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
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
BMC Geriatrics
Published in: BMC Geriatrics 1/2018

Open Access 01-12-2018 | Study protocol

DREAMeR: Drug use Reconsidered in the Elderly using goal Attainment scales during Medication Review; study protocol of a randomised controlled trial

Authors: Sanne Verdoorn, Henk-Frans Kwint, Jeanet Blom, Jacobijn Gussekloo, Marcel L. Bouvy

Published in: BMC Geriatrics | Issue 1/2018

Login to get access

Abstract

Background

Clinical medication reviews (CMR) are increasingly performed in older patients with polypharmacy. Studies have shown positive effects of CMR on process- and intermediate outcomes, like drug-related problems (DRPs). Little effect has been shown on clinical outcomes, like hospital admissions or health-related quality of life (HR-QoL). In particular, HR-QoL is related to the individual health-related goals and complaints of patients. The aim of this study is to investigate the effects of a CMR focused on personal goals on HR-QoL and health-related complaints in older patients with polypharmacy.

Methods

A randomised controlled trial will be performed in 35 Dutch community pharmacies aiming to include 630 patients aged 70 years and older using seven or more chronic drugs. Patients will be randomly assigned to control or intervention group by block-randomisation per pharmacy. Patients in the intervention group receive a CMR focused on patients’ preferences, personal goals and health-related complaints. With every goal a goal attainment scale (GAS) will be proposed. Primary outcome measures are HR-QoL, measured with the EQ-5D-5L and EQ-VAS and the number of health-related complaints per patient measured with a written questionnaire, during a follow-up period of six months. Secondary outcomes are healthcare utilisation, number and type of drug changes, number and type of health-related goals, scores on GAS and number and type of DRPs and interventions.

Discussion

This study is expected to add evidence on the effects of a CMR on HR-QoL and health-related complaints in older patients with polypharmacy. New in this study is the use of personal goals measured with GAS and health-related complaints as patient-related outcome measures.

