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Completed

NCT Number: NCT01171339

Prioritising and Optimising Multi-medication in Multimorbidity

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.

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Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Frankfurt am Main, Hesse, D-60590, Germany

About this study

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

  • Basic assessment of medicines that were actually taken (brown bag review) by a general practice based health care assistant (HCA) and
  • 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.
  • 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
  • prioritizes medication in the physician-patient consultation taking into consideration patient's preferences.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: Intervention arm

Primary outcomes

  1. Medication Appropriateness Index (MAI)-Score

    Time frame: 6 months from baseline

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

Secondary outcomes

  1. MAI-Score

    Time frame: 9 months from baseline

    Difference in Medication Appropriateness Index (MAI)-Score 9 months from baseline minus baseline (MAI T1-T0)

  2. Generic health related quality of life: EQ-5D

    Time frame: 6 months from baseline

    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)

  3. Generic health related quality of life: EQ-5D

    Time frame: 9 months

    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)

  4. Functional disability: Vulnerable Elderly Survey (VES-13)

    Time frame: 6 months

    Change in functional disability measured as the difference in the VES-13-Score 6 months from baseline minus baseline (T1-T0)

  5. Functional disability: Vulnerable Elderly Survey (VES-13)

    Time frame: 9 months

    Change in functional disability measured as the difference in the VES-13-Score 9 months from baseline minus baseline (T2-T0)

  6. Change in all cause hospitalisation

    Time frame: 6 months and 9 months

  7. "Observed" adherence

    Time frame: 6 months from baseline and 9 months from baseline

    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)

  8. Self-reported adherence (Morisky)

    Time frame: 6 and 9 months from baseline

    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)

  9. Future life expectancy / years of desired life

    Time frame: 6 and 9 months from baseline

    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

  10. medication complexity

    Time frame: 6 and 9 months from baseline

    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)

  11. Beliefs about Medicines Questionaire (BMQ)

    Time frame: 6 and 9 months from baseline

    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)

  12. Severity of chronic pain

    Time frame: 6 and 9 months from baseline

    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)

  13. Satisfaction with shared decision making (Man Son Hing scale, MSH)

    Time frame: 6 and 9 months from baseline

    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)

  14. Cognitive dysfunction in verbal fluency

    Time frame: 6 and 9 months from baseline

    Change in cognitive (dys)function measured as the difference in the Verbal Fluency Test (VFT) interval 6 months from baseline minus baseline (T1-T0) and 9 months from baseline minus baseline (T2-T0)

  15. Depressive symptoms

    Time frame: 6 and 9 months from baseline

    Change in depressive symptoms measured as the difference in the Geriatric Depression Scale (GDS) interval 6 months from baseline minus baseline (T1-T0) and 9 months from baseline minus baseline (T2-T0)

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Collaborators

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

Registry information

Official study title

Prioritising and Optimising Multiple Medications in Elderly Multimorbid Patients in General Practice. - A Pragmatic Cluster-randomised Controlled Trial.

Acronym: PRIMUM

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 28, 2010
Registry last updated
Oct 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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