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Health services research
Protocol
Interdisciplinary collaboration across secondary and primary care to improve medication safety in the elderly (IMMENSE study): study protocol for a randomised controlled trial
  1. Jeanette Schultz Johansen1,
  2. Kjerstin Havnes1,
  3. Kjell H. Halvorsen1,
  4. Stine Haustreis2,
  5. Lillann Wilsgård Skaue2,
  6. Elena Kamycheva3,4,
  7. Liv Mathiesen5,
  8. Kirsten K. Viktil5,6,
  9. Anne Gerd Granås5,
  10. Beate H. Garcia1
  1. 1 Department of Pharmacy, Faculty of Health Sciences, UiT—The Arctic University of Norway, Tromsø, Norway
  2. 2 Hospital Pharmacy of North Norway Trust, Tromsø, Norway
  3. 3 Department of Medicine, University Hospital of North Norway, Tromsø, Norway
  4. 4 Department of Clinical Medicine, Faculty of Health Sciences, UiT—The Arctic University of Norway, Tromsø, Norway
  5. 5 School of Pharmacy, University of Oslo, Oslo, Norway
  6. 6 Diakonhjemmet Hospital Pharmacy, Oslo, Norway
  1. Correspondence to Jeanette Schultz Johansen; jeajoh{at}uit.no

Abstract

Introduction Drug-related problems (DRPs) are common in the elderly, leading to suboptimal therapy, hospitalisations and increased mortality. The integrated medicines management (IMM) model is a multifactorial interdisciplinary methodology aiming to optimise individual medication therapy throughout the hospital stay. IMM has been shown to reduce readmissions and drug-related hospital readmissions. Using the IMM model as a template, we have designed an intervention aiming both to improve medication safety in hospitals, and communication across the secondary and primary care interface. This paper presents the study protocol to explore the effects of the intervention with regard to healthcare use, health-related quality of life (HRQoL) and medication appropriateness in elderly patients.

Methods and analysis A total of 500 patients aged ≥70 years will be included and randomised to control (standard care) or intervention group (1:1). The intervention comprises five steps mainly performed by pharmacists: (1) medication reconciliation at admission, (2) medication review during hospital stay, (3) patient counselling about the use of medicines, (4) a comprehensible and patient-friendly medication list with explanations in discharge summary and (5) postdischarge phone calls to the primary care level. The primary outcome is the difference between intervention and control patients in the rate of emergency medical visits (acute readmissions and visits to emergency department) 12 months after discharge. Secondary outcomes include length of index hospital stay, time to first readmission, mortality, hip fractures, strokes, medication changes, HRQoL and medication appropriateness. Patient inclusion started in September 2016.

Ethics and dissemination The trial was approved by the Norwegian Centre for Research Data and the Norwegian Data Protection Authority. We aim to publish the results in international peer-reviewed open access journals, at national and international conferences, and as part of two PhD theses.

Trial registration number NCT02816086.

  • geriatric medicine
  • quality in healthcare
  • preventive medicine
  • adverse events
  • clinical pharmacology

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-020106

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    Footnotes

    • Contributors JSJ, KH, KHH, BHG, SH, EK, LWS, KKV, LM and AGG were involved in study design. JSJ, KH, KHH and BHG drafted the manuscript. SH, EK, LWS, KKV, LM and AGG read and commented on the draft. JSJ, KH, KHH, BHG, SH, EK, LWS, KKV, LM and AGG all read and approved the final manuscript.

    • Funding This work is supported by the Northern Norway Regional Health Authority grant number HST1314-16. The publication charges for this article have been funded by a grant from the publication fund of UiT—The Arctic University of Norway.

    • Disclaimer The sponsor has no part in collection, management, analysis and interpretation of the data, as well as writing and reporting study conclusions.

    • Competing interests None declared.

    • Patient consent Obtained.

    • Ethics approval The study has approval from the Norwegian Centre for Research Data and the Norwegian Data Protection Authority to collect, store and link research data.

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