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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01602744
First Posted: May 21, 2012
Last Update Posted: April 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wolfson Medical Center
  Purpose
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.

Condition Intervention
Adverse Drug Effects Other: STOPP/START screening tools for medication intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official 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

Resource links provided by NLM:


Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • 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.

  • 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.

  • Falls [ Time Frame: At the end of the 12 month follow up ]
    Average number of falls per year.

  • Hospitalizations [ Time Frame: Outcome measures were assessed at the end of the 12 month follow up ]
    The average number of hospitalizations per year.

  • 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 Outcome Measures:
  • 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.


Enrollment: 382
Study Start Date: April 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602744


Locations
Israel
Givaat Hashlosha Geriatric Hospital
Petach Tikva, Israel
Sponsors and Collaborators
Wolfson Medical Center
Investigators
Principal Investigator: Ariella Herskowits, MBA Wolfson Medical Center
  More Information

Responsible Party: Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01602744     History of Changes
Other Study ID Numbers: 0036-12 WOMC
First Submitted: May 1, 2012
First Posted: May 21, 2012
Results First Submitted: November 24, 2013
Results First Posted: March 12, 2014
Last Update Posted: April 16, 2014
Last Verified: March 2014

Keywords provided by Wolfson Medical Center:
STOPP screening tool
START screening tool
MIP-medication inappropriate prescription
PIM-Potentially inappropriate medication

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders


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