Personalized Disease Prevention

N/AActive Not RecruitingNCT05463887

Glen Taksler660 enrolled

Overview

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.

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: 1. To measure whether use of individualized preventive care recommendations is likely to help patients live a longer life 2. To assess comprehension of the decision tool 3. To assess readiness to change 4. To assess use of shared decision-making 5. To measure outcomes for specific preventive services

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: 1. A provider assigned to the intervention arm of the RCT is the patient's primary care physician (PCP) of record in the EHR. 2. Aged 40-75 years. High-priority patients are defined as eligible patients who also meet all of the following inclusion criteria: 1. A modifiable lifestyle factor with a large impact on quality-adjusted life expectancy, assessed by ≥1 of the following: 1. current smoker 2. BMI ≥30.0 kg/m\^2 3. BP ≥140/90 mmHg 4. 10-year ASCVD risk ≥10% 5. HbA1c ≥9% 6. alcohol/week \>4.2 oz (98 g) for female or \>8.4 oz (196 g) for male 2. 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: 1. current smoker 2. BMI ≥27.0 kg/m\^2 3. systolic BP \>130 mmHg 4. 10-year ASCVD risk ≥7.5% 5. HbA1c ≥7.5% 6. alcohol/week \>4.2 oz (98 g) for female or \>8.4 oz (196 g) for male 7. Overdue or due soon for colorectal cancer screening, as of date that study team confirms "high-priority" eligibility criteria 8. Overdue or due soon for lung cancer screening, as of date that study team confirms "high-priority" eligibility criteria 9. Overdue for breast cancer screening for ≥1 year, as of date that study team confirms "high-priority" eligibility criteria 10. Overdue for osteoporosis screening for ≥1 year, as of date that study team confirms "high-priority" eligibility criteria 3. Ongoing primary care in the health system, defined as ≥2 visits with a primary care provider in the prior 730 days. 1. 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. 2. The term "visit" is defined as an in-person or virtual visit encounter. 4. An eligible encounter with the patient's primary care physician (PCP) of record in the EHR. "Eligible encounter" is defined as follows: 1. 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. 2. 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: 1. Cancer in the past 3 years (other than non-melanoma skin) 2. Diagnosis of alcohol abuse in past 3 years 3. History of myocardial infarction 4. History of stroke 5. End-stage renal disease 6. Moderate-severe congestive heart failure (moderate-severe may be ignored if needed to facilitate automatic data extraction) 7. Moderate-severe chronic obstructive pulmonary disease (moderate-severe may be ignored if needed to facilitate automatic data extraction) 8. Other comorbidity with limited life expectancy, in the opinion of ≥2 members of the study team. 9. 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: 1. Known current pregnancy. 2. Known acute care need that is likely to limit time available for discussion of preventive care. 3. 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.

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 6 months

Change in life expectancy

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

Time frame: 12 months

Change in life expectancy

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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).