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

Consorci Sanitari del Maresme503 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

503

Conditions

Polypharmacy Elderly

Interventions

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of patients with medications discontinued, reduced dose or changed.

Time frame: baseline, 3, 6 and 12 months

Number of discontinued medications, changed or changing doses.

Time frame: baseline, 3, 6 and 12 months

Secondary Outcomes

Resumption of medication

Time frame: 3, 6 and 12 months

Medication adherence

Morisky-Green questionnaire

Time frame: baseline, 3 and 6 months

Quality of life

EuroQoL questionnaire

Time frame: baseline, 3 and 6 months

Pharmaceutical recommendations acceptance rate

Time frame: 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.

Time frame: 3, 6 and 12 months

Mortality

Time frame: 3, 6 and 12 months