Personalized Disease Prevention

NCT05463887 | Completed DMC

• 2 other identifiers: 19-151R01AG059979
• Study Type: interventional
• Target: 721
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Preventive care services; Individualized disease prevention; Personalized medicine; Chronic disease management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (25)

• Change in quality-adjusted life expectancy

  12 months

• Change in quality-adjusted life expectancy

  Through study completion, approximately 2 to 3 years on average

• Change in life expectancy

  6 months

• Change in life expectancy

  12 months

• Change in life expectancy

  Through study completion, approximately 2 to 3 years on average

Other Outcomes (5)

• Patient health

  Within 3 business days of baseline encounter

• Not ready to change (top-ranked)

  Within 3 business days of baseline encounter

• Not ready to change (bottom-ranked)

  Within 3 business days of baseline encounter

Study Arms (2)

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.

Behavioral: Individualized preventive care recommendations (decision tool)

Interventions

Individualized preventive care recommendations (decision tool) BEHAVIORAL

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)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• 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
• year ASCVD risk ≥7.5%
• HbA1c ≥7.5%

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Glen Taksler: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (11)

• 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.

  PMID: 34726747 BACKGROUND

• 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.

  PMID: 32716515 BACKGROUND

• 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.

  PMID: 31192307 BACKGROUND

• 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.

  PMID: 23922061 BACKGROUND

• 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.

  PMID: 23922066 BACKGROUND

• 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.

  PMID: 29863918 BACKGROUND

• 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.

  PMID: 32902588 BACKGROUND

• 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.

  PMID: 23799943 BACKGROUND

• 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.

  PMID: 19879711 BACKGROUND

• 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.

  PMID: 33069327 BACKGROUND

• 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.

  PMID: 36273151 DERIVED

Related Links

• A and B Recommendations. US Preventive Services Task Force. Updated May 2021. Accessed August 3, 2021

Study Officials

• Glen Taksler, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: With the exception of the study biostatistician(s) and a safety assessor(s), all Co-Investigators participating in the randomized trial will be blinded to outcomes and safety events by study arm. 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff

Model Details: parallel, partially-blinded, 1:1 allocation ratio.

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: July 19, 2022
• Study Start: August 5, 2022
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data expected to be available by the online publication date of manuscript(s) resulting from this study, or the date of institutional approval to share data, whichever is later. Data expected to remain available for at least 6 years after study conclusion.
• Access Criteria: Data must be used for academic research purposes. Use for commercial purposes and by individuals employed by for-profit institutions excluded. Only qualified users may access the data. Users must accept a legal disclaimer, make no attempt to reveal personal or private information, and have institutional review board approval or a determination that such approval is not required. Other access criteria in accordance with NIH policy, institutional review board requirements and applicable laws (e.g., HIPAA) and regulations may be required.

Locations

US (1)