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

NCT ID: NCT02275572

Last Updated: 2014-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 503 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31

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.

Conditions

Polypharmacy; Elderly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pharmacist Intervention

Intervention Type: PROCEDURE

Control

Usual procedure.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pharmacist Intervention

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consorci Sanitari del Maresme

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Campins L, Serra-Prat M, Gozalo I, Lopez D, Palomera E, Agusti C, Cabre M; REMEI Group. Randomized controlled trial of an intervention to improve drug appropriateness in community-dwelling polymedicated elderly people. Fam Pract. 2017 Feb;34(1):36-42. doi: 10.1093/fampra/cmw073. Epub 2016 Sep 7.

Reference Type: DERIVED

PMID: 27605543 (View on PubMed)

Other Identifiers

05/12

Identifier Type: -

Identifier Source: org_study_id