Singh S, Cocoros NM, Li X, Mazor KM, Antonelli MT, Parlett L, Paullin M, Harkins TP, Zhou Y, Rochon PA, Platt R, Dashevsky I, Massino C, Saphirak C, Crawford SL, Gurwitz JH. Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in the Elderly with Alzheimer’s Disease (D-PRESCRIBE-AD): Trial protocol and rationale of an open-label pragmatic, prospective randomized controlled trial. PLoS One. 2024 Feb 12;19(2):e0297562. doi: 10.1371/journal.pone.0297562. PMID: 38346025; PMCID: PMC10861034.
The D-PRESCRIBE-AD trial aims to evaluate the effectiveness of educational outreach by health plans in reducing inappropriate medication use among elderly individuals with Alzheimer’s disease or related dementias (AD/ADRD). These patients are particularly vulnerable to the risks associated with sedative/hypnotics, antipsychotics, and strong anticholinergic agents, which are medications that are deemed potentially inappropriate according to the AGS Beers criteria. The trial seeks to promote discussions on deprescribing to lessen the negative impacts of these medications, such as cognitive decline, falls, hospitalizations, and reduced quality of life.
The trial is an open-label, pragmatic, randomized controlled trial involving three groups: one receiving educational mailings for both patients and physicians, one for physicians only, and a usual care group not receiving the intervention, each with 4,814 participants from two U.S. based health plans. The study aims to measure the impact of these mailings on reducing inappropriate medication use over a six-month period, following a three-month blackout period after the mailings. Data for the study are sourced from administrative claims and managed within a secure, distributed network, ensuring patient and provider privacy. Patients eligible for the study are those over 50 with Alzheimer’s disease or related dementias and using specific potentially inappropriate prescriptions. Providers are included based on their prescription activity. The intervention materials were adapted from those developed by Tannenbaum et al. for the EMPOWER intervention, with adaptation occurring with stakeholder input and tailoring to encourage deprescribing conversations. Randomization is conducted at the patient level, and the educational content provided through mailings and a dedicated study website.
The study’s strengths lie in its large sample size and pragmatic design, focusing on real-world applicability. Limitations include reliance on administrative claims data, potential misclassification of polypharmacy due to unaccounted over-the-counter medication use, and mortality assessment constraints. In addition, the results will be pertinent mainly to commercially insured populations, with uncertain generalizability to people covered in other types of health systems.
“There are concerns about inappropriate prescribing of high-risk medications like antipsychotics, sedative-hypnotics, and strong anticholinergics among persons living with dementia. Through this large pragmatic health plan-based pragmatic trial, we hope to determine whether mailed educational materials designed to stimulate patient/caregiver communication with the prescriber can lead to deprescribing of these inappropriate medications.“
