Toolkit for Preventive Health Services

Recruiting at 2 trial locations

Overseen By Danielle Schramm, MSPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

22485 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to improve the use of preventive health services by implementing a multilevel intervention to stimulate Annual Wellness Visit use in diverse practices across the United States. This is a stepped wedge cluster randomized controlled trial. The intervention will be implemented in a total of 24 primary care practices over 24 months. Every 3 months, 6 practices will receive the intervention. Electronic health record (EHR) data extractions will be used to collect outcomes in a population cohort of patients. Semi-structured interviews will be conducted with clinicians/staff and patients to assess intervention implementation. The investigators hypothesize that the implementation will increase AWV visit use and consequently, use of preventive health services.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Medicare AWV Practice Redesign Toolkit?

Research shows that redesigning healthcare practices, like the Medicare Annual Wellness Visit, can improve the quality and safety of patient care. For example, a project at the Mayo Clinic found that standardizing care processes led to better patient outcomes and higher satisfaction among patients and healthcare providers. ^{1 2 3 4 5}

How is the Medicare AWV Practice Redesign Toolkit treatment different from other treatments?

The Medicare AWV Practice Redesign Toolkit is unique because it focuses on preventive health services specifically for older adults, offering a comprehensive health risk assessment and personalized health promotion plan. Unlike other treatments, it is a free, prevention-focused visit for Medicare recipients, emphasizing disease prevention, health maintenance, and independence, tailored to the diverse needs of older adults. ^{1 6 7 8 9}

Research Team

Derjung M Tarn, MD, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

This trial is for primary care practices across the United States aiming to boost their use of preventive health services, specifically focusing on increasing Annual Wellness Visit (AWV) use among patients. The study will involve diverse practices and will collect data via electronic health records.

Inclusion Criteria

Must have had at least one visit to the practice in the past 12 months

Must not be deceased

I am covered by Medicare.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Implementation

The multilevel intervention is implemented in 24 primary care practices to increase AWV utilization and preventive health services

24 months

Every 3 months, 6 practices receive the intervention

Follow-up

Participants are monitored for the utilization of AWV and preventive health services, and reduction in racial/ethnic disparities

12 months

Treatment Details

Interventions

• Medicare AWV Practice Redesign Toolkit

Trial Overview The study tests a 'Medicare AWV Practice Redesign Toolkit' intervention in a stepped wedge cluster randomized controlled trial over 24 months. Every three months, six new practices start using the toolkit to see if it helps increase AWVs and other preventive services.

Participant Groups

Group I: Medicare AWV Toolkit Experimental Treatment 1 Intervention

Practice-tailored intervention combining EHR tools with practice redesign workflows and templates for completing AWVs

Medicare AWV Practice Redesign Toolkit is already approved in United States for the following indications:

Approved in United States as Medicare Annual Wellness Visit for:

• Preventive health services
• Health risk assessment
• Personalized prevention plan

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

MetroHealth System, Ohio

Collaborator

Trials

8

Recruited

26,100+

American Academy of Family Physicians National Research Network

Collaborator

Trials

8

Recruited

50,500+

DARTNet

Collaborator

Trials

3

Recruited

39,800+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+

The MetroHealth System

Collaborator

Trials

5

Recruited

24,500+

Findings from Research

The Practice-Tailored AWV intervention significantly increased the utilization of Medicare Annual Wellness Visits (AWVs) from 7% to 54% within 8 months, demonstrating its effectiveness in promoting preventive health services during the COVID-19 pandemic.

Patients who completed an AWV were more likely to receive recommended preventive services, with notable increases in advance care planning, depression screening, and alcohol misuse screening, highlighting the intervention's role in improving overall patient health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of A Virtual Practice-Tailored Medicare Annual Wellness Visit Intervention. Tarn, DM., Pace, WD., Tseng, CH., et al.[2023]

A quality improvement initiative at a free clinic successfully implemented four interventions that significantly enhanced preventative care, surpassing national averages in six key health measures.

Five out of six outcomes achieved were above the Healthy People 2020 goals, demonstrating the effectiveness of the approach for other clinics seeking to improve care and obtain Patient-Centered Medical Home certification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for Increasing the Quality of Preventive Care at a Free Clinic. Burger, M., Taddeo, MS., Hushla, D., et al.[2020]

The Plummer Project at the Mayo Clinic successfully improved patient care quality and safety by standardizing the rooming process, leading to more accurate medication lists.

