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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01602744
First received: May 1, 2012
Last updated: March 23, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Average number of falls per year.

  • Hospitalizations [ Time Frame: Outcome measures were assessed at the end of the 12 month follow up ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01602744     History of Changes
Other Study ID Numbers: 0036-12 WOMC
Study First Received: May 1, 2012
Results First Received: November 24, 2013
Last Updated: March 23, 2014
Health Authority: Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on November 25, 2014