Toolkit for Preventive Health Services

Not currently recruiting at 2 trial locations

Overseen By Danielle Schramm, MSPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Under 50, No Medicare, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to boost the use of preventive health services by helping primary care practices improve their Annual Wellness Visits (AWV). Researchers will introduce the Medicare AWV Practice Redesign Toolkit to 24 primary care practices over two years to determine if it encourages more patients to attend these visits. The study will measure success using electronic health records and interviews. It suits individuals aged 50 or older who have Medicare and have visited their doctor in the past year. As an unphased trial, this study offers participants the opportunity to contribute to enhancing healthcare practices and preventive services for Medicare patients.

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 prior data suggests that this toolkit is safe for use in primary care practices?

Research has shown that the Medicare AWV Practice Redesign Toolkit is a well-accepted method in healthcare settings. This toolkit helps doctors and clinics optimize Annual Wellness Visits (AWVs), which are check-ups designed to prevent health issues.

The toolkit combines electronic health record tools with innovative ways to organize clinic tasks. Studies have found these tools safe because they focus on improving clinic operations without introducing new drugs or medical procedures that could pose risks.

The toolkit simplifies processes and ensures clinics are better organized to provide preventive services, making it a safe choice for clinics and patients seeking to enhance their use of preventive health services. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Medicare AWV Practice Redesign Toolkit because it offers a fresh approach to preventive health services for Medicare patients. Unlike traditional methods, which often rely heavily on manual processes, this toolkit integrates electronic health record (EHR) tools with redesigned practice workflows and templates specifically for Annual Wellness Visits (AWVs). This streamlined approach aims to enhance efficiency and accuracy, making it easier for healthcare providers to deliver comprehensive preventive care. By tailoring the intervention to fit individual practice settings, the toolkit has the potential to improve patient outcomes and optimize the use of healthcare resources.

What evidence suggests that the Medicare AWV Practice Redesign Toolkit is effective for increasing the use of preventive health services?

Research has shown that the Medicare Annual Wellness Visit (AWV) Practice Redesign Toolkit, under study in this trial, greatly increases the use of AWV services. In one study, the use of AWV services rose from 7% to 54% just eight months after introducing the toolkit. This toolkit also led to more screenings for important health issues, such as depression and alcohol misuse. Additionally, advance care planning, which involves making decisions about future healthcare, increased by over 10%. These findings suggest the toolkit effectively promotes preventive health services. ^{1 2 6 7 8}

Who Is on the Research Team?

Derjung M Tarn, MD, PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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

I am covered by Medicare.

I am 50 years old or older.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. jabfm.org jabfm.org/content/jabfp/36/3/501.full.pdf

Outcomes of A Virtual Practice-Tailored Medicare Annual ... The intervention increased AWV utilization from 7% to 54%, and increased advance care planning, depression, and alcohol misuse screenings. Virtual ...

2. hqin.org hqin.org/wp-content/uploads/2021/07/Annual-Wellness-Visit-AWV-Toolkit.pdf

Annual Wellness Visit (AWV) Toolkit The Annual Wellness Visit (AWV) is an added opportunity for providers to comprehensively review and screen the patient's health status at no cost. However, ...

3. escholarship.org escholarship.org/uc/item/8kh3b9t5

Outcomes of A Virtual Practice-Tailored Medicare Annual ... AWV utilization went from 7% at baseline to 54% 8 months postintervention implementation; advance care planning increased 10.7% (from 7.9% to 18.6%); depression ...

4. ucla.clinicaltrials.researcherprofiles.org ucla.clinicaltrials.researcherprofiles.org/trial/NCT05563415

AWV Practice Redesign Toolkit (Tailored Intervention) The goal of this study is to improve the use of preventive health services by implementing the AWV Practice Redesign Toolkit to stimulate AWV visit use in ...

5. researchgate.net researchgate.net/publication/369895798_Outcomes_of_A_Virtual_Practice-Tailored_Medicare_Annual_Wellness_Visit_Intervention

Outcomes of A Virtual Practice-Tailored Medicare Annual ... The intervention combines EHR-based tools with practice redesign approaches and resources. Outcomes included completion of AWV and fulfillment ...

6. comagine.org comagine.org/resource/1378

Annual Wellness Visit Toolkit This page is designed to help practices and providers find the tools and resources they need to successfully implement or improve their AWV process.

7. cms.gov cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/preventive-services/medicare-wellness-visits.html

MLN6775421 – Medicare Wellness Visits The Annual Wellness Visits video helps you understand these exams, as well as their purpose and claim submission requirements.

8. edhub.ama-assn.org edhub.ama-assn.org/steps-forward/module/2757861

Medicare Annual Wellness Visit (AWV) - AMA Ed Hub This toolkit will assist you in establishing a team-based approach to conducting useful and effective Medicare Annual Wellness Visits (AWV).