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

Primary Purpose

Adverse Drug Effects

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
STOPP/START screening tools for medication intervention
Sponsored by
Wolfson Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Adverse Drug Effects focused on measuring STOPP screening tool, START screening tool, MIP-medication inappropriate prescription, PIM-Potentially inappropriate medication

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Givaat Hashlosha Geriatric Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Controll

Intervention screening medication group

Arm Description

The medications in this arm will not be screened.

STOPP/START screening tools are used for medication intervention

Outcomes

Primary Outcome Measures

Quality of Life- Mental Component Summaty (MCS)
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)
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
Average number of falls per year.
Hospitalizations
The average number of hospitalizations per year.
Functional Independence Measure (FIM)
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
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.

Full Information

First Posted
May 1, 2012
Last Updated
March 23, 2014
Sponsor
Wolfson Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01602744
Brief Title
The Use of STOPP/START Criteria for Medication Intervention Among Elderly Population Living in a Geriatric Hospital
Acronym
STOPP
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wolfson Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Drug Effects
Keywords
STOPP screening tool, START screening tool, MIP-medication inappropriate prescription, PIM-Potentially inappropriate medication

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
382 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Controll
Arm Type
No Intervention
Arm Description
The medications in this arm will not be screened.
Arm Title
Intervention screening medication group
Arm Type
Active Comparator
Arm Description
STOPP/START screening tools are used for medication intervention
Intervention Type
Other
Intervention Name(s)
STOPP/START screening tools for medication intervention
Other Intervention Name(s)
STOPP Criteria, START Criteria, medication intervention
Intervention Description
In the intervention arm the investigator will use the screening tools STOPP/START to screen the medications.
Primary Outcome Measure Information:
Title
Quality of Life- Mental Component Summaty (MCS)
Description
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.
Time Frame
Outcome measures were assessed at the end of the 12 month follow up
Title
SF-12 Health Survey questionnaire-the Physical Component Summary (PCS)
Description
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.
Time Frame
Outcome measures were assessed at the end of the 12 month follow up
Title
Falls
Description
Average number of falls per year.
Time Frame
At the end of the 12 month follow up
Title
Hospitalizations
Description
The average number of hospitalizations per year.
Time Frame
Outcome measures were assessed at the end of the 12 month follow up
Title
Functional Independence Measure (FIM)
Description
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.
Time Frame
Outcome measures were assessed at the end of the 12 month follow up
Secondary Outcome Measure Information:
Title
Pharmacoeconomics Analysis-Costs of Medication
Description
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.
Time Frame
Outcome measures were assessed at the end of the 12 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariella Herskowits, MBA
Organizational Affiliation
Wolfson Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Givaat Hashlosha Geriatric Hospital
City
Petach Tikva
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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