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

Elderly Clinical Trial

— REMEI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02275572
• Other study ID #: 05/12
• Status: Completed
• Phase: N/A
• First received: October 21, 2014
• Last updated: October 23, 2014
• Start date: March 2012

Study information

• Verified date: October 2014
• Source: Consorci Sanitari del Maresme
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 503
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Elderly
• Polypharmacy

Intervention

Procedure:
• Pharmacist Intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari del Maresme

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with medications discontinued, reduced dose or changed.		baseline, 3, 6 and 12 months	No
Primary	Number of discontinued medications, changed or changing doses.		baseline, 3, 6 and 12 months	No
Secondary	Resumption of medication		3, 6 and 12 months	No
Secondary	Medication adherence	Morisky-Green questionnaire	baseline, 3 and 6 months	No
Secondary	Quality of life	EuroQoL questionnaire	baseline, 3 and 6 months	No
Secondary	Pharmaceutical recommendations acceptance rate		baseline	No
Secondary	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	Yes
Secondary	Mortality		3, 6 and 12 months	Yes