Personalized Disease Prevention

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Personalized Disease Prevention (PDP): A Randomized Clinical Trial

Conditions
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Primary Prevention, Healthy Aging, Quality of Life, Decision Support Techniques

Intervention / Treatment
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* Behavioral: Individualized preventive care recommendations (decision tool)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel, partially-blinded, 1:1 allocation ratio.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Control arm: Participants will not receive individualized preventive care recommendations (decision tool). | |
| Active Comparator: Individualized preventive care recommendations (decision tool)<br>Intervention arm: Providers will receive individualized preventive care recommendations (decision tool) for eligible patients, and discuss them with patients using shared decision-making. | Behavioral: Individualized preventive care recommendations (decision tool)<br>* Providers will receive individualized preventive care recommendations (decision tool) for eligible patients, and discuss them with patients using shared decision-making<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality-adjusted life expectancy | Change in quality-adjusted life expectancy for high-priority patients in the intervention arm, as compared with the control arm. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality-adjusted life expectancy | Change in quality-adjusted life expectancy for high-priority patients in the intervention arm, as compared with the control arm. | 12 months | 
| Change in quality-adjusted life expectancy | Change in quality-adjusted life expectancy for high-priority patients in the intervention arm, as compared with the control arm. | Through study completion, approximately 2 to 3 years on average | 
| Change in life expectancy | Change in life expectancy for high-priority patients in the intervention arm, as compared with the control arm. | 6 months | 
| Change in life expectancy | Change in life expectancy for high-priority patients in the intervention arm, as compared with the control arm. | 12 months | 
| Change in life expectancy | Change in life expectancy for high-priority patients in the intervention arm, as compared with the control arm. | Through study completion, approximately 2 to 3 years on average | 
| Service most likely to improve quality-adjusted life expectancy | 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. | Within 3 business days of baseline encounter | 
| Service least likely to improve quality-adjusted life expectancy | 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. | Within 3 business days of baseline encounter | 
| True age | 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. | Within 3 business days of baseline encounter | 
| Readiness to change (top-ranked) | 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. | Within 3 business days of baseline encounter | 
| Readiness to change (bottom-ranked) | 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. | Within 3 business days of baseline encounter | 
| Shared decision-making | 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). | Within 3 business days of baseline encounter | 
| Weight loss | 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). | 6 months (12 months and all follow-up time points may be assessed) | 
| Systolic blood pressure | Change in systolic blood pressure since baseline encounter (mmHg). Assessed for subgroup of high-priority patients whose individualized preventive care recommendations included hypertension control. | 6 months (12 months and all follow-up time points may be assessed) | 
| HbA1c | Change in HbA1c since baseline encounter (percentage points). Assessed for subgroup of high-priority patients whose individualized preventive care recommendations included glycemic control. | 6 months (12 months and all follow-up time points may be assessed) | 
| Cardiovascular disease risk | 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. | 6 months (12 months and all follow-up time points may be assessed) | 
| LDL cholesterol | Change in LDL cholesterol (mg/dL). Assessed for subgroup of high-priority patients whose individualized preventive care recommendations included lipids control (cholesterol reduction). | 6 months (12 months and all follow-up time points may be assessed) | 
| Total cholesterol | Change in total cholesterol (mg/dL). Assessed for subgroup of high-priority patients whose individualized preventive care recommendations included lipids control (cholesterol reduction). | 6 months (12 months and all follow-up time points may be assessed) | 
| Healthy diet | 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. | 6 months (12 months and all follow-up time points may be assessed) | 
| Physical activity | 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. | 6 months (12 months and all follow-up time points may be assessed) | 
| Alcohol misuse | 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. | 6 months (12 months and all follow-up time points may be assessed) | 
| Tobacco cessation | Proportion of patients who quit smoking. Assessed for subgroup of high-priority patients whose individualized preventive care recommendations included tobacco cessation (quitting smoking). | 6 months (12 months and all follow-up time points may be assessed) | 
| Breast cancer screening | Proportion of patients who received breast cancer screening. Assessed for subgroup of high-priority patients whose individualized preventive care recommendations included breast cancer screening. | 6 months (12 months and all follow-up time points may be assessed) | 
| Cervical cancer screening | Proportion of patients who received cervical cancer screening. Assessed for subgroup of high-priority patients whose individualized preventive care recommendations included cervical cancer screening. | 6 months (12 months and all follow-up time points may be assessed) | 
| Colorectal cancer screening | Proportion of patients who received colorectal cancer screening. Assessed for subgroup of high-priority patients whose individualized preventive care recommendations included colorectal cancer screening. | 6 months (12 months and all follow-up time points may be assessed) | 
| Lung cancer screening | Proportion of patients who received lung cancer screening. Assessed for subgroup of high-priority patients whose individualized preventive care recommendations included lung cancer screening. | 6 months (12 months and all follow-up time points may be assessed) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preventive care services, Individualized disease prevention, Personalized medicine, Chronic disease management