Trial registration

Netherlands Trial Register; NTR5713.
Literature
1.
2.
Tommelein E, Mehuys E, Petrovic M, Somers A, Colin P, Boussery K. Potentially inappropriate prescribing in community-dwelling older people across Europe: a systematic literature review. Eur J Clin Pharmacol. 2015;71:1415–27.CrossRefPubMed
3.
Stichting Farmaceutische Kengetallen. Kwart 75-plussers gebruikt zeven of meer geneesmiddelen. Pharmaceutisch Weekblad. 2015;26:09.
4.
Warle-van Herwaarden MF, Kramers C, Sturkenboom MC, van den Bemt PM, De Smet PA. Dutch HARM-wrestling task force. Targeting outpatient drug safety: recommendations of the Dutch HARM-wrestling task force. Drug Saf. 2012;35:245–59.CrossRefPubMed
5.
Leendertse AJ, Egberts AC, Stoker LJ, van den Bemt PM, HARM Study Group. Frequency of and risk factors for preventable medication-related hospital admissions in the Netherlands. Arch Intern Med. 2008;168:1890–6.PubMed
6.
Leendertse AJ, de Koning GH, Goudswaard AN, Belitser SV, Verhoef M, de Gier HJ, et al. Preventing hospital admissions by reviewing medication (PHARM) in primary care: an open controlled study in an elderly population. J Clin Pharm Ther. 2013;38:379–87.CrossRefPubMed
7.
Nederlands Huisartsen Genootschap ism andere beroepsorganisaties/instanties/verenigingen [Dutch College of General Practitioners in collaboration with other professional organisations]. Multidisciplinaire Richtlijn Polyfarmacie bij ouderen [Multidisciplinary Guideline Polypharmacy in Elderly]. 2012;NHG.
8.
Milos V, Rekman E, Bondesson A, Eriksson T, Jakobsson U, Westerlund T, et al. Improving the quality of pharmacotherapy in elderly primary care patients through medication reviews: a randomised controlled study. Drugs Aging. 2013;30:235–46.CrossRefPubMed
9.
Lenander C, Elfsson B, Danielsson B, Midlov P, Hasselstrom J. Effects of a pharmacist-led structured medication review in primary care on drug-related problems and hospital admission rates: a randomized controlled trial. Scand J Prim Health Care. 2014;32(4):180–6.
10.
Zermansky AG, Silcock J. Is medication review by primary-care pharmacists for older people cost effective?: a narrative review of the literature, focusing on costs and benefits. Pharmacoeconomics. 2009;27:11–24.CrossRefPubMed
11.
Lenaghan E, Holland R, Brooks A. Home-based medication review in a high risk elderly population in primary care--the POLYMED randomised controlled trial. Age Ageing. 2007;36:292–7.CrossRefPubMed
12.
Kempen TGH, van de Steeg-van Gompel CH, Hoogland P, Liu Y, Bouvy ML. Large scale implementation of clinical medication reviews in Dutch community pharmacies: drug-related problems and interventions. Int J Clin Pharm. 2014;36:630–5.CrossRefPubMed
13.
Jokanovic N, Tan EC, Sudhakaran S, Kirkpatrick CM, Dooley MJ, Ryan-Atwood TE, et al. Pharmacist-led medication review in community settings: an overview of systematic reviews. Res Social Adm Pharm. 2017;13:661–85.CrossRefPubMed
14.
Kwint HF, Faber A, Gussekloo J, Bouvy ML. Effects of medication review on drug-related problems in patients using automated drug-dispensing systems: a pragmatic randomized controlled study. Drugs Aging. 2011;28:305–14.CrossRefPubMed
15.
Kwint HF, Faber A, Gussekloo J, den EIzen WPJ, Bouvy ML. Dissertation: Improving inappropriate medication use for older people in primary care - Home medication review in older patients - a randomised controlled trial in primary care. 2013.
16.
Vinks TH, Egberts TC, de Lange TM, de Koning FH. Pharmacist-based medication review reduces potential drug-related problems in the elderly: the SMOG controlled trial. Drugs Aging. 2009;26:123–33.CrossRefPubMed
17.
Stuijt CC, Franssen EJ, Egberts AC, Hudson SA. Appropriateness of prescribing among elderly patients in a Dutch residential home: observational study of outcomes after a pharmacist-led medication review. Drugs Aging. 2008;25:947–54.CrossRefPubMed
18.
Santschi V, Chiolero A, Paradis G, Colosimo AL, Burnand B. Pharmacist interventions to improve cardiovascular disease risk factors in diabetes: a systematic review and meta-analysis of randomized controlled trials. Diabetes Care. 2012;35:2706–17.CrossRefPubMedPubMedCentral
19.
Bunting BA, Smith BH, Sutherland SE. The Asheville Project: clinical and economic outcomes of a community-based long-term medication therapy management program for hypertension and dyslipidemia. J Am Pharm Assoc (2003). 2008;48:23–31.CrossRef
20.
Zermansky AG, Alldred DP, Petty DR, Raynor DK, Freemantle N, Eastaugh J, et al. Clinical medication review by a pharmacist of elderly people living in care homes--randomised controlled trial. Age Ageing. 2006;35:586–91.CrossRefPubMed
21.
22.
Patterson SM, Cadogan CA, Kerse N, Cardwell CR, Bradley MC, Ryan C, et al. Interventions to improve the appropriate use of polypharmacy for older people. Cochrane Database Syst Rev. 2014;10:CD008165.
23.
Thomas R, Huntley AL, Mann M, Huws D, Elwyn G, Paranjothy S, et al. Pharmacist-led interventions to reduce unplanned admissions for older people: a systematic review and meta-analysis of randomised controlled trials. Age Ageing. 2014;43:174–87.CrossRefPubMed
24.
Holland R, Desborough J, Goodyer L, Hall S, Wright D, Loke YK. Does pharmacist-led medication review help to reduce hospital admissions and deaths in older people? A systematic review and meta-analysis. Br J Clin Pharmacol. 2008;65:303–16.CrossRefPubMed
25.
26.
