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

ABSTRACT: General 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.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.The 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.This 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.ClinicalTrials.gov Protocol Registration System NCT01187056.

SUBMITTER: Kirkegaard P

PROVIDER: S-EPMC2954954 | biostudies-literature | 2010 Sep

REPOSITORIES: biostudies-literature

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

Kirkegaard Pia P Edwards Adrian G K AG Hansen Bo B Hansen Mette D MD Jensen Morten S A MS Lauritzen Torsten T Risoer Mette B MB Thomsen Janus L JL

BMC family practice 20100922

<h4>Background</h4>General 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.<h4>Aim</h4>1) to systematically develop, describe and evaluate a complex intervention comprising a training programme for GPs in risk communication and shared decision-making, ...[more]

PMID: 20860820

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Project description:Background:Practice facilitation is a method of introducing and sustaining organizational change. It involves the use of skilled healthcare professionals called practice facilitators (PFs) to help address the challenges associated with implementing evidence-based guidelines and complex interventions into practice. PFs provide a framework for translating research into practice by building relationships, improving communication, fostering change, and sharing resources. Nurses are well positioned to serve as PFs for the implementation of complex interventions, however, there is little evidence currently available to describe nurses in this role. Additionally, the best strategies to implement complex interventions into practices are still not fully understood. Combining practice facilitation with the train-the-trainer model has the potential to spread knowledge and skills. Shared decision making (SDM), which involves patients and providers jointly engaging in decisions around treatment options, has been shown to improve outcomes for patients with asthma. The goal of this manuscript is to describe and evaluate the practice facilitation process from the ADAPT-NC Study which successfully utilized research nurses to implement a complex asthma SDM toolkit intervention into primary care practices. Methods:As part of a larger study, 10 primary care practices were recruited for a facilitator-led dissemination intervention involving a 12-week rollout of an asthma SDM toolkit (trial registration: 1.28.2014, #NCT02047929). An experienced lead PF trained research nurses as PFs from each of the 4 participating practice-based research networks (PBRNs) in a train-the-trainer model utilizing a one-day training event and subsequent remote meetings. Evaluation of PF engagement was measured through process improvement surveys. Results:Overall, the asthma SDM intervention was successfully implemented within the 4 PBRNs. All 10 facilitator-led practices remained engaged with their PFs, with 8 out of the 10 practices able to incorporate and sustain SDM visits or clinics. Responses from the surveys for process improvement yielded improved PF communication and team dynamics over time. Conclusions:This study demonstrated effective use of research nurses as practice facilitators during the dissemination of an asthma SDM intervention into primary care practices, adding to the knowledge of best practices by describing a model of large-scale implementation of a complex intervention through practice facilitation with nurses. Trial registration:"Comparing Traditional and Participatory Dissemination of a Shared Decision Making Intervention" was retrospectively registered at https://clinicaltrials.gov/ on January 28th, 2014 (NCT02047929).

Project description:ObjectivesTo explore older people's perspectives and experiences with shared decision-making (SDM) about medication for cardiovascular disease (CVD) prevention.Design, setting and participantsSemi-structured interviews with 30 general practice patients aged 75 years and older in New South Wales, Australia, who had elevated CVD risk factors (blood pressure, cholesterol) or had received CVD-related lifestyle advice. Data were analysed by multiple researchers using Framework analysis.ResultsTwenty eight participants out of 30 were on CVD prevention medication, half with established CVD. We outlined patient experiences using the four steps of the SDM process, identifying key barriers and challenges: Step 1. Choice awareness: taking medication for CVD prevention was generally not recognised as a decision requiring patient input; Step 2. Discuss benefits/harms options: CVD prevention poorly understood with emphasis on benefits; Step 3. Explore preferences: goals, values and preferences (eg, length of life vs quality of life, reducing disease burden vs risk reduction) varied widely but generally not discussed with the general practitioner; Step 4. Making the decision: overall preference for directive approach, but some patients wanted more active involvement. Themes were similar across primary and secondary CVD prevention, different levels of self-reported health and people on and off medication.ConclusionsResults demonstrate how older participants vary widely in their health goals and preferences for treatment outcomes, suggesting that CVD prevention decisions are preference sensitive. Combined with the fact that the vast majority of participants were taking medications, and few understood the aims and potential benefits and harms of CVD prevention, it seems that older patients are not always making an informed decision. Our findings highlight potentially modifiable barriers to greater participation of older people in SDM about CVD prevention medication and prevention in general.

