Pilot Test of a Clinical Trial Evaluating the Impact of an Educational Strategy With Anti-Delirium Measures Aimed at Caregivers of Patients Over 75 Years Old

Introduction: Hospital delirium is a common condition in older adults. To date, no effective pharmacological measures have been described for its prevention; however, there is evidence of non-pharmacological measures with dual purpose: prevention and management. These measures are usually implemented by healthcare personnel; nevertheless, the time required to apply them, and the number of patients assigned to a healthcare professional, limit their execution. In this study, we sought to evaluate whether the implementation of an educational strategy created by the researchers and aimed at the family members and/or caregivers of hospitalized patients over 75 years old can impact the incidence of delirium in a fourth-level institution in Bogotá, Colombia. Method: We report the second phase of a three-part research study. The initial phase involved constructing a multicomponent educational strategy, encompassing visual and auditory materials (brochure, video and emails), along with accompanying visits to reinforce information. The second phase, the pilot study, seeks to identify barriers, limitations, and difficulties in applying the educational strategy to eligible participants’ family members and/or caregivers. The methodology we use was a randomized, open-label, controlled trial titled EduCu-Delirium (Educational Strategy for Caregivers of Individuals over 75 to Reduce the incidence of Delirium) designed by the working group and was conducted over a 21-day period. Results: Data collection during this period involved 33 caregivers. They were predominantly women (n = 24, 75%), with an average age of 41 years (range: 20-76 years). Main challenges included administering questionnaires, significant patient attrition, conducting effective follow-ups, and the specific hospital area where education was provided. Conclusions: The pilot phase emerges as a pivotal element in refining the current study's design and offering critical insights, especially concerning measurement instruments. Proactive identification and resolution of barriers and limitations before the initiation of phase 3 have significantly contributed to enhancing protocol robustness and the methodological adaptability of the study.