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Completed

NCT Number: 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 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.

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Key information

Conditions

Primary Prevention Decision Support Techniques Healthy Aging Quality of Life

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

The study will evaluate whether patients and their providers benefit from an evidence-based decision tool to help prioritize preventive services based on their potential to improve quality-adjusted life expectancy, individualized for patient risk factors. This partially-blinded 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. It is hypothesized that quality-adjusted life expectancy will increase by more in high-priority patients who receive the intervention, as compared with a control group.

Objectives:

Primary objective: To measure whether use of individualized preventive care recommendations is likely to help patients live a longer, healthier life.

Secondary objectives:

  • To measure whether use of individualized preventive care recommendations is likely to help patients live a longer life
  • To assess comprehension of the decision tool
  • To assess readiness to change
  • To assess use of shared decision-making
  • To measure outcomes for specific preventive services

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Patient eligibility criteria. This study define 2 types of patients, "eligible" patients and "high-priority" patients. "Eligible" patients are a broadly-defined group of patients of the intervention arm providers, for whom the providers will be able to access individualized preventive care recommendations. Eligible patients are subject to a waiver of informed consent. "High-priority" patients are a more narrowly-defined subset of eligible patients, who will be contacted by the study team for follow-up.

Eligible patients will have the following inclusion criteria:

  • A provider assigned to the intervention arm of the RCT is the patient's primary care physician (PCP) of record in the EHR.
  • Aged 40-75 years.

High-priority patients are defined as eligible patients who also meet all of the following inclusion criteria:

  • A modifiable lifestyle factor with a large impact on quality-adjusted life expectancy, assessed by ≥1 of the following:
  • current smoker
  • BMI ≥30.0 kg/m^2
  • BP ≥140/90 mmHg
  • 10-year ASCVD risk ≥10%
  • HbA1c ≥9%
  • alcohol/week >4.2 oz (98 g) for female or >8.4 oz (196 g) for male
  • Eligible for a high number of preventive services, assessed by ≥3 of the following. Factor(s) used to satisfy criteria 1 also count toward satisfying criteria 2:
  • current smoker
  • BMI ≥27.0 kg/m^2
  • systolic BP >130 mmHg
  • 10-year ASCVD risk ≥7.5%
  • HbA1c ≥7.5%
  • alcohol/week >4.2 oz (98 g) for female or >8.4 oz (196 g) for male
  • Overdue or due soon for colorectal cancer screening, as of date that study team confirms "high-priority" eligibility criteria
  • Overdue or due soon for lung cancer screening, as of date that study team confirms "high-priority" eligibility criteria
  • Overdue for breast cancer screening for ≥1 year, as of date that study team confirms "high-priority" eligibility criteria
  • Overdue for osteoporosis screening for ≥1 year, as of date that study team confirms "high-priority" eligibility criteria
  • Ongoing primary care in the health system, defined as ≥2 visits with a primary care provider in the prior 730 days.
  • The term "primary care provider" is defined as an attending physician, nurse practitioner or physician assistant in the Department of Internal Medicine or Department of Family Medicine with an established patient panel.
  • The term "visit" is defined as an in-person or virtual visit encounter.
  • An eligible encounter with the patient's primary care physician (PCP) of record in the EHR. "Eligible encounter" is defined as follows:
  • An annual wellness visit (sometimes called a physical) with scheduled length of 40 minutes, or for some practice sites or departments, 30 minutes. These encounters typically focus on preventive care and are more likely to allow enough time to engage in shared decision-making.
  • For patients without an annual wellness visit in the prior 2 years, a visit with scheduled length at least 30 minutes, or a shorter length directly related to at least one service relevant to the research study (e.g., the EHR notes field indicates that a patient is scheduled for a follow-up of hypertension).

Eligible patients have the following exclusion criteria, defined as ≥1 of the following:

  • Cancer in the past 3 years (other than non-melanoma skin)
  • Diagnosis of alcohol abuse in past 3 years
  • History of myocardial infarction
  • History of stroke
  • End-stage renal disease
  • Moderate-severe congestive heart failure (moderate-severe may be ignored if needed to facilitate automatic data extraction)
  • Moderate-severe chronic obstructive pulmonary disease (moderate-severe may be ignored if needed to facilitate automatic data extraction)
  • Other comorbidity with limited life expectancy, in the opinion of ≥2 members of the study team.
  • Inability to communicate or limited communication (speaking, reading, writing) in the English language.

In addition to the above, high-priority eligible patients also have the following exclusion criteria, defined as ≥1 of the following:

  • Known current pregnancy.
  • Known acute care need that is likely to limit time available for discussion of preventive care.
  • The first primary care encounter since a hospitalization, surgery or emergency department utilization.

There will be no exclusion from the study on the basis of race or ethnicity.

Treatment and study plan

Individualized preventive care recommendations (decision tool)

Behavioral

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

Primary outcomes

  1. Change in quality-adjusted life expectancy

    Time frame: 6 months

    Change in quality-adjusted life expectancy for high-priority patients in the intervention arm, as compared with the control arm.

Secondary outcomes

  1. Change in quality-adjusted life expectancy

    Time frame: 12 months

    Change in quality-adjusted life expectancy for high-priority patients in the intervention arm, as compared with the control arm.

  2. Change in quality-adjusted life expectancy

    Time frame: Through study completion, approximately 2 to 3 years on average

    Change in quality-adjusted life expectancy for high-priority patients in the intervention arm, as compared with the control arm.

  3. Change in life expectancy

    Time frame: 6 months

    Change in life expectancy for high-priority patients in the intervention arm, as compared with the control arm.

  4. Change in life expectancy

    Time frame: 12 months

    Change in life expectancy for high-priority patients in the intervention arm, as compared with the control arm.

  5. Change in life expectancy

    Time frame: Through study completion, approximately 2 to 3 years on average

    Change in life expectancy for high-priority patients in the intervention arm, as compared with the control arm.

  6. Service most likely to improve quality-adjusted life expectancy

    Time frame: Within 3 business days of baseline encounter

    Correct identification of the service most likely to improve a patient's quality-adjusted life expectancy. Assessed by survey administered to high-priority patients. Correct answer based on each patient's individualized preventive care recommendations.

  7. Service least likely to improve quality-adjusted life expectancy

    Time frame: Within 3 business days of baseline encounter

    Correct identification of the service least likely to improve a patient's quality-adjusted life expectancy. Assessed by survey administered to high-priority patients. Correct answer based on each patient's individualized preventive care recommendations.

  8. True age

    Time frame: Within 3 business days of baseline encounter

    Correct identification of a patient's true age (the age most commonly associated with his/her quality-adjusted life expectancy), in relation to his/her biological age. Assessed by survey administered to high-priority patients. Correct answer based on each patient's individualized preventive care recommendations.

  9. Readiness to change (top-ranked)

    Time frame: Within 3 business days of baseline encounter

    Proportion of a patient's top-ranked individualized preventive recommendations that s/he is ready to change over the next 1 month. "Ready to change" defined as self-rated score of ≥6 on a 7-point scale. Assessed by survey administered to high-priority patients.

    Minimum=0, maximum=1, higher score indicates greater readiness to change (a better outcome).

    Top-ranked individualized preventive care recommendations defined as follows: top 3 for patients with ≥6 recommendations, 2 for patients with 4-5 recommendations, 1 for patients with 3 recommendations, not applicable for patients with ≤2 recommendations.

  10. Readiness to change (bottom-ranked)

    Time frame: Within 3 business days of baseline encounter

    Proportion of a patient's bottom-ranked individualized preventive recommendations that s/he is ready to change over the next 1 month. "Ready to change" defined as self-rated score of ≥6 on a 7-point scale. Assessed by survey administered to high-priority patients.

