Medication Reviews in Elderly in Primary Care

July 31, 2019 updated by: Region Skane

The Impact of Medication Reviews Conducted in Primary Care on Hospital Admissions and Mortality - a Randomized Controlled Trial

The study is a follow-up of a randomized controlled study performed in 2011-2012 with medication reviews in elderly patients in Sweden. Additional data about mortality and hospital admissions have been collected.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background Drug-related problems among the elderly population are common and increasing. Multi-professional medication reviews (MR) have arisen as a method to optimize drug therapy for frail elderly patients. Research has not yet been able to show conclusive evidence of the effect of MRs on mortality or hospital admissions. Aim The aim of this study was to assess the impact of MRs' on hospital admissions and mortality after six and 12 months in a frail population of 369 patients in primary care in a randomized controlled study. Methods Patients were blindly randomized to an intervention group (receiving MRs) and a control group (receiving usual care). Descriptive data on mortality and hospital admissions at six and 12 months were collected. Survival analysis was performed for time to death and time to the first hospital admission within 12 months.

Study Type

Interventional

Enrollment (Actual)

369

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

75 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age>75 years, living in nursing homes or community-dwelling with municipality-provided care, with multi-dose drug dispensing

Exclusion Criteria:

  • lack of multi-dose drug dispensing, living at home with no municipality-provided care, <75 years old

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
Patients in the intervention groups received multi-professional medication reviews. A nurse performed a symptom evaluation, a pharmacist assessed the drug list and made adjustment suggestions and finally a physician took action and performed medication changes.
Other: Medication review
Multi-professional medication review
NO_INTERVENTION: Control
Patients were treated according to the usual routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hospital admission
Time Frame: six months
time to the first hospital admission
six months
hospital admission
Time Frame: twelve months
time to the first hospital admission
twelve months
Survival analysis
Time Frame: six months
time to death
six months
Survival analysis
Time Frame: twelve months
time to death
twelve months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of hospital admissions
Time Frame: six months
number of hospital admissions
six months
number of hospital admissions
Time Frame: twelve months
number of hospital admissions
twelve months
mortality
Time Frame: six months
number of deaths
six months
mortality
Time Frame: twelve months
number of deaths
twelve months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of drugs
Time Frame: base-line
number of drugs
base-line

Collaborators and Investigators

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

Sponsor

Region Skane

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 (ACTUAL)

September 1, 2011

Primary Completion (ACTUAL)

December 31, 2018

Study Completion (ACTUAL)

March 31, 2019

Study Registration Dates

First Submitted

July 29, 2019

First Submitted That Met QC Criteria

July 31, 2019

First Posted (ACTUAL)

August 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 1, 2019

Last Update Submitted That Met QC Criteria

July 31, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018/8

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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