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Prioritising and Optimising Multi-medication in Multimorbidity (PRIMUM)

Primary Purpose

Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Optimization strategy (complex intervention)
Sponsored by
Goethe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Disease focused on measuring elderly, multimorbidity, polypharmacy, multimedication, medication appropriateness, medication appropriateness index, cluster-randomised controlled trial, pragmatic trial

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention arm

Arm Description

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

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

MAI-Score
Difference in Medication Appropriateness Index (MAI)-Score 9 months from baseline minus baseline (MAI T1-T0)
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)
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)
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)
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)
Change in all cause hospitalisation
"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)
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)
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
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)
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)
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)
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)
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)
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)

Full Information

First Posted
July 27, 2010
Last Updated
October 29, 2017
Sponsor
Goethe University
Collaborators
German Federal Ministry of Education and Research, Johann Wolfgang Goethe University Hospital, University Hospital Heidelberg, Heidelberg University, Maastricht University Medical Center, University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT01171339
Brief Title
Prioritising and Optimising Multi-medication in Multimorbidity
Acronym
PRIMUM
Official Title
Prioritising and Optimising Multiple Medications in Elderly Multimorbid Patients in General Practice. - A Pragmatic Cluster-randomised Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2010 (Actual)
Primary Completion Date
February 29, 2012 (Actual)
Study Completion Date
February 29, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Goethe University
Collaborators
German Federal Ministry of Education and Research, Johann Wolfgang Goethe University Hospital, University Hospital Heidelberg, Heidelberg University, Maastricht University Medical Center, University of Oxford

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
elderly, multimorbidity, polypharmacy, multimedication, medication appropriateness, medication appropriateness index, cluster-randomised controlled trial, pragmatic trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
505 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care in accordance with recommended standard# #Recommended standard: clinical practice guideline "Geriatrie" of the guideline group of Hesse (part 1 and 2)
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Optimization strategy (complex intervention)
Other Intervention Name(s)
Intervention arm
Intervention Description
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)
Primary Outcome Measure Information:
Title
Medication Appropriateness Index (MAI)-Score
Description
Difference in Medication Appropriateness Index (MAI)-Score 6 months from baseline minus baseline (MAI T1-T0)
Time Frame
6 months from baseline
Secondary Outcome Measure Information:
Title
MAI-Score
Description
Difference in Medication Appropriateness Index (MAI)-Score 9 months from baseline minus baseline (MAI T1-T0)
Time Frame
9 months from baseline
Title
Generic health related quality of life: EQ-5D
Description
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)
Time Frame
6 months from baseline
Title
Generic health related quality of life: EQ-5D
Description
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)
Time Frame
9 months
Title
Functional disability: Vulnerable Elderly Survey (VES-13)
Description
Change in functional disability measured as the difference in the VES-13-Score 6 months from baseline minus baseline (T1-T0)
Time Frame
6 months
Title
Functional disability: Vulnerable Elderly Survey (VES-13)
Description
Change in functional disability measured as the difference in the VES-13-Score 9 months from baseline minus baseline (T2-T0)
Time Frame
9 months
Title
Change in all cause hospitalisation
Time Frame
6 months and 9 months
Title
"Observed" adherence
Description
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)
Time Frame
6 months from baseline and 9 months from baseline
Title
Self-reported adherence (Morisky)
Description
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)
Time Frame
6 and 9 months from baseline
Title
Future life expectancy / years of desired life
Description
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
Time Frame
6 and 9 months from baseline
Title
medication complexity
Description
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)
Time Frame
6 and 9 months from baseline
Title
Beliefs about Medicines Questionaire (BMQ)
Description
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)
Time Frame
6 and 9 months from baseline
Title
Severity of chronic pain
Description
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)
Time Frame
6 and 9 months from baseline
Title
Satisfaction with shared decision making (Man Son Hing scale, MSH)
Description
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)
Time Frame
6 and 9 months from baseline
Title
Cognitive dysfunction in verbal fluency
Description
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)
Time Frame
6 and 9 months from baseline
Title
Depressive symptoms
Description
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)
Time Frame
6 and 9 months from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christiane Muth, MD, MPH
Organizational Affiliation
Institute for General Practice, Goethe-University Frankfurt / Main
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for General Practice, Goethe-University Frankfurt / Main, Germany
City
Frankfurt / Main
State/Province
Hesse
ZIP/Postal Code
D-60590
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30055583
Citation
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.
Results Reference
derived
PubMed Identifier
29478012
Citation
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.
Results Reference
derived

Learn more about this trial

Prioritising and Optimising Multi-medication in Multimorbidity

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