Alzheimer Disease (AD), Dementia, Mild Cognitive Impairment (MCI)
Conditions
Brief summary
This clinical trial will evaluate a multi-level scalable intervention called Improving Dementia Care (IDC). The investigators hypothesize that IDC will increase dementia detection in patients with impaired cognition more than the control condition, Enhanced Usual Care (EUC), over 6 months.
Detailed description
This pilot RCT (N = 80) will evaluate the feasibility and effectiveness of a new multi-level intervention-Improving Dementia Care (IDC)-which aims to increase detection of Alzheimer disease (AD) in older primary care patients with impaired cognition. In IDC, investigators will screen older primary care patients for subjective cognitive concerns and objective cognitive impairment on the Telephone Interview for Cognitive Status (TICS). To eligible patients, the research team will deliver AD Education and Personalized Decision Counseling-eliciting values and goals to reach informed, preference-based decisions on whether to have an AD evaluation. In IDC, investigators will also send to primary care physicians (PCPs) the TICS results and a smart order set (i.e., orders for AD-relevant lab and neuroimaging) via the electronic health record (EHR). The research team posits that IDC-a patient-level and PCP-level intervention-will increase AD detection more than Enhanced Usual Care (EUC), which is usual care enhanced with sending the TICS results and smart order set to the PCPs of controls-solely a PCP-level intervention. At 6 months, investigators will compare IDC's vs. EUC's effectiveness to increase rates of: 1) Incident cognitive diagnoses (e.g., Mild Cognitive Impairment, AD); 2) Orders for AD-relevant lab and neuroimaging studies, 3) Completed AD-relevant lab and neuroimaging studies; 4) Prescribed AD medications; and 5) Referrals to AD specialists, masked to treatment assignment.
Interventions
OTHERImproving Dementia Care
During a phone session, participants receive ADRD Education and Personalized Decision Counseling, which consists of eliciting values and goals to reach informed, preference-based decisions on whether to have an ADRD evaluation. Participants' primary care physicians are sent cognitive screening results and a smart order set (i.e., orders for ADRD-relevant lab and neuroimaging) via the electronic health record (EHR).
OTHEREnhanced Usual Care
Usual care enhanced with notices sent to participants' primary care physicians with cognitive screening results and a smart order set (i.e., orders for ADRD-relevant lab and neuroimaging) via the electronic health record (EHR).
Sponsors
Thomas Jefferson University
Independence Blue Cross
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Participants will be randomly assigned to treatment group in a 1:1 allocation ratio. The research team anticipates randomizing 40 participants to each treatment group (i.e., IDC and EUC). After randomization, the research team will send participants' PCPs cognitive screen results and a smart order set for Alzheimer's Disease and Related Dementias (ADRD)-relevant lab tests and neuroimaging that meets current clinical practice guidelines. This information will be sent to PCPs regardless of treatment group assignment.
Eligibility
Sex/Gender
ALL
Age
66 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* No previous diagnosis of mild cognitive impairment (MCI) or Alzheimer's disease (AD). * Have a scheduled PCP visit in the next 4-6 weeks * Have subjective cognitive impairment * Score ≥ 26 on the Telephone Interview for Cognitive Status (TICS)
Exclusion criteria
* EHR evidence or previous cognitive evaluations, diagnosis of MCI or AD, or use of AD medications * TICS score of ≤ 11.00 * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incident cognitive diagnoses. | 6 months | Chart reviews will identify the number of patients with a new cognitive diagnosis in each arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Orders for Alzheimer's disease-relevant lab and neuroimaging | 6 months | Chart reviews will identify the number of patients with a new relevant lab and imaging tests. |
| Prescribed Alzheimer's disease (AD) medications. | 6 months | Chart reviews will identify the number of patients with a new AD medications. |
| Referrals to Alzheimer's disease specialists | 6 months | Chart reviews will identify the number of patients with relevant referrals. |
| Completed AD-relevant lab and neuroimaging studies | 6 months | Chart reviews will identify the number of patients with completed orders. |
Contacts
CONTACTNina Diamond, MPH
PRINCIPAL_INVESTIGATORBarry Rovner, MD
Thomas Jefferson University
Outcome results
None listed