Primary PreventionPDPNCT05463887
Personalized Disease Prevention
A study testing Individualized preventive care recommendations (decision tool) in people with Primary Prevention and Healthy Aging, run by Glen Taksler at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Prevention, Healthy Aging, Quality of Life
- What is being tested?
- Individualized preventive care recommendations (decision tool)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 721 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2022to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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:
- A provider assigned to the intervention arm of the RCT is the patient's primary care physician (PCP) of record in the EHR.
- Aged 40-75 years.
High-priority patients are defined as eligible patients who also meet all of the following inclusion criteria:
- A modifiable lifestyle factor with a large impact on quality-adjusted life expectancy, assessed by ≥1 of the following:
- current smoker
- BMI ≥30.0 kg/m^2
- BP ≥140/90 mmHg
- 10-year ASCVD risk ≥10%
- HbA1c ≥9%
- alcohol/week >4.2 oz (98 g) for female or >8.4 oz (196 g) for male
- 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:
- current smoker
- BMI ≥27.0 kg/m^2
- systolic BP >130 mmHg
- 10-year ASCVD risk ≥7.5%
- HbA1c ≥7.5%
- alcohol/week >4.2 oz (98 g) for female or >8.4 oz (196 g) for male
- Overdue or due soon for colorectal cancer screening, as of date that study team confirms "high-priority" eligibility criteria
- Overdue or due soon for lung cancer screening, as of date that study team confirms "high-priority" eligibility criteria
- Overdue for breast cancer screening for ≥1 year, as of date that study team confirms "high-priority" eligibility criteria
- Overdue for osteoporosis screening for ≥1 year, as of date that study team confirms "high-priority" eligibility criteria
- Ongoing primary care in the health system, defined as ≥2 visits with a primary care provider in the prior 730 days.
- 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.
- The term "visit" is defined as an in-person or virtual visit encounter.
- An eligible encounter with the patient's primary care physician (PCP) of record in the EHR. "Eligible encounter" is defined as follows:
- 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.
- 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:
- Cancer in the past 3 years (other than non-melanoma skin)
- Diagnosis of alcohol abuse in past 3 years
- History of myocardial infarction
- History of stroke
- End-stage renal disease
- Moderate-severe congestive heart failure (moderate-severe may be ignored if needed to facilitate automatic data extraction)
- Moderate-severe chronic obstructive pulmonary disease (moderate-severe may be ignored if needed to facilitate automatic data extraction)
- Other comorbidity with limited life expectancy, in the opinion of ≥2 members of the study team.
- 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:
- Known current pregnancy.
- Known acute care need that is likely to limit time available for discussion of preventive care.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Disease Prevention (PDP): A Randomized Clinical Trial
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.
Read the 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:
- To measure whether use of individualized preventive care recommendations is likely to help patients live a longer life
- To assess comprehension of the decision tool
- To assess readiness to change
- To assess use of shared decision-making
- To measure outcomes for specific preventive services
- Being tested
- Individualized preventive care recommendations (decision tool)
- Keywords
- Preventive care services, Individualized disease prevention, Personalized medicine, Chronic disease management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized preventive care recommendations (decision tool)Behavioural
Providers will receive individualized preventive care recommendations (decision tool) for eligible patients, and discuss them with patients using shared decision-making
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Control arm: Participants will not receive individualized preventive care recommendations (decision tool). |
| Individualized preventive care recommendations (decision tool) | Active comparator | Intervention arm: Providers will receive individualized preventive care recommendations (decision tool) for eligible patients, and discuss them with patients using shared decision-making. Receives: Behavioral: Individualized preventive care recommendations (decision tool) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (25)
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Change in life expectancy
Change in life expectancy for high-priority patients in the intervention arm, as compared with the control arm.
Measured: 12 months
Change in life expectancy
Change in life expectancy for high-priority patients in the intervention arm, as compared with the control arm.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 6 months (12 months and all follow-up time points may be assessed)
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.
Measured: 6 months (12 months and all follow-up time points may be assessed)
HbA1c
Change in HbA1c since baseline encounter (percentage points). Assessed for subgroup of high-priority patients whose individualized preventive care recommendations included glycemic control.
Measured: 6 months (12 months and all follow-up time points may be assessed)
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.
Measured: 6 months (12 months and all follow-up time points may be assessed)
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).
Measured: 6 months (12 months and all follow-up time points may be assessed)
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).
Measured: 6 months (12 months and all follow-up time points may be assessed)
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.
Measured: 6 months (12 months and all follow-up time points may be assessed)
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.
Measured: 6 months (12 months and all follow-up time points may be assessed)
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.
Measured: 6 months (12 months and all follow-up time points may be assessed)
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).
Measured: 6 months (12 months and all follow-up time points may be assessed)
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.
Measured: 6 months (12 months and all follow-up time points may be assessed)
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.
Measured: 6 months (12 months and all follow-up time points may be assessed)
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.
Measured: 6 months (12 months and all follow-up time points may be assessed)
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.