Project description:BackgroundEnhanced communication with health care providers (HCPs) can improve symptom management and health-related quality of life (HRQoL) for patients with chronic health conditions. Access to appropriate communication venues is needed to improve communication, however. As such, digital communication interventions mediated by patient portals carry the potential to support patient-provider communication and interaction and through this, also facilitate shared decision-making (SDM). The InvolveMe intervention was designed to provide patients with the opportunity to communicate symptoms and informational needs prior to consultation via digital assessment, including prioritizing what is most important to discuss with their HCPs, as well as to interact with HCPs through secure messages between outpatient visits.ObjectiveThe aim of this study was to assess the feasibility of the InvolveMe intervention by investigating acceptability, demand (ie, system use), and limited efficacy.MethodsThe study was designed as a single-arm, pre-post feasibility study combining quantitative and qualitative methods for data collection. Patients from an endocrine outpatient clinic were invited to use the InvolveMe intervention for 3 months, and HCPs administering InvolveMe were invited to participate in a focus group. Guided by descriptions of how to design feasibility studies by Bowen et al, feasibility was tested by exploring (1) acceptability, using data collected during recruitment from patient participants and nonparticipants (ie, declined to participate or did not meet study requirements), HCP experiences with recruitment, and the System Usability Scale (SUS); (2) demand via exploration of system use through extraction of system log data and HCP experiences with system use; and (3) limited efficacy testing, via exploration of potential effects from the Short-Form Health Survey (RAND 36), Hospital Anxiety and Depression Scale, and Health Literacy Questionnaire.ResultsPatient participants (N=23) were a median 54 (range 26-78) years old and primarily male (14/23, 61%). Nonparticipants (N=16) were a median 73 (range 55-80) years old and primarily male (12/16, 75%). The average SUS score was 72.2, indicating good system usability. Assessments were completed by 8 participants from home prior to outpatient visits. The assessments entailed various bodily symptoms and needs for information. Participants sent 17 secure messages related to patient administrative matters, symptoms, and challenges. Focus group participants (N=4) were all female and registered nurses. Data were analyzed in 2 predefined themes: Acceptability and Demand. Acceptability included the subthemes intervention attractiveness and intervention suitability. Demand included the subthemes elements of SDM and intervention challenges and opportunities. All patient participants completed outcome measures at baseline, and 19 (19/23, 83%) completed outcome measures at 3 months. These preliminary efficacy findings were mixed and inconclusive.ConclusionsThe study design provided findings from both patient and HCP perspectives and supported feasibility of the InvolveMe intervention. The investigation of acceptability and demand supported the potential for remote SDM mediated by patient portals using assessments and secure messages.Trial registrationClinicalTrials.gov NCT NCT04218721; https://www.clinicaltrials.gov/ct2/show/NCT04218721.

Project description:BackgroundRisk communication is a core aspect of a physician's work and a fundamental prerequisite for successful shared decision-making. However, many physicians are not able to adequately communicate risks to patients due to a lack of understanding of statistics as well as inadequate management of conflicts of interest (COI).ObjectiveTo evaluate the effects of an integrated curriculum encompassing COI and shared decision-making on the participants' risk communication competence, that is, their competence to advise patients on the benefits and harms of diagnostic or therapeutic interventions.DesignA rater-blind randomized controlled trial with a 30 (± 1)-week follow-up conducted from October 2016 to June 2017 at two German academic medical centers.ParticipantsSixty-three medical students in their fourth or fifth year.InterventionsParticipants received either a newly developed 15-h curriculum or a course manual adapted from teaching as usual.Main measuresPrimary outcome: change in risk communication performance in a video-observed structured clinical examination (VOSCE).Key resultsParticipants were 25.7 years old on average (SD 3.6); 73% (46/63) were female. Increase in risk communication performance was significantly higher in the intervention group with post-intervention Cohen's d of 2.35 (95% confidence interval (CI) 1.62 to 3.01, p < 0.01) and of 1.83 (CI 1.13 to 2.47, p < 0.01) 30 (± 1) weeks later. Secondary outcomes with the exception of frequency of interactions with the pharmaceutical industry also showed relevant improvements in the intervention as compared with the control group (d between 0.91 and 2.04 (p < 0.001)).ConclusionsOur results show that an integrated curriculum encompassing COI and risk communication leads to a large and sustainable increase in risk communication performance. We interpret the large effect sizes to be a result of the integration of topics that are usually taught separately, leading to a more effective organization of knowledge.Trial registrationThe trial is registered in the International Clinical Trials Registry with the trial number DRKS00010890.

Project description:BackgroundWhile shared decision making (SDM) and adherence to clinical practice guidelines (CPGs) are important, some believe they are incompatible. This study explored the mutual influence between physicians' intention to engage in SDM and their intention to follow CPGs.MethodsEmbedded within a clustered randomized trial to assess the impact of training physicians in SDM about using antibiotics to treat acute respiratory tract infections, this study evaluated physicians' intentions to both engage in SDM and follow CPGs. A self-administered questionnaire based on the theory of planned behavior evaluated both behavioral intentions and their respective determinants (attitude, subjective norm and perceived behavioral control) at study entry and exit. We used path analysis to explore the relationships between the intentions. We conducted statistical analyses using the maximum likelihood method and the variance-covariance matrix. Goodness of fit indices encompassed the chi-square statistic, the comparative fit index and the root mean square error of approximation.ResultsWe analyzed 244 responses at entry and 236 at exit. In the control group, at entry we observed that physicians' intention to engage in SDM (r?=?0, t?=?0.03) did not affect their intention to follow CPGs; however, their intention to follow CPGs (r?=?-0.31 t?=?-2.82) did negatively influence their intention to engage in SDM. At exit, neither behavioral intention influenced the other. In the experimental group, at entry neither behavioral intention influenced the other; at exit, the intention to engage in SDM still did not influence the intention to use CPGs, although the intention to follow CPGs (r?=?-0.15 t?=?-2.02) slightly negatively influenced the intention to engage in SDM, but this was not clinically significant.ConclusionPhysicians' intention to engage in SDM does not affect their intention to adopt CPGs even after SDM training. Physicians' intention to adopt CPGs had no clinically significant influence on intention to engage in SDM.Trial registrationClinicalTrials.gov NCT01116076.

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

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

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