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

Not Applicable

Completed

• Conditions: Elderly; Polypharmacy

• Registration Number: NCT02275572
• Lead Sponsor: Consorci Sanitari del Maresme

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-05
• Status Verified: 2014-10
• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-10-23
• Last Update Submitted: 2014-10-23
• Study First Posted: 2014-10-27
• Last Update Posted: 2014-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 503

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

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