CHAPS 2011.
Methods |
Design: Cluster‐RCT Setting: Ontario, Canada. Cluster eligibility: population of 10,000 ‐ 60,000, 5+ GPs, 2+ pharmacies, Registered Persons Database to Census Population ratio < 10%, no recent geographical amalgamation into a major centre. Community recruitment via personalised invitation letter from participating family physicians or other local lead organisation (e.g. seniors centres, hospitals, community centres) Also advertised CHAP sessions by flyers, posters, paid and unpaid adverts in local media Dates: Autumn 2006 start Follow‐up: 1 year |
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Participants |
Intervention N = 20 clusters Control N = 19 clusters All over‐65s included (but anyone could participate) At baseline, % diabetic: 22% control, 21% intervention At baseline, % with history of CCF: 12% control, 12% intervention Age (mean, SD) control: 74.49 (0.43); intervention: 74.82 (0.62) Men (%, SD) control: 42.65 (1.19); intervention: 42.92 (2.16) Diabetes (%, SD) control: 22.16 (2.34); intervention: 21.20 (2.79) Hx of CHF (%, SD) control: 12.19 (1.19); intervention: 12.45 (2.34) |
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Interventions |
Setting: Community pharmacy Intervention: Standardised 10‐week programme. 3‐hour weekday BP and CVS risk factor assessment and education sessions held in community bases. Participants were given their risk profile, specific educational materials and info regarding availability of local community resources. Any participants identified as high risk (according to BP) were assessed by a nurse and referred immediately to family physician. At the end of the 10‐week programme, results sent to family physicians (with reports ordering participants by SBP) along with their diagnostic/treatment status. These data was resent to the GPs at 6 months, along with aggregate‐level data showing the performance of their practice compared to others in the locality regarding attaining target SBP. Risk factors assessed: BP, smoking, alcohol intake, diet, physical activity, height, weight Control: No intervention |
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Outcomes | Total mortality, stroke, MI, in‐hospital death from CVD, CHF, composite (hospital admissions for MI, stroke or CCF) | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number generator |
Allocation concealment (selection bias) | Low risk | States undertaken by an independent expert |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Names of control communities were not publicised and the control community members were not notified that the study was taking place |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Data outcomes taken from routinely‐collected population‐based administrative health data, and data analysts were blinded to group allocation |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Numbers of individuals followed/lost to follow‐up not reported. Cluster‐level data reported only |
Selective reporting (reporting bias) | Unclear risk | Unclear |
Other bias | Unclear risk | Unclear |