학술논문

Optimizing Retention in a Pragmatic Trial of Community‐Living Older Persons: The STRIDE Study
Document Type
article
Source
Journal of the American Geriatrics Society. 68(6)
Subject
Health Services and Systems
Biomedical and Clinical Sciences
Clinical Sciences
Health Sciences
Prevention
Clinical Research
Patient Safety
Clinical Trials and Supportive Activities
Accidental Falls
Aged
Aged
80 and over
Female
Humans
Independent Living
Interviews as Topic
Longitudinal Studies
Male
Primary Health Care
Risk Assessment
older persons
retention
pragmatic trials
Medical and Health Sciences
Geriatrics
Biomedical and clinical sciences
Health sciences
Psychology
Language
Abstract
ObjectivesThe Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study is testing the effectiveness of a multifactorial intervention to prevent serious fall injuries. Our aim was to describe procedures that were implemented to optimize participant retention; report retention yields by age, sex, clinical site, and follow-up time; provide reasons for study withdrawals; and highlight the successes and lessons learned from the STRIDE retention efforts.DesignPragmatic cluster randomized trial.SettingA total of 86 primary care practices within 10 US healthcare systems.ParticipantsA total of 5451 community-living persons, 70 years of age or older, at high risk for serious fall injuries.MeasurementsStudy outcomes were collected every 4 months by a central call center. Reconsent was required to extend follow-up beyond the originally planned 36 months.ResultsOver a median follow-up of 3.2 years (interquartile range = 2.8-3.7 y), 439 (8.1%) participants died and 600 (11.0%) withdrew their consent or did not reconsent to extend follow-up beyond 36 months, yielding rates (per 100 person-years) of deaths and withdrawals of 2.6 and 3.6, respectively. The withdrawal rate increased with advancing age, was comparable for men and women, and did not differ much by clinical site. The most common reasons for withdrawal were illness and unable to contact for reconsent at 36 months. Completion of the follow-up interviews was greater than 93% at each time point. Most participants completed all (71.8%) or all but one (9.2%) of the follow-up interviews. The most common reason for not completing a follow-up interview was unable to contact, with rates ranging from 2.8% at 40 months to 4.6% at 20 months.ConclusionCompletion of the thrice-yearly follow-up interviews in STRIDE was high, and retention of participants over 44 months exceeded the original projections. The procedures used in STRIDE, together with lessons learned, should assist other investigators who are planning or conducting large pragmatic trials of vulnerable older persons. J Am Geriatr Soc 68:1242-1249, 2020.