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

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: Adverse Drug Effects
• Intervention / Treatment: Other: STOPP/START screening tools for 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.

• Study Type: Interventional
• Enrollment (Actual): 382
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	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)	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	Average number of falls per year.	At the end of the 12 month follow up
Hospitalizations	The average number of hospitalizations per year.	Outcome measures were assessed at the end of the 12 month follow up
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.	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	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

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

Study record dates

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: STOPP screening tool; START screening tool; MIP-medication inappropriate prescription; PIM-Potentially inappropriate medication
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: 0036-12 WOMC