Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Implementation Science
Published in: Implementation Science 1/2014

Open Access 01-12-2014 | Study protocol

Optimizing polypharmacy among elderly hospital patients with chronic diseases—study protocol of the cluster randomized controlled POLITE-RCT trial

Authors: Christin Löffler, Eva Drewelow, Susanne D Paschka, Martina Frankenstein, Julia Eger, Lisa Jatsch, Emil C Reisinger, Johannes F Hallauer, Bernd Drewelow, Karen Heidorn, Helmut Schröder, Anja Wollny, Gönther Kundt, Christian Schmidt, Attila Altiner

Published in: Implementation Science | Issue 1/2014

Login to get access

Abstract

Background

Treatment of patients with multimorbidity is challenging. A rational reduction of long-term drugs can lead to decreased mortality, less acute hospital treatment, and a reduction of costs. Simplification of drug treatment schemes is also related to higher levels of patient satisfaction and adherence. The POLITE-RCT trial will test the effectiveness of an intervention aiming at reducing the number of prescribed long-term drugs among multimorbid and chronically ill patients. The intervention focuses on the interface between primary and secondary health care and includes a pharmacist-based, patient-centered medication review prior to the patient's discharge from hospital.

Methods

The POLITE-RCT trial is a cluster randomized controlled trial. Two major secondary health care providers of Mecklenburg-Western Pomerania, Germany, take part in the study. Clusters are wards of both medical centers. All wards where patients with chronic diseases and multimorbidity are regularly treated will be included. Patients aged 65+ years who take five or more prescribed long-term drugs and who are likely to spend at least 5 days in the participating hospitals will be recruited and included consecutively. Cluster-randomization takes place after a six-month baseline data collection period. Patients of the control group receive care as usual. The independent two main primary outcomes are (1) health-related quality of life (EQ-5D) and (2) the difference in the number of prescribed long-term pharmaceutical agents between intervention and control group. The secondary outcomes are appropriateness of prescribed medication (PRISCUS list, Beers Criteria, MAI), patient satisfaction (TSQM), patient empowerment (PEF-FB-9), patient autonomy (IADL), falls, re-hospitalization, and death. The points of measurement are at admission to (T0) and discharge from hospital (T1) as well as 6 and 12 months after discharge from the hospital (T2 and T3). In 42 wards, 1,626 patients will be recruited.

Discussion

In case of positive evaluation, the proposed study will provide evidence for a sustainable reduction of polypharmacy by enhancing patient-centeredness and patient autonomy.

