Dementia
Conditions
Brief summary
STOP-FALLS-D is an educational intervention to inform and activate patients, their care partner(s), and their primary care providers to work together to reduce use of central nervous system (CNS) active medications and prevent adverse outcomes (falls and injuries) associated with their use.
Detailed description
The study design is a pragmatic, one-arm pilot trial to test the feasibility and acceptability of implementing a deprescribing intervention with older people with dementia and their care partners in primary care. The intervention consists of patient-facing educational brochures on CNS-active medications and decision support for the primary care provider. Ethnic/minority groups will be over-sampled to ensure a diverse study sample.
Interventions
BEHAVIORALSTOP Falls D Educational Intervention
This is one-arm, health-system embedded pragmatic pilot trial
Sponsors
National Institute on Aging (NIA)
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Older Adult Sample Inclusion Criteria: * Diagnosed dementia (dementia diagnosis code or prescription for dementia medication) * Receiving primary care at a Kaiser Permanente Washington integrated group practice outpatient clinic * Prescribed at least one CNS-active medication on a chronic (3 months or more) basis
Exclusion criteria
* Skilled nursing facility resident * Current cancer diagnosis * On hospice or palliative care Care Partner Sample Inclusion Criteria: * Aged 18 years or older * Self-identify as a care partner for the older adult with dementia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dementia With Medically Treated Falls | Through study completion, up to 6 months | Number of older adult participants with dementia with a fall-related healthcare visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dementia With All-cause Emergency Department Visits or Hospitalizations | Through study completion, up to 6 months | Number of older adult participants with dementia with an emergency department visit or hospitalization for any reason |
| Number of Participants With Dementia With Skilled Nursing Facility Placement | Through study completion, up to 6 months | Number of older adult participants with dementia admitted to a skilled nursing facility |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Educational Intervention Group Educational Intervention
STOP Falls D Educational Intervention: This is one-arm, health-system embedded pragmatic pilot trial | 114 |
| Care Partners Care partners of older people with dementia | 9 |
| Total | 123 |
Baseline characteristics
| Characteristic | Total | Educational Intervention Group | Care Partners |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 113 Participants | 107 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 7 Participants | 3 Participants |
| Age, Continuous | 79.9 years STANDARD_DEVIATION 9.1 | 79.9 years STANDARD_DEVIATION 9.1 | — |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 6 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) White | 108 Participants | 99 Participants | 9 Participants |
| Region of Enrollment United States | 123 Participants | 114 Participants | 9 Participants |
| Sex: Female, Male Female | 88 Participants | 82 Participants | 6 Participants |
| Sex: Female, Male Male | 35 Participants | 32 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 114 |
| other Total, other adverse events | 0 / 114 |
| serious Total, serious adverse events | 0 / 114 |
Outcome results
Primary
Number of Participants With Dementia With Medically Treated Falls
Number of older adult participants with dementia with a fall-related healthcare visit
Time frame: Through study completion, up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Educational Intervention | Number of Participants With Dementia With Medically Treated Falls | 24 Participants |
Secondary
Number of Participants With Dementia With All-cause Emergency Department Visits or Hospitalizations
Number of older adult participants with dementia with an emergency department visit or hospitalization for any reason
Time frame: Through study completion, up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Educational Intervention | Number of Participants With Dementia With All-cause Emergency Department Visits or Hospitalizations | 29 Participants |
Secondary
Number of Participants With Dementia With Skilled Nursing Facility Placement
Number of older adult participants with dementia admitted to a skilled nursing facility
Time frame: Through study completion, up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Educational Intervention | Number of Participants With Dementia With Skilled Nursing Facility Placement | 5 Participants |