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Polypharmacy in chronic diseases-Reduction of Inappropriate Medication and Adverse drug events in older populations by electronic Decision Support (PRIMA-eDS): study protocol for a randomized controlled trial

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Polypharmacy in chronic diseases-Reduction of Inappropriate Medication and Adverse drug events in older populations by electronic Decision Support (PRIMA-eDS): study protocol for a randomized controlled trial. / Sönnichsen, Andreas; Trampisch, Ulrike S; Rieckert, Anja; Piccoliori, Giuliano; Vögele, Anna; Flamm, Maria; Johansson, Tim; Esmail, Aneez; Reeves, David; Löffler, Christin; Höck, Jennifer; Klaassen-Mielke, Renate; Trampisch, Hans Joachim; Kunnamo, Ilkka.

In: TRIALS, Vol. 17, 29.01.2016, p. 57.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Sönnichsen, A, Trampisch, US, Rieckert, A, Piccoliori, G, Vögele, A, Flamm, M, Johansson, T, Esmail, A, Reeves, D, Löffler, C, Höck, J, Klaassen-Mielke, R, Trampisch, HJ & Kunnamo, I 2016, 'Polypharmacy in chronic diseases-Reduction of Inappropriate Medication and Adverse drug events in older populations by electronic Decision Support (PRIMA-eDS): study protocol for a randomized controlled trial', TRIALS, vol. 17, pp. 57. https://doi.org/10.1186/s13063-016-1177-8

APA

Sönnichsen, A., Trampisch, U. S., Rieckert, A., Piccoliori, G., Vögele, A., Flamm, M., Johansson, T., Esmail, A., Reeves, D., Löffler, C., Höck, J., Klaassen-Mielke, R., Trampisch, H. J., & Kunnamo, I. (2016). Polypharmacy in chronic diseases-Reduction of Inappropriate Medication and Adverse drug events in older populations by electronic Decision Support (PRIMA-eDS): study protocol for a randomized controlled trial. TRIALS, 17, 57. https://doi.org/10.1186/s13063-016-1177-8

Vancouver

Sönnichsen A, Trampisch US, Rieckert A, Piccoliori G, Vögele A, Flamm M et al. Polypharmacy in chronic diseases-Reduction of Inappropriate Medication and Adverse drug events in older populations by electronic Decision Support (PRIMA-eDS): study protocol for a randomized controlled trial. TRIALS. 2016 Jan 29;17:57. https://doi.org/10.1186/s13063-016-1177-8