Trial registration

Current Controlled Trials ISRCTN42003273
Appendix
Available only for authorised users
Literature
1.
Casselli G, Mesle F, Vallin J: Epidemiologic transition theory exceptions. Genus: J Popul Sci. 2002, 9: 9-51.
2.
Harper K, Armelagos G: The changing disease-shape in the third epidemiological transition. Int J Environ Res Public Health. 2010, 7 (2): 675-697. 10.3390/ijerph7020675.CrossRefPubMedPubMedCentral
3.
Schäfer I, von Leitner EC, Schön G, Koller D, Hansen H, Kolonko T, Kaduszkiewicz H, Wegscheider K, Glaeske G, van den Bussche H: Multimorbidity patterns in the elderly: a new approach of disease clustering identifies complex interrelations between chronic conditions. PLoS One. 2010, 5 (12): e15941-10.1371/journal.pone.0015941.CrossRefPubMedPubMedCentral
4.
Bregnhøj L, Thirstrup S, Kristensen MB, Bjerrum L, Sonne J: Combined intervention programme reduces inappropriate prescribing in elderly patients exposed to polypharmacy in primary care. Eur J Clin Pharmacol. 2009, 65: 199-207. 10.1007/s00228-008-0558-7.CrossRefPubMed
5.
Denneboom W, Dautzenberg M, Grol R, De Smet P: Treatment reviews of older people on polypharmacy in primary care: cluster controlled trial comparing two approaches. Br J Gen Prac. 2007, 57 (542): 723-731.
6.
Heppner HJ, Christ M, Gosch M, Mühlberg W, Bahrmann P, Bertsch T, Sieber C, Singler K: Polypharmacy in the elderly from the clinical toxicologist perspective. Z Gerontol Geriatr. 2012, 45 (6): 473-478. 10.1007/s00391-012-0383-6.CrossRefPubMed
7.
Boyd CM, Darer J, Boult C, Fried LP, Boult L, Wu AW: Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases: implications for pay for performance. JAMA. 2005, 294 (6): 716-724. 10.1001/jama.294.6.716.CrossRefPubMed
8.
Manhart A, Geerdes-Fenge H, Drewelow E, Löffler C, Reisinger E, Heidorn K, Drewelow B, Kundt G, Altiner A: Verminderung von Polypharmazie bei Patienten mit chronischen Erkrankungen (POLITE). Abschlussbericht für das Ministerium für Arbeit, Gleichstellung und Soziales: Innovative Projekte zur Anpassung der Versorgung an die demografische Entwicklung in Mecklenburg-Vorpommern. 2012
9.
Junius-Walker U, Theile G, Hummers-Pradier E: Prevalence and predictors of polypharmacy among older primary care patients in Germany. Fam Pract. 2007, 24 (1): 14-19. 10.1093/fampra/cml067.CrossRefPubMed
10.
Maher RL, Hanlon JT, Hajjar ER: Clinical consequences of polypharmacy in elderly. Expert Opin Drug Saf. 2014, 13 (1): 57-65. 10.1517/14740338.2013.827660.CrossRefPubMed
11.
Walsh EK, Cussen K: "Take ten minutes": a dedicated ten minute medication review reduces polypharmacy in the elderly. Ir Med J. 2010, 103 (8): 236-238.PubMed
12.
Maeda K: Systematic review of the effects of improvement of prescription to reduce the number of medications in the elderly with polypharmacy. Yakugaku Zasshi. 2009, 129 (5): 631-645. 10.1248/yakushi.129.631.CrossRefPubMed
13.
Schnurrer JU, Frölich JC: Zur Häufigkeit und Vermeidbarkeit von tödlichen unerwünschten Arzneimittelwirkungen. Internist. 2003, 44 (7): 889-895. 10.1007/s00108-003-0988-3.CrossRefPubMed
14.
Garfinkel D, Mangin D: Feasibility study of a systematic approach for discontinuation of multiple medications in older adults: addressing polypharmacy. Arch Intern Med. 2010, 170 (18): 1648-1654. 10.1001/archinternmed.2010.355.CrossRefPubMed
15.
Vass M, Hendriksen C: Polypharmacy and other people—the GP perspective. Z Gerontol Geriatr. 2005, 38 (Suppl 1): I14-I17. 10.1007/s00391-005-1104-1.CrossRefPubMed
16.
Ostini R, Hegney D, Jackson C, Williamson M, Mackson JM, Gurman K, Hall W, Tett SE: Systematic review of interventions to improve prescribing. Ann Pharmacother. 2009, 43 (5): 502-513. 10.1345/aph.1L488.CrossRefPubMed
17.
