Educational Program for Alzheimer's Disease

(DPRESCRIBE-AD2 Trial)

Overseen By Cassie L Saphirak, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Must be taking: Alzheimer's medications

Must not be taking: Sedatives, Antipsychotics, Anticholinergics

Disqualifiers: Nursing home, Palliative care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

11375 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it focuses on reducing potentially inappropriate prescriptions. It might involve discussions with your healthcare provider about the safety of your current medications.

What data supports the effectiveness of the treatment Educational Materials, Culturally and Linguistically Tailored Cancer Education Materials for Alzheimer's Disease?

Research shows that culturally tailored educational programs can improve knowledge about Alzheimer's disease among African American and Latino communities, suggesting that similar approaches may be effective in increasing understanding and awareness of Alzheimer's disease in diverse populations. ^{1 2 3 4 5}

Is the Educational Program for Alzheimer's Disease safe for humans?

The research articles do not provide specific safety data for the Educational Program for Alzheimer's Disease or similar educational materials, but they highlight the importance of clear communication and understanding in patient education to prevent safety issues. ^{6 7 8 9 10}

How is the Educational Program for Alzheimer's Disease different from other treatments?

This treatment is unique because it uses culturally and linguistically tailored educational materials to improve understanding and decision-making, which is different from standard medical treatments that focus on medication or clinical interventions. ^{11 12 13 14 15}

What is the purpose of this trial?

Potentially inappropriate prescribing includes the use of medications that may no longer be necessary or that may increase the risk of harm. Inappropriate prescribing can increase the overall symptom burden, and negatively affect health-related quality of life and function. The inappropriate prescription of certain drug categories such as sedative/hypnotics, antipsychotics, and strong anticholinergic agents poses particular risks for older adults, and may be more common among those with Alzheimer's disease and Alzheimer's disease- related dementias (AD/ADRD) due to a higher prevalence of multimorbidity and more frequent prescription of five or more medications. The D-PRESCRIBE-AD (Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer's Disease) study will test a health plan-based intervention using the NIH Collaboratory's Distributed Research Network, which employs the Food and Drug Administration (FDA) Sentinel System infrastructure. The overarching goal of this randomized controlled trial is to assess the effect of a patient/caregiver- centered, multifaceted educational intervention on potentially inappropriate prescribing in patients with AD/ADRD. The research hypothesis is that education on inappropriate prescribing among patients/caregivers and their providers can reduce medication-related morbidity in patients with AD/ADRD and improve medication safety for this vulnerable population. The study population will include community-dwelling patients with AD/ADRD, identified based on diagnoses codes of AD/ADRD or use of a medication for Alzheimer's Disease, who have evidence of potentially inappropriate prescribing the three drug classes above. The trial will evaluate the effect of mailed educational interventions, including the effect of a second reminder mailing, designed to spur patient/caregiver-provider communication about medication safety (versus usual care) on the proportion of patients with inappropriate prescribing, the primary outcome of this study. The trial will be conducted in two large, national health plans.

Research Team

Jerry H Gurwitz, MD

Principal Investigator

UMass Chan Medical School; UMass Memorial Medical Center;

Eligibility Criteria

This trial is for older adults with Alzheimer's Disease who live in the community, have been diagnosed based on specific codes or are taking Alzheimer's medication, and may be receiving potentially inappropriate medications like sedatives or antipsychotics.

Inclusion Criteria

I have been diagnosed with Alzheimer's or related dementia and have been treated with specific medications for it in the last year.

I am 50 years old or older.

I have been prescribed antipsychotics, sedatives, or strong anticholinergics in the last 3 months.

Exclusion Criteria

Incomplete/missing prescriber ID or incomplete contact information for either patient or prescribing provider

On 'do not contact' list

I live in a nursing home or receive palliative care.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a combined patient/caregiver and provider educational intervention with one or two mailings to spur communication about medication safety

6 weeks

Observation

Participants are monitored for the absence of inappropriate medication prescription dispensing and other secondary outcomes

6 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

3 months

Treatment Details

Interventions

• Educational Materials

Trial Overview The study tests an educational program designed to inform patients with Alzheimer's and their caregivers about the risks of certain medications. The goal is to see if this education can reduce unnecessary or harmful prescriptions compared to usual care.

Participant Groups

Group I: Two Mailings Experimental Treatment 1 Intervention

A combined patient/caregiver and provider educational intervention with a second identical mailing, following the first within 45 days

Group II: Single Mailing Experimental Treatment 1 Intervention

A combined patient/caregiver and provider educational intervention with one mailing to each.

