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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01171339
Other study ID # 1-Muth
Secondary ID
Status Completed
Phase N/A
First received July 27, 2010
Last updated October 29, 2017
Start date August 1, 2010
Est. completion date February 29, 2012

Study information

Verified date October 2017
Source Goethe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 505
Est. completion date February 29, 2012
Est. primary completion date February 29, 2012
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
Germany Institute for General Practice, Goethe-University Frankfurt / Main, Germany Frankfurt / Main Hesse

Sponsors (7)

Lead Sponsor Collaborator
Goethe University German Federal Ministry of Education and Research, Heidelberg University, Johann Wolfgang Goethe University Hospital, Maastricht University Medical Center, University Hospital Heidelberg, University of Oxford

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 MAI-Score Difference in Medication Appropriateness Index (MAI)-Score 9 months from baseline minus baseline (MAI T1-T0) 9 months from baseline
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Change in all cause hospitalisation 6 months and 9 months
Secondary "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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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