Prioritising and Optimising Multi-medication in Multimorbidity
NCT ID: NCT01171339
Last Updated: 2017-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
505 participants
INTERVENTIONAL
2010-08-01
2012-02-29
Brief Summary
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Study hypothesis: The primary objective of the study is to determine whether the complex intervention will improve the appropriateness of prescriptions compared to usual care. The primary efficacy endpoint is the change in the Medication Appropriateness Index (MAI) score from baseline (T0) to 6 months after baseline (T1), i.e. the difference MAI T1-T0.
Detailed Description
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1. Basic assessment of medicines that were actually taken (brown bag review) by a general practice based health care assistant (HCA) and
2. Checklist-based (MediMoL - Medication-Monitoring-List) pre-consultation interview on problems relating to medicines (technical handling, potential adverse drug reactions) and patient's therapeutic aims by HCA provides structured information in the Medication-Monitoring-List (MediMoL) for the general practitioner (GP) and enables patients to discuss their problems with the GP.
3. GP uses a computerized decision support system (pharmaceutical information system, AiD+) to optimize medication (reducing number of inappropriate prescriptions, e.g. pharmaceutical interactions, renal dose adjustments, duplicate prescriptions) and
4. prioritizes medication in the physician-patient consultation taking into consideration patient's preferences.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Usual care in accordance with recommended standard#
#Recommended standard: clinical practice guideline "Geriatrie" of the guideline group of Hesse (part 1 and 2)
No interventions assigned to this group
Intervention arm
Intervention: Healthcare assistant (HCA) and computer assisted optimization of multi-medication (complex intervention) in accordance with recommended standard#
#Recommended standard: clinical practice guideline "Geriatrie" of the guideline group of Hesse (part 1 and 2)
Optimization strategy (complex intervention)
Healthcare assistant (HCA) and computer assisted optimization of multi-medication (complex intervention) in accordance with recommended standard#
#Recommended standard: clinical practice guideline "Geriatrie" of the guideline group of Hesse (part 1 and 2)
Interventions
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Optimization strategy (complex intervention)
Healthcare assistant (HCA) and computer assisted optimization of multi-medication (complex intervention) in accordance with recommended standard#
#Recommended standard: clinical practice guideline "Geriatrie" of the guideline group of Hesse (part 1 and 2)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* at least three chronic diseases affecting two or more organ systems, which require pharmaceutical treatment
* at least five long-term prescriptions with systemic effects
* health care provided by GP (at least one contact in most recent quarter)
* patient is legally competent to sign any documents
* ability to understand and participate in trial of own free will, to fill out questionnaires and participate in telephone interviews
* written informed consent to participate in trial
Exclusion Criteria
* abuse of alcohol or illegal drugs and visible clinical signs or symptoms thereof
* cognitive impairment that prevents trial participation (MMSE \< 26)
* emotional stress that prevents trial participation
* participation in a clinical trial within the last 30 days
60 Years
ALL
No
Sponsors
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German Federal Ministry of Education and Research
OTHER_GOV
Johann Wolfgang Goethe University Hospital
OTHER
University Hospital Heidelberg
OTHER
Heidelberg University
OTHER
Maastricht University Medical Center
OTHER
University of Oxford
OTHER
Goethe University
OTHER
Responsible Party
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Christiane Muth
Dr. Chrstiane Muth, MD, MPH
Principal Investigators
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Christiane Muth, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Institute for General Practice, Goethe-University Frankfurt / Main
Locations
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Institute for General Practice, Goethe-University Frankfurt / Main, Germany
Frankfurt am Main, Hesse, Germany
Countries
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References
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von Buedingen F, Hammer MS, Meid AD, Muller WE, Gerlach FM, Muth C. Changes in prescribed medicines in older patients with multimorbidity and polypharmacy in general practice. BMC Fam Pract. 2018 Jul 28;19(1):131. doi: 10.1186/s12875-018-0825-3.
Muth C, Uhlmann L, Haefeli WE, Rochon J, van den Akker M, Perera R, Guthlin C, Beyer M, Oswald F, Valderas JM, Knottnerus JA, Gerlach FM, Harder S. Effectiveness of a complex intervention on Prioritising Multimedication in Multimorbidity (PRIMUM) in primary care: results of a pragmatic cluster randomised controlled trial. BMJ Open. 2018 Feb 24;8(2):e017740. doi: 10.1136/bmjopen-2017-017740.
Other Identifiers
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1-Muth
Identifier Type: -
Identifier Source: org_study_id