Personalized Disease Prevention
- Conditions
- Primary PreventionHealthy AgingDecision Support TechniquesQuality of Life
- Interventions
- Behavioral: Individualized preventive care recommendations (decision tool)
- Registration Number
- NCT05463887
- Lead Sponsor
- Glen Taksler
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 660
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Individualized preventive care recommendations (decision tool) Individualized preventive care recommendations (decision tool) Intervention arm: Providers will receive individualized preventive care recommendations (decision tool) for eligible patients, and discuss them with patients using shared decision-making.
- Primary Outcome Measures
Name Time Method Change in quality-adjusted life expectancy 6 months Change in quality-adjusted life expectancy for high-priority patients in the intervention arm, as compared with the control arm.
- Secondary Outcome Measures
Name Time Method LDL cholesterol 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).
Change in life expectancy 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.
Service least likely to improve quality-adjusted life expectancy 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.
Weight loss 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).
Systolic blood pressure 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.
Service most likely to improve quality-adjusted life expectancy 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.
True age 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.
Readiness to change (bottom-ranked) 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.Shared decision-making 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).Change in quality-adjusted life expectancy 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.
Readiness to change (top-ranked) 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.HbA1c 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.
Cardiovascular disease risk 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.
Healthy diet 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.
Breast cancer screening 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.
Physical activity 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.
Alcohol misuse 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.
Tobacco cessation 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).
Cervical cancer screening 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.
Colorectal cancer screening 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.
Lung cancer screening 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.
Total cholesterol 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).
Trial Locations
- Locations (1)
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States