Personalized Prevention Plan for Healthy Aging

(PDP Trial)

Overseen By Glen Taksler, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Glen Taksler

Disqualifiers: Cancer, Alcohol abuse, Myocardial infarction, Stroke, others

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

Compensation: Varies

Number of Visits: 1

660 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate whether patients and their providers benefit from an evidence-based decision tool to help prioritize preventive (and select chronic disease management) services based on their potential to improve quality-adjusted life expectancy, individualized for patient risk factors. The study seeks to enroll 600 patients and 60 primary care providers. Half of providers will be assigned to an intervention to utilize the decision tool with approximately 10 high-priority patients each (patients of particular interest to the research study, on whom follow-up outcomes will be collected), and half will be assigned to usual care. Surveys will be administered at baseline and approximately 6 months later; electronic health records data on preventive service utilization will be collected; and optional qualitative interviews may be conducted.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on preventive care and lifestyle factors, so it's best to discuss your medications with your doctor.

What data supports the effectiveness of the treatment Individualized preventive care recommendations (decision tool)?

Research shows that patients are highly interested in individualized preventive care recommendations, finding them easy to understand, useful, and trustworthy. This approach can motivate patients to adhere to preventive care, as many are more likely to visit their doctor if they know these personalized recommendations will be discussed. ^{1 2 3 4 5}

Is the Personalized Prevention Plan for Healthy Aging safe for humans?

The research highlights the importance of using tools and consultations to prevent adverse drug events (unwanted or harmful effects from medications) in older adults, suggesting that personalized prevention plans should include careful medication review to ensure safety. ^{6 7 8 9 10}

How is the Personalized Prevention Plan for Healthy Aging treatment different from other treatments?

This treatment is unique because it offers individualized preventive care recommendations based on personal risk factors, which can motivate patients to adhere to preventive services more effectively than standard approaches. Unlike typical treatments, it focuses on personalized advice to improve healthy aging, making it more relevant and engaging for patients. ^{1 2 3 11 12}

Research Team

Glen Taksler, PhD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

This trial is for adults aged 40-75 who see their primary care provider regularly and have a modifiable lifestyle factor impacting life expectancy, like smoking or high blood pressure. They must be due for various preventive health screenings but can't join if they've had recent cancer (except skin), severe kidney disease, or other serious health issues.

Inclusion Criteria

High-priority patients must meet the modifiable lifestyle factors criteria and be eligible for a high number of preventive services, among other criteria

Provider eligibility criteria: Any attending physician, nurse practitioner, or physician assistant practicing in internal medicine or family medicine

Ongoing primary care in the health system, defined as ≥2 visits with a primary care provider in the prior 730 days

Exclusion Criteria

Eligible patients: Cancer in the past 3 years (other than non-melanoma skin), Diagnosis of alcohol abuse in the past 3 years, History of myocardial infarction, History of stroke, End-stage renal disease, Moderate-severe congestive heart failure, Moderate-severe chronic obstructive pulmonary disease, Other comorbidity with limited life expectancy, Inability to communicate or limited communication in English

High-priority eligible patients: Known current pregnancy, Known acute care need likely to limit time for preventive care discussion, First primary care encounter since hospitalization, surgery, or emergency department utilization

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Surveys are administered to assess baseline readiness to change and preventive service utilization

1 week

1 visit (in-person or virtual)

Intervention

Providers use the decision tool to discuss individualized preventive care recommendations with high-priority patients

6 months

Ongoing visits as needed

Follow-up

Participants are monitored for changes in preventive service utilization and health outcomes

6 months

Surveys and health record assessments

Treatment Details

Interventions

• Individualized preventive care recommendations (decision tool)

Trial Overview The study tests an evidence-based decision tool used by healthcare providers to prioritize preventive services for patients. It aims to improve patient quality of life by personalizing care recommendations based on individual risk factors.

Participant Groups

Group I: Usual care Active Control 1 Intervention

Control arm: Participants will not receive individualized preventive care recommendations (decision tool).

Group II: Individualized preventive care recommendations (decision tool) Active Control 1 Intervention

Intervention arm: Providers will receive individualized preventive care recommendations (decision tool) for eligible patients, and discuss them with patients using shared decision-making.

Who Is Running the Clinical Trial?

Glen Taksler

Lead Sponsor

Trials

2

Recruited

760+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

The FDA's ASTER pilot study demonstrated that electronic health record (EHR)-triggered adverse event reports can provide valuable postmarketing safety information, particularly for known adverse drug events (ADEs).

However, the quality of the reports varied, with many lacking critical details such as informative descriptions and relevant laboratory data, highlighting the need for improved data quality to enhance the utility of EHR-triggered ADE reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration. Brajovic, S., Piazza-Hepp, T., Swartz, L., et al.[2012]

In a study reviewing 1289 charts of older adults with cardiovascular diagnoses, 50% had triggers indicating potential adverse drug events (ADEs), with 232 of these triggers confirmed as ADEs, highlighting the prevalence of medication-related issues in this population.

Only nine out of 39 triggers were highly predictive of ADEs, accounting for 94.4% of the detected events, suggesting that a more streamlined trigger tool could be developed to improve the identification of ADEs in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with a trigger tool for identifying adverse drug events among older adults in ambulatory primary care. Singh, R., McLean-Plunckett, EA., Kee, R., et al.[2022]

References

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

Assessing Patient Interest in Individualized Preventive Care Recommendations. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Risk factors and recommendations for 230 adult primary care patients, based on U.S. Preventive Services Task Force guidelines. [2015]

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

Patient-Entered Wellness Data and Tailored Electronic Recommendations Increase Preventive Care. [2018]

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

Project ACTIVE: a Randomized Controlled Trial of Personalized and Patient-Centered Preventive Care in an Urban Safety-Net Setting. [2022]

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

Health promotion and disease prevention in the care of older adults: preventive practice in primary care. [2004]

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

Adverse Drug Event Prevention and Detection in Older Emergency Department Patients. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Incidence, preventability and consequences of adverse events in older people: results of a retrospective case-note review. [2022]

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

Patient perceptions of osteoporosis treatment thresholds. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration. [2012]

10. England pubmed.ncbi.nlm.nih.gov

Experience with a trigger tool for identifying adverse drug events among older adults in ambulatory primary care. [2022]

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

Use of Decision Models in the Development of Evidence-Based Clinical Preventive Services Recommendations: Methods of the U.S. Preventive Services Task Force. [2022]

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

Effect of Individualized Preventive Care Recommendations vs Usual Care on Patient Interest and Use of Recommendations: A Pilot Randomized Clinical Trial. [2022]