Jodar-Sanchez F, Malet-Larrea A, Martin JJ, Garcia-Mochon L, Lopez Del Amo MP, Martinez-Martinez F, et al. Cost-utility analysis of a medication review with follow-up service for older adults with polypharmacy in community pharmacies in Spain: the conSIGUE program. Pharmacoeconomics. 2015;33:599–610.CrossRefPubMed
27.
Beuscart JB, Pont LG, Thevelin S, Boland B, Dalleur O, Rutjes AWS, et al. A systematic review of the outcomes reported in trials of medication review in older patients: the need for a core outcome set. Br J Clin Pharmacol. 2017;83:942–52.CrossRefPubMed
28.
Schoenmakers TW, Teichert M, Wensing M, de Smet PA. Evaluation of potentially drug-related patient-reported common symptoms assessed during clinical medication reviews: a cross-sectional observational study. Drug Saf. 2017;40:419–30.CrossRefPubMedPubMedCentral
29.
Toto PE, Skidmore ER, Terhorst L, Rosen J, Weiner DK. Goal attainment scaling (GAS) in geriatric primary care: a feasibility study. Arch Gerontol Geriatr. 2015;60:16–21.CrossRefPubMed
30.
Rockwood K, Howlett S, Stadnyk K, Carver D, Powell C, Stolee P. Responsiveness of goal attainment scaling in a randomized controlled trial of comprehensive geriatric assessment. J Clin Epidemiol. 2003;56:736–43.CrossRefPubMed
31.
Farrell B, Tsang C, Raman-Wilms L, Irving H, Conklin J, Pottie K. What are priorities for deprescribing for elderly patients? Capturing the voice of practitioners: a modified delphi process. PLoS One. 2015;10:e0122246.CrossRefPubMedPubMedCentral
32.
Page AT, Clifford RM, Potter K, Schwartz D, Etherton-Beer CD. The feasibility and effect of deprescribing in older adults on mortality and health: a systematic review and meta-analysis. Br J Clin Pharmacol. 2016;82:583–623.CrossRefPubMedPubMedCentral
33.
Jansen J, Naganathan V, Carter SM, McLachlan AJ, Nickel B, Irwig L, et al. Too much medicine in older people? Deprescribing through shared decision making. BMJ. 2016;353:i2893.CrossRefPubMed
34.
Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010;152:726–32.CrossRefPubMed
35.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7.CrossRefPubMedPubMedCentral
36.
van Houwelingen AH, den Elzen WP, le Cessie S, Blom JW, Gussekloo J. Consequences of interaction of functional, somatic, mental and social problems in community-dwelling older people. PLoS One. 2015;10:e0121013.CrossRefPubMedPubMedCentral
37.
Blom J, den Elzen W, van Houwelingen AH, Heijmans M, Stijnen T, Van den Hout W, et al. Effectiveness and cost-effectiveness of a proactive, goal-oriented, integrated care model in general practice for older people. A cluster randomised controlled trial: integrated systematic care for older people--the ISCOPE study. Age Ageing. 2016;45:30–41.CrossRefPubMedPubMedCentral
38.
Hoeymans N, van Lindert H, Westert GP. The health status of the Dutch population as assessed by the EQ-6D. Qual Life Res. 2005;14:655–63.CrossRefPubMed
39.
Lamers LM, Stalmeier PF, McDonnell J, Krabbe PF, van Busschbach JJ. Measuring the quality of life in economic evaluations: the Dutch EQ-5D tariff. Ned Tijdschr Geneeskd. 2005;149:1574–8.PubMed
40.
van Blijswijk SC, Chan OY, van Houwelingen AH, Gussekloo J, den Elzen WP, Blom JW. Self-reported hindering health complaints of community-dwelling older persons: a cross-sectional study. PLoS One. 2015;10:e0142416.CrossRefPubMedPubMedCentral
41.
Bouwmans C, Hakkaart-van Roijen L, Koopmanschap M, Krol M, Severens H, Brouwer W. Handleiding iMTA Medical Cost Questionnaire (iMCQ). Rotterdam: iMTA, Erasmus Universiteit Rotterdam; 2013. [https://​www.​imta.​nl/​].
42.
Hakkaart-van Roijen L, van der Linden N, Bouwmans C, Kanters T, Tan S. Kostenhandleiding: Methodologie van kostenonderzoek en referentieprijzen voor economische evaluaties in de gezondheidszorg. Institute for Medical Technology Assessment; Erasmus Universiteit Rotterdam; 2015.
43.
Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical care. Am J Hosp Pharm. 1990;47:533–43.PubMed
44.
Gnjidic D, Le Couteur DG, Kouladjian L, Hilmer SN. Deprescribing trials: methods to reduce polypharmacy and the impact on prescribing and clinical outcomes. Clin Geriatr Med. 2012;28:237–53.CrossRefPubMed
45.
Ruble L, McGrew JH, Toland MD. Goal attainment scaling as an outcome measure in randomized controlled trials of psychosocial interventions in autism. J Autism Dev Disord. 2012;42:1974–83.CrossRefPubMedPubMedCentral
46.
Kiresuk TJ, Sherman RE. Goal attainment scaling: a general method for evaluating comprehensive community mental health programs. Community Ment Health J. 1968;4:443–53.CrossRefPubMed
47.
Kiresuk T, Smith A, Cardillo J. Goal Attainment Scaling: Applications, Theory, and Measurement. Hillsdale: New Jersey: Erlbaum; 1994.
48.
Kwint HF, Bermingham L, Faber A, Gussekloo J, Bouvy ML. The relationship between the extent of collaboration of general practitioners and pharmacists and the implementation of recommendations arising from medication review: a systematic review. Drugs Aging. 2013;30:91–102.CrossRefPubMed
Metadata
Title
DREAMeR: Drug use Reconsidered in the Elderly using goal Attainment scales during Medication Review; study protocol of a randomised controlled trial
Authors
Sanne Verdoorn
Henk-Frans Kwint
Jeanet Blom
Jacobijn Gussekloo
Marcel L. Bouvy
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Geriatrics / Issue 1/2018
Electronic ISSN: 1471-2318
DOI
https://doi.org/10.1186/s12877-018-0877-1

