Trial Outcomes & Findings for The Use of STOPP/START Criteria for Medication Intervention Among Elderly Population Living in a Geriatric Hospital (NCT NCT01602744)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

382 participants

Primary outcome timeframe

Outcome measures were assessed at the end of the 12 month follow up

Results posted on

2014-04-16

Participant Flow

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).

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.

Participant milestones

Participant milestones
Measure	Controll The medications in this arm will not be screened.	Intervention STOPP/START Screening medications with STOPP/START critera
Overall Study STARTED	176	183
Overall Study COMPLETED	146	160
Overall Study NOT COMPLETED	30	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Controll The medications in this arm will not be screened.	Intervention STOPP/START Screening medications with STOPP/START critera
Overall Study Death	17	15
Overall Study Lost to Follow-up	13	8

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Controll n=176 Participants The medications in this arm will not be screened.	Intervention STOPP/START n=183 Participants Screening medications with STOPP/START critera	Total n=359 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	176 Participants n=5 Participants	183 Participants n=7 Participants	359 Participants n=5 Participants
Age, Continuous	82.2 years STANDARD_DEVIATION 9.4 • n=5 Participants	83.1 years STANDARD_DEVIATION 7.99 • n=7 Participants	82.7 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	110 Participants n=5 Participants	129 Participants n=7 Participants	239 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants	54 Participants n=7 Participants	120 Participants n=5 Participants
Region of Enrollment Israel	176 participants n=5 Participants	183 participants n=7 Participants	359 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Controll n=146 Participants The medications in this arm will not be screened.	Intervention STOPP/START n=160 Participants Screening medications with STOPP/START critera
Quality of Life- Mental Component Summaty (MCS)	39.6 units on a scale Standard Deviation 11.3	37.7 units on a scale Standard Deviation 11.69

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Controll n=146 Participants The medications in this arm will not be screened.	Intervention STOPP/START n=160 Participants Screening medications with STOPP/START critera
SF-12 Health Survey questionnaire-the Physical Component Summary (PCS)	33 units on a scale Standard Deviation 8.3	33.1 units on a scale Standard Deviation 8.1

PRIMARY outcome

Timeframe: At the end of the 12 month follow up

Average number of falls per year.

Outcome measures

Outcome measures
Measure	Controll n=146 Participants The medications in this arm will not be screened.	Intervention STOPP/START n=160 Participants Screening medications with STOPP/START critera
Falls	1.26 Number of falls per year Standard Deviation 2.4	0.8 Number of falls per year Standard Deviation 1.34

PRIMARY outcome

Timeframe: Outcome measures were assessed at the end of the 12 month follow up

The average number of hospitalizations per year.

Outcome measures

Outcome measures
Measure	Controll n=146 Participants The medications in this arm will not be screened.	Intervention STOPP/START n=160 Participants Screening medications with STOPP/START critera
Hospitalizations	0.47 Number of hospitalizations per year Standard Deviation 0.87	0.49 Number of hospitalizations per year Standard Deviation 1.05

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Controll n=146 Participants The medications in this arm will not be screened.	Intervention STOPP/START n=160 Participants Screening medications with STOPP/START critera
Functional Independence Measure (FIM)	55.4 units on a scale Standard Deviation 36.8	54.3 units on a scale Standard Deviation 35.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Controll n=146 Participants The medications in this arm will not be screened.	Intervention STOPP/START n=160 Participants Screening medications with STOPP/START critera
Pharmacoeconomics Analysis-Costs of Medication	402.3 New Israeli shekels per month Standard Deviation 291.2	279 New Israeli shekels per month Standard Deviation 171.9

Adverse Events

Controll

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention STOPP/START

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dvora Frankenthal

Tel Aviv University

Phone: 0097235326835

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place