Text Size

Prioritising and Optimising Multi-medication in Multimorbidity (PRIMUM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Goethe University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
Johann Wolfgang Goethe University Hospitals
University Hospital Heidelberg
University of Heidelberg
Maastricht University Medical Center
University of Oxford
Information provided by:
Goethe University
ClinicalTrials.gov Identifier:
NCT01171339
First received: July 27, 2010
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention
Chronic Disease
 Other: Optimization strategy (complex intervention)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prioritising and Optimising Multiple Medications in Elderly Multimorbid Patients in General Practice. - A Pragmatic Cluster-randomised Controlled Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Goethe University:

Primary Outcome Measures:
  • Medication Appropriateness Index (MAI)-Score [ Time Frame: 6 months from baseline ] [ Designated as safety issue: No ]
    Difference in Medication Appropriateness Index (MAI)-Score 6 months from baseline minus baseline (MAI T1-T0)


Secondary Outcome Measures:
  • MAI-Score [ Time Frame: 9 months from baseline ] [ Designated as safety issue: No ]
    Difference in Medication Appropriateness Index (MAI)-Score 9 months from baseline minus baseline (MAI T1-T0)

  • Generic health related quality of life: EQ-5D [ Time Frame: 6 months from baseline ] [ Designated as safety issue: No ]
    Change in generic health related quality of life measured as the difference in the EQ-5D-Score 6 months from baseline minus baseline (T1-T0)

  • Generic health related quality of life: EQ-5D [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Change in generic health related quality of life measured as the difference in the EQ-5D-Score 9 months from baseline minus baseline (T2-T0)

  • Functional disability: Vulnerable Elderly Survey (VES-13) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change in functional disability measured as the difference in the VES-13-Score 6 months from baseline minus baseline (T1-T0)

  • VES-13 [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Change in functional disability measured as the difference in the VES-13-Score 9 months from baseline minus baseline (T2-T0)

  • Change in all cause hospitalisation [ Time Frame: 6 months and 9 months ] [ Designated as safety issue: No ]
  • Observed adherence [ Time Frame: 6 months from baseline and 9 months from baseline ] [ Designated as safety issue: No ]
    Change in observed adherence measured as the difference between intake (patient's interview) and prescribed medication (CRF reported by physician's) 6 months from baseline minus baseline (T1-T0) and 9 months from baseline minus baseline (T2-T0)

  • Self-reported adherence (Morisky) [ Time Frame: 6 and 9 months from baseline ] [ Designated as safety issue: No ]
    Change in self-reported adherence measured as the difference in the Morisky-Score 6 months from baseline minus baseline (T1-T0) and 9 months from baseline minus baseline (T2-T0)

  • Future life expectancy / years of desired life [ Time Frame: 6 and 9 months from baseline ] [ Designated as safety issue: No ]
    Change in perceived future life expectancy reflects concepts of will to life or years of desired life [YDL] measured as the difference of the three items future expectation / expected lifetime duration / desired lifetime duration in the interval 6 months

  • medication complexity [ Time Frame: 6 and 9 months from baseline ] [ Designated as safety issue: No ]

    Change in complexity of medication measured as the difference 6 months from baseline minus baseline (T1-T0) and 9 months from baseline minus baseline (T2-T0)

    • Total number of prescriptions
    • Number of single doses / day
    • Medication Regimen Complexity Index (MRCI)

  • Beliefs about Medicines Questionaire (BMQ) [ Time Frame: 6 and 9 months from baseline ] [ Designated as safety issue: No ]
    Change in health and illness beliefs and attitudes measured as the difference in the Beliefs about Medicines Questionaire (BMQ) score 6 months from baseline minus baseline (T1-T0) and 9 months from baseline minus baseline (T2-T0)

  • Severity of chronic pain [ Time Frame: 6 and 9 months from baseline ] [ Designated as safety issue: No ]
    Change in severity of chronic pain measured as the difference in Characteristic Pain Intensity score, the Disability Score, in Disability Points and the resulting Grades of chronic pain severity in accordance with M. von Korff, J. Ormel et al. the interval 6 months from baseline minus baseline (T1-T0) and 9 months from baseline minus baseline (T2-T0)

  • Satisfaction with shared decision making (Man Son Hing scale, MSH) [ Time Frame: 6 and 9 months from baseline ] [ Designated as safety issue: No ]
    Change in satisfaction with shared decision making measured as the difference in the Man Son Hing scale (MSH) interval 6 months from baseline minus baseline (T1-T0) and 9 months from baseline minus baseline (T2-T0)


Estimated Enrollment: 490
Study Start Date: August 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control

Usual care in accordance with recommended standard#

#Recommended standard: clinical practice guideline "Geriatrie" of the guideline group of Hesse (part 1 and 2)
Experimental: 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)

 Other: 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 Name: Intervention arm

Detailed Description:

Key elements (1 to 4) of the complex intervention:

  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.
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171339

Locations
Germany
Institute for General Practice, Goethe-University Frankfurt / Main, Germany
Frankfurt / Main, Hesse, Germany, D-60590
Sponsors and Collaborators
Goethe University
German Federal Ministry of Education and Research
Johann Wolfgang Goethe University Hospitals
University Hospital Heidelberg
University of Heidelberg
Maastricht University Medical Center
University of Oxford
Investigators
Principal Investigator: Christiane Muth, MD, MPH Institute for General Practice, Goethe-University Frankfurt / Main
  More Information

Additional Information:
English Homepage of the PRIMUM study  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Christiane Muth, MD, MPH / Principal Investigator, Institute for General Practice, Johann Wolfgang Goethe University, Frankfurt/Main, Germany
ClinicalTrials.gov Identifier: NCT01171339     History of Changes
Other Study ID Numbers: 1-Muth
Study First Received: July 27, 2010
Last Updated: June 22, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Goethe University:
elderly
multimorbidity
polypharmacy
multimedication
 medication appropriateness
medication appropriateness index
cluster-randomised controlled trial
pragmatic trial

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013