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OpenTrials
Completed

NCT Number: NCT02275572

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

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.

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Key information

Conditions

Polypharmacy Elderly

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacist Intervention

Procedure

Primary outcomes

  1. Number of patients with medications discontinued, reduced dose or changed.

    Time frame: baseline, 3, 6 and 12 months

  2. Number of discontinued medications, changed or changing doses.

    Time frame: baseline, 3, 6 and 12 months

Secondary outcomes

  1. Resumption of medication

    Time frame: 3, 6 and 12 months

  2. Medication adherence

    Time frame: baseline, 3 and 6 months

    Morisky-Green questionnaire

  3. Quality of life

    Time frame: baseline, 3 and 6 months

    EuroQoL questionnaire

  4. Pharmaceutical recommendations acceptance rate

    Time frame: baseline

  5. 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.

  6. Mortality

    Time frame: 3, 6 and 12 months

Sponsors and collaborators

Lead sponsor

Consorci Sanitari del Maresme

Other

Registry information

Acronym: REMEI

Important dates

Study start
2012
Primary completion
2012
First posted
Oct 27, 2014
Registry last updated
Oct 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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