Clinical trial NCT05463887: Personalized Disease Prevention
Official title: Personalized Disease Prevention (PDP): a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Primary Prevention
Healthy Aging
Quality of Life
Decision Support Techniques
Keywords: Preventive care services
Individualized disease prevention
Personalized medicine
Chronic disease management
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-07-19
Enrollment: 660
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel, partially-blinded, 1:1 allocation ratio.
Primary purpose: PREVENTION

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change in quality-adjusted life expectancy
timeFrame: 6 months
Secondary outcomes:
measure: Change in quality-adjusted life expectancy
timeFrame: 12 months
measure: Change in quality-adjusted life expectancy
timeFrame: Through study completion, approximately 2 to 3 years on average
measure: Change in life expectancy
timeFrame: 6 months
measure: Change in life expectancy
timeFrame: 12 months
measure: Change in life expectancy
timeFrame: Through study completion, approximately 2 to 3 years on average
measure: Service most likely to improve quality-adjusted life expectancy
timeFrame: Within 3 business days of baseline encounter
measure: Service least likely to improve quality-adjusted life expectancy
timeFrame: Within 3 business days of baseline encounter
measure: True age
timeFrame: Within 3 business days of baseline encounter
measure: Readiness to change (top-ranked)
timeFrame: Within 3 business days of baseline encounter
measure: Readiness to change (bottom-ranked)
timeFrame: Within 3 business days of baseline encounter
measure: Shared decision-making
timeFrame: Within 3 business days of baseline encounter
measure: Weight loss
timeFrame: 6 months (12 months and all follow-up time points may be assessed)
measure: Systolic blood pressure
timeFrame: 6 months (12 months and all follow-up time points may be assessed)
measure: HbA1c
timeFrame: 6 months (12 months and all follow-up time points may be assessed)
measure: Cardiovascular disease risk
timeFrame: 6 months (12 months and all follow-up time points may be assessed)
measure: LDL cholesterol
timeFrame: 6 months (12 months and all follow-up time points may be assessed)
measure: Total cholesterol
timeFrame: 6 months (12 months and all follow-up time points may be assessed)
measure: Healthy diet
timeFrame: 6 months (12 months and all follow-up time points may be assessed)
measure: Physical activity
timeFrame: 6 months (12 months and all follow-up time points may be assessed)
measure: Alcohol misuse
timeFrame: 6 months (12 months and all follow-up time points may be assessed)
measure: Tobacco cessation
timeFrame: 6 months (12 months and all follow-up time points may be assessed)
measure: Breast cancer screening
timeFrame: 6 months (12 months and all follow-up time points may be assessed)
measure: Cervical cancer screening
timeFrame: 6 months (12 months and all follow-up time points may be assessed)
measure: Colorectal cancer screening
timeFrame: 6 months (12 months and all follow-up time points may be assessed)
measure: Lung cancer screening
timeFrame: 6 months (12 months and all follow-up time points may be assessed)
Other outcomes:
measure: Patient health
timeFrame: Within 3 business days of baseline encounter
measure: Not ready to change (top-ranked)
timeFrame: Within 3 business days of baseline encounter
measure: Not ready to change (bottom-ranked)
timeFrame: Within 3 business days of baseline encounter
measure: Mean readiness to change (top-ranked)
timeFrame: Within 3 business days of baseline encounter
measure: Mean readiness to change (bottom-ranked)
timeFrame: Within 3 business days of baseline encounter
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Glen Taksler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taksler GB, Hu B, DeGrandis F Jr, Montori VM, Fagerlin A, Nagykaldi Z, Rothberg MB. Effect of Individualized Preventive Care Recommendations vs Usual Care on Patient Interest and Use of Recommendations: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2021 Nov 1;4(11):e2131455. doi: 10.1001/jamanetworkopen.2021.31455.
citation: Zhang JJ, Rothberg MB, Misra-Hebert AD, Gupta NM, Taksler GB. Assessment of Physician Priorities in Delivery of Preventive Care. JAMA Netw Open. 2020 Jul 1;3(7):e2011677. doi: 10.1001/jamanetworkopen.2020.11677.
citation: Taksler GB, Beth Mercer M, Fagerlin A, Rothberg MB. Assessing Patient Interest in Individualized Preventive Care Recommendations. MDM Policy Pract. 2019 May 27;4(1):2381468319850803. doi: 10.1177/2381468319850803. eCollection 2019 Jan-Jun.
citation: Taksler GB, Keshner M, Fagerlin A, Hajizadeh N, Braithwaite RS. Personalized estimates of benefit from preventive care guidelines: a proof of concept. Ann Intern Med. 2013 Aug 6;159(3):161-8. doi: 10.7326/0003-4819-159-3-201308060-00005.
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citation: Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30.
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citation: Taksler GB, Le P, Hu B, Alberts J, Flynn AJ, Rothberg MB. Personalized Disease Prevention (PDP): study protocol for a cluster-randomized clinical trial. Trials. 2022 Oct 22;23(1):892. doi: 10.1186/s13063-022-06750-7.