VALFORTA: a randomised trial to validate the FORTA (Fit fOR The Aged) classification

Martin Wehling; Heinrich Burkhardt; Alexandra Kuhn-Thiel; Farhad Pazan; Christina Throm; Christel Weiss; Helmut Frohnhofen

doi:10.1093/ageing/afv200

VALFORTA: a randomised trial to validate the FORTA (Fit fOR The Aged) classification

Age Ageing. 2016 Mar;45(2):262-7. doi: 10.1093/ageing/afv200. Epub 2016 Jan 18.

Authors

Martin Wehling¹, Heinrich Burkhardt², Alexandra Kuhn-Thiel¹, Farhad Pazan¹, Christina Throm¹, Christel Weiss³, Helmut Frohnhofen⁴

Affiliations

¹ Clinical Pharmacology, University of Heidelberg, Mannheim 68169, Germany.
² IV. Medical Clinic, Geriatrics, University Hospital Mannheim, Heidelberg University, Mannheim, Germany.
³ Department of Medical Statistics, Biomathematics and Information Processing, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
⁴ Essen-Mitte Hospital, Knappschafts Hospital, Teaching Hospital at the University of Duisburg in Essen, Am Deimelsberg 34a, 45276 Essen, Germany and Faculty of Health, University of Witten-Herdecke, Witten, Germany.

PMID: 26786346
DOI: 10.1093/ageing/afv200

Abstract

Trial design: to further validate the FORTA (Fit fOR The Aged) concept, a bicentric randomised, controlled trial was run in two geriatric clinics.

Methods: patients (≥65 years, ≥3 drugs or ≥60 years, ≥6 drugs) with three relevant diseases and hospitalisation for ≥5 days were randomised. In the intervention, but not the control group, a FORTA team instructed ward physicians on FORTA. FORTA is the first positive/negative listing approach labelling medications used to treat chronic illnesses in older patients from A (indispensable), B (beneficial), C (questionable) to D (avoid). The primary end point was the FORTA score: sum of medication errors classified as over-, under- and mistreatment. Consecutive patients were randomised to the intervention and control ward; outcome assessment was blinded.

Results: four hundred and nine patients (age 81.5 years, 64% female, hospitalisation 17.4 days) were included. The primary end point was significantly (P < 0.0001) more reduced in the intervention versus control groups (2.7 ± 2.25 versus 1 ± 1.8, mean ± SD, intergroup comparison of admission/discharge differences). Over- and under-treatment scores and use of A (increase) and D (decrease) drugs were significantly improved (P < 0.01). The total number of adverse drug reactions (ADRs) was significantly reduced by FORTA (P < 0.05, number needed to treat is 5). Activities of daily living and renal failure improved significantly (P < 0.05). Blood pressure remained constant in the intervention, but decreased significantly in the control group.

Conclusion: applying FORTA to hospitalised geriatric patients leads to improvement of medication quality and may improve secondary clinical end points (e.g. ADRs). The concept is amenable to successful communication and implementation. Registration (DRKS-ID): DRKS00000531.

Funding: DFG-German Research Foundation (WE 1184/15-1).

Keywords: FORTA score; activities of daily living; clinical trial; geriatric pharmacotherapy; older people; polypharmacy.

Publication types

Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Activities of Daily Living
Age Factors
Aged
Aged, 80 and over
Aging*
Blood Pressure
Comorbidity
Drug-Related Side Effects and Adverse Reactions / prevention & control*
Female
Geriatric Assessment / methods*
Germany
Health Status Indicators*
Health Status*
Humans
Inappropriate Prescribing / prevention & control
Male
Medication Errors / prevention & control*
Medication Therapy Management* / standards
Middle Aged
Patient Admission
Polypharmacy
Quality Improvement
Quality Indicators, Health Care
Renal Insufficiency / diagnosis
Renal Insufficiency / therapy
Risk Factors

Associated data

DRKS/DRKS00000531