Dataset Information

Engaging participants in a complex intervention trial in Australian General Practice.

ABSTRACT:

Background

The paper examines the key issues experienced in recruiting and retaining practice involvement in a large complex intervention trial in Australian General Practice.

Methods

Reflective notes made by research staff and telephone interviews with staff from general practices which expressed interest, took part or withdrew from a trial of a complex general practice intervention.

Results

Recruitment and retention difficulties were due to factors inherent in the demands and context of general practice, the degree of engagement of primary care organisations (Divisions of General Practice), perceived benefits by practices, the design of the trial and the timing and complexity of data collection.

Conclusion

There needs to be clearer articulation to practices of the benefits of the research to participants and streamlining of the design and processes of data collection and intervention to fit in with their work practices. Ultimately deeper engagement may require additional funding and ongoing participation through practice research networks.

Trial registration

Current Controlled Trials ACTRN12605000788673.

SUBMITTER: Perkins D

PROVIDER: S-EPMC2533668 | biostudies-literature | 2008 Aug

REPOSITORIES: biostudies-literature

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Publications

Engaging participants in a complex intervention trial in Australian General Practice.

Perkins David D Harris Mark F MF Tan Jocelyn J Christl Bettina B Taggart Jane J Fanaian Mahnaz M

BMC medical research methodology 20080813

<h4>Background</h4>The paper examines the key issues experienced in recruiting and retaining practice involvement in a large complex intervention trial in Australian General Practice.<h4>Methods</h4>Reflective notes made by research staff and telephone interviews with staff from general practices which expressed interest, took part or withdrew from a trial of a complex general practice intervention.<h4>Results</h4>Recruitment and retention difficulties were due to factors inherent in the demands ...[more]

PMID: 18700984

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Project description: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.

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Dataset Information

Engaging participants in a complex intervention trial in Australian General Practice.

Background

Methods

Results

Conclusion

Trial registration

Publications

Engaging participants in a complex intervention trial in Australian General Practice.

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