Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
660 participants
INTERVENTIONAL
2022-08-05
2026-01-31
Brief Summary
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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
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
The nature of the randomized trial requires interaction with participants throughout the study (e.g., ongoing feedback from intervention arm providers, qualitative interviews with patients and providers), the assignment of participants to the intervention vs. control arm will be unblinded for the entire study team. Only the stratification of outcomes and safety events by study arm will be blinded.
Study Groups
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Usual care
Control arm: Participants will not receive individualized preventive care recommendations (decision tool).
No interventions assigned to this group
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. Aged 40-75 years.
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).
Exclusion Criteria
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.
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.
40 Years
75 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Glen Taksler
OTHER
Responsible Party
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Glen Taksler
Staff, Cleveland Clinic and Associate Professor of Medicine, Cleveland Clinic Lerner College of Medicine
Principal Investigators
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Glen Taksler, PhD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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A and B Recommendations. US Preventive Services Task Force. Updated May 2021. Accessed August 3, 2021
Other Identifiers
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19-151
Identifier Type: -
Identifier Source: org_study_id