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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
| Johann Wolfgang Goethe University Hospital | OTHER |
| University Hospital Heidelberg | OTHER |
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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.
Key elements (1 to 4) of the complex intervention:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Usual care in accordance with recommended standard# #Recommended standard: clinical practice guideline "Geriatrie" of the guideline group of Hesse (part 1 and 2) | |
| Intervention arm | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christiane Muth, MD, MPH | Institute for General Practice, Goethe-University Frankfurt / Main | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for General Practice, Goethe-University Frankfurt / Main, Germany | Frankfurt am Main | Hesse | D-60590 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30055583 | Derived | 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. | |
| 29478012 | Derived | 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. |
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| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Heidelberg University |
| OTHER |
| Maastricht University Medical Center | OTHER |
| University of Oxford | OTHER |
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| 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)
| 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 |