Accidental Fall, Aging
Conditions
Brief summary
The overall objective of STOP-FALLS is to test whether a patient-centered deprescribing intervention that focuses on CNS-active medications reduces medically treated falls among older adults. The aims are: AIM 1: Adapt and pilot-test an evidence-based medication reduction intervention for use in an integrated health care system. AIM 2: Implement and evaluate the adapted intervention using a cluster-randomized controlled trial design. Aim 3: Assess barriers and facilitators to intervention implementation.
Detailed description
Background: Central nervous system (CNS) active medications have been consistently linked to falls in older people. However, few randomized trials have evaluated whether CNS-active medication reduction reduces falls and fall-related injuries. The objective of the Reducing CNS-active Medications to Prevent Falls and Injuries in Older Adults (STOP-FALLS) trial is to test the effectiveness of a health-system-embedded deprescribing intervention focused on CNS-active medications on the incidence of medically treated falls among community-dwelling older adults. This is a pragmatic, cluster-randomized, parallel-group, controlled clinical trial within Kaiser Permanente Washington to test the effectiveness of a 12-month deprescribing intervention consisting of: 1) an educational brochure and self-care handouts mailed to older adults prescribed one or more CNS-active medications (aged 60+: opioids, benzodiazepines and Z-drugs; aged 65+: skeletal muscle relaxants, tricyclic antidepressants, and antihistamines) and 2) decision support for their primary health care providers. Outcomes are examined over 18-26 months post-intervention. The primary outcome is first incident (post-baseline) medically treated fall as determined from health plan data. Sample size calculations ensured at least 80% power to detect a 20% reduction in the rate of medically treated falls for participants receiving care within the intervention (n=9) versus usual care clinics (n=9) assuming 18 months of follow-up. Secondary outcomes include medication discontinuation or dose reduction of any target medications. Safety outcomes include serious adverse drug withdrawal events, unintentional overdose, and death. The study team will also examine medication signetur fields for attempts to decrease medications. The study team will report factors affecting implementation of the intervention.
Interventions
BEHAVIORALSTOP 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.
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* For opioid and sedative-hypnotic medications, eligible participants are aged 60 years or older, while for skeletal muscle relaxants, tricyclic antidepressants, and first-generation antihistamines, eligible participants are aged 65 years or older. Eligible participants must be long-term users of the target medication, defined as pharmacy dispensing of at least one of the target medication classes for at least 70 of the prior 90 days. Further, eligible participants must either be assigned to a primary care provider (PCP) or have had 1+ visits in the prior year with a PCP at one of the 18 Kaiser Permanente Washington clinics participating in the study.
Exclusion criteria
1. diagnosis of dementia or a prescription for a medication used to treat dementia (i.e., a cholinesterase inhibitor or memantine); 2. residence in a skilled nursing facility; 3. metastatic cancer diagnosis in the prior 12 months; 4. receiving hospice or palliative care; 5. legally blind (unable to read print materials); 6. indication the participant requires a translator (cannot read materials printed in English); g) enrolled in other KPWA opioid deprescribing research studies; h) enrolled in a KPWA pharmacy-driven initiative to reduce opioid doses; or i) diagnosed with opioid use disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medically Treated Falls | up to 26 months following intervention | Falls for which medical attention is sought |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Discontinuation | 6 months following intervention | Target medication has not been prescribed for 90 days 6 months post intervention |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1,106 |
| Usual Care Usual care
Those receiving usual care and no intervention | 1,261 |
| Total | 2,367 |
Baseline characteristics
| Characteristic | Intervention | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 861 Participants | 979 Participants | 1840 Participants |
| Age, Categorical Between 18 and 65 years | 245 Participants | 282 Participants | 527 Participants |
| Age, Continuous | 70.3 years STANDARD_DEVIATION 7.4 | 70.9 years STANDARD_DEVIATION 7.7 | 70.6 years STANDARD_DEVIATION 7.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 38 Participants | 40 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1068 Participants | 1221 Participants | 2289 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 18 Participants | 11 Participants | 29 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 21 Participants | 37 Participants |
| Race (NIH/OMB) Black or African American | 38 Participants | 30 Participants | 68 Participants |
| Race (NIH/OMB) More than one race | 24 Participants | 32 Participants | 56 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 8 Participants | 4 Participants | 12 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 45 Participants | 64 Participants | 109 Participants |
| Race (NIH/OMB) White | 957 Participants | 1099 Participants | 2056 Participants |
| Sex: Female, Male Female | 704 Participants | 784 Participants | 1488 Participants |
| Sex: Female, Male Male | 402 Participants | 477 Participants | 879 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 86 / 1,106 | 72 / 1,261 |
| other Total, other adverse events | 0 / 1,106 | 0 / 1,261 |
| serious Total, serious adverse events | 10 / 1,106 | 4 / 1,261 |
Outcome results
Primary
Medically Treated Falls
Falls for which medical attention is sought
Time frame: up to 26 months following intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Medically Treated Falls | 328 Participants |
| Usual Care | Medically Treated Falls | 349 Participants |
p-value: 0.1195% CI: [0.944, 1.306]Log Rank
Secondary
Medication Discontinuation
Target medication has not been prescribed for 90 days 6 months post intervention
Time frame: 6 months following intervention
Population: Number of participants who were not prescribed the target medication of interest 90 days post intervention
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Medication Discontinuation | Muscle Relaxants | 34 Participants |
| Intervention | Medication Discontinuation | Antihistamines (rx) | 5 Participants |
| Intervention | Medication Discontinuation | Opioids | 32 Participants |
| Intervention | Medication Discontinuation | Benzodiazepines | 55 Participants |
| Intervention | Medication Discontinuation | Tricyclic Antidepressants | 34 Participants |
| Usual Care | Medication Discontinuation | Tricyclic Antidepressants | 23 Participants |
| Usual Care | Medication Discontinuation | Benzodiazepines | 49 Participants |
| Usual Care | Medication Discontinuation | Antihistamines (rx) | 0 Participants |
| Usual Care | Medication Discontinuation | Muscle Relaxants | 40 Participants |
| Usual Care | Medication Discontinuation | Opioids | 40 Participants |
p-value: 0.18395% CI: [0.9, 1.7]Regression, modified Poisson