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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controll | No Intervention | The medications in this arm will not be screened. | |
| Intervention screening medication group | Active Comparator | STOPP/START screening tools are used for medication intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STOPP/START screening tools for medication intervention | Other | In the intervention arm the investigator will use the screening tools STOPP/START to screen the medications. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ariella Herskowits, MBA | Wolfson Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Givaat Hashlosha Geriatric Hospital | Petah Tikva | Israel |
23 residents were excluded: 10 were younger than 65 years of age, one was not taking medications, 5 had a terminal illness and 7 had been on a short stay in the facility.
Data were collected on April 2012 from 382 residents' records in "Givaat Hashlosha" geriatric facility.23 residents were excluded for not fulfilling study entry criteria. The final study group was comprised of 359 residents. 359 residents were randomized on May 2012 to recieve either STOPP/START screening (N=183) or usual care (n=176).
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| ID | Title | Description |
|---|---|---|
| FG000 | Controll | The medications in this arm will not be screened. |
| FG001 | Intervention STOPP/START | Screening medications with STOPP/START critera |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
All residents in the geriatric facility (382) were recruited for the trial. 23 were excluded for not fulfilling study entry criteria. The final study group was comprised of 359 residents. Residents were randomized to recieve either STOPP/START screening (intervention, n=183) or usual care (control, n=176).
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| ID | Title | Description |
|---|---|---|
| BG000 | Controll | The medications in this arm will not be screened. |
| BG001 | Intervention STOPP/START | Screening medications with STOPP/START critera |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Outcome measures were assessed at the end of the 12 month follow up |
|
One year of follow up.
A daily follow up of the chief physician un the geriatric facility.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Controll | The medications in this arm will not be screened. |
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The limitations of the study were that it was conducted in a single geriatric center. This precludes the possibility of generalizing its findings to other older segments of the community.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dvora Frankenthal | Tel Aviv University | 0097235326835 | shai_f@zahav.net.il |
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| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D000067561 | Potentially Inappropriate Medication List |
| ID | Term |
|---|---|
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| 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. | Posted | Mean | Standard Deviation | New Israeli shekels per month | Outcome measures were assessed at the end of the 12 month follow up |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Outcome measures were assessed at the end of the 12 month follow up |
|
|
|
| Primary | Falls | Average number of falls per year. | Posted | Mean | Standard Deviation | Number of falls per year | At the end of the 12 month follow up |
|
|
|
| Primary | Hospitalizations | The average number of hospitalizations per year. | Posted | Mean | Standard Deviation | Number of hospitalizations per year | Outcome measures were assessed at the end of the 12 month follow up |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Outcome measures were assessed at the end of the 12 month follow up |
|
|
|
| 0 |
| 176 |
| 0 |
| 176 |
| EG001 | Intervention STOPP/START | Screening medications with STOPP/START critera | 0 | 183 | 0 | 183 |
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