The Use of STOPP/START Criteria for Medication Intervention Among Elderly Population Living in a Geriatric Hospital (STOPP)

March 23, 2014 updated by: Wolfson Medical Center

The Use of STOPP/START Criteria for Medication Intervention and the Risk of Falls, Hospitalization, Functioning and Quality of Life Among Elderly Population Living in a Geriatric Hospital in Israel and Comparison to Beers

The purpose of this study is to determine if the use of STOPP/START criteria (STOPP-screening tool of older persons potentially inappropriate prescriptions START-screening tool to alert doctors to right treatment)for medication intervention in elderly population living in a geriatric hospital will lower the number of falls,hospitalization,will improve functioning, quality of life and reduce financial costs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Inappropriate prescribing is common in older people and is associated with adverse drug effects,hospitalization and falls. In this trial we want to check the efficacy of the screening tools STOPP/START which were developed and validated in order to reduce inappropriate prescribing. STOPP comprises of 65 indicators of drug-drug, drug-disease interactions and therapeutic duplication. START incorporates 22 evidence based indicators of common prescribing omissions. We will conduct a randomized controlled trial to test the hypothesis that screening the medications of older patients living permanently in a geriatric hospital will improve their quality of life. The compliance of the doctor working in the geriatric hospital to the recommendations of the screening tools will also be checked.

Study Type

Interventional

Enrollment (Actual)

382

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petach Tikva, Israel
        • Givaat Hashlosha Geriatric Hospital

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

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age over 65
  • live in the geriatric hospital "Givaat Hashlosha" permanently.

Exclusion Criteria:

  • people with a terminal illness that will not live more than a year.
  • people who enter the geriatric hospital for a short while (are not permanent).

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: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Controll
The medications in this arm will not be screened.
ACTIVE_COMPARATOR: Intervention screening medication group
STOPP/START screening tools are used for medication intervention
Other: STOPP/START screening tools for medication intervention
In the intervention arm the investigator will use the screening tools STOPP/START to screen the medications.
Other Names:
  • STOPP Criteria
  • START Criteria
  • medication intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life- Mental Component Summaty (MCS)
Time Frame: Outcome measures were assessed at the end of the 12 month follow up
Quality of life will be measured by MOS SF-12 Health Survey questionnare. Results are expressed in terms of two meta scores: The Physical Component Summary(PCS) and the Mental Component Summary (MCS). The PCS and MCS scores have a range of 0 to 100, thus scores greater than 50 represent a better than average health status.
Outcome measures were assessed at the end of the 12 month follow up
SF-12 Health Survey questionnaire-the Physical Component Summary (PCS)
Time Frame: Outcome measures were assessed at the end of the 12 month follow up
Quality of life was assessed by the SF-12 Health Survey questionnare. Results are expressed in terms of two meta scores:the Physical Component Summary (PCS) AND Mental Component Summary (MCS). The PCS and MCS scores have a range of 0 to 100, thus scores greater than 50 represent a better than average health status.
Outcome measures were assessed at the end of the 12 month follow up
Falls
Time Frame: At the end of the 12 month follow up
Average number of falls per year.
At the end of the 12 month follow up
Hospitalizations
Time Frame: Outcome measures were assessed at the end of the 12 month follow up
The average number of hospitalizations per year.
Outcome measures were assessed at the end of the 12 month follow up
Functional Independence Measure (FIM)
Time Frame: Outcome measures were assessed at the end of the 12 month follow up
Functioning was assessed by the FIM score. The FIM rates 18 activities of daily living on a 7 point scale ranging from fully dependent (=1) to independent (=7). A maximum score of 126 indicates functional independence and the lowest score of 18 indicates functional dependence.
Outcome measures were assessed at the end of the 12 month follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacoeconomics Analysis-Costs of Medication
Time Frame: Outcome measures were assessed at the end of the 12 month follow up
The costs on medications in the geriatric hospital before and after intervention e.g. pharmaeconomic analysis of the intervention. Costs of medications were calculated in New Israeli shekels per month and taken from the Ministry of Health's medication price list.
Outcome measures were assessed at the end of the 12 month follow up

Collaborators and Investigators

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

Sponsor

Wolfson Medical Center

Investigators

  • Principal Investigator: Ariella Herskowits, MBA, Wolfson Medical Center

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

April 1, 2012

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

May 1, 2012

First Submitted That Met QC Criteria

May 18, 2012

First Posted (ESTIMATE)

May 21, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 16, 2014

Last Update Submitted That Met QC Criteria

March 23, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0036-12 WOMC

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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