Bibtex

@article{785c28d438b74adc84a11e4d50c128cb,
title = "Polypharmacy in chronic diseases-Reduction of Inappropriate Medication and Adverse drug events in older populations by electronic Decision Support (PRIMA-eDS): study protocol for a randomized controlled trial",
abstract = "BACKGROUND: Multimorbidity is increasing in aging populations with a corresponding increase in polypharmacy as well as inappropriate prescribing. Depending on definitions, 25-50 % of patients aged 75 years or older are exposed to at least five drugs. Evidence is increasing that polypharmacy, even when guidelines advise the prescribing of each drug individually, can potentially cause more harm than benefit to older patients, due to factors such as drug-drug and drug-disease interactions. Several approaches reducing polypharmacy and inappropriate prescribing have been proposed, but evidence showing a benefit of these measures regarding clinically relevant endpoints is scarce. There is an urgent need to implement more effective strategies. We therefore set out to develop an evidence-based electronic decision support (eDS) tool to aid physicians in reducing inappropriate prescribing and test its effectiveness in a large-scale cluster-randomized controlled trial.METHODS: The {"}Polypharmacy in chronic diseases-Reduction of Inappropriate Medication and Adverse drug events in older populations{"} (PRIMA)-eDS tool is a tool comprising an indication check and recommendations for the reduction of polypharmacy and inappropriate prescribing based on systematic reviews and guidelines, the European list of inappropriate medications for older people, the SFINX-database of interactions, the PHARAO-database on adverse effects, and the RENBASE-database on renal dosing. The tool will be evaluated in a cluster-randomized controlled trial involving 325 general practitioners (GPs) and around 3500 patients across five study centres in the United Kingdom, Germany, Austria and Italy. GP practices will be asked to recruit 11 patients aged 75 years or older who are taking at least eight medications and will be cluster-randomized after completion of patient recruitment. Intervention GPs will have access to the PRIMA-eDS tool, while control GPs will treat their patients according to current guidelines (usual care) without access to the PRIMA-eDS tool. After an observation time of 2 years, intervention and control groups will be compared regarding the primary composite endpoint of first non-elective hospitalization or death.DISCUSSION: The principal hypothesis is that reduction of polypharmacy and inappropriate prescribing can improve the clinical composite outcome of hospitalization or death. A positive result of the trial will contribute substantially to the improvement of care in multimorbidity. The trial is necessary to investigate not only whether the reduction of polypharmacy improves outcome, but also whether GPs and patients are willing to follow the recommendations of the PRIMA-eDS tool.TRIAL REGISTRATION: This trial has been registered with Current Controlled Trials Ltd. on 31 July 2014 (ISRCTN10137559).",
keywords = "Aged, Aged, 80 and over, Chronic Disease, Clinical Protocols, Decision Support Systems, Clinical, Drug-Related Side Effects and Adverse Reactions, Humans, Inappropriate Prescribing, Outcome Assessment (Health Care), Polypharmacy, Sample Size, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't",
author = "Andreas S{\"o}nnichsen and Trampisch, {Ulrike S} and Anja Rieckert and Giuliano Piccoliori and Anna V{\"o}gele and Maria Flamm and Tim Johansson and Aneez Esmail and David Reeves and Christin L{\"o}ffler and Jennifer H{\"o}ck and Renate Klaassen-Mielke and Trampisch, {Hans Joachim} and Ilkka Kunnamo",
year = "2016",
month = jan,
day = "29",
doi = "10.1186/s13063-016-1177-8",
language = "English",
volume = "17",
pages = "57",
journal = "TRIALS",
issn = "1745-6215",
publisher = "Current Controlled Trials Ltd.",

}

RIS

TY - JOUR

T1 - Polypharmacy in chronic diseases-Reduction of Inappropriate Medication and Adverse drug events in older populations by electronic Decision Support (PRIMA-eDS): study protocol for a randomized controlled trial

AU - Sönnichsen, Andreas

AU - Trampisch, Ulrike S

AU - Rieckert, Anja

AU - Piccoliori, Giuliano

AU - Vögele, Anna

AU - Flamm, Maria

AU - Johansson, Tim

AU - Esmail, Aneez

AU - Reeves, David

AU - Löffler, Christin

AU - Höck, Jennifer

AU - Klaassen-Mielke, Renate

AU - Trampisch, Hans Joachim

AU - Kunnamo, Ilkka

PY - 2016/1/29

Y1 - 2016/1/29

N2 - BACKGROUND: Multimorbidity is increasing in aging populations with a corresponding increase in polypharmacy as well as inappropriate prescribing. Depending on definitions, 25-50 % of patients aged 75 years or older are exposed to at least five drugs. Evidence is increasing that polypharmacy, even when guidelines advise the prescribing of each drug individually, can potentially cause more harm than benefit to older patients, due to factors such as drug-drug and drug-disease interactions. Several approaches reducing polypharmacy and inappropriate prescribing have been proposed, but evidence showing a benefit of these measures regarding clinically relevant endpoints is scarce. There is an urgent need to implement more effective strategies. We therefore set out to develop an evidence-based electronic decision support (eDS) tool to aid physicians in reducing inappropriate prescribing and test its effectiveness in a large-scale cluster-randomized controlled trial.METHODS: The "Polypharmacy in chronic diseases-Reduction of Inappropriate Medication and Adverse drug events in older populations" (PRIMA)-eDS tool is a tool comprising an indication check and recommendations for the reduction of polypharmacy and inappropriate prescribing based on systematic reviews and guidelines, the European list of inappropriate medications for older people, the SFINX-database of interactions, the PHARAO-database on adverse effects, and the RENBASE-database on renal dosing. The tool will be evaluated in a cluster-randomized controlled trial involving 325 general practitioners (GPs) and around 3500 patients across five study centres in the United Kingdom, Germany, Austria and Italy. GP practices will be asked to recruit 11 patients aged 75 years or older who are taking at least eight medications and will be cluster-randomized after completion of patient recruitment. Intervention GPs will have access to the PRIMA-eDS tool, while control GPs will treat their patients according to current guidelines (usual care) without access to the PRIMA-eDS tool. After an observation time of 2 years, intervention and control groups will be compared regarding the primary composite endpoint of first non-elective hospitalization or death.DISCUSSION: The principal hypothesis is that reduction of polypharmacy and inappropriate prescribing can improve the clinical composite outcome of hospitalization or death. A positive result of the trial will contribute substantially to the improvement of care in multimorbidity. The trial is necessary to investigate not only whether the reduction of polypharmacy improves outcome, but also whether GPs and patients are willing to follow the recommendations of the PRIMA-eDS tool.TRIAL REGISTRATION: This trial has been registered with Current Controlled Trials Ltd. on 31 July 2014 (ISRCTN10137559).

