Adverse Drug Effects Clinical Trial
— STOPPOfficial 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
| Verified date | March 2014 |
| Source | Wolfson Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ethics Commission |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 382 |
| Est. completion date | September 2013 |
| Est. primary completion date | September 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 65 Years and older |
| Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening
| Country | Name | City | State |
|---|---|---|---|
| Israel | Givaat Hashlosha Geriatric Hospital | Petach Tikva |
| Lead Sponsor | Collaborator |
|---|---|
| Wolfson Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | Falls | Average number of falls per year. | At the end of the 12 month follow up | Yes |
| Primary | Hospitalizations | The average number of hospitalizations per year. | Outcome measures were assessed at the end of the 12 month follow up | Yes |
| Primary | 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 | No |
| Secondary | 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 | No |