Clinical trial NCT02275572: Clinical and Economical Assessment of an Intervention to Reduce Potentially Inappropriate Medication in Polymedicated Elderly Patients
Official title: Clinical and Economical Assessment of an Intervention to Reduce Potentially Inappropriate Medication in Polymedicated Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polypharmacy
Elderly
Lead sponsor: Consorci Sanitari del Maresme
Sponsor class: OTHER
First posted: 2014-10-27
Enrollment: 503
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Number of patients with medications discontinued, reduced dose or changed.
timeFrame: baseline, 3, 6 and 12 months
measure: Number of discontinued medications, changed or changing doses.
timeFrame: baseline, 3, 6 and 12 months
Secondary outcomes:
measure: Resumption of medication
timeFrame: 3, 6 and 12 months
measure: Medication adherence
timeFrame: baseline, 3 and 6 months
measure: Quality of life
timeFrame: baseline, 3 and 6 months
measure: Pharmaceutical recommendations acceptance rate
timeFrame: baseline
measure: Healthcare resource consumption
timeFrame: 3, 6 and 12 months
measure: Mortality
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.