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The effectiveness of a minimal intervention strategy to reduce falls in older women at high risk of falling Karin Swart k.swart@vumc.nl

Introduction (I) 1 out of 3 older persons (65+ yrs) falls yearly 10% physical injury Internal and external risk factors Balance and strength training Multi-factorial interventions

Introduction (II) The Netherlands: 1. De Vries et al. (2010) Recent fall and high fall risk of recurrent falling Multi-disciplinary assessment Treatment of multi-factorial risk factors 2. Hendriks et al. (2008) Seen in emergency department after fall Medical and occupational-therapy assessment Recommendations/referals No effect after 12 months 65+ers

Introduction (III) The Netherlands: Multi-factorial interventions not effective CBO guidelines “Preventie van valincidenten bij ouderen (2004)”: Fall risk assessment after a fall Case-finding Treatment of risk factors  Usual care extensive?  Interventions not effective to further decrease fall risk? Lack of contrast

Research aim To study the effectiveness of a minimal intervention, i.e. informing the GP, on falling among women with a high risk of falling?

Methods SALT Osteoporosis Study Pragmatic trial 10.465 women ≥65 yr ≥ 1 clinical risk factors for fractures Individual randomization Intervention group: Screening and treatment of high fracture risk Control group: Usual care Exclusie: age 91 years or older, weight ≥135 kg, actual use or usage in previous 5 years of bone-sparing drugs, use of high dose corticosteroids, suffering from terminal illness,

Methods Screening: Treatment advice to GP Bone mineral density (DXA) Vertebral fractures (IVA) Absolute fracture risk (FRAX) Fall risk Treatment advice to GP  Current study: women with high fall risk Expert team for treatment advices

Methods High fall risk: Minimal intervention: ≥2 falls in past year, or 1 fall + high fear of falling/ use of walking aid Minimal intervention: Written notification of GP of high fall risk No further action, therapies, recommendations, referrals

Methods Primary outcomes: Secondary outcome: Falling in past 12 months Recurrent falling: ≥2 falls in past 12 months Secondary outcome: Fear of falling “How worried are you to fall?” (0-10 scale) 18 and 36 months follow-up Questionnaire data

High drop out rate Randomization Intervention group N=5,302   Intervention group N=5,302 Control group N=5,163 Questionnaire 2 N=772 Exclusion or no clinical risk factor for fractures N=15,079 Baseline questionnaire N=27,024 Exclusion by GP or not willing to participate Female ≥65 years of age N=54,093 Questionnaire 3 N=647 High fall risk N=1,219 N=764 ≥1 clinical risk factors for fractures N=10,465 No high fall risk N=4,083 N=661 N=1,163 N=4,000 36 months 18 months Baseline High drop out rate

Baseline characteristics Intervention group (N=1219) Control group (N=1163) P-value Age (years) 77.1 (7.1) 77.3 (7.2) 0.39 Living independently (% yes) 89.0 89.3 0.52 Education level % primary % secondary % higher   25.7 63.9 10.4 26.3 62.2 11.6 0.58 Fractures after age 50 years(% yes) 41.3 42.6 ≥2 falls in past 12 months (% yes) 69.6 68.7 0.61 Fear of falling score (range 1-10) 6.0 [4.0-8.0] 7.0 [5.0-8.0] 0.01* Use of walking aid (% yes) 59.1 60.5 0.49 Severe mobility limitations (% yes) 49.6 53.9 0.04* Body Mass Index (kg/m2) 27.5 (5.3) 27.5 (5.2) 0.77 Smoking (% yes) 10.7 0.83 Alcohol use (number of glasses/day) % 0-1 % 1-2 % ≥3 78.8 15.6 5.6 77.1 18.8 4.1 Vitamin D supplementation (% yes) 22.8 25.9 0.09 Number of medicines 4.0 [2.0-7.0] 0.47 Selection of randomized groups: some baseline differences

Results on falling Intervention group Control group Total Fallers (%)   Total Fallers (%) Falling in past 12 months 18 months 36 months 764 661 414 (54%) 347 (53%) 772 647 421 (55%) 355 (55%) Recurrent falling in past 12 months 241 (32%) 199 (30%) 266 (35%) 216 (33%)

Results on falling Outcome Intervention group Control group   Total Fallers (%) Falling in past 12 months 18 months 36 months 764 661 414 (54%) 347 (53%) 772 647 421 (55%) 355 (55%) Recurrent falling in past 12 months 241 (32%) 199 (30%) 266 (35%) 216 (33%) OR (95% CI) unadjusted adjusteda Falling in past 12 months 18 months 36 months 0.98 (0.80; 1.20) 0.87 (0.71; 1.08) 0.97 (0.78; 1.21) 0.92 (0.73; 1.16) Recurrent falling in past 12 months 0.91 (0.73; 1.13) 0.86 (0.68; 1.08) 0.89 (0.71; 1.14) 0.86 (0.67; 1.10) Multi-level analysis with GP practice as random effect

Results on fear of falling Intervention group Control group   Total N Fear of falling (mean ± SD) 18 months 36 months 745 648 5.3 (2.8) 5.8 (2.7) 766 641 5.5 (2.8)

Results on fear of falling Intervention group Control group   Total N Fear of falling (mean ± SD) 18 months 36 months 745 648 5.3 (2.8) 5.8 (2.7) 766 641 5.5 (2.8)  Unstandardized beta (95% CI) unadjusted adjusted 18 months 36 months -0.03 (-0.27; 0.22) 0.08 (-0.18; 0.34) 0.00 (-0.24; 0.24) 0.15 (-0.11; 0.41) Multi-level analysis with GP practice as random effect

Discussion (I) Possible explanations: Good identification high risk patients by GP GP did not take action GP did take action, but not effective Interventions effective in high risk patients? “Awareness” for falling among GP’s by trial participation, also in control group Increased fall exposure in intervention group Falling secondary outcome Not clear if and which fall prevention actions were taken by GP Busy agenda’s

Discussion (II) Differences between GP’s Registration falls High rate of lost to follow-up Falling secondary outcome Pragmatic nature The most frail were lost to FU

Discussion (III) Black box: process analysis Notification of GP’s about patients’ fall risk is not effective in reducing falls and fear of falling

Acknowledgements Thijs Morgenstern Petra Elders Thomas Merlijn Natasja van Schoor Coen Netelenbos Christy Niemeijer