Reduction of inappropriate medication and adverse drug events in older patients

Polypharmacy - Reduction of Inappropriate Medication and Adverse drug events in older patients: a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN38449870

Enrollment

600

Registered

2013-09-30

Start date

2012-12-01

Completion date

Unknown

Last updated

2021-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reduction of polypharmacy in elderly patients Injury, Occupational Diseases, Poisoning

Interventions

A cluster-randomized controlled trial aiming at the outcome after reduction and/or discontinuation of inappropriate medication in older patients. In the proposed trial, the physicians will be randomiz

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged over 74 years 2. Taking eight or more drugs

Exclusion criteria

Exclusion criteria: 1. Life expectancy assumed to be less than three months 2. Advanced cancer 3. Ongoing chemotherapy and/or therapeutic radiation 4. Severe dementia 5. Patients not able to give informed consent

Design outcomes

Primary

Measure	Time frame
Hazard ratio for the composite endpoint of first hospital admission and death measured by the number of deaths in the study population at 24 months	—

Secondary

Measure	Time frame
1. Mortality, measured by the number of deaths (the numerator of the mortality rate) in patients of the two study groups (the population denominator of the mortality rate), respectively, at the time point 24 months after study enrolment 2. Hospital admission, measured as number of admissions to local hospitals and length of hospital stays measured in days as recorded in a single database within a time period of 24 months after study enrolment 3. Adverse drug events, measured as number of severe adverse events documented in patients charts of the general practitioner or in hospital discharge letters in patients of the two study groups, respectively, at the time point 24 months after study enrolment 4. Falls, measured as number of events which result in a person coming to rest inadvertently on the ground or floor or other lower level as documented in patient charts of the general practitioner and of the hospital in patients of the two study groups, respectively, during the period of 24 months after study enrolment 5. Fractures, measured as number of bone fractures documented radiographically in charts of patients of the two study groups, respectively, during the period of 24 months after study enrolment 6. Health expenditure, measured as estimated sum of the expenditure due drugs and hospital admissions in patients of the two study groups, respectively, at the time point 24 months after study enrolment 7. Improvement of the cognitive function assessed by the Mini Mental Status 8. Quality of life, measured by the SF12 9. Mental wellness, assessed by the Geriatric Depression Scale	—

Measure

Time frame

1. Mortality, measured by the number of deaths (the numerator of the mortality rate) in patients of the two study groups (the population denominator of the mortality rate), respectively, at the time point 24 months after study enrolment 2. Hospital admission, measured as number of admissions to local hospitals and length of hospital stays measured in days as recorded in a single database within a time period of 24 months after study enrolment 3. Adverse drug events, measured as number of severe adverse events documented in patients charts of the general practitioner or in hospital discharge letters in patients of the two study groups, respectively, at the time point 24 months after study enrolment 4. Falls, measured as number of events which result in a person coming to rest inadvertently on the ground or floor or other lower level as documented in patient charts of the general practitioner and of the hospital in patients of the two study groups, respectively, during the period of 24 months after study enrolment 5. Fractures, measured as number of bone fractures documented radiographically in charts of patients of the two study groups, respectively, during the period of 24 months after study enrolment 6. Health expenditure, measured as estimated sum of the expenditure due drugs and hospital admissions in patients of the two study groups, respectively, at the time point 24 months after study enrolment 7. Improvement of the cognitive function assessed by the Mini Mental Status 8. Quality of life, measured by the SF12 9. Mental wellness, assessed by the Geriatric Depression Scale

—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026