The initiative not only enhanced patient safety but also increased physician efficiency and satisfaction, as well as the satisfaction of clinical assistants involved in the training process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized care processes to improve quality and safety of patient care in a large academic practice: the Plummer Project of the Department of Medicine, Mayo Clinic. Wood, DL., Brennan, MD., Chaudhry, R., et al.[2022]

In a study of 42 practices, higher scores on the Key Drivers Implementation Scales (KDIS) were linked to improved control of low-density lipoprotein (LDL) levels in diabetes patients, indicating that effective implementation of care practices can enhance patient outcomes.

Specifically, improvements in LDL control were associated with better use of registries and protocols, highlighting their importance in diabetes management, although no significant improvements were found for hemoglobin A1C or blood pressure measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

More extensive implementation of the chronic care model is associated with better lipid control in diabetes. Halladay, JR., DeWalt, DA., Wise, A., et al.[2022]

Pharmacists can effectively deliver Medicare Annual Wellness Visits (AWVs), performing an average of 3.5 to 5.4 interventions per patient, which can enhance patient access to healthcare services.

The implementation of AWV services by pharmacists can generate significant revenue, ranging from $3750 to $22,340 quarterly, highlighting the financial viability of integrating these services into pharmacy practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medicare Annual Wellness Visits: A Scoping Review of Current Practice Models and Opportunities for Pharmacists. Hohmann, LA., Hastings, TJ., Qian, J., et al.[2022]

Implementing RN-led Medicare annual wellness visits (AWVs) using the 4Ms framework significantly increased patient access to primary care, allowing for two additional visits per provider each day.

These visits not only enhanced the role of registered nurses in health promotion but also facilitated important discussions about patients' mental and emotional well-being, quality of life, and personal health goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Age-friendly health care and the 4Ms in RN-led annual wellness visits. Garbarino, JT., O'Connor, S., Pepin, RL., et al.[2023]

The utilization of the Medicare Annual Wellness Visit (AWV) increased significantly from 8.1% to 23.0% between 2011 and 2016, indicating a growing acceptance of this preventive care service among beneficiaries.

However, disparities in AWV utilization persist, with non-Hispanic Black and Hispanic/Latino beneficiaries using the service at significantly lower rates compared to non-Hispanic white beneficiaries, suggesting a need for targeted efforts to increase access and utilization among these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persistent Disparities in Medicare's Annual Wellness Visit Utilization. Lind, KE., Hildreth, KL., Perraillon, MC.[2021]

By 2030, with 1 in 5 Americans over 65, the Welcome to Medicare and Annual Wellness Visits (AWVs) are crucial for preventing health issues in older adults, focusing on comprehensive assessments and personalized health plans.

These visits not only enhance the delivery of preventive care for older patients but can also provide financial benefits to healthcare practices when conducted and documented properly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Geriatric Care in the Community Setting: Welcome to Medicare and Annual Wellness Visits. McClester Brown, M.[2022]

The current Medicare annual wellness visits (AWVs) do not adequately address the diverse needs of older adults, as they follow a 'one size fits all' model that overlooks important factors like medical, psychological, and socio-economic diversity.

To improve AWVs, a more tailored approach is recommended, utilizing geriatrics care strategies such as Glidepaths and the 4Ms of an Age-Friendly Health System, which can help create personalized wellness plans for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medicare's annual wellness visit: 10 years of opportunities gained and lost. Coll, PP., Batsis, JA., Friedman, SM., et al.[2022]

References

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

Outcomes of A Virtual Practice-Tailored Medicare Annual Wellness Visit Intervention. [2023]

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

Interventions for Increasing the Quality of Preventive Care at a Free Clinic. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Standardized care processes to improve quality and safety of patient care in a large academic practice: the Plummer Project of the Department of Medicine, Mayo Clinic. [2022]

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

More extensive implementation of the chronic care model is associated with better lipid control in diabetes. [2022]

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

Medicare Annual Wellness Visits: A Scoping Review of Current Practice Models and Opportunities for Pharmacists. [2022]

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

Age-friendly health care and the 4Ms in RN-led annual wellness visits. [2023]

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

Persistent Disparities in Medicare's Annual Wellness Visit Utilization. [2021]

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

Geriatric Care in the Community Setting: Welcome to Medicare and Annual Wellness Visits. [2022]

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

Medicare's annual wellness visit: 10 years of opportunities gained and lost. [2022]