Grindrod KA, Patel P, Martin JE: What interventions should pharmacists employ to impact health practitioners’ prescribing practices?. Ann Pharmacother. 2006, 40 (9): 1546-1557. 10.1345/aph.1G300.CrossRefPubMed
18.
Fick DM, Cooper JW, Wade WE, Waller JL, Maclean JR, Beers MH: Updating the Beers criteria for potentially inappropriate medication use in older adults: results of a US consensus panel of experts. Arch Intern Med. 2003, 22: 2716-2724. 10.1001/archinte.163.22.2716.CrossRef
19.
Sönnichsen A: Polypharmakotherapie - mehr Medikamente, weniger Gesundheit?. Z Allg Med. 2011, 3: 108-110.
20.
Kaduszkiewicz H, Stolzenbach CO, Reich CA, Schäfer I, van den Bussche H, Streich W, Abholz HH, Steinmann S, Wiese B, Löffler C, Altiner A: Wie lässt sich das Chronic Care Model in die hausärztliche Versorgung umsetzen? Presentation and Poster, Colloquium of the BMBF research network “Health in old age”, Berlin 1. 2010
21.
Resnick B, Fick DM: 2012 Beers criteria update: how should practicing nurses use the criteria?. Geriatr Nurs. 2012, 33 (4): 253-255. 10.1016/j.gerinurse.2012.06.001.CrossRefPubMed
22.
Holt S, Schmiedl S, Thürmann PA: Potentially inappropriate medications in the elderly: the PRISCUS list. Dtsch Arztebl Int. 2010, 107 (31-32): 543-551.PubMedPubMedCentral
23.
Amann U, Schmedt N, Garbe E: Prescribing of potentially inappropriate medications for the elderly: an analysis based on the PRISCUS list. Dtsch Arztebl Int. 2012, 109 (5): 69-75.PubMedPubMedCentral
24.
Härtel U, Volger E: Inanspruchnahme und Akzeptanz klassischer Naturheilverfahren und alternativer Heilmethoden in Deutschland - Ergebnisse einer repräsentativen Bevölkerungsstudie. Forsch Komplementarmed Klass Naturheilkd. 2004, 11 (6): 327-334. 10.1159/000082814.CrossRefPubMed
25.
Fulton MM, Allen ER: Polypharmacy in the elderly: a literature review. J Am Acad Nurse Pract. 2005, 17 (4): 123-132. 10.1111/j.1041-2972.2005.0020.x.CrossRefPubMed
26.
Yuan C-S, Wei G, Dey L, Karrison T, Nahlik L, Maleckar S, Kasza K, Ang-Lee M, Moss J: Brief communication: American ginseng reduces warfarin,s effect in healthy patients. Ann Intern Med. 2004, 141 (1): 23-27. 10.7326/0003-4819-141-1-200407060-00011.CrossRefPubMed
27.
Bayer Pharma AG: Fachinformation Xarelto® Bayer Vital GmbH. Berlin: 2014.
28.
Gallagher P, O'Mahony D: STOPP (Screening Tool of Older Persons' potentially inappropriate prescriptions): application to acutely ill elderly patients and comparison with Beers' criteria. Age Ageing. 2008, 37 (6): 673-679. 10.1093/ageing/afn197.CrossRefPubMed
29.
Hanlon JT, Weinberger M, Samsa GP, Schmader KE, Uttech KM, Lewis IK, Cowper PA, Landsman PB, Cohen HJ, Feussner JR: A randomized, controlled trial of a clinical pharmacist intervention to improve inappropriate prescribing in elderly outpatients with polypharmacy. Am J Med. 1996, 100 (4): 428-437. 10.1016/S0002-9343(97)89519-8.CrossRefPubMed
30.
Jameson JP, VanNoord GR: Pharmacotherapy consultation on polypharmacy patients in ambulatory care. Ann Pharmacother. 2001, 35 (7-8): 835-840. 10.1345/aph.10259.CrossRefPubMed
31.
32.
Meyer TJ, van Kooten D, Marsh S, Prochazka AV: Reduction of polypharmacy by feedback to clinicians. J Gen Intern Med. 1991, 6 (2): 133-136. 10.1007/BF02598309.CrossRefPubMed
33.
Williams ME, Pulliam CC, Hunter R, Johnson TM, Owens JE, Kincaid J, Porter C, Koch G: The short-term effect of interdisciplinary medication review on function and cost in ambulatory elderly people. J Am Geriatr Soc. 2004, 52 (1): 93-98. 10.1111/j.1532-5415.2004.52016.x.CrossRefPubMed
34.
Lampela P, Hartikainen S, Lavikainen P, Sulkava R, Huupponen R: Effects of medication assessment as part of a comprehensive geriatric assessment on drug use over a 1-year period: a population-based intervention study. Drugs Aging. 2010, 27 (6): 507-521. 10.2165/11536650-000000000-00000.CrossRefPubMed
