 30, 2020 TRIAL STATUS: This study received ethics approval on April 17, 2020. The current trial protocol is version 2 (approved February 17, 2021). The first subject had not yet been enrolled at the time of submission.

Project description:IntroductionThe Diabetes Prevention Program, an intensive lifestyle change program, effectively reduces the risk of progression from prediabetes to type 2 diabetes but is underutilized. An implementation study using formative research was undertaken to increase Diabetes Prevention Program referrals at a primary care clinic.Study designA pragmatic, cluster randomized, mixed-methods study.Setting/particpantsClusters were teams of primary care clinicians from 2 primary care clinics. The 3 intervention clusters had 8-11 clinicians, and the 3 control clusters had 7-20 clinicians.InterventionImplementation activities occurred from December 2017 to February 2019. The activities included targeted clinician education, a prediabetes clinician champion, and a custom electronic health record report identifying patients with prediabetes.Main outcome measuresThe primary outcome was referral of patients with prediabetes to the institutional Diabetes Prevention Program. Study data, including patient demographic and clinical variables, came from electronic health record. Interviews with clinicians evaluated the implementation strategies. Generalized estimating equation analyses that accounted for multiple levels of correlation and interview content analysis occurred in 2019.ResultsStudy clinicians cared for 2,992 patients with a prediabetes diagnosis or HbA1c indicative of prediabetes (5.7%-6.4%). Clinicians in the intervention clusters referred 6.9% (87 of 1,262) of patients with prediabetes to the Diabetes Prevention Program and those in the control clusters referred 1.5% (26 of 1,730). When adjusted for patient age, sex, race, HbA1c value, HbA1c test location, and insurance type, intervention clinicians had 3.85 (95% CI=0.40, 36.78) greater odds of referring a patient with prediabetes to the Diabetes Prevention Program. The 11 interviewed intervention clinicians had mixed opinions about the utility of the interventions, reporting the prediabetes clinic champion (n=7, 64%) and educational presentations (n=6, 55%) as most helpful.ConclusionsIntervention clinicians were more likely to make Diabetes Prevention Program referrals; however, the study lacked power to achieve statistical significance. Clinician interviews suggested that intervention components that triggered Diabetes Prevention Program referrals varied among clinicians.

Project description:BackgroundInformal carers play a significant role in supporting people living with dementia; however, carers in rural areas are often isolated, with limited access to support services. Although dementia-friendly communities provide valued support for carers, access to them is limited as they are few and geographically dispersed.ObjectiveThis study's aim was to increase support and services for rural informal carers of people living with dementia by using information and communication technologies accessed through an integrated website and mobile app-the Verily Connect app. The objective of this protocol is to detail the research design used in a complex study that was situated in a challenging real-world setting integrating web-based and on-ground technology and communication. Therefore, it is anticipated that this protocol will strengthen the research of others exploring similar complex concepts.MethodsA stepped-wedge, open-cohort cluster randomized controlled trial was conducted to implement Verily Connect across 12 rural Australian communities. The Verily Connect intervention delivered web-based, curated information about dementia, a localized directory of dementia services and support, group and individual chat forums, and peer support through videoconference. During the implementation phase of 32 weeks, Verily Connect was progressively implemented in four 8-weekly waves of 3 communities per wave. Usual care, used as a comparator, was available to carers throughout the study period. Participants and researchers were unblinded to the intervention. There were 3 cohorts of participants: carers, volunteers, and staff; participants were recruited from their communities. The primary outcome measure was perceived carer social support measured using the Medical Outcomes Study-Social Support Survey. Volunteers and staff provided feedback on their participation in Verily Connect as qualitative data. Qualitative data were collected from all cohorts of participants through interviews and focus groups. Process evaluation data were collected through interviews and memos written by research staff. Data on the costs of implementing Verily Connect were collected by the research team members and evaluated by a health economist.ResultsBetween August 2018 and September 2019, a total of 113 participants were recruited. There were 37 (32.7%) carers, 39 (34.5%) volunteers, and 37 (32.7%) health service staff. The study was complex because of the involvement of multiple and varied communities of carers, volunteers, health service staff, and research team members originating from 5 universities. Web-based technologies were used as intervention strategies to support carers and facilitate the process of undertaking the study.ConclusionsThe Verily Connect trial enabled the testing and further development of a web-based approach to increasing support for carers of people living with dementia across a diverse rural landscape in Australia. This protocol provides an example of how to conduct a pragmatic evaluation of a complex and co-designed intervention involving multiple stakeholders.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12618001213235; https://tinyurl.com/4rjvrasf.International registered report identifier (irrid)RR1-10.2196/33023.

