Methods | Purpose: to compare tracking patient influenza vaccination uptake, providing reminders, patient recall and outreach to patients to standard care in each of 7 clinics Design: RCT, individual seniors were randomised within each clinic to intervention or control Duration of study: 29 September to 13 October 2004 (depending on arrival of influenza vaccine) to 22 January 2004 Interval between intervention and when outcome was measured: 15 weeks Power computation: 170 patients/group to demonstrate 15% difference in vaccination uptake (control rate = 50%) P < 0.05, power 0.80, 2‐tailed; as interest was also to collect data across multiple sites and ethic groups, more patients were enrolled than required by power computation Statistics: Chi2, Fisher's exact, logistic regression; intention‐to‐treat |
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Participants | Country: USA Setting: 7 clinics in Rochester, NY Eligible participants: (health status): 2004 (control), 1748 (intervention); 50% White, 33% African American, 10% Hispanic, 7% Other Age: avg 74.2 Gender: 62% f |
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Interventions | Intervention 1: outreach workers in each of 7 clinics tracked patient influenza vaccination uptake, provided reminders, recalled patients, recalled and phoned patients Control: standard routine for each clinic Co‐interventions: none |
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Outcomes | Outcome measured: % influenza vaccination Time points reported in the study: from 29 September to 13 October 2004 (depending on arrival of influenza vaccine) to 22 January 2004 |
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Notes | Funding; Centers for Disease Control National Immunization Program | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "individual seniors within PCCs to intervention or standard‐of‐care control groups" according to whether last digit of SSN odd or even |
Allocation concealment (selection bias) | Unclear risk | No statement |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Blinding not possible due to recalls and prompts |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 3752 eligibles randomised (patients who died during the trial were analyzed as randomised). However: "Each outreach worker was responsible for tracking approximately 900 to 1,000 eligible patients" (which implies for 7 clinics total eligibles = 6300 to 7000) |
Selective reporting (reporting bias) | Low risk | No selective reporting |