35.
Pitkala KH, Strandberg TE, Tilvis RS: Is it possible to reduce polypharmacy in the elderly? A randomised controlled trial. Drugs Aging. 2001, 18 (2): 143-149. 10.2165/00002512-200118020-00007.CrossRefPubMed
36.
Kroenke K, Pintholt EM: Reducing polypharmacy in the elderly. A controlled trial of physician feedback. J Am Geriatr Soc. 1990, 38 (1): 31-36.CrossRefPubMed
37.
Anthierens S, Tansens A, Petrovic M, Christiaens T: Qualitative insights into general practitioners views on polypharmacy. BMC Fam Pract. 2010, 11: 65-10.1186/1471-2296-11-65.CrossRefPubMedPubMedCentral
38.
Patterson SM, Hughes C, Kerse N, Cardwell CR, Bradley MC: Interventions to improve the appropriate use of polypharmacy for older people. Cochrane Database Syst Rev. 2012, 5: CD008165-PubMed
39.
Tamblyn R: Medication use in seniors: challenges and solutions. Therapie. 1996, 51: 269-282.PubMed
40.
Borne R, Cumbler E, Glasheen JJ: Reducing polypharmacy: is hospitalization the right time?. Arch Intern Med. 2011, 171 (9): 869-10.1001/archinternmed.2011.208.CrossRefPubMed
41.
Drewelow E, Manhart A, Geerdes-Fenge H, Heidorn K, Drewelow B, Altiner A, Reisinger E: Pilotstudie zur Optimierung der Schnittstelle aus der sekundären in die primäre Krankenversorgung zur Reduktion von Polypharmazie (POLITE). Z Allg Med 2012; 88 (ZFA Hauptprogramm + Abstractband 2012); Posterbeitrag des 46. 2012, Rostock, DEGAM Kongresses
42.
Clyne W, Blenkinsopp A, Seal R: A Guide to Medication Review. 2008, National Prescribing Centre, Liverpool
43.
44.
45.
Seidling HM, Schmitt SP, Bruckner T, Kaltschmidt J, Pruszydlo MG, Senger C, Bertsche T, Walter-Sack I, Haefeli WE: Patient-specific electronic decision support reduces prescription of excessive doses. Qual Saf Health Care. 2010, 19 (5): 1-7.
46.
Moock J: Präferenzbasierte Lebensqualitätsmessung: Der EQ-5D Fragebogen. Phys Med Rehab Kuror. 2008, 18: 245-249. 10.1055/s-0028-1082329.CrossRef
47.
Szende A, Oppe M, Devlin N: Hrsg. EQ-5D Value Sets: Inventory, Comparative Review and User Guide. 2007, Springer, DordrechtCrossRef
48.
Greiner W, Claes C, Busschbach JJV, von der Schulenburg JM: Validating the EQ-5D with time trade off for the German population. Eur J Health Econ. 2005, 6 (2): 124-130. 10.1007/s10198-004-0264-z.CrossRefPubMed
49.
Beers MH, Ouslander JG, Rollingher I, Reuben DB, Brooks J, Beck JC: Explicit criteria for determining inappropriate medication use in nursing home residents. UCLA Division of Geriatric Medicine Arch Intern Med. 1991, 151 (9): 1825-1832.PubMed
50.
Schwalbe O, Freiberg I, Kloft C: Die Beers-Liste. Ein Instrument zur Optimierung der Arzneimitteltherapie geriatrischer Patienten. Med Monatsschr Pharm. 2007, 30: 244-248.PubMed
51.
Hanlon JT, Schmader KE, Samsa GP, Weinberger M, Uttech KM, Lewis IK, Cohen HJ, Feussner JR: A method for assessing drug therapy appropriateness. J Clin Epidemiol. 1992, 45 (10): 1045-1051. 10.1016/0895-4356(92)90144-C.CrossRefPubMed
52.
Samsa GP, Hanlon JT, Schmader KE, Weinberger M, Clipp EC, Uttech KM, Lewis IK, Landsman PB, Cohen HJ: A summated score for the medication appropriateness index: development and assessment of clinimetric properties including content validity. J Clin Epidemiol. 1994, 47 (8): 891-896. 10.1016/0895-4356(94)90192-9.CrossRefPubMed
53.
Atkinson MJ, Sinha A, Hass SL, Colman SS, Kumar RN, Brod M, Rowland CR: Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease. Health Qual Life Outcomes. 2004, 2: 12-10.1186/1477-7525-2-12.CrossRefPubMedPubMedCentral
54.
Atkinson MJ, Kumar R, Cappelleri JC, Hass SL: Hierarchical construct validity of the treatment satisfaction questionnaire for medication (TSQM version II) among outpatient pharmacy consumers. Value Health. 2005, 8 (Suppl 1): S9-S24. 10.1111/j.1524-4733.2005.00066.x.CrossRefPubMed
