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| ID | Type | Description | Link |
|---|---|---|---|
| 3U54AG063546 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational Intervention | Experimental | Educational Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STOP Falls D Educational Intervention | Behavioral | This is one-arm, health-system embedded pragmatic pilot trial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dementia With Medically Treated Falls | Number of older adult participants with dementia with a fall-related healthcare visit | Through study completion, up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion, up to 6 months |
| Number of Participants With Dementia With Skilled Nursing Facility Placement |
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Older Adult Sample
Inclusion Criteria:
Exclusion Criteria:
Care Partner Sample
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Phelan, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Health Research Institute | Seattle | Washington | 98101 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Educational Intervention | Educational Intervention STOP Falls D Educational Intervention: This is one-arm, health-system embedded pragmatic pilot trial |
| FG001 | Care Partners | Persons who help care for the older person with dementia |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Educational Intervention Group | Educational Intervention STOP Falls D Educational Intervention: This is one-arm, health-system embedded pragmatic pilot trial |
| BG001 | Care Partners |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dementia With Medically Treated Falls | Number of older adult participants with dementia with a fall-related healthcare visit | Posted | Count of Participants | Participants | Through study completion, up to 6 months |
|
|
6 months after initial mailing date
Adverse events data were collected only for the older adults with dementia.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Educational Intervention | Educational Intervention STOP Falls D Educational Intervention: This is one-arm, health-system embedded pragmatic pilot trial |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elizabeth Phelan | University of Washington | (206) 520-5000 | phelane@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 17, 2022 | Feb 16, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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Number of older adult participants with dementia admitted to a skilled nursing facility |
| Through study completion, up to 6 months |
Care partners of older people with dementia
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Exact age was not collected for care partners. Age categories were collected. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | 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 | Posted | Count of Participants | Participants | Through study completion, up to 6 months |
|
|
|
| Secondary | Number of Participants With Dementia With Skilled Nursing Facility Placement | Number of older adult participants with dementia admitted to a skilled nursing facility | Posted | Count of Participants | Participants | Through study completion, up to 6 months |
|
|
|
| 6 |
| 114 |
| 0 |
| 114 |
| 0 |
| 114 |
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| D001523 | Mental Disorders |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|