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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special decision tool can help doctors and patients prioritize important preventive health services to improve quality of life. The tool uses personal health information to recommend the most beneficial services for patients. Participants will be divided into two groups: one where doctors use the tool and another where they follow usual care practices. Individuals with conditions like high blood pressure, diabetes, or who are current smokers, and who have regular visits with their primary care doctor might be a good fit. The trial will track health service use and survey participants to assess the tool's impact. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance preventive health care for many.

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 prior data suggests that this decision tool is safe for use in preventive care?

Research has shown that a personalized tool for preventive care is safe for patients. An earlier study found this tool easy to use and well-received by users. It helped patients understand how to prevent diseases before they start. No reports of negative effects or side effects have emerged from using this tool. Instead, it facilitates discussions between doctors and patients about health choices and preventive care. This suggests the tool is well-tolerated and safe for use in medical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Personalized Prevention Plan for Healthy Aging because it introduces a fresh approach to preventive care through individualized recommendations. Unlike standard care, which often involves a one-size-fits-all approach, this method uses a decision tool that tailors preventive care plans to each patient's unique health profile. This personalized strategy aims to enhance shared decision-making between patients and providers, potentially leading to more effective and targeted preventive measures. By focusing on customization, this approach could improve health outcomes and promote healthier aging, making it a promising development in preventive care.

What evidence suggests that this decision tool is effective for improving quality-adjusted life expectancy?

Research has shown that personalized health advice can be very effective. In this trial, some participants will receive individualized preventive care recommendations through a decision tool. Studies have demonstrated that this tool helps people understand how to prevent diseases before they start. Patients who used the tool rated it 9 out of 10 in surveys, describing it as very helpful. The tool prioritizes health services that could improve life expectancy, based on each person's unique risk factors. Overall, it makes healthcare more personal and effective by focusing on what each person specifically needs to stay healthy. ^{1 2 3 6 7}

Who Is on the Research Team?

Glen Taksler, PhD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8564576/

Effect of Individualized Preventive Care Recommendations ... An individualized preventive care decision tool was feasible, acceptable, and improved patient understanding of primary prevention. This ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05463887

NCT05463887 | Personalized Disease Prevention This study will evaluate whether patients and their providers benefit from an evidence-based decision tool to help prioritize preventive (and select chronic ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3487658/

Clinical Preventive Services for Older Adults - PubMed Central These and other innovative evaluative tools are vital to assessing the value of health spending, the quality of care delivered, and the outcomes realized for ...

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06750-7

Personalized Disease Prevention (PDP): study protocol for a ... Patients randomized to receive individualized preventive care recommendations found the tool helpful (median rating by survey, 9/10) and wanted ...

5. odphp.health.gov odphp.health.gov/news/202401/prevention-still-best-medicine

Prevention Is Still the Best Medicine - News & Events It also features a tool that people can use to get personalized recommendations for CPS. In addition, health professionals can add free ...

6. healthaffairs.org healthaffairs.org/doi/10.1377/hlthaff.2017.1248

Few Americans Receive All High-Priority, Appropriate ... ... Tools. Add to favorites · Download Citations · Track Citations · Permissions ... SOURCE Authors' analysis of data from the Preventive Services Self ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03023813

Individualizing Disease Prevention for Middle-Aged Adults ... A tailored decision tool will be provided to each participant during primary care appointments to facilitate discussion between the participant and his/her ...