55.
Kriston L, Scholl I, Hölzel L, Simon D, Loh A, Härter M: The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010, 80 (1): 94-99. 10.1016/j.pec.2009.09.034.CrossRefPubMed
56.
Lawton MP, Brody EM: Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969, 9 (3): 179-186. 10.1093/geront/9.3_Part_1.179.CrossRefPubMed
57.
Robertson MC, Devlin N, Gardner MM, Campbell AJ: Effectiveness and economic evaluation of a nurse delivered home exercise programme to prevent falls 1: randomised controlled trial. BMJ. 2001, 322: 697-701. 10.1136/bmj.322.7288.697.CrossRefPubMedPubMedCentral
58.
Jöckel KH, Babitsch B, Bellach BM, Bloomfield K, Hoffmeyer-Zlotnik J, Winkler J, Wolf C: Empfehlungen der Arbeitsgruppe "Epidemiologische Methoden" in der Deutschen Arbeitsgemeinschaft Epidemiologie der GMDS und der DGSMP zur Messung und Quantifizierung soziodemographischer Merkmale in epidemiologischen Studien. Hrsg. Edited by: Ahrens W. 1998, Messung soziodemographischer Merkmale in der Epidemiologie, München
59.
Altiner A, Brockmann S, Sielk M, Wilm S, Wegscheider K, Abholz HH: Reducing antibiotic prescriptions for acute cough by motivating GPs to change their attitudes to communication and empowering patients: a cluster-randomized intervention study. J Antimicrob Chemother. 2007, 60 (3): 638-644. 10.1093/jac/dkm254.CrossRefPubMed
60.
Campbell MK, Mollison J, Steen N, Grimshaw JM, Eccles M: Analysis of cluster randomized trials in primary care: a practical approach. Fam Pract. 2000, 17 (2): 192-196. 10.1093/fampra/17.2.192.CrossRefPubMed
61.
Campbell MJ, Donner A, Klar N: Developments in cluster randomized trials and Statistics in Medicine. Stat Med. 2007, 26 (1): 2-19. 10.1002/sim.2731.CrossRefPubMed
62.
Muth E, Scholz R, Kruse A, Doblehammer G: Der demografische Wandel in Mecklenburg-Vorpommern - Veränderung der Altersstruktur, demografische Alterung und Schrumpfung von 1982 bis 2007. 2010, Statistische Hefte, StatA MV
Metadata
Title
Optimizing polypharmacy among elderly hospital patients with chronic diseases—study protocol of the cluster randomized controlled POLITE-RCT trial
Authors
Christin Löffler
Eva Drewelow
Susanne D Paschka
Martina Frankenstein
Julia Eger
Lisa Jatsch
Emil C Reisinger
Johannes F Hallauer
Bernd Drewelow
Karen Heidorn
Helmut Schröder
Anja Wollny
Gönther Kundt
Christian Schmidt
Attila Altiner
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Implementation Science / Issue 1/2014
Electronic ISSN: 1748-5908
DOI
https://doi.org/10.1186/s13012-014-0151-7

Other articles of this Issue 1/2014

Implementation Science 1/2014 Go to the issue

Research

Understanding practice: the factors that influence management of mild traumatic brain injury in the emergency department-a qualitative study using the Theoretical Domains Framework

Research

Exploring mentorship as a strategy to build capacity for knowledge translation research and practice: a scoping systematic review

Methodology

GRAIDs: a framework for closing the gap in the availability of health promotion programs and interventions for people with disabilities

Research

‘Changing Minds’: determining the effectiveness and key ingredients of an educational intervention to enhance healthcare professionals’ intentions to prescribe physical activity to patients with physical disabilities

Study protocol

Evaluation of the implementation of centralized waiting lists for patients without a family physician and their effects across the province of Quebec

Study protocol

Protocol: Adaptive Implementation of Effective Programs Trial (ADEPT): cluster randomized SMART trial comparing a standard versus enhanced implementation strategy to improve outcomes of a mood disorders program