Trial Outcomes & Findings for Reducing CNS-Active Medications to Prevent Falls and Injuries in Older Adults (NCT NCT05689554)

NCT ID: NCT05689554

Last Updated: 2024-12-09

Results Overview

Falls for which medical attention is sought

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 2367 participants
• Primary outcome timeframe: up to 26 months following intervention
• Results posted on: 2024-12-09

Participant Flow

Unit of analysis: Clinic

Participant milestones

Measure	Intervention Educational intervention STOP Falls Educational Intervention: This is a pragmatic, cluster-randomized, parallel-group, controlled clinical trial. The unit of randomization is the clinic, to avoid the risk of contamination if healthcare providers within a clinic were randomized (i.e., reducing the potential for intervention providers to communicate with control providers about the intervention and share materials). Eighteen clinics were identified for the trial, of which 9 were randomized to the intervention and 9 to usual care.	Usual Care Usual care
Overall Study STARTED	1106 9	1261 9
Overall Study COMPLETED	1106 9	1261 9
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reducing CNS-Active Medications to Prevent Falls and Injuries in Older Adults

Baseline characteristics by cohort

Measure	Intervention n=1106 Participants Educational intervention STOP Falls Educational Intervention: This is a pragmatic, cluster-randomized, parallel-group, controlled clinical trial. The unit of randomization is the clinic, to avoid the risk of contamination if healthcare providers within a clinic were randomized (i.e., reducing the potential for intervention providers to communicate with control providers about the intervention and share materials). Eighteen clinics were identified for the trial, of which 9 were randomized to the intervention and 9 to usual care.	Usual Care n=1261 Participants Usual care Those receiving usual care and no intervention	Total n=2367 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	245 Participants n=5 Participants	282 Participants n=7 Participants	527 Participants n=5 Participants
Age, Categorical >=65 years	861 Participants n=5 Participants	979 Participants n=7 Participants	1840 Participants n=5 Participants
Age, Continuous	70.3 years STANDARD_DEVIATION 7.4 • n=5 Participants	70.9 years STANDARD_DEVIATION 7.7 • n=7 Participants	70.6 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	704 Participants n=5 Participants	784 Participants n=7 Participants	1488 Participants n=5 Participants
Sex: Female, Male Male	402 Participants n=5 Participants	477 Participants n=7 Participants	879 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	38 Participants n=5 Participants	40 Participants n=7 Participants	78 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1068 Participants n=5 Participants	1221 Participants n=7 Participants	2289 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	18 Participants n=5 Participants	11 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) Asian	16 Participants n=5 Participants	21 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Black or African American	38 Participants n=5 Participants	30 Participants n=7 Participants	68 Participants n=5 Participants
Race (NIH/OMB) White	957 Participants n=5 Participants	1099 Participants n=7 Participants	2056 Participants n=5 Participants
Race (NIH/OMB) More than one race	24 Participants n=5 Participants	32 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	45 Participants n=5 Participants	64 Participants n=7 Participants	109 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 26 months following intervention

Falls for which medical attention is sought

Outcome measures

Measure	Intervention n=1106 Participants Educational intervention STOP Falls Educational Intervention: This is a pragmatic, cluster-randomized, parallel-group, controlled clinical trial. The unit of randomization is the clinic, to avoid the risk of contamination if healthcare providers within a clinic were randomized (i.e., reducing the potential for intervention providers to communicate with control providers about the intervention and share materials). Eighteen clinics were identified for the trial, of which 9 were randomized to the intervention and 9 to usual care.	Usual Care n=1261 Participants Usual care Those receiving usual care and no intervention
Medically Treated Falls	328 Participants	349 Participants

SECONDARY outcome

Timeframe: 6 months following intervention

Population: Number of participants who were not prescribed the target medication of interest 90 days post intervention

Target medication has not been prescribed for 90 days 6 months post intervention

Outcome measures

Measure	Intervention n=1106 Participants Educational intervention STOP Falls Educational Intervention: This is a pragmatic, cluster-randomized, parallel-group, controlled clinical trial. The unit of randomization is the clinic, to avoid the risk of contamination if healthcare providers within a clinic were randomized (i.e., reducing the potential for intervention providers to communicate with control providers about the intervention and share materials). Eighteen clinics were identified for the trial, of which 9 were randomized to the intervention and 9 to usual care.	Usual Care n=1261 Participants Usual care Those receiving usual care and no intervention
Medication Discontinuation Muscle Relaxants	34 Participants	40 Participants
Medication Discontinuation Opioids	32 Participants	40 Participants
Medication Discontinuation Benzodiazepines	55 Participants	49 Participants
Medication Discontinuation Tricyclic Antidepressants	34 Participants	23 Participants
Medication Discontinuation Antihistamines (rx)	5 Participants	0 Participants

Adverse Events

Intervention

Serious events: 10 serious events

Other events: 0 other events

Deaths: 86 deaths

Usual Care

Serious events: 4 serious events

Other events: 0 other events

Deaths: 72 deaths

Serious adverse events

Measure	Intervention n=1106 participants at risk Educational intervention STOP Falls Educational Intervention: This is a pragmatic, cluster-randomized, parallel-group, controlled clinical trial. The unit of randomization is the clinic, to avoid the risk of contamination if healthcare providers within a clinic were randomized (i.e., reducing the potential for intervention providers to communicate with control providers about the intervention and share materials). Eighteen clinics were identified for the trial, of which 9 were randomized to the intervention and 9 to usual care.	Usual Care n=1261 participants at risk Usual care
General disorders Serious adverse drug withdrawal events involving opioids or sedative-hypnotics	0.90% 10/1106 • Number of events 10 • Events were collected 6 months after study enrollement	0.32% 4/1261 • Number of events 4 • Events were collected 6 months after study enrollement

Other adverse events

Adverse event data not reported

Additional Information

Dr. Elizabeth Phelan

University of Washington

Phone: (206) 744-9112

Email: phelane@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place