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

NCT02275572 | Completed

• 1 other identifier: 05/12
• Study Type: interventional
• Target: 503
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Resumption of medication

  3, 6 and 12 months

• Medication adherence

  baseline, 3 and 6 months

• Quality of life

  baseline, 3 and 6 months

• Pharmaceutical recommendations acceptance rate

  baseline

• Healthcare resource consumption

  3, 6 and 12 months

Study Arms (2)

Pharmacist Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Usual procedure.

Interventions

Pharmacist Intervention PROCEDURE

Pharmacist Intervention

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Consorci Sanitari del Maresme: lead

Related Publications (1)

• 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.

  PMID: 27605543 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: October 27, 2014
• Study Start: March 1, 2012
• Primary Completion: May 1, 2012
• Last Updated: October 27, 2014

Record last verified: 2014-10