Effects of a clinical decision support system and patient portal for preventing medication-related falls in older fallers: Protocol of a cluster randomized controlled trial with embedded process and economic evaluations (ADFICE_IT)

PLoS One. 2023 Sep 26;18(9):e0289385. doi: 10.1371/journal.pone.0289385. eCollection 2023.

Abstract

Background: Falls are the leading cause of injury-related mortality and hospitalization among adults aged ≥ 65 years. An important modifiable fall-risk factor is use of fall-risk increasing drugs (FRIDs). However, deprescribing is not always attempted or performed successfully. The ADFICE_IT trial evaluates the combined use of a clinical decision support system (CDSS) and a patient portal for optimizing the deprescribing of FRIDs in older fallers. The intervention aims to optimize and enhance shared decision making (SDM) and consequently prevent injurious falls and reduce healthcare-related costs.

Methods: A multicenter, cluster-randomized controlled trial with process evaluation will be conducted among hospitals in the Netherlands. We aim to include 856 individuals aged ≥ 65 years that visit the falls clinic due to a fall. The intervention comprises the combined use of a CDSS and a patient portal. The CDSS provides guideline-based advice with regard to deprescribing and an individual fall-risk estimation, as calculated by an embedded prediction model. The patient portal provides educational information and a summary of the patient's consultation. Hospitals in the control arm will provide care-as-usual. Fall-calendars will be used for measuring the time to first injurious fall (primary outcome) and secondary fall outcomes during one year. Other measurements will be conducted at baseline, 3, 6, and 12 months and include quality of life, cost-effectiveness, feasibility, and shared decision-making measures. Data will be analyzed according to the intention-to-treat principle. Difference in time to injurious fall between the intervention and control group will be analyzed using multilevel Cox regression.

Discussion: The findings of this study will add valuable insights about how digital health informatics tools that target physicians and older adults can optimize deprescribing and support SDM. We expect the CDSS and patient portal to aid in deprescribing of FRIDs, resulting in a reduction in falls and related injuries.

Trial registration: ClinicalTrials.gov NCT05449470 (7-7-2022).

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Accidental Falls / prevention & control
  • Aged
  • Cost-Benefit Analysis
  • Decision Support Systems, Clinical*
  • Humans
  • Multicenter Studies as Topic
  • Patient Portals*
  • Quality of Life
  • Randomized Controlled Trials as Topic

Associated data

  • ClinicalTrials.gov/NCT05449470

Grants and funding

The funders did not and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.