Clinical trial NCT04418232: Feasibility of a Systems Approach for Alzheimer's Services Among Latinos Attending Primary Care Practices
Official title: Feasibility of a Novel Systems Approach for Improving Utilization of Alzheimer's Disease Services Among Latinos Attending Primary Care Practices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dementia
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2020-06-05
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The research team will train primary care practitioners from Kansas City clinics to enhance skills in cultural competence, dementia detection, treatment and referral to a Health Navigator among Latinos 65 and older with dementia. The Health Navigator will provide patient/caregiver dyads referred by Alianza Latina providers with care management, psychosocial support and links to relevant community resources. Outcomes include feasibility and acceptability of 1) PCP training and 2) patient and caregiver dementia care.

Detailed description: Alzheimer's disease and related dementias (ADRD) are a major cause of mortality and disability in later life and cost the US healthcare system more than cancer or heart disease. The National Alzheimer's Plan Act and the National Institutes of Health have identified ADRD disparities among ethnic minorities as a public health priority. Latinos with ADRD experience substantial disparities with reduced rates of early diagnosis and lower quality care compared to their non-Latino white peers, which put them at an increased risk for steeper cognitive decline, morbidity, mortality and higher caregiver burden. A number of barriers conspire to create these disparities including a lack of an evidence-based strategy to address ADRD in clinics, patient and primary care provider (PCP) reduced ADRD knowledge, negative attitudes regarding ADRD, PCP's lack of time, cultural and language barriers and health insurance status. To improve healthcare delivery to Latinos with ADRD, researchers need to redesign current ADRD detection and care systems to follow evidence-based recommendations for early detection and culturally appropriate chronic care.

The overall aim of this proposal is to enhance the delivery of ADRD services to Latinos in primary care through a scalable systems approach that includes evidence-based recommendations. Primary care clinics are the ideal setting to provide ADRD services, as 93% of older Latinos have a usual source of healthcare. The novel systems approach (Alianza Latina/Latino Alliance) will enhance timely ADRD diagnosis and optimal care to minimize behavioral symptoms and cognitive decline among Latinos in a linguistically and culturally-appropriate way. Alianza Latina will use the Collaborative Care Framework that capitalizes on PCPs and Health Navigators. 1) PCPs will undergo evidence-based training to enhance timely and culturally appropriate diagnosis and implement it in their work routine. 2) PCPs will detect, treat and refer Latino ADRD patients to a bilingual Health Navigator to provide chronic care management, which will reduce PCP time burden.

Aim 2: Test the feasibility and acceptability of Alianza Latina. Aim 2.a: The research team will train PCPs from Kansas City clinics to enhance skills in cultural competence, ADRD detection, treatment and referral to a Health Navigator among Latinos 65 and older with ADRD. Aim 2.b. The Health Navigator will provide patients/caregiver dyads referred by Alianza Latina PCPs with care management, psychosocial support and links to relevant community resources. The research team will assess the feasibility and acceptability of 1) PCP training and 2) patient and caregiver ADRD care. Caregivers will be enrolled in a text messaging program, called CuidaTEXT, that will educate about memory and thinking problems, solve problems that are common among families with memory and thinking problems, send reminders for appointments and medications, and improve communication with the PCP, family, friends, and other resources.

Eligibility criteria: Inclusion Criteria for care recipients within the dyad:

* Identify as Latino
* Community dwelling
* Diagnosed with mild cognitive impairment or dementia
* Have a caregiver 18 years old or older
* Have co-participant with access to a privately-owned cell phone with a flat fee for text messages

Inclusion Criteria for primary care providers:

* Be 18 years old or older
* Work as a primary care provider in the US

Exclusion Criteria for care recipients within the dyad:

* Not identify as Latino
* Not community dwelling
* Not diagnosed with mild cognitive impairment or dementia
* Not having a caregiver 18 years old or older
* Not having a co-participant with access to a privately-owned cell phone with a flat fee for text messages

Exclusion Criteria for primary care providers:

* Younger than 18 years old
* Not work as a primary care provider in the US

Primary outcomes:
measure: Provider Recruitment Feasibility
timeFrame: During the 9 months of the provider intervention period
measure: Provider Retention Feasibility
timeFrame: During the 9 months of the provider intervention period
measure: Provider Fidelity Feasibility 1
timeFrame: 9 months (end of the provider intervention period)
measure: Provider Assessment Feasibility 1
timeFrame: During the 9 months of the provider intervention period
measure: Provider Fidelity Feasibility 2
timeFrame: During the 9 months of the provider intervention period
measure: Overall Provider Satisfaction With Training
timeFrame: 9 months (end of the provider intervention period)
measure: Importance of Navigators to Providers
timeFrame: 9 months (end of the provider intervention period)
measure: Participant Recruitment Fidelity
timeFrame: During the 15 months of the whole intervention period
measure: Participant Retention Fidelity
timeFrame: During the 6 months of the Navigator intervention period
measure: Participant Assessment Fidelity
timeFrame: During the 6 months of the Navigator intervention period
measure: Participant Treatment Adherence
timeFrame: During the 6 months of the Navigator intervention period
measure: Overall Participant Satisfaction With the Clinic Side of the Intervention
timeFrame: 6 months after baseline
measure: Overall Participant Satisfaction With the Navigator Side of the Intervention
timeFrame: 6 months after baseline
measure: Participant Suggestions of Improvement
timeFrame: 6 months after baseline
measure: Practitioner Adherence to Guideline Recommendations
timeFrame: 6 months after baseline
Secondary outcomes:
measure: Patients' Behavioral Symptoms
timeFrame: Baseline and 6 months from baseline
measure: Patients' Depression
timeFrame: Baseline and 6 months from baseline
measure: Patients' Quality of Life
timeFrame: Baseline and 6 months from baseline
measure: Caregivers' Quality of Life
timeFrame: Baseline and 6 months from baseline
measure: Caregivers' Depression
timeFrame: Baseline and 6 months from baseline
measure: Caregivers' Burden
timeFrame: Baseline and 6 months from baseline
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: KUMC
name: Jaime Perales Puchalt, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: