Article Text

Protocol
Pharmaceutical management of elderly high-risk patients in perioperative settings (PHAROS): protocol of a pilot sequential intervention study
  1. Julia Richter1,
  2. Moritz Sebastian Schönfeld2,
  3. Claudia Langebrake1,3,
  4. Corinna Bergelt2,
  5. Levente Kriston2,
  6. Cynthia Olotu4,
  7. Rainer Kiefmann4
  1. 1 Hospital Pharmacy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  2. 2 Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  3. 3 Department of Stem Cell Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  4. 4 Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  1. Correspondence to Mr Moritz Sebastian Schönfeld; mo.schoenfeld{at}uke.de

Abstract

Introduction With increasing age, the risk of complications after surgery rises in elderly patients. Furthermore, the prevalence of multimorbidity and polypharmacy rises with age, making this elderly population especially vulnerable for drug-related problems and posing an additional risk for postoperative complications. Still, only few studies have concentrated on investigating how medication safety can be improved in these patients. The aim of this pilot study is to examine the impact of a comprehensive intervention (interprofessional systematic medication therapy management) on medication appropriateness in elderly polymedicated, multimorbid patients during hospital stay for elective surgery.

Methods and analysis This pilot study will include a total number of 140 patients. Surgical high-risk patients ≥65 years taking more than five chronic systemic drugs will be recruited consecutively for 9 months in the control group capturing usual care regarding medication history and in-hospital medication therapy management without any study intervention. Recruitment of the intervention group will be conducted for another 9 months. The intervention consists of the following components: an additional medication history by a hospital pharmacist before admission, a subsequent medication review, optimisation of the long-term medication and recommendations to the patient’s general practitioner. A follow-up will be performed 3 months after surgery. As the primary study outcome, medication appropriateness will be measured using the Medication Appropriateness Index.

Secondary outcomes are postoperative complications, incidence and frequency of adverse drug reactions and potentially inappropriate medication in the elderly, satisfaction with inpatient and outpatient care, medication reconciliation and health-related quality of life. Multivariable analyses will be used to analyse all quantitative research questions.

Ethics and dissemination Ethics approval was obtained by the medical ethics committee of the Medical Chamber of Hamburg (study ID: PV5754). Data will be published in peer-reviewed journals and presented at conferences.

Trial registration number The study is registered at www.drks.de: DRKS00014621.

  • geriatric medicine
  • public health
  • adverse events
  • clinical trials
  • clinical pharmacology
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Footnotes

  • CO and RK share last authorship.

  • JR and MSS contributed equally.

  • Correction notice Joint last authorship has been added for this article.

  • Contributors CO and RK are the principal investigators of the study. The study concept was developed by CO, RK, CL, CB and LK. CO, JR, CL, MSS and CB developed the intervention and the study materials. LK, MSS and JR will analyse and interpret the data. The first draft of the study protocol was written by JR and MSS. CO, RK, CL, CB and LK critically revised it. All authors read and approved the final manuscript. JR and MSS contributed equally to this article.

  • Funding The study is funded after peer review by the German Federal Ministry of Health (Bundesministerium für Gesundheit, BMG, grant number G111F01001). The BMG is not involved in the study design, data collection, data analysis and interpretation and in writing this manuscript.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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