    Minimum=0, maximum=1, higher score indicates greater readiness to change (a better outcome).

    Bottom-ranked individualized preventive care recommendations defined as follows: bottom 3 for patients with ≥6 recommendations, 2 for patients with 4-5 recommendations, 1 for patients with 3 recommendations, not applicable for patients with ≤2 recommendations.

  11. Shared decision-making

    Time frame: Within 3 business days of baseline encounter

    Use of shared decision-making at baseline encounter, measured by score on SDM-Q-9 validated survey metric. Assessed by survey administered to high-priority patients.

    SDM-Q-9 scale of shared decision-making: minimum=9, maximum=54, higher score indicates greater use of shared decision-making (a better outcome).

  12. Weight loss

    Time frame: 6 months (12 months and all follow-up time points may be assessed)

    Percent change in body weight since baseline encounter. Assessed for subgroup of high-priority patients whose individualized preventive care recommendations included a preventive service to help lose weight (e.g., healthy diet, physical activity, consideration of bariatric surgery).

  13. Systolic blood pressure

    Time frame: 6 months (12 months and all follow-up time points may be assessed)

    Change in systolic blood pressure since baseline encounter (mmHg). Assessed for subgroup of high-priority patients whose individualized preventive care recommendations included hypertension control.

  14. HbA1c

    Time frame: 6 months (12 months and all follow-up time points may be assessed)

    Change in HbA1c since baseline encounter (percentage points). Assessed for subgroup of high-priority patients whose individualized preventive care recommendations included glycemic control.

  15. Cardiovascular disease risk

    Time frame: 6 months (12 months and all follow-up time points may be assessed)

    Change in 10-year atherosclerotic cardiovascular disease risk (percentage points), measured by American College of Cardiology/American Heart Association pooled cohort equations. Assessed for subgroup of high-priority patients whose individualized preventive care recommendations included control of hypertension or hyperlipidemia.

  16. LDL cholesterol

    Time frame: 6 months (12 months and all follow-up time points may be assessed)

    Change in LDL cholesterol (mg/dL). Assessed for subgroup of high-priority patients whose individualized preventive care recommendations included lipids control (cholesterol reduction).

  17. Total cholesterol

    Time frame: 6 months (12 months and all follow-up time points may be assessed)

    Change in total cholesterol (mg/dL). Assessed for subgroup of high-priority patients whose individualized preventive care recommendations included lipids control (cholesterol reduction).

  18. Healthy diet

    Time frame: 6 months (12 months and all follow-up time points may be assessed)

    Change in dietary quality (score on modified Starting the Conversation dietary assessment): minimum=0, maximum=16, higher score indicates less healthy diet (a worse outcome). Assessed for subgroup of high-priority patients whose individualized preventive care recommendations included healthy diet.

  19. Physical activity

    Time frame: 6 months (12 months and all follow-up time points may be assessed)

    Change in physical activity (score on modified International Physical Activity Questionnaire-Short Form): minimum=0, maximum=5508, higher score indicates more physical activity (a better outcome). Assessed for subgroup of high-priority patients whose individualized preventive care recommendations included physical activity.

  20. Alcohol misuse

    Time frame: 6 months (12 months and all follow-up time points may be assessed)

    Change in alcohol misuse (score on AUDIT-C questionnaire): minimum=0, maximum=12, higher score indicates greater alcohol misuse (a worse outcome). Assessed for subgroup of high-priority patients whose individualized preventive care recommendations included alcohol use reduction.

  21. Tobacco cessation

    Time frame: 6 months (12 months and all follow-up time points may be assessed)

    Proportion of patients who quit smoking. Assessed for subgroup of high-priority patients whose individualized preventive care recommendations included tobacco cessation (quitting smoking).

