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

October 23, 2014 updated by: Consorci Sanitari del Maresme

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

503

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pharmacist Intervention
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
NO_INTERVENTION: Control
Usual procedure.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resumption of medication
Time Frame: 3, 6 and 12 months
3, 6 and 12 months
Medication adherence
Time Frame: baseline, 3 and 6 months
Morisky-Green questionnaire
baseline, 3 and 6 months
Quality of life
Time Frame: baseline, 3 and 6 months
EuroQoL questionnaire
baseline, 3 and 6 months
Pharmaceutical recommendations acceptance rate
Time Frame: baseline
baseline
Healthcare resource consumption
Time Frame: 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.
3, 6 and 12 months
Mortality
Time Frame: 3, 6 and 12 months
3, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorci Sanitari del Maresme

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

October 21, 2014

First Submitted That Met QC Criteria

October 23, 2014

First Posted (ESTIMATE)

October 27, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 27, 2014

Last Update Submitted That Met QC Criteria

October 23, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 05/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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