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Chronic DiseasePRIMUMNCT01171339

Prioritising and Optimising Multi-medication in Multimorbidity

A study testing Optimization strategy (complex intervention) in people with Chronic Disease, run by Goethe University at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Chronic Disease
What is being tested?
Optimization strategy (complex intervention)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
505 participants
Where
1 siteGermany
Study dates
1 Aug 2010to 29 Feb 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    Frankfurt am Main, Hesse, D-60590

Other trials in Germany

About this study

Official title: 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.

Read the 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.
Conditions
Chronic Disease
Being tested
Optimization strategy (complex intervention)
Keywords
elderly, multimorbidity, polypharmacy, multimedication, medication appropriateness, medication appropriateness index, cluster-randomised controlled trial, pragmatic trial
Medical subject headings
Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optimization strategy (complex intervention)Other

    Also called Intervention arm

    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)

Study groups in NCT01171339
Study groupRoleWhat they receive
ControlNo interventionUsual care in accordance with recommended standard# #Recommended standard: clinical practice guideline "Geriatrie" of the guideline group of Hesse (part 1 and 2)
Intervention armExperimentalIntervention: 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)
Receives: Other: Optimization strategy (complex intervention)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Medication Appropriateness Index (MAI)-Score

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

    Measured: 6 months from baseline

Secondary outcomes (15)

  1. MAI-Score

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

    Measured: 9 months from baseline

  2. 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)

    Measured: 6 months from baseline

  3. 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)

    Measured: 9 months

  4. 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)

    Measured: 6 months

  5. 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)

    Measured: 9 months

  6. Change in all cause hospitalisation

    Measured: 6 months and 9 months

  7. "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)

    Measured: 6 months from baseline and 9 months from baseline

  8. 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)

    Measured: 6 and 9 months from baseline

  9. 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

    Measured: 6 and 9 months from baseline

  10. 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)

    Measured: 6 and 9 months from baseline

  11. 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)

    Measured: 6 and 9 months from baseline

  12. 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)

    Measured: 6 and 9 months from baseline

  13. 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)

    Measured: 6 and 9 months from baseline

  14. 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)

    Measured: 6 and 9 months from baseline

  15. 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)

    Measured: 6 and 9 months from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2010 (estimated)
  2. Study start1 Aug 2010
  3. Primary completion29 Feb 2012
  4. Study completion29 Feb 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
505 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01171339
Sponsor's protocol ID
1-Muth
Acronym
PRIMUM
Status last verified
Oct 2017
First submitted
27 Jul 2010
Last updated
31 Oct 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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.

    PubMed 30055583

  • 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.

    PubMed 29478012

Questions about this trial

What is this clinical trial studying?

A study testing Optimization strategy (complex intervention) in people with Chronic Disease, run by Goethe University at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medication Appropriateness Index (MAI)-Score (time frame: 6 months from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01171339, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2017.

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PRIMUM Clinical Trial NCT01171339 | AzTrials