  22. Breast cancer screening

    Time frame: 6 months (12 months and all follow-up time points may be assessed)

    Proportion of patients who received breast cancer screening. Assessed for subgroup of high-priority patients whose individualized preventive care recommendations included breast cancer screening.

  23. Cervical cancer screening

    Time frame: 6 months (12 months and all follow-up time points may be assessed)

    Proportion of patients who received cervical cancer screening. Assessed for subgroup of high-priority patients whose individualized preventive care recommendations included cervical cancer screening.

  24. Colorectal cancer screening

    Time frame: 6 months (12 months and all follow-up time points may be assessed)

    Proportion of patients who received colorectal cancer screening. Assessed for subgroup of high-priority patients whose individualized preventive care recommendations included colorectal cancer screening.

  25. Lung cancer screening

    Time frame: 6 months (12 months and all follow-up time points may be assessed)

    Proportion of patients who received lung cancer screening. Assessed for subgroup of high-priority patients whose individualized preventive care recommendations included lung cancer screening.

Other outcomes

  1. Patient health

    Time frame: Within 3 business days of baseline encounter

    Patient self-rating of health (excellent, very good, good, fair, poor, prefer not to answer)

  2. Not ready to change (top-ranked)

    Time frame: Within 3 business days of baseline encounter

    Proportion of a patient's top-ranked individualized preventive recommendations that s/he is not ready to change over the next 1 month. "Not ready to change" defined as self-rated score of ≤2 on a 7-point scale. Assessed by survey administered to high-priority patients.

    Minimum=0, maximum=1, higher score indicates lower readiness to change (a worse outcome).

    Top-ranked individualized preventive care recommendations defined as follows: top 3 for patients with ≥6 recommendations, 2 for patients with 4-5 recommendations, 1 for patients with 3 recommendations, not applicable for patients with ≤2 recommendations.

  3. Not ready to change (bottom-ranked)

    Time frame: Within 3 business days of baseline encounter

    Proportion of a patient's bottom-ranked individualized preventive recommendations that s/he is not ready to change over the next 1 month. "Not ready to change" defined as self-rated score of ≤2 on a 7-point scale. Assessed by survey administered to high-priority patients.

    Minimum=0, maximum=1, higher score indicates lower readiness to change (a worse outcome).

    Bottom-ranked individualized preventive care recommendations defined as follows: bottom 3 for patients with ≥6 recommendations, 2 for patients with 4-5 recommendations, 1 for patients with 3 recommendations, not applicable for patients with ≤2 recommendations.

  4. Mean readiness to change (top-ranked)

    Time frame: Within 3 business days of baseline encounter

    Mean readiness to change for a patient's top-ranked individualized preventive recommendations over the next 1 month. Self-reported by patients on a 7-point scale. Assessed by survey administered to high-priority patients.

    Minimum=1, maximum=7, higher score indicates greater readiness to change (a better outcome).

    Top-ranked individualized preventive care recommendations defined as follows: top 3 for patients with ≥6 recommendations, 2 for patients with 4-5 recommendations, 1 for patients with 3 recommendations, not applicable for patients with ≤2 recommendations.

  5. Mean readiness to change (bottom-ranked)

    Time frame: Within 3 business days of baseline encounter

    Mean readiness to change for a patient's bottom-ranked individualized preventive recommendations over the next 1 month. Self-reported by patients on a 7-point scale. Assessed by survey administered to high-priority patients.

    Minimum=1, maximum=7, higher score indicates greater readiness to change (a better outcome).

    Bottom-ranked individualized preventive care recommendations defined as follows: bottom 3 for patients with ≥6 recommendations, 2 for patients with 4-5 recommendations, 1 for patients with 3 recommendations, not applicable for patients with ≤2 recommendations.

Sponsors and collaborators

Lead sponsor

Glen Taksler

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Personalized Disease Prevention (PDP): A Randomized Clinical Trial

Acronym: PDP

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 19, 2022
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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