Feasibility of a Systems Approach for Alzheimer's Services Among Latinos Attending Primary Care Practices

Dementia Clinical Trial

Official title:

Feasibility of a Novel Systems Approach for Improving Utilization of Alzheimer's Disease Services Among Latinos Attending Primary Care Practices

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04418232
• Other study ID #: STUDY00145615
• Status: Recruiting
• Phase: Phase 1
• Start date: May 1, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: October 2023
• Source: University of Kansas Medical Center
• Contact: Jaime Perales Puchalt, PhD, MPH
• Phone: 913-588-3716
• Email: jperales[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Dementia

Intervention

Combination Product:
• Alianza Latina
The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Provider recruitment feasibility	Metrics of the number of providers who agree to be trained per month	During the 9 months of the provider intervention period
Primary	Provider retention feasibility	Metrics of the percentage of providers who continue to partner with the study team by the end of the provider intervention period	During the 9 months of the provider intervention period
Primary	Provider fidelity feasibility 1	Percentage of providers able to implement screenings in regular workflow, measured via survey with the question "To what extent were you able to implement screenings in regular workflow" with three response options: "not at all", "to some degree", "usually", "almost always" and "always"	9 months (end of the provider intervention period)
Primary	Provider assessment feasibility 1	Metrics of the percentage of providers who complete baseline and follow-up surveys about dementia knowledge, attitudes and skills	During the 9 months of the provider intervention period
Primary	Provider fidelity feasibility 2	Metrics of the Number of referrals to Health Navigator per month	During the 9 months of the provider intervention period
Primary	Overall provider satisfaction with training	Survey question including a 5-item Likert scale on satisfaction with training (not at all to very much)	9 months (end of the provider intervention period)
Primary	Importance of Navigators to providers	Survey question including a 5-item Likert scale on the perceived importance of Navigators to providers (not at all to very much)	9 months (end of the provider intervention period)
Primary	Participant recruitment fidelity	Metrics of percentage of referred Latino dementia dyads who enroll in Health Navigator services	During the 15 months of the whole intervention period
Primary	Participant Retention fidelity	Metrics of percentage of referred Latino dementia dyads followed up at six months	During the 6 months of the Navigator intervention period
Primary	Participant assessment fidelity	Metrics of the percentage of planned baseline and follow-up survey ratings completed	During the 6 months of the Navigator intervention period
Primary	Participant treatment adherence	Metrics of the percentage of referred Latino dementia dyads who attends at least 50% of Health Navigator visits	During the 6 months of the Navigator intervention period
Primary	Overall participant satisfaction with the clinic side of the intervention	Survey question including a 5-item Likert scale on satisfaction with clinic services (not at all to very much)	6 months after baseline
Primary	Overall participant satisfaction with the Navigator side of the intervention	Survey question including a 5-item Likert scale on satisfaction with Navigator services (not at all to very much)	6 months after baseline
Primary	Participant suggestions of improvement	Survey question including an open-ended question about which aspects of the intervention they would change	6 months after baseline
Primary	Practitioner adherence to guideline recommendations	10-item checklist administered to the dyads asking about the implementations of different aspects of dementia service guidelines	6 months after baseline
Secondary	Patients' behavioral symptoms	Brief version of the Neuropsychiatry Inventory Questionnaire: This is a validated clinical instrument for evaluating psychopathology in dementia. If any of the 12 neuropsychiatric symptoms is present, caregivers rate their own distress on a six-point scale (not distressing at all-extreme or very severe distress). For example, if the caregiver responds yes to "is the patient resistive to help from others at times, or hard to handle?", the following question would follow: "rate the severity of the symptom". An overall severity summary score is calculated by adding the severity scores of all items and higher scores mean higher severity.	Baseline and 6 months from baseline
Secondary	Patients' depression	Short Geriatric Depression Scale: This scale consists of 15 yes vs no questions. Questions from the Long Form GDS which had the highest correlation with depressive symptoms in validation studies were selected for the short version. Of the 15 items, 10 indicated the presence of depression when answered positively, while the rest (question numbers 1, 5, 7, 11, 13) indicated depression when answered negatively. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.	Baseline and 6 months from baseline
Secondary	Patients' quality of life	Quality of Life in Alzheimer's Disease: The QoL-AD is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole). Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better QoL.	Baseline and 6 months from baseline
Secondary	Caregivers' quality of life	In general, how satisfied are you with your life?" with a 4-point scale from 1 (Very Satisfied) to 4 (Very Dissatisfied)	Baseline and 6 months from baseline
Secondary	Caregivers' depression	10-item Center for Epidemiologic Studies-Depression scale (CES-D-10): This is a 10-item, self-report rating scale that measures characteristic symptoms of depression in the past week (e.g. depression, loneliness, restless sleep). Each item is rated on a 4-point scale, from 0 (rarely or none of the time) to 3 (most or all of the time) with positively worded items (items 5 and 8) reverse scored. Items yield summary scores that range from 0 to 30, with higher scores indicating higher severity. An example of an item is: "I was bothered by things that usually don't bother me"	Baseline and 6 months from baseline
Secondary	Caregivers' burden	Short Zarit Burden Interview: This scale has 6 items and address the perceived impact of the act of providing care on the physical health, emotional health, social activities and financial situation of the caregiver. Each item has five response options ranging from "never" to "nearly always". Higher scores mean higher burden.	Baseline and 6 months from baseline