Other articles of this Issue 1/2018

BMC Geriatrics 1/2018 Go to the issue

Research Article

Experiences of fear of falling in persons with Parkinson’s disease – a qualitative study

Study protocol

A digitally supported home-based exercise training program and dietary protein intervention for community dwelling older adults: protocol of the cluster randomised controlled VITAMIN trial

Research article

Geriatric syndromes, multimorbidity, and disability overlap and increase healthcare use among older Chinese

Correction

Correction to: Hand dexterity, not handgrip strength, is associated with executive function in Japanese community-dwelling older adults: a cross-sectional study

Research article

Effect of cognitive and executive functions on perception of quality of life of cognitively normal elderly people dwelling in residential aged care facilities in Sri Lanka

Research article

Cross-sectional study of prevalence of dementia, behavioural symptoms, mobility, pain and other health parameters in nursing homes in Austria and the Czech Republic: results from the DEMDATA project
Obesity Clinical Trial Summary

At a glance: The STEP trials

Read more

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine

Highlights from the ACC 2024 Congress

Year in Review: Pediatric cardiology

Pediatric Cardiology Video

Watch Dr. Anne Marie Valente present the last year's highlights in pediatric and congenital heart disease in the official ACC.24 Year in Review session.

Year in Review: Pulmonary vascular disease

Cardiopulmonary Comorbidity Video

The last year's highlights in pulmonary vascular disease are presented by Dr. Jane Leopold in this official video from ACC.24.

Year in Review: Valvular heart disease

Valvular Heart Disease Video

Watch Prof. William Zoghbi present the last year's highlights in valvular heart disease from the official ACC.24 Year in Review session.

Year in Review: Heart failure and cardiomyopathies

Heart Failure Video

Watch this official video from ACC.24. Dr. Biykem Bozkurt discusses last year's major advances in heart failure and cardiomyopathies.

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Heart Failure Video

Watch this official video from ACC.24. Dr. Biykem Bozkurt discusses last year's major advances in heart failure and cardiomyopathies.

Watch now

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

16-04-2024 Type 2 Diabetes News

Incentivised to exercise

11-04-2024 Lifestyle Modifications News

New intervention for STEMI-related cardiogenic shock

10-04-2024 Myocardial Infarction News

» View more highlights on the ACC 2024 congress hub page

Image Credits