Individualizing Disease Prevention for Middle-Aged Adults

Study Overview
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Brief Summary
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The primary objective of this study is to help patients compare the benefits of various preventive care services, based on their individual risk factors (such as smoking status, obesity, high blood pressure, high cholesterol, etc.). A tailored decision tool will be provided to each participant during primary care appointments to facilitate discussion between the participant and his/her provider regarding prioritizing preventive service recommendations.

Official Title
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Individualizing Disease Prevention for Middle-Aged Adults

Conditions
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Primary Health Care

Intervention / Treatment
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* Other: Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for an appointment with primary care provider during study period Two or more of the following risk factors: Tobacco use Overweight/obese Hypertension Hyperlipidemia Diabetes Alcohol Misuse Depression History of Sexually Transmitted Infection Being overdue for the following screenings: Colorectal, cervical, breast, lung Exclusion Criteria: - Severely limited life expectancy (cancer, congestive heart failure, chronic obstructive pulmonary disease, end stage renal disease)

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 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: Multiple round pilot testing. Some round(s) will have a single group with 1 arm. Other round(s) will be parallel with 2 arms.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Individualized preventive care recommendations will be distributed to subjects. | Other: Intervention<br>* Written material provided.<br>|
| No Intervention: Control<br>Usual care | |
| Experimental: Development Phase<br>Non-randomized receipt of individualized preventive care recommendations | Other: Intervention<br>* Written material provided.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interest in Individualized Preventive Care Recommendations. | Measured by individualized preventive service recommendations, tailored to patient's specific medical conditions. Measured by surveys. Survey question: Overall, how helpful did you find the written materials (handouts)? Ten point scale (minimum 1, maximum 10, higher score is better outcome) | Within 3 days of index primary care appointment. | 
| Interest in Individualized Preventive Care Recommendations. | Measured by individualized preventive service recommendations, tailored to patient's specific medical conditions. Measured by surveys. Survey question: In the future, would you like to see updated written materials (handouts)? Ten point scale (minimum 1, maximum 10, higher score is better outcome) | Within 3 days of index primary care appointment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of Shared Decision Making. | Measured by surveys. Survey metric: Shared Decision Making (SDM)-Q-9 validated scale, converted to 100 point denominator 100 point scale (minimum 1, maximum 100, higher score is better outcome) | Within 3 days of index primary care appointment. | 
| Patient Readiness to Change Health Behaviors. | Measured by surveys. Proportion of top-3 individualized preventive service recommendations ready to change over next 1 month Numerator: Number of top-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 1 month (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower | Within 3 days of index primary care appointment. | 
| Patient Readiness to Change Health Behaviors | Measured by surveys Proportion of top-3 individualized preventive service recommendations ready to change over next 2-6 months Numerator: Number of top-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 2-6 months (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower | Within 3 days of index primary care appointment | 
| Patient Readiness to Change Health Behaviors. | Measured by surveys Proportion of bottom-3 individualized preventive service recommendations ready to change over next 1 month Numerator: Number of bottom-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 1 month (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower | Within 3 days of index primary care appointment | 
| Patient Readiness to Change Health Behaviors | Measured by surveys. Proportion of bottom-3 individualized preventive service recommendations ready to change over next 2-6 months Numerator: Number of bottom-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 2-6 months (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower | Within 3 days of index primary care appointment | 
| Decisional Comfort. | Measured by surveys. Survey metric: Decisional Conflict Scale (validated scale), converted to 100 point denominator 100 point scale (minimum 1, maximum 100, higher score is better outcome) | Within 3 days of index primary care appointment. | 
| Preventive Care Outcomes for Patients. | Number of participants with at least 1 follow-up encounter during the 1 year after an index encounter. | Within 1 year of index primary care appointment. |