AB - BACKGROUND: Multimorbidity is increasing in aging populations with a corresponding increase in polypharmacy as well as inappropriate prescribing. Depending on definitions, 25-50 % of patients aged 75 years or older are exposed to at least five drugs. Evidence is increasing that polypharmacy, even when guidelines advise the prescribing of each drug individually, can potentially cause more harm than benefit to older patients, due to factors such as drug-drug and drug-disease interactions. Several approaches reducing polypharmacy and inappropriate prescribing have been proposed, but evidence showing a benefit of these measures regarding clinically relevant endpoints is scarce. There is an urgent need to implement more effective strategies. We therefore set out to develop an evidence-based electronic decision support (eDS) tool to aid physicians in reducing inappropriate prescribing and test its effectiveness in a large-scale cluster-randomized controlled trial.METHODS: The "Polypharmacy in chronic diseases-Reduction of Inappropriate Medication and Adverse drug events in older populations" (PRIMA)-eDS tool is a tool comprising an indication check and recommendations for the reduction of polypharmacy and inappropriate prescribing based on systematic reviews and guidelines, the European list of inappropriate medications for older people, the SFINX-database of interactions, the PHARAO-database on adverse effects, and the RENBASE-database on renal dosing. The tool will be evaluated in a cluster-randomized controlled trial involving 325 general practitioners (GPs) and around 3500 patients across five study centres in the United Kingdom, Germany, Austria and Italy. GP practices will be asked to recruit 11 patients aged 75 years or older who are taking at least eight medications and will be cluster-randomized after completion of patient recruitment. Intervention GPs will have access to the PRIMA-eDS tool, while control GPs will treat their patients according to current guidelines (usual care) without access to the PRIMA-eDS tool. After an observation time of 2 years, intervention and control groups will be compared regarding the primary composite endpoint of first non-elective hospitalization or death.DISCUSSION: The principal hypothesis is that reduction of polypharmacy and inappropriate prescribing can improve the clinical composite outcome of hospitalization or death. A positive result of the trial will contribute substantially to the improvement of care in multimorbidity. The trial is necessary to investigate not only whether the reduction of polypharmacy improves outcome, but also whether GPs and patients are willing to follow the recommendations of the PRIMA-eDS tool.TRIAL REGISTRATION: This trial has been registered with Current Controlled Trials Ltd. on 31 July 2014 (ISRCTN10137559).

KW - Aged

KW - Aged, 80 and over

KW - Chronic Disease

KW - Clinical Protocols

KW - Decision Support Systems, Clinical

KW - Drug-Related Side Effects and Adverse Reactions

KW - Humans

KW - Inappropriate Prescribing

KW - Outcome Assessment (Health Care)

KW - Polypharmacy

KW - Sample Size

KW - Journal Article

KW - Multicenter Study

KW - Randomized Controlled Trial

KW - Research Support, Non-U.S. Gov't

U2 - 10.1186/s13063-016-1177-8

DO - 10.1186/s13063-016-1177-8

M3 - SCORING: Journal article

C2 - 26822311

VL - 17

SP - 57

JO - TRIALS

JF - TRIALS

SN - 1745-6215

ER -