Project description:BackgroundThe COVID-19 pandemic disrupted the normality of daily life for many children, their families, and schools, resulting in heightened levels of anxiety, depression, social isolation, and loneliness among young people. An integrated public health model of interventions is needed to address the problem and to safeguard the mental health and wellbeing of children. The Triple P - Positive Parenting Program is one system of parenting support with a strong evidence-base and wide international reach. When implemented as a public health approach, Triple P has demonstrated population level positive effects on child wellbeing. This study will be the first large-scale, multi-site randomised controlled trial of a newly developed, low-intensity variant of Triple P, a school-based seminar series, as a response to the impacts of the pandemic.MethodsThe evaluation will employ an Incomplete Batched Stepped Wedge Cluster Randomised Trial Design. At least 300 Australian primary schools, from South Australia, Queensland, and Victoria will be recruited and randomised in three batches. Within each batch, schools will be randomly assigned to either start the intervention immediately or start in six weeks. Parents will be recruited from participating schools. The Triple P seminar series includes three seminars titled: "The Power of Positive Parenting", "Helping Your Child to Manage Anxiety", and "Keeping your Child Safe from Bullying". Parents will complete measures about child wellbeing, parenting, parenting self-regulation and other key intervention targets at baseline, six weeks after baseline, and 12 weeks after baseline. Intervention effectiveness will be evaluated with a Multilevel Piecewise Latent Growth Curve Modelling approach. Data collection is currently underway, and the current phase of the project is anticipated to be completed in January 2024.DiscussionThe findings from this study will extend the current knowledge of the effects of evidence-based parenting support delivered through brief, universally offered, low intensity, school-based parenting seminars in a post pandemic world.Trial registrationThe trial is registered at the Australian New Zealand Clinical Trials Registry (Trial Registration Number: ACTRN12623000852651).

Project description:PurposeDespite a call for earlier diagnosis of dementia, the diagnostic yield of case finding and its impact on the mental health of patients and relatives are unclear. This study assessed the effect of a two-component intervention of case finding and subsequent care on these outcomes.MethodsIn a cluster RCT we assessed whether education of family physicians (FPs; trial stage 1) resulted in more mild cognitive impairment (MCI) and dementia diagnoses among older persons in whom FPs suspected cognitive decline and whether case finding by a practice nurse and the FP (trial stage 2) added to this number of diagnoses. In addition, we assessed mental health effects of case finding and subsequent care (trial stage 2). FPs of 15 primary care practices (PCPs = clusters) judged the cognitive status of all persons ≥ 65 years. The primary outcome, new MCI and dementia diagnoses by FPs after 12 months as indicated on a list, was assessed among all persons in whom FPs suspected cognitive impairment but without a formal diagnosis of dementia. The secondary outcome, mental health of patients and their relatives, was assessed among persons consenting to participate in trial stage 2. Trial stage 1 consisted of either intervention component 1: training FPs to diagnose MCI and dementia, or control: no training. Trial stage 2 consisted of either intervention component 2: case finding of MCI and dementia and care by a trained nurse and the FP, or control: care as usual.ResultsSeven PCPs were randomized to the intervention; eight to the control condition. MCI or dementia was diagnosed in 42.3% (138/326) of persons in the intervention, and in 30.5% (98/321) in the control group (estimated difference GEE: 10.8%, OR: 1.51, 95%-CI 0.60-3.76). Among patients and relatives who consented to stage 2 of the trial (n = 145; 25%), there were no differences in mental health between the intervention and control group.ConclusionsWe found a non-significant increase in the number of new MCI diagnoses. As we cannot exclude a clinically relevant effect, a larger study is warranted to replicate ours.Trial registrationNederlands Trial Register NTR3389.

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Dataset Information

Mixed methods evaluation of targeted case finding for cardiovascular disease prevention using a stepped wedged cluster RCT.

Background

Methods/design

Discussion

Publications

Mixed methods evaluation of targeted case finding for cardiovascular disease prevention using a stepped wedged cluster RCT.

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