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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01602744

Acronym

STOPP

Enrollment

382

Registered

2012-05-21

Start date

2012-04-30

Completion date

2013-09-30

Last updated

2014-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Drug Effects

Keywords

STOPP screening tool, START screening tool, MIP-medication inappropriate prescription, PIM-Potentially inappropriate medication

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.

Interventions

OTHERSTOPP/START screening tools for medication intervention

In the intervention arm the investigator will use the screening tools STOPP/START to screen the medications.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
Quality of Life- Mental Component Summaty (MCS)	Outcome measures were assessed at the end of the 12 month follow up	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)	Outcome measures were assessed at the end of the 12 month follow up	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	At the end of the 12 month follow up	Average number of falls per year.
Hospitalizations	Outcome measures were assessed at the end of the 12 month follow up	The average number of hospitalizations per year.
Functional Independence Measure (FIM)	Outcome measures were assessed at the end of the 12 month follow up	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

Measure	Time frame	Description
Pharmacoeconomics Analysis-Costs of Medication	Outcome measures were assessed at the end of the 12 month follow up	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.

Countries

Israel

Participant flow

Recruitment details

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).

Pre-assignment details

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.

Participants by arm

Arm	Count
Controll The medications in this arm will not be screened.	176
Intervention STOPP/START Screening medications with STOPP/START critera	183
Total	359

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	17	15
Overall Study	Lost to Follow-up	13	8

Baseline characteristics

Characteristic	Intervention STOPP/START	Controll	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	183 Participants	176 Participants	359 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Age, Continuous	83.1 years STANDARD_DEVIATION 7.99	82.2 years STANDARD_DEVIATION 9.4	82.7 years STANDARD_DEVIATION 8.7
Region of Enrollment Israel	183 participants	176 participants	359 participants
Sex: Female, Male Female	129 Participants	110 Participants	239 Participants
Sex: Female, Male Male	54 Participants	66 Participants	120 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 176	0 / 183
serious Total, serious adverse events	0 / 176	0 / 183

Outcome results

Primary

Falls

Average number of falls per year.

Time frame: At the end of the 12 month follow up

Arm	Measure	Value (MEAN)	Dispersion
Controll	Falls	1.26 Number of falls per year	Standard Deviation 2.4
Intervention STOPP/START	Falls	0.8 Number of falls per year	Standard Deviation 1.34

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.