Personalized Disease Prevention

Quality of Life Clinical Trial

— PDP  

Official title:

Personalized Disease Prevention (PDP): A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05463887
• Other study ID #: 19-151
• Secondary ID: R01AG059979
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2023
• Source: The Cleveland Clinic
• Contact: Glen Taksler, PhD
• Phone: 216-445-7499
• Email: taksleg[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 660
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Decision Support Techniques
• Healthy Aging
• Primary Prevention
• Quality of Life

Intervention

Behavioral:
• Individualized preventive care recommendations (decision tool)
Providers will receive individualized preventive care recommendations (decision tool) for eligible patients, and discuss them with patients using shared decision-making

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Glen Taksler	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (10)

Borsky A, Zhan C, Miller T, Ngo-Metzger Q, Bierman AS, Meyers D. Few Americans Receive All High-Priority, Appropriate Clinical Preventive Services. Health Aff (Millwood). 2018 Jun;37(6):925-928. doi: 10.1377/hlthaff.2017.1248. — View Citation

GBD 2019 Risk Factors Collaborators. Global burden of 87 risk factors in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1223-1249. doi: 10.1016/S0140-6736(20)30752-2. — View Citation

Krist AH, Glenn BA, Glasgow RE, Balasubramanian BA, Chambers DA, Fernandez ME, Heurtin-Roberts S, Kessler R, Ory MG, Phillips SM, Ritzwoller DP, Roby DH, Rodriguez HP, Sabo RT, Sheinfeld Gorin SN, Stange KC; MOHR Study Group. Designing a valid randomized pragmatic primary care implementation trial: the my own health report (MOHR) project. Implement Sci. 2013 Jun 25;8:73. doi: 10.1186/1748-5908-8-73. — View 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. — View Citation

Muntner P, Hardy ST, Fine LJ, Jaeger BC, Wozniak G, Levitan EB, Colantonio LD. Trends in Blood Pressure Control Among US Adults With Hypertension, 1999-2000 to 2017-2018. JAMA. 2020 Sep 22;324(12):1190-1200. doi: 10.1001/jama.2020.14545. — View Citation

Owens DK, Goldhaber-Fiebert JD. Prioritizing guideline-recommended interventions. Ann Intern Med. 2013 Aug 6;159(3):223-4. doi: 10.7326/0003-4819-159-3-201308060-00014. No abstract available. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient health	Patient self-rating of health (excellent, very good, good, fair, poor, prefer not to answer)	Within 3 business days of baseline encounter
Other	Not ready to change (top-ranked)	Proportion of a patient's top-ranked individualized preventive recommendations that s/he is not ready to change over the next 1 month. "Not ready to change" defined as self-rated score of =2 on a 7-point scale. Assessed by survey administered to high-priority patients.; Minimum=0, maximum=1, higher score indicates lower readiness to change (a worse 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
Other	Not ready to change (bottom-ranked)	Proportion of a patient's bottom-ranked individualized preventive recommendations that s/he is not ready to change over the next 1 month. "Not ready to change" defined as self-rated score of =2 on a 7-point scale. Assessed by survey administered to high-priority patients.; Minimum=0, maximum=1, higher score indicates lower readiness to change (a worse 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
Other	Mean readiness to change (top-ranked)	Mean readiness to change for a patient's top-ranked individualized preventive recommendations over the next 1 month. Self-reported by patients on a 7-point scale. Assessed by survey administered to high-priority patients.; Minimum=1, maximum=7, 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
Other	Mean readiness to change (bottom-ranked)	Mean readiness to change for a patient's bottom-ranked individualized preventive recommendations over the next 1 month. Self-reported by patients on a 7-point scale. Assessed by survey administered to high-priority patients.; Minimum=1, maximum=7, 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
Primary	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	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
Secondary	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
Secondary	Change in life expectancy	Change in life expectancy for high-priority patients in the intervention arm, as compared with the control arm.	6 months
Secondary	Change in life expectancy	Change in life expectancy for high-priority patients in the intervention arm, as compared with the control arm.	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   A and B Recommendations. US Preventive Services Task Force. Updated May 2021. Accessed August 3, 2021
•   The National Institute on Aging: Strategic Directions for Research, 2020-2025 National Institute on Aging. Accessed August 21, 2020,