Measured: 6 months (12 months and all follow-up time points may be assessed)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start5 Aug 2022
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Primary PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel, partially-blinded, 1:1 allocation ratio.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 721 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glen Taksler
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Glen Taksler, The Cleveland Clinic
- Investigators
- Glen Taksler, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463887
- Sponsor's protocol ID
- 19-151
- Other IDs
- R01AG059979
- Acronym
- PDP
- Status last verified
- Feb 2026
- First submitted
- 20 Jun 2022
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data, subject to compliance with institutional policies (for example, approval from Cleveland Clinic Institutional Review Board). Specific variables may be excluded based on organizational policies, local institutional review board rules, and local, state and federal laws and regulations, including the HIPAA Privacy Rule. Examples include any data that the study team is legally prohibited from sharing, data for which subjects do not provide consent or data which could result in identification of subjects. Should this trial result in an invention or intended patent, some aspects of data sharing may be delayed or withheld as appropriate; for example, to allow time to complete necessary filings and/or execute the invention or patent.
Publications
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.
PubMed 34726747Zhang 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.
PubMed 32716515Taksler 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.
PubMed 31192307Taksler 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.
PubMed 23922061Owens 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.
PubMed 23922066Borsky 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.
PubMed 29863918Muntner 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.
PubMed 32902588Krist 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.
PubMed 23799943Kriston 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.
PubMed 19879711GBD 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.
PubMed 33069327Taksler 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.
PubMed 36273151
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Disease Prevention (PDP): A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05463887
- Acronym / sponsor ID
- PDP / 19-151
- Keywords
- Preventive care services, Individualized disease prevention, Personalized medicine, Chronic disease management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 721 participants (actual)
- Lead sponsor
- Glen TakslerUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To measure whether use of individualized preventive care recommendations is likely to help patients live a longer life
- To assess comprehension of the decision tool
- To assess readiness to change
- To assess use of shared decision-making
- To measure outcomes for specific preventive services
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- parallel, partially-blinded, 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Control arm: Participants will not receive individualized preventive care recommendations (decision tool). |
| Individualized preventive care recommendations (decision tool) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Individualized preventive care recommendations (decision tool) |
Primary outcome
Change in quality-adjusted life expectancy
Time frame: 6 months
Change in quality-adjusted life expectancy for high-priority patients in the intervention arm, as compared with the control arm.
25 secondary outcomes
Change in quality-adjusted life expectancy
Time frame: 12 months
Change in quality-adjusted life expectancy
Time frame: Through study completion, approximately 2 to 3 years on average
Change in life expectancy
Time frame: 6 months
Change in life expectancy
Time frame: 12 months
Change in life expectancy
Time frame: Through study completion, approximately 2 to 3 years on average
Service most likely to improve quality-adjusted life expectancy
Time frame: Within 3 business days of baseline encounter
Service least likely to improve quality-adjusted life expectancy
Time frame: Within 3 business days of baseline encounter
True age
Time frame: Within 3 business days of baseline encounter
Readiness to change (top-ranked)
Time frame: Within 3 business days of baseline encounter
Readiness to change (bottom-ranked)
Time frame: Within 3 business days of baseline encounter
Shared decision-making
Time frame: Within 3 business days of baseline encounter
Weight loss
Time frame: 6 months (12 months and all follow-up time points may be assessed)
Systolic blood pressure
Time frame: 6 months (12 months and all follow-up time points may be assessed)
HbA1c
Time frame: 6 months (12 months and all follow-up time points may be assessed)
Cardiovascular disease risk
Time frame: 6 months (12 months and all follow-up time points may be assessed)
LDL cholesterol
Time frame: 6 months (12 months and all follow-up time points may be assessed)
Total cholesterol
Time frame: 6 months (12 months and all follow-up time points may be assessed)
Healthy diet
Time frame: 6 months (12 months and all follow-up time points may be assessed)
Physical activity
Time frame: 6 months (12 months and all follow-up time points may be assessed)
Alcohol misuse
Time frame: 6 months (12 months and all follow-up time points may be assessed)
Tobacco cessation
Time frame: 6 months (12 months and all follow-up time points may be assessed)
Breast cancer screening
Time frame: 6 months (12 months and all follow-up time points may be assessed)
Cervical cancer screening
Time frame: 6 months (12 months and all follow-up time points may be assessed)
Colorectal cancer screening
Time frame: 6 months (12 months and all follow-up time points may be assessed)
Lung cancer screening
Time frame: 6 months (12 months and all follow-up time points may be assessed)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Background: PubMed 34726747Taksler 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.
- Background: PubMed 32716515Zhang 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.
- Background: PubMed 31192307Taksler 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.
- Background: PubMed 23922061Taksler 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.
- Background: PubMed 23922066Owens 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.
- Background: PubMed 29863918Borsky 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.
- Background: PubMed 32902588Muntner 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.
- Background: PubMed 23799943Krist 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.
- Background: PubMed 19879711Kriston 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.
- Background: PubMed 33069327GBD 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.
- Derived from this study: PubMed 36273151Taksler 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.
- A and B Recommendations. US Preventive Services Task Force. Updated May 2021. Accessed August 3, 2021Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data, subject to compliance with institutional policies (for example, approval from Cleveland Clinic Institutional Review Board). Specific variables may be excluded based on organizational policies, local institutional review board rules, and local, state and federal laws and regulations, including the HIPAA Privacy Rule. Examples include any data that the study team is legally prohibited from sharing, data for which subjects do not provide consent or data which could result in identification of subjects. Should this trial result in an invention or intended patent, some aspects of data sharing may be delayed or withheld as appropriate; for example, to allow time to complete necessary filings and/or execute the invention or patent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glen Taksler, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized preventive care recommendations (decision tool) in people with Primary Prevention and Healthy Aging, run by Glen Taksler at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality-adjusted life expectancy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05463887, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.