Preventing and Managing Cognitive Impairment

NCT ID: NCT05471141

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-13
• Study Completion Date: 2024-02-28

Brief Summary

This randomized controlled trial (RCT) is used to address the knowledge translation of primary care practitioners (PCPs) for the early identification of cognitive impairment. Cognitive impairment is experienced by people with many different underlying health problems, e.g., diabetes, cardiovascular problems, COVID-19, neurodegenerative diseases, and mental health problems. Older adults are more likely to have cognitive decline which may develop into Alzheimer's disease or dementia but 40% of dementia can be prevented by managing the risks. Cognitive impairment can demand vast societal resources, the burden is reported to be more among Hispanics and blacks. By 2029, all baby boomers will be over 65, comprising at least 20% of the U.S. population. So, it is critical for PCPs to effectively identify, prevent, and manage the hidden signs of cognitive impairment. People with early signs of cognitive impairment will have opportunities to benefit from suitable cognitive remediation to reverse it or prevent rapid progression. It is critically important for people who are socioeconomically disadvantaged, those who are black, indigenous, and people of color (BIPoC). These people are often served by safety-net hospitals, such as clinics of the Los Angeles County (LAC) Department of Health Services and the federally qualified health centers at the Community Clinics Association of LAC. Many PCPs in these clinics are often BIPoC. The intervention used in this RCT is called "Cognition ECHO" based on the proven model of ECHO (Extension of Healthcare Outcomes) for knowledge dissemination and translation. Cognition ECHO is a virtual activity incorporating a short didactic presentation and de-identified case discussion to solve real-world patient care challenges and ease direct knowledge translation. PCPs in the LAC will be randomized into Groups 1 and 2. Group 1 will attend the five Cognition ECHO for four months, Group 2 will be the control. Group 2 will attend Cognition ECHO starting on July 25, 2023, five times till November 7, 2023, when Group 1 is the follow-up. Most sessions are scheduled on the fourth Tuesday of the month with the addition of June 6 and November 7, 2023. Focusing on cognitive impairment and targeting PCPs at the LAC, the goal of this study is to evaluate if Cognition ECHO can improve PCPs' capacity to detect early cognitive impairment and manage it. It will result in opportunities to mitigate the risk factors of early cognitive impairment, especially for minority patients in LAC, and conduct efficacy studies in the future to address cognitive impairment focusing on BIPoC.

Conditions

Knowledge Translation; Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Group 1

To receive intervention during the phase 1 and will receive nothing during the phase 2, will complete the measure at the end of phase 2 as the follow-up

Group Type: EXPERIMENTAL

Cognition ECHO

Intervention Type: OTHER

Cognition ECHO is the intervention designed to be used by the study participants who are primary care practitioners. No involvement of patients in this study. The panel will consist of the CI and Co-PIs of this study, a neurologist as a co-moderator, a medical specialist who is the expert on the subject, an occupational therapist, a psychologist, and a speech and language pathologist with experience and expertise in CI. A patient with CI and a caregiver, family member, or community representative who is not a healthcare professional will join the panel because CI is frequently observed with lived experience of family members and loved ones, as two non-clinician panelists. The five topics with the integration of related diagnoses for Cognition ECHO are listed in Table 4. The time allocated for the didactic will be 15-20 minutes and the de-identified case discussion will be 40 - 45 minutes.

Group 2

To serve as the control during phase 1 and receive intervention during the phase 2

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognition ECHO

Cognition ECHO is the intervention designed to be used by the study participants who are primary care practitioners. No involvement of patients in this study. The panel will consist of the CI and Co-PIs of this study, a neurologist as a co-moderator, a medical specialist who is the expert on the subject, an occupational therapist, a psychologist, and a speech and language pathologist with experience and expertise in CI. A patient with CI and a caregiver, family member, or community representative who is not a healthcare professional will join the panel because CI is frequently observed with lived experience of family members and loved ones, as two non-clinician panelists. The five topics with the integration of related diagnoses for Cognition ECHO are listed in Table 4. The time allocated for the didactic will be 15-20 minutes and the de-identified case discussion will be 40 - 45 minutes.

Intervention Type: OTHER

Other Intervention Names

Tele-mentoring with (1) a didactic presentation and (2) de-identified discussion by a panel with experts, a patient, and a family member.

Eligibility Criteria

Inclusion Criteria

1. Primary care practitioner (i.e. physician, NP or PA) at least 21-year-old.

2. Spending at least 40% of the work hours in patient care with adult patients currently.

3. Self-identifying being comfortable to attend virtual learning sessions using their own smartphones, laptops/desktop computers, or mobile devices in their work setting.

4. Willingness to send in a total of four electronic copies (in WORD) of de-identified clinic notes written documenting the initial encounters of patients with poorly controlled type 2 diabetes (A1c >= 8%) or any patients with early signs of neurodegenerative diseases, Alzheimer's diseases or other conditions that may affect the cognition.

Exclusion Criteria

• Do not work at least 40% of the week for care provision in primary care
• Do not work in the outpatient clinics of the Los Angeles County (LAC) Department of Health Services (DHS) and member clinics of the Community Clinics of the Los Angeles County (CCALAC) with the federally qualified health centers (FQHCs).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charles Drew University of Medicine and Science

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shan-Pin C Fanchiang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Charles Drew University of Medicine and Science

Other Identifiers

1931012

Identifier Type: -

Identifier Source: org_study_id