Group III: Usual Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Carelon Research

Collaborator

Trials

76

Recruited

125,000+

Harvard Pilgrim Health Care

Collaborator

Trials

61

Recruited

27,990,000+

Humana Healthcare Research, Inc.

Collaborator

Trials

2

Recruited

15,600+

Findings from Research

About one-third of the 251 adult patients surveyed at a public hospital clinic had low literacy levels, which significantly impacted their ability to correctly interpret prescription medication warning labels.

Patients with low literacy were 3.4 times less likely to understand these labels correctly, highlighting the need for clearer, simpler warning labels that are easier for all patients to comprehend, especially those with lower literacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low literacy impairs comprehension of prescription drug warning labels. Davis, TC., Wolf, MS., Bass, PF., et al.[2022]

An 11-minute educational DVD combined with a group discussion led by an oncology nurse effectively improved patients' understanding of chemotherapy side effects and self-care management.

Surveys conducted after the class and at an eight-week follow-up indicated that this approach empowered patients and families, enhancing their confidence in managing side effects of chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowering individuals to self-manage chemotherapy side effects. Fee-Schroeder, K., Howell, L., Kokal, J., et al.[2022]

Current medication labeling standards in the U.S. pose significant safety risks for immigrant and language-minority families, particularly those with limited English proficiency and literacy in their native language.

There is a pressing need for new research and policy changes to improve medication understanding and adherence among recent Latin American immigrants, as existing regulations do not adequately address their cultural and linguistic needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lost in translation: Medication labeling for immigrant families. Smith, MC., Yin, HS., Sanders, LM.[2021]

A participatory approach involving over 200 health providers and clients led to the creation of culturally targeted cancer education brochures for Native Hawaiians, focusing on various types of cancer.

The new brochures, featuring culturally relevant imagery and language, were found to be more appealing and comprehensible, especially to younger Hawaiians, suggesting they could effectively improve cancer education in this community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a participatory four-step protocol to develop culturally targeted cancer education brochures. Kulukulualani, M., Braun, KL., Tsark, JU.[2021]

Culturally sensitive cancer prevention education materials are essential for effectively reaching ethnically diverse populations, as most existing resources focus primarily on breast cancer and target African American communities.

There is a lack of standardized definitions and reliable measures for assessing cultural sensitivity in cancer education materials, highlighting the need for best practice guidelines that incorporate the specific cancer knowledge and beliefs of ethnic minority groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of culturally sensitive cancer prevention resources for ethnic minorities. Hoffman-Goetz, L., Friedman, DB.[2021]

A study assessing printed cancer education materials (PCEMs) for African Americans found that over half (56.2%) were culturally insensitive, particularly in their visual messaging.

To improve effectiveness, future PCEMs should incorporate culturally sensitive visuals, and the newly developed assessment tool can help ensure these materials resonate better with African American audiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing cultural sensitivity in printed cancer materials. Guidry, JJ., Walker, VD.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Feasibility of an Alzheimer's disease knowledge intervention in the Latino community. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Knowledge of Alzheimer's disease and subjective memory impairment in Latin American seniors in the Greater Toronto Area. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Improving dementia health literacy using the FLOW mnemonic: pilot findings from the Old SCHOOL hip-hop program. [2022]

4. England pubmed.ncbi.nlm.nih.gov

BrainWorks: A Comparative Effectiveness Trial to Examine Alzheimer's Disease Education for Community-Dwelling African Americans. [2022]

5. Brazil pubmed.ncbi.nlm.nih.gov

Health literacy for caregivers of elders with alzheimer's disease. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Low literacy impairs comprehension of prescription drug warning labels. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Empowering individuals to self-manage chemotherapy side effects. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Improving Medication Safety in Cancer Services for Ethnic Minority Consumers: Protocol for a Pilot Feasibility and Acceptability Study of a Co-Designed Consumer Engagement Intervention. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Communication barriers in counselling foreign-language patients in public pharmacies: threats to patient safety? [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Lost in translation: Medication labeling for immigrant families. [2021]

11. England pubmed.ncbi.nlm.nih.gov

The Cancer Clear & Simple Story: Developing a Cancer Prevention Curriculum for Rural Wisconsin Through a Community Partnership. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Using a participatory four-step protocol to develop culturally targeted cancer education brochures. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Facilitating behavior change with low-literacy patient education materials. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

A systematic review of culturally sensitive cancer prevention resources for ethnic minorities. [2021]

15. United States pubmed.ncbi.nlm.nih.gov

Assessing cultural sensitivity in printed cancer materials. [2022]