The RISAP-study: a complex intervention in risk communication and shared decision-making in general practice

Abstract

BackgroundGeneral practitioners (GPs) and patients find it difficult to talk about risk of future disease, especially when patients have asymptomatic conditions, and treatment options are unlikely to cause immediate perceptible improvements in well-being. Further studies in risk communication training are needed. Aim:1) to systematically develop, describe and evaluate a complex intervention comprising a training programme for GPs in risk communication and shared decision-making, 2) to evaluate the effect of the training programme on real-life consultations between GPs and patients with high cholesterol levels, and 3) to evaluate patients' reactions during and after the consultations.Methods/DesignThe effect of the complex intervention, based around a training programme, will be evaluated in a cluster-randomised controlled trial with an intervention group and an active control group with 40 GPs and 280 patients in each group.The GPs will receive a questionnaire at baseline and after 6 months about attitudes towards risk communication and cholesterol-reducing medication. After each consultation with a participating high cholesterol-patient, the GPs will complete a questionnaire about decision satisfaction (Provider Decision Process Assessment Instrument). The patients will receive a questionnaire at baseline and after 3 and 6 months. It includes questions about adherence to chosen treatment (Morisky Compliance Scale), self-rated health (SF-12), enablement (Patient Enablement Instrument), and risk communication and decision-making effectiveness (COMRADE Scale). Prescriptions, contacts to the health services, and cholesterol level will be drawn from the registers.In each group, 12 consultations will be observed and tape-recorded. The patients from these 24 consultations will be interviewed immediately after the consultation and re-interviewed after 6 months.Eight purposefully selected GPs from the intervention group will be interviewed in a focus group 6 months after participation in the training programme.The process and context of the RISAP-study will be investigated in detail using an action research approach, in order to analyse adaptation of the intervention model to the specific context.DiscussionThis study aims at providing GPs and patients with a firm basis for active deliberation about preventive treatment options, with a view to optimising adherence to chosen treatment.Trial registrationClinicalTrials.gov Protocol Registration System NCT01187056

Communicating risk using absolute risk reduction or prolongation of life formats: cluster-randomised trial in general practice

“…This study aimed at pitching the teaching at an appropriate level, in that academic GPs and social scientists in the project group developed the instruction programme based on experiences and knowledge from other trials within the field. 11,[36][37][38] Although a degree of performance bias cannot be ruled out, it is the study's belief that overall intervention fidelity is likely to have been good, as the GPs only had access to the specific information sheets corresponding to their respective allocations. The sheets held information not published elsewhere at the time of the trial, thus GPs could not readily compute the alternative information format from resources available elsewhere.…”

“…This is consistent with the tension between public health, guidelines, and informed decisionmaking found in previous studies. 37,[43][44][45] It is important that GPs are aware of this tension when talking about health prevention and potential medication with their patients, and that in the decision-making process they handle numerical information on effectiveness with care.…”

Barriers in using cardiometabolic risk information among consumers with low health literacy

“…It is known that people with low socio-economic status and health literacy tend to participate less in screening programmes (Bennett, Chen, Soroui, & White, 2009;Berkman, Sheridan, Donahue, Halpern, & Crotty, 2011;Dobbins, Simpson, Oldenburg, Owen, & Harris, 1998;Dryden, Williams, McCowan, & Themessl-Hube, 2012;Guerra, Krumholz, & Shea, 2005;Kobayashi, Wardle, & Von Wagner, 2014;White, Chen, & Atchison, 2008). Different reasons have been suggested, such as invitational materials being difficult to understand (Kobayashi et al, 2014).…”

“…It is known that people with low socio-economic status and health literacy tend to participate less in screening programmes (Bennett, Chen, Soroui, & White, 2009;Berkman, Sheridan, Donahue, Halpern, & Crotty, 2011;Dobbins, Simpson, Oldenburg, Owen, & Harris, 1998;Dryden, Williams, McCowan, & Themessl-Hube, 2012;Guerra, Krumholz, & Shea, 2005;Kobayashi, Wardle, & Von Wagner, 2014;White, Chen, & Atchison, 2008). Different reasons have been suggested, such as invitational materials being difficult to understand (Kobayashi et al, 2014). Other more general explanations are that people with lower socio-economic status and/or inadequate health literacy also have lower perceived self-efficacy (Berkman et al, 2011;Norman & Conner, 1993) or lower patient activation (Greene & Hibbard, 2012;Rademakers, Nijman, Brabers, de Jong, & Hendriks, 2014), as well as typical beliefs and values about screening and health behaviours (Wardle, McCaffery, Nadel, & Atkin, 2004), which may all hinder engagement with health screening.…”

A qualitative exploration of clinicians’ strategies to communicate risks to patients in the complex reality of clinical practice

“…The latter concept is based on an iterative approach comprising three phases: team talk, option talk and decision talk. The communication of risks and benefits (risk communication) is an essential part of the option talk in which various screening, diagnostic, treatment or palliative alternatives are compared [2,[4][5][6][7][8][9].…”