Prioritising and Optimising Multi-medication in Multimorbidity

NCT01171339 | Completed DMC

• 1 other identifier: 1-Muth
• Study Type: interventional
• Target: 505
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To investigate whether the complex intervention will improve the appropriateness of prescriptions in elderly multi-morbid patients with multi-medication in general practices. 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.

Conditions

Chronic Disease

Keywords

elderly; multimorbidity; polypharmacy; multimedication; medication appropriateness; medication appropriateness index; cluster-randomised controlled trial; pragmatic trial

Outcome Measures

Primary Outcomes (1)

• Medication Appropriateness Index (MAI)-Score

  Difference in Medication Appropriateness Index (MAI)-Score 6 months from baseline minus baseline (MAI T1-T0)

  6 months from baseline

Secondary Outcomes (15)

• MAI-Score

  9 months from baseline

• Generic health related quality of life: EQ-5D

  6 months from baseline

• Generic health related quality of life: EQ-5D

  9 months

• Functional disability: Vulnerable Elderly Survey (VES-13)

  6 months

• Functional disability: Vulnerable Elderly Survey (VES-13)

  9 months

Study Arms (2)

Control

NO INTERVENTION

Usual care in accordance with recommended standard# #Recommended standard: clinical practice guideline "Geriatrie" of the guideline group of Hesse (part 1 and 2)

Intervention arm

EXPERIMENTAL

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: Optimization strategy (complex intervention)

Interventions

Optimization strategy (complex intervention) OTHER

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)

Also known as: Intervention arm

Intervention arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 60 years old of both sexes
• 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

You may not qualify if:

• diseases cause life expectancy of less than 12 months
• 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

Sponsors & Collaborators

• Goethe University: lead
• German Federal Ministry of Education and Research: collaborator
• Johann Wolfgang Goethe University Hospital: collaborator
• University Hospital Heidelberg: collaborator
• Heidelberg University: collaborator
• Maastricht University Medical Center: collaborator
• University of Oxford: collaborator

Study Sites (1)

Institute for General Practice, Goethe-University Frankfurt / Main, Germany

Frankfurt am Main, Hesse, D-60590, Germany

Location

Related Publications (2)

• 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.

  PMID: 30055583 DERIVED

• 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.

  PMID: 29478012 DERIVED

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christiane Muth, MD, MPH

  Institute for General Practice, Goethe-University Frankfurt / Main

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Chrstiane Muth, MD, MPH

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: July 28, 2010
• Study Start: August 1, 2010
• Primary Completion: February 29, 2012
• Study Completion: February 29, 2012
• Last Updated: October 31, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)