AWV Practice Redesign Toolkit for Preventive Health Services

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: Unknown

13321 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment AWV Practice Redesign Toolkit for Preventive Health Services?

Research shows that redesigning healthcare practices, like the Plummer Project at Mayo Clinic, can improve patient care quality and safety by standardizing processes and enhancing efficiency. Additionally, interventions to increase the use of Medicare Annual Wellness Visits can help in planning personalized preventive health services, suggesting that practice redesign can be effective in improving preventive care. ^{1 2 3 4 5}

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

The Medicare AWV Practice Redesign Toolkit is unique because it focuses on preventive health services through annual wellness visits, which are free for Medicare recipients and emphasize health maintenance, risk assessment, and prevention of illness. Unlike other treatments, it incorporates the 4Ms of age-friendly healthcare—what matters, medication, mentation, and mobility—into the visit, and can be delivered by registered nurses or pharmacists, making it more accessible and tailored to individual needs. ^{1 3 6 7 8}

What is the purpose of this trial?

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 diverse practices across the United States. This is a stepped wedge cluster randomized controlled trial. The intervention will be implemented in a total of 16 small-to-mid-size primary care practices (at the practice level) with clinicians and staff. Eight practices will participate in the main clinical trial, and 8 in a replication study. The main clinical trial (with community-based practices) and replication study (with Federally Qualified Health Center practices) will be conducted simultaneously. 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 toolkit implementation will increase AWV visit use and consequently, use of preventive health services.

Research Team

Derjung M Tarn, MD,PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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 50 years old or older.

I am covered by Medicare.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

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

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

2. 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]

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

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

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

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

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

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

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

Community pharmacist-delivered Medicare Annual Wellness Visits within a family medicine practice. [2018]

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

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