Stuck 2015.
Study characteristics | ||
Methods | Randomised trial, Switzerland | |
Participants | Individuals aged 65 years or older registered with one of 19 primary care physician (PCP) practices in a mixed rural and urban area in Switzerland. A total of 4,115 patients aged 65 years and older were assessed for eligibility, 3,493 were eligible, and 2,284 were included in the study and underwent randomisation. In all, 874 participants were allocated to the intervention group, and 1,410 to the control group. | |
Interventions | The intervention consisted of HRA based on self‐administered questionnaires and individualised computer‐generated feedback reports, combined with nurse and PCP counselling over a 2‐y period. Intervention features Multiple simple feedback (one PROM at multiple times) PROM(s) used as intervention: Health Risk Assessment for Older Persons (HRA‐O) Constructs measured: Functioning Instrument categories/domains: Domain/Disease specific (geriatric health) Administration features Where PROMs administered: Non‐clinical setting How administered: Self‐administered Format of PROMs questionnaire(s): Paper Feedback features Format of PROMs feedback: Electronic How often information fed back: Twice (baseline and 1 year) Who information fed back to: Clinicians, Patients Information fed back: Scores, Management recommendations |
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Outcomes | Main outcomes: health behaviours, preventive care use (2 years), all‐cause mortality (8 years) | |
Notes | The study was supported by a European Union (QLK6‐CT‐1999‐02205) (AS SI CS); the Federal Education and Science Ministry (Bern, Switzerland, BBW 990311.1) (AS); the Swiss National Science Foundation (32‐52804.97) (AS); the Swiss National Science Foundation Swiss National Cohort (projects 0071, 3347CO‐108806, 33CS30_134273 and 33CS30_148415) (ME); the Swiss Foundation for Health Promotion (Project No. 398) (AS); the Velux Foundation (AS); the Langley Research Institute (JCB). The study period was not reported. The authors declared no conflicts of interest. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated method. |
Allocation concealment (selection bias) | Low risk | Group allocation. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Due to nature of intervention not possible to blind patients and personnel. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Due to nature of the intervention blinding of outcomes not possible: PROM used for feedback also used to assess outcome, patients were aware they received the intervention. |
Baseline outcome measurements similar | Low risk | There were no statistically significant differences between the intervention and control groups for self‐reported dependency in basic activities of daily living or for nursing home admissions. |
Baseline characteristics similar | Low risk | There were no significant differences between the intervention and control groups in any of the baseline characteristics. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 94% intervention group and 93% control group of the participants completed the outcome questionnaire at 2 year follow‐up. |
Was study protected against contamination | High risk | Primary care physicians received training and gained experience in preventive care, which likely resulted in improved care for individuals in the control group. |
Selective reporting (reporting bias) | Low risk | None apparent. |