AWV Practice Redesign Toolkit for Preventive Health Services

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: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a toolkit designed to help doctors and staff offer preventive health services during Medicare Annual Wellness Visits (AWV) more easily. The researchers aim to determine if this toolkit can increase the number of wellness visits and enhance overall preventive care. Individuals with Medicare, aged 50 or older, who have visited their doctor's office in the past year, might qualify for this study. Various primary care practices across the U.S. participate to evaluate the toolkit's effectiveness in different settings. As an unphased trial, this study provides a unique opportunity to contribute to the improvement of preventive healthcare services for Medicare patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on improving preventive health services rather than changing medication use.

What prior data suggests that the AWV Practice Redesign Toolkit is safe for use in primary care practices?

Research has shown that the Medicare Annual Wellness Visit (AWV) Practice Redesign Toolkit improves preventive health services. This toolkit helps clinics organize and enhance wellness visits with patients. Studies have found that using this toolkit can lead to more completed wellness visits and better overall patient care.

The AWV Toolkit is not a medication or medical procedure, so it poses no safety concerns like side effects or adverse reactions. Instead, it provides tools and methods for clinics to use, focusing on improving healthcare processes rather than introducing new treatments.

In summary, the AWV Practice Redesign Toolkit is safe for use in clinics. It helps healthcare providers offer better preventive care without any known risks to patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Medicare AWV Practice Redesign Toolkit because it aims to enhance preventive health services in a novel way. Unlike traditional approaches that may not systematically integrate preventive care into routine practice, this toolkit provides a structured method for practices to redesign their workflows to prioritize preventive services effectively. By focusing on improving the delivery of Annual Wellness Visits (AWVs) for Medicare patients, the toolkit seeks to streamline processes and ensure that preventive measures are consistently and efficiently implemented. This could lead to better health outcomes for patients by catching potential health issues earlier and maintaining overall wellness more proactively.

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

Research has shown that the Medicare AWV Practice Redesign Toolkit, under study in this trial, can increase access to preventive health services. One study found that patients who had an Annual Wellness Visit (AWV) increased their use of these services from 47.5% to 53.8%. This indicates that more individuals received necessary check-ups and screenings after using the toolkit. Patients with AWVs completed more recommended health services compared to those without AWVs. These findings suggest that the toolkit can promote more preventive care visits, leading to improved overall health management. ^{6 7 8 9 10}

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 individuals aged 50 or older with Medicare insurance who have visited one of the participating primary care practices in the past year and are not deceased. It aims to engage both patients and healthcare staff.

Inclusion Criteria

I am covered by Medicare.

I am 50 years old or older.

Patient 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

Control Period

Initial control period where no clusters receive the intervention

4 months

Intervention Implementation

Sequential implementation of the AWV Practice Redesign Toolkit across clusters

16 months

Regular intervals for cluster transitions

Follow-up

Participants are monitored for the completion of preventive health services and AWV utilization

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Medicare AWV Practice Redesign Toolkit

Trial Overview

The study tests a toolkit designed to increase preventive health service visits among Medicare recipients. It's a stepped wedge cluster randomized controlled trial involving 16 small-to-mid-size primary care practices.

How Is the Trial Designed?

Group I: Medicare AWV Toolkit Experimental Treatment 1 Intervention

This is a stepped-wedged study. All practices will receive the intervention.

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+

DARTNet

Collaborator

Trials

3

Recruited

39,800+

American Academy of Family Physicians National Research Network

Collaborator

Trials

8

Recruited

50,500+

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]

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]

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 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]

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]

Citations

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Outcomes of A Virtual Practice-Tailored Medicare Annual ...

Outcome measures were: AWV completion in the past 12 months, receipt of pre- ventive health services and screenings (being up- to-date at the time of assessment); ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05910736

Study Details | NCT05910736 | Increasing the Feasibility, ...

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 ...

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escholarship.org

escholarship.org/uc/item/8kh3b9t5

Outcomes of A Virtual Practice-Tailored Medicare Annual ...

At the patient level, fulfillment of all eligible preventive services (of a maximum of 12 evaluated) went from 47.5% to 53.8% (P < .001). Subgroup analyses ...

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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 ...

Subgroup analyses showed that patients with AWVs completed a greater percentage of their total recommended preventive health services than those ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1555415520306607

Enhancing Annual Wellness Visit Outcomes: Patient ...

This brief report describes factors that impact the effectiveness of Medicare's Annual Wellness Visit (AWV).

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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, ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10352446/

A Virtual Practice-Tailored Medicare Annual Wellness Visit ...

Outcomes were assessed through EHR data extractions. Outcome measures were: AWV completion in the past 12 months, receipt of preventive health ...

8.

comagine.org

comagine.org/sites/default/files/resources/SQI%20QIN%20Community%20-%20AWV%20Toolkit.pdf

Annual Wellness Visit Toolkit

What data do you need on the report or list to schedule the AWV? 3. Include patients who will be Medicare eligible within two months on your ...

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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 ...

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pchpca.org

pchpca.org/images/pdf/acp-for-healthcare-professionals/Medicare_AWV_PCH_Toolkit.pdf

Medicare AWV Physician Practice Guide

Annual Wellness visit; include a personalized prevention plan of service. (PPS), initial visit. RVU. 2.60. (Updated 4/25/23). To code/bill for ...