Personalized Disease Prevention (PDP): study protocol for a cluster-randomized clinical trial

Abstract Background The US Preventive Services Task Force recommends 25 primary preventive services for middle-aged adults, but it can be difficult to do them all. Methods The Personalized Disease Prevention (PDP) cluster-randomized clinical trial will evaluate whether patients and their providers b...

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Main Authors: Glen B. Taksler, Phuc Le, Bo Hu, Jay Alberts, Allen J. Flynn, Michael B. Rothberg
Format: Article
Language:English
Published: BMC 2022-10-01
Series:Trials
Subjects:
Online Access:https://doi.org/10.1186/s13063-022-06750-7
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author Glen B. Taksler
Phuc Le
Bo Hu
Jay Alberts
Allen J. Flynn
Michael B. Rothberg
author_facet Glen B. Taksler
Phuc Le
Bo Hu
Jay Alberts
Allen J. Flynn
Michael B. Rothberg
author_sort Glen B. Taksler
collection DOAJ
description Abstract Background The US Preventive Services Task Force recommends 25 primary preventive services for middle-aged adults, but it can be difficult to do them all. Methods The Personalized Disease Prevention (PDP) cluster-randomized clinical trial will evaluate whether patients and their providers benefit from an evidence-based decision tool to prioritize preventive services based on their potential to improve quality-adjusted life expectancy. The decision tool will be individualized for patient risk factors and available in the electronic health record. This Phase III trial seeks to enroll 60 primary care providers (clusters) and 600 patients aged 40–75 years. Half of providers will be assigned to an intervention to utilize the decision tool with approximately 10 patients each, and half will be assigned to usual care. Mixed-methods follow-up will include collection of preventive care utilization from electronic health records, patient and physician surveys, and qualitative interviews. We hypothesize that quality-adjusted life expectancy will increase by more in patients who receive the intervention, as compared with controls. Discussion PDP will test a novel, holistic approach to help patients and providers prioritize the delivery of preventive services, based on patient risk factors in the electronic health record. Trial registration ClinicalTrials.gov NCT05463887. Registered on July 19, 2022.
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spelling doaj.art-e827271164c7449887edea16b794018f2022-12-22T02:37:17ZengBMCTrials1745-62152022-10-0123111410.1186/s13063-022-06750-7Personalized Disease Prevention (PDP): study protocol for a cluster-randomized clinical trialGlen B. Taksler0Phuc Le1Bo Hu2Jay Alberts3Allen J. Flynn4Michael B. Rothberg5Cleveland Clinic Community Care, Cleveland ClinicCleveland Clinic Community Care, Cleveland ClinicDepartment of Quantitative Health Sciences, Cleveland ClinicDepartment of Biomedical Engineering, Cleveland ClinicSchool of Information and Department of Learning Health Sciences, University of MichiganCleveland Clinic Community Care, Cleveland ClinicAbstract Background The US Preventive Services Task Force recommends 25 primary preventive services for middle-aged adults, but it can be difficult to do them all. Methods The Personalized Disease Prevention (PDP) cluster-randomized clinical trial will evaluate whether patients and their providers benefit from an evidence-based decision tool to prioritize preventive services based on their potential to improve quality-adjusted life expectancy. The decision tool will be individualized for patient risk factors and available in the electronic health record. This Phase III trial seeks to enroll 60 primary care providers (clusters) and 600 patients aged 40–75 years. Half of providers will be assigned to an intervention to utilize the decision tool with approximately 10 patients each, and half will be assigned to usual care. Mixed-methods follow-up will include collection of preventive care utilization from electronic health records, patient and physician surveys, and qualitative interviews. We hypothesize that quality-adjusted life expectancy will increase by more in patients who receive the intervention, as compared with controls. Discussion PDP will test a novel, holistic approach to help patients and providers prioritize the delivery of preventive services, based on patient risk factors in the electronic health record. Trial registration ClinicalTrials.gov NCT05463887. Registered on July 19, 2022.https://doi.org/10.1186/s13063-022-06750-7Preventive careMedicine, PreventivePreventive Health ServicesPrevention, PrimaryDisease prevention, PrimaryPatient-specific modeling
spellingShingle Glen B. Taksler
Phuc Le
Bo Hu
Jay Alberts
Allen J. Flynn
Michael B. Rothberg
Personalized Disease Prevention (PDP): study protocol for a cluster-randomized clinical trial
Trials
Preventive care
Medicine, Preventive
Preventive Health Services
Prevention, Primary
Disease prevention, Primary
Patient-specific modeling
title Personalized Disease Prevention (PDP): study protocol for a cluster-randomized clinical trial
title_full Personalized Disease Prevention (PDP): study protocol for a cluster-randomized clinical trial
title_fullStr Personalized Disease Prevention (PDP): study protocol for a cluster-randomized clinical trial
title_full_unstemmed Personalized Disease Prevention (PDP): study protocol for a cluster-randomized clinical trial
title_short Personalized Disease Prevention (PDP): study protocol for a cluster-randomized clinical trial
title_sort personalized disease prevention pdp study protocol for a cluster randomized clinical trial
topic Preventive care
Medicine, Preventive
Preventive Health Services
Prevention, Primary
Disease prevention, Primary
Patient-specific modeling
url https://doi.org/10.1186/s13063-022-06750-7
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