Clinical and Economical Assessment of an Intervention to Reduce Potentially Inappropriate Medication in Polymedicated Elderly Patients

Study Overview
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Brief Summary
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Objective: To evaluate the clinical and economic impact of the application of an algorithm to improve the adequacy and safety of pharmacotherapy in elderly polymedicated (receiving 8 or more medications), not institutionalized. Design: randomized, open, multicenter and two branches of parallel intervention clinical trial. Intervention Study: primary care pharmacist apply the GP-GP algorithm to each drug with the support of STOPP criteria, Beers and / or recommendations CatSalut. The pharmacist submit to doctor his findings and reach a consensus and decide which recommendations will be presented to patient. Control intervention: usual procedure. Main outcome measures: a) Discontinued medications, changed or changing doses, b) GP consultations, hospital emergency department and hospital admissions for acute illness, c) pharmaceutical expenditure, d) restart medication e) complications underlying diseases. Follow-up control at 1 month (security) and at 3, 6 and 12 months.

Official Title
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Clinical and Economical Assessment of an Intervention to Reduce Potentially Inappropriate Medication in Polymedicated Elderly Patients

Conditions
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Polypharmacy, Elderly

Intervention / Treatment
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* Procedure: Pharmacist Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 70 years or more Currently receiving eight or more drugs, except ointments and administered via topical nonprescription Give their informed written consent to participate in the study. Exclusion Criteria: Estimated life expectancy less than 6 months. Active cancer Participation in any other clinical trial or program for evaluation of medication in the elderly. Institutionalized in nursing homes. Surgical intervention scheduled for the next 6 months

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacist Intervention<br>Primary care pharmacist apply the GP-GP algorithm to each drug with the support of STOPP criteria, Beers and / or recommendations CatSalut. The pharmacist submit to doctor his findings and reach a consensus and decide which recommendations will be presented to patient. | Procedure: Pharmacist Intervention<br> <br> |
| No Intervention: Control<br>Usual procedure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with medications discontinued, reduced dose or changed. |  | baseline, 3, 6 and 12 months | 
| Number of discontinued medications, changed or changing doses. |  | baseline, 3, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resumption of medication |  | 3, 6 and 12 months | 
| Medication adherence | Morisky-Green questionnaire | baseline, 3 and 6 months | 
| Quality of life | EuroQoL questionnaire | baseline, 3 and 6 months | 
| Pharmaceutical recommendations acceptance rate |  | baseline | 
| Healthcare resource consumption | Number of visits to Primary care center, Number of visits to hospital emergency department, Number of hospital admission, Number of outpatients hospital visits. | 3, 6 and 12 months | 
| Mortality |  | 3, 6 and 12 months |