Alzheimer Disease, Dementia, Mild Cognitive Impairment
Conditions
Brief summary
The objectives of this study are to demonstrate the feasibility of implementing a deprescribing nudge intervention using pragmatic methods, confirm that outcomes can be feasibly measured and evaluated at scale in a subsequent embedded pragmatic clinical trial (ePCT), and explore representativeness of persons living with dementia and care partners identified.
Detailed description
The PCP nudge will consist of: a 'pre-commitment' EHR nudge triggered when a PCP opens a patient encounter (i.e., prompt to first have a discussion and then later deprescribe) and a brief message within the in-basket prior to upcoming visits including information about their patient. The patient living with dementia (PLWD)/care partner nudge will include an electronic message delivered prior to upcoming visits (in their primary language recorded in the EHR) that includes a recommendation for the PLWD (and care partner, if available) to discuss medications with the PCP at the visit.
Interventions
BEHAVIORALNudge Intervention
PCPs will receive an enhanced EHR alert (nudge) that triggers when a PCP opens an encounter for an eligible patient living with dementia (PLWD). The nudge will provide information about the risks of continued medication use as well as tips and tools to help providers discuss medication discontinuation with patients and care partners. Additionally, the providers will receive a brief message in their in-basket 10 days before the patient's appointment as a reminder. Eligible PLWD of a randomized PCP will receive the nudge intervention which includes a brief recommendation for the PLWD (and care partner, if available) via the linked patient portal prior to upcoming visits (unless explicitly opted out by the PCP) to discuss medications with the PCP at the visit and link to a general handout about medications, unless explicitly opted out by the PCP. For PLWD without a portal account, the handout will be sent to their mailing address recorded in the EHR.
Sponsors
Brigham and Women's Hospital
Brown University
National Institute on Aging (NIA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Primary care providers will be the primary unit of identification and randomization. Primary care providers inclusion criteria: * Providers within Brigham and Women's Hospital primary care practices * Having prescribed at least one of the high-risk medications of interest Eligible patients will be identified through this providers within the health care system. Patient inclusion criteria: * At least 65 years of age * Prescribed at least 90 pills of one of the high-risk medications of interest in the last 180 days in the EHR system, which most guidelines consider chronic use, and have a diagnosis of dementia in the EHR.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of the Percentage of Eligible PCPs or Their PLWD/Care Partners Who View or Click on Information on or Before the Primary Care Provider Visit, up to 10 Days | On or before the primary care provider visit, up to 10 days | This is the primary progression criteria for the study, measured on the patient level. This is measured as a composite of the number of eligible PCPs or their PLWD/care partners who view or click on information on or before the primary care provider visit, up to 10 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Nudges That Fire as Intended: Fidelity | On the primary care provider visit date | Number of patients who had provider EHR alerts that fired as intended, measured among patients who had a completed target visit (n=99) within EHR data. |
| Discontinuation or Prescribed Reduction in Medication | Within 60 days on or after the primary care provider visit | Discontinuation or prescribed reduction in dose of at least one high-risk medication of interest within 60 days after the visit using data from the EHR system, measured on the patient-level as the number of patients who have medications discontinued or have a prescribed reduction. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJulie Lauffenburger, PharmD, PhD
Brigham and Women's Hospital
Participant flow
Recruitment details
Providers, patients, and care partners were identified using existing EHR data at BWH.
Pre-assignment details
Of eligible PCPs, 120 were randomly selected to receive the intervention and were enrolled. From these PCPs, we identified 130 patients within the EHR who met eligibility criteria and were considered enrolled. Eligible patients were determined based on their age (≥65 years), use of an enrolled PCP, diagnosis of mild cognitive impairment or Alzheimer's Disease and related dementias, and use of a high-risk medication. 12 care partners of those patients were also identified, resulting in 262 total.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 76.6 years STANDARD_DEVIATION 8 |
| Baseline use of high-risk medication (number of pills) | 219.1 number of pills prescribed STANDARD_DEVIATION 210.5 |
| English language as primary language | 109 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 113 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants |
| Race (NIH/OMB) White | 90 Participants |
| Region of Enrollment United States | 130 participants |
| Sex: Female, Male Female | 105 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 9 / 130 |
| other Total, other adverse events | 0 / 130 |
| serious Total, serious adverse events | 59 / 130 |
Outcome results
None listed