Assessing the quality of a non-randomized pragmatic trial for primary prevention of falls among older adults.
Current approaches to falls prevention mostly rely on secondary and tertiary prevention and target individuals at high risk of falls. An alternative is primary prevention, in which all seniors are screened, referred as appropriate, and educated regarding falls risk. Little information is available on research designs that allow investigation of this approach in the setting of aging services delivery, where randomization may not be possible. Healthy Steps for Older Adults, a statewide program of the Pennsylvania (PA) Department of Aging, involves a combination of education about falls and screening for balance problems, with referral to personal physicians and home safety assessments. We developed a non-randomized statewide trial, Falls Free PA, to assess its effectiveness in reducing falls incidence over 12 months. We recruited 814 seniors who completed the program (503 first-time participants, 311 people repeating the program) and 1,020 who did not participate in the program, from the same sites. We assessed the quality of this non-randomized design by examining recruitment, follow-up across study groups, and comparability at baseline. Of older adults approached in senior centers, 90.5 % (n = 2,219) signed informed consent, and 1,834 (82.4 %) completed baseline assessments and were eligible for follow-up. Attrition in the three groups over 12 months was low and non-differential (<10 % for withdrawal and <2 % for other loss to follow-up). Median follow-up, which involved standardized monthly assessment of falls, was 10 months in all study groups. At baseline, the groups did not differ in measures of health or falls risk factors. Comparable status at baseline, recruitment from common sites, and similar experience with retention suggest that the non-randomized design will be effective for assessment of this approach to primary prevention of falls.
Department of Behavioral and Community Health Sciences, Graduate School of Public Health, University of Pittsburgh, 208 Parran Hall, 130 Desoto Street, Pittsburgh, PA, 15261, USA, smalbert@pitt.edu.
Steven M
SM
Albert
Offer
O
Edelstein
Jennifer
J
King
Jason
J
Flatt
Chyongchiou J
CJ
Lin
Robert
R
Boudreau
Anne B
AB
Newman
D000058:Accidental Falls / Q000517:prevention & control*; D000203:Activities of Daily Living; D000368:Aged; D011307:Drug Prescriptions / Q000706:statistics & numerical data; D005260:Female; D015577:Geriatric Assessment; D006801:Humans; D008297:Male; D008569:Memory Disorders / Q000175:diagnosis; D008875:Middle Aged; D051346:Mobility Limitation; D010414:Pennsylvania; D011322:Primary Prevention; D016730:Program Development; D015397:Program Evaluation; D011788:Quality of Life; D012107:Research Design; D018570:Risk Assessment; D012650:Self Disclosure; D020377:Self Efficacy; D011795:Surveys and Questionnaires; D013689:Telephone