Prioritising and Optimising Multi-medication in Multimorbidity (PRIMUM)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Disease
• Intervention / Treatment: Other: Optimization strategy (complex intervention)

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.

• Study Type: Interventional
• Enrollment (Actual): 505
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hesse
    • Frankfurt / Main, Hesse, Germany, D-60590
      • Institute for General Practice, Goethe-University Frankfurt / Main, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Intervention arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
MAI-Score	Difference in Medication Appropriateness Index (MAI)-Score 9 months from baseline minus baseline (MAI T1-T0)	9 months from baseline
Generic health related quality of life: EQ-5D	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)	6 months from baseline
Generic health related quality of life: EQ-5D	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)	9 months
Functional disability: Vulnerable Elderly Survey (VES-13)	Change in functional disability measured as the difference in the VES-13-Score 6 months from baseline minus baseline (T1-T0)	6 months
Functional disability: Vulnerable Elderly Survey (VES-13)	Change in functional disability measured as the difference in the VES-13-Score 9 months from baseline minus baseline (T2-T0)	9 months
Change in all cause hospitalisation		6 months and 9 months
"Observed" adherence	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)	6 months from baseline and 9 months from baseline
Self-reported adherence (Morisky)	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)	6 and 9 months from baseline
Future life expectancy / years of desired life	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	6 and 9 months from baseline
medication complexity	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)	6 and 9 months from baseline
Beliefs about Medicines Questionaire (BMQ)	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)	6 and 9 months from baseline
Severity of chronic pain	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)	6 and 9 months from baseline
Satisfaction with shared decision making (Man Son Hing scale, MSH)	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)	6 and 9 months from baseline
Cognitive dysfunction in verbal fluency	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)	6 and 9 months from baseline
Depressive symptoms	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)	6 and 9 months from baseline

Collaborators and Investigators

• Sponsor: Goethe University
• Collaborators: Maastricht University Medical Center; German Federal Ministry of Education and Research; University of Oxford; Heidelberg University; Johann Wolfgang Goethe University Hospital; University Hospital Heidelberg
• Investigators: Principal Investigator: Christiane Muth, MD, MPH, Institute for General Practice, Goethe-University Frankfurt / Main

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2010
• Primary Completion (Actual): February 29, 2012
• Study Completion (Actual): February 29, 2012

Study Registration Dates

• First Submitted: July 27, 2010
• First Submitted That Met QC Criteria: July 27, 2010
• First Posted (Estimate): July 28, 2010

Study Record Updates

• Last Update Posted (Actual): October 31, 2017
• Last Update Submitted That Met QC Criteria: October 29, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: elderly; multimorbidity; polypharmacy; multimedication; medication appropriateness; medication appropriateness index; cluster-randomised controlled trial; pragmatic trial
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 1-Muth

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No