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  • Effectiveness of a complex intervention on Prioritising Multimedication in Multimorbidity (PRIMUM) in primary care: results of a pragmatic cluster randomised controlled trial

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Patient-centred medicine
Research
Effectiveness of a complex intervention on Prioritising Multimedication in Multimorbidity (PRIMUM) in primary care: results of a pragmatic cluster randomised controlled trial
  1. Christiane Muth1,
  2. Lorenz Uhlmann2,
  3. Walter E Haefeli3,
  4. Justine Rochon2,
  5. Marjan van den Akker4,5,
  6. Rafael Perera6,
  7. Corina Güthlin1,
  8. Martin Beyer1,
  9. Frank Oswald7,
  10. Jose Maria Valderas8,
  11. J André Knottnerus4,
  12. Ferdinand M Gerlach1,
  13. Sebastian Harder9
  1. 1 Institute of General Practice, Johann Wolfgang Goethe University, Frankfurt, Germany
  2. 2 Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany
  3. 3 Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg, Germany
  4. 4 Department of Family Medicine, School CAPHRI, Maastricht University, Maastricht, The Netherlands
  5. 5 Department of Public Health and Primary Care, Academic Center for General Practice, KU Leuven, Leuven, Belgium
  6. 6 Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
  7. 7 Interdisciplinary Ageing Research (IAW), Faculty of Educational Sciences, Johann Wolfgang Goethe University, Frankfurt, Germany
  8. 8 APEx Collaboration for Academic Primary Care, University of Exeter Medical School, Exeter, UK
  9. 9 Institute for Clinical Pharmacology, Johann Wolfgang Goethe University Hospital, Frankfurt / Main, Germany
  1. Correspondence to Dr Christiane Muth; muth{at}allgemeinmedizin.uni-frankfurt.de

Abstract

Objectives Investigate the effectiveness of a complex intervention aimed at improving the appropriateness of medication in older patients with multimorbidity in general practice.

Design Pragmatic, cluster randomised controlled trial with general practice as unit of randomisation.

Setting 72 general practices in Hesse, Germany.

Participants 505 randomly sampled, cognitively intact patients (≥60 years, ≥3 chronic conditions under pharmacological treatment, ≥5 long-term drug prescriptions with systemic effects); 465 patients and 71 practices completed the study.

Interventions Intervention group (IG): The healthcare assistant conducted a checklist-based interview with patients on medication-related problems and reconciled their medications. Assisted by a computerised decision support system, the general practitioner optimised medication, discussed it with patients and adjusted it accordingly. The control group (CG) continued with usual care.

Outcome measures The primary outcome was a modified Medication Appropriateness Index (MAI, excluding item 10 on cost-effectiveness), assessed in blinded medication reviews and calculated as the difference between baseline and after 6 months; secondary outcomes after 6 and 9 months’ follow-up: quality of life, functioning, medication adherence, and so on.

Results At baseline, a high proportion of patients had appropriate to mildly inappropriate prescriptions (MAI 0–5 points: n=350 patients). Randomisation revealed balanced groups (IG: 36 practices/252 patients; CG: 36/253). Intervention had no significant effect on primary outcome: mean MAI sum scores decreased by 0.3 points in IG and 0.8 points in CG, resulting in a non-significant adjusted mean difference of 0.7 (95% CI −0.2 to 1.6) points in favour of CG. Secondary outcomes showed non-significant changes (quality of life slightly improved in IG but continued to decline in CG) or remained stable (functioning, medication adherence).

Conclusions The intervention had no significant effects. Many patients already received appropriate prescriptions and enjoyed good quality of life and functional status. We can therefore conclude that in our study, there was not enough scope for improvement.

Trial registration number ISRCTN99526053. NCT01171339; Results.

  • multimorbidity
  • multiple chronic conditions
  • polypharmacy
  • medication reconciliation
  • computer-assisted drug therapy
  • Medication Appropriateness Index

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-2017-017740

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    Footnotes

    • Contributors CM drafted the manuscript, coordinated the study and contributed to the conception, design, data collection and data analyses. SH contributed to the conception and design, and conducted the MAI ratings. FMG was the guarantor of the study. JR and LU contributed to the conception and design, and conducted the data analyses. WEH contributed to the conception and design, and provided the study version of CDSS. CG, MB, FO, RP, MvdA, JAK, JMV and FMG provided specific advice on the conception, methods and coordination of the study. All authors critically revised and agreed on the final version of the manuscript.

    • Funding Funding has been provided by the German Federal Ministry of Education and Research, BMBF (grant number 01GK0702).

    • Competing interests CM, FMG, CG, MB, SH, WEH, JR and LU report receiving grants from the German Federal Ministry of Education and Research, BMBF, grant number 01GK0702, during the course of the study. WEH reports other grants from Dosing, Heidelberg, during the course of the study; he received personal fees, non-financial support and other from Aqua Institute Göttingen; personal fees, non-financial support and other from Aspen Europe; personal fees and other from Diaplan; grants, personal fees, non-financial support and other from Actelion; personal fees and other from GSK GER/UK/Slovakia/France; personal fees from Thieme Verlag; personal fees and other from Daiichi Sankyo; personal fees and other from Bristol-Myers Squibb; personal fees and other from MSD Sharp & Dohme; personal fees and other from AstraZenica; personal fees and other from Boehringer; personal fees and other from Grünenthal; personal fees and other from KWHC; personal fees and other from Novartis; personal fees and other from Berlin-Chemie; grants, personal fees and other from Landesapothekerkammer BW; grants and other from BMBF (DZIF, ESTHER); grants, personal fees, non-financial support and other from BayerPharma; grants from CHIESI; personal fees and other from Doctrina Med; personal fees and other from GSK France, UK, Germany, Slovakai; personal fees, non-financial support and other from Pfizer; grants from Smooth ClinicalTrials; grants from Sumaya Biotec; grants from Klaus Tschira Stiftung; other from University Frankfurt; grants from Vaximm, outside the submitted work. FO, MvdA, JMV, RP and JAK have nothing to disclose.

    • Patient consent Not required.

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

    • Data sharing statement No additional data available.

    • Presented at Oral presentations and posters: Muth C, Uhlmann L, Haefeli WE, Rochon J, van den Akker M, Beyer M, Perera R, Knottnerus A, Gerlach FM, Harder S (2014). PRIorisierung von MUltimedikation bei Multimorbidität (PRIMUM)* Cluster-RCT in Hausarztpraxen zeigte keine Effekte auf die Angemessenheit der Verschreibung. 48. Kongress der DEGAM, 18; 20 September 2014, Hamburg; Abstractband V3c | 3, S. 88. Muth C, Rochon J, Namyst A, Fullerton B, Harder S, van den Akker M, Perera-Salazar R, Gerlach FM, Beyer M. Anwendung der MRC Guidance in der allgemeinmedizinischen Forschung: Ergebnisse aus der PRIMUM-Studie (PRIorisierung von MUltimedikation bei Multimorbidität). Vortrag auf 13. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin, Hamburg, 15; 17 March 2012, Abstractband IV/1a.