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Completed

NCT Number: NCT01602744

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

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.

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Key information

Conditions

Adverse Drug Effects Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Givaat Hashlosha Geriatric Hospital

Petah Tikva, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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).

Treatment and study plan

STOPP/START screening tools for medication intervention

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. Falls

    Time frame: At the end of the 12 month follow up

    Average number of falls per year.

  4. Hospitalizations

    Time frame: Outcome measures were assessed at the end of the 12 month follow up

    The average number of hospitalizations per year.

  5. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Wolfson Medical Center

Other Gov

Registry information

Official study title

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

Acronym: STOPP

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 21, 2012
Registry last updated
Apr 16, 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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