Abstract
BackgroundThis paper describes the study protocol, the recruitment, and base-line data for evaluating the success of randomisation of the PRO-AGE (PRevention in Older people – Assessment in GEneralists' practices) project.Methods/DesignA group of general practitioners (GPs) in London (U.K.), Hamburg (Germany) and Solothurn (Switzerland) were trained in risk identification, health promotion, and prevention in older people. Their non-disabled older patients were invited to participate in a randomised controlled study. Participants allocated to the intervention group were offered the Health Risk Appraisal for Older Persons (HRA-O) instrument with a site-specific method for reinforcement (London: physician reminders in electronic medical record; Hamburg: one group session or two preventive home visits; Solothurn: six-monthly preventive home visits over a two-year period). Participants allocated to the control group received usual care. At each site, an additional group of GPs did not receive the training, and their eligible patients were invited to participate in a concurrent comparison group. Primary outcomes are self-reported health behaviour and preventative care use at one-year follow-up. In Solothurn, an additional follow-up was conducted at two years. The number of older persons agreeing to participate (% of eligible persons) in the randomised controlled study was 2503 (66.0%) in London, 2580 (53.6%) in Hamburg, and 2284 (67.5%) in Solothurn. Base-line findings confirm that randomisation of participants was successful, with comparable characteristics between intervention and control groups. The number of persons (% of eligible) enrolled in the concurrent comparison group was 636 (48.8%) in London, 746 (35.7%) in Hamburg, and 1171 (63.0%) in Solothurn.DiscussionPRO-AGE is the first large-scale randomised controlled trial of health risk appraisal for older people in Europe. Its results will inform about the effects of implementing HRA-O with different methods of reinforcement.
Highlights
This paper describes the study protocol, the recruitment, and base-line data for evaluating the success of randomisation of the PRO-AGE (PRevention in Older people – Assessment in GEneralists' practices) project
One promising approach is based on Health Risk Appraisal (HRA)
Multiple controlled trials conducted in the United States addressed short or medium term effects of HRA and showed positive effects on health behaviour and uptake of preventative care in older persons, provided HRA was combined with a system of personal reinforcement [3]
Summary
To our knowledge this is the first randomised study of a HRA-O intervention conducted in Europe. This paper, the PRO-AGE project was successful in recruiting the large number of older persons required to evaluate – with adequate statistical power – the effects of a HRA-O intervention on health behaviour and use of preventative care. Due to budgetary constraints it was not feasible to implement a reminder system or use some other mechanism for obtaining outcome data from persons who did not respond or only partially responded to the one-year follow-up questionnaire The magnitude of this limitation will depend on the percentage of missing information among study participants at the three study sites. This might be related to the fact that the number of clusters randomised was only 4 in London, and 3 in Solothurn To address this limitation, the analyses comparing outcomes between intervention and concurrent comparison groups will adjust for base-line characteristics. The database containing cross-sectional and longitudinal information on multiple health risks in older people will be useful for refining existing instruments or methods of risk prediction in older people
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