Project ACTIVE a Clinical Intervention

Project ACTIVE: A Randomized Controlled Trial of Personalized and Patient-Centered Preventive Care

This is a clinical Randomized Controlled Trial where the study personnel will run a personalized prevention clinic with patients in attempts to improve their preventive health outcomes and compare their health outcomes with a matched control sample of patients who do not receive the clinical intervention.

Study Overview

• Status: Completed
• Conditions: Obesity; Alcohol Abuse
• Intervention / Treatment: Behavioral: ACTIVE intervention

Detailed Description

The Project ACTIVE intervention was constructed around the following framework, and then adapted to suit workflow demands of a busy inner-city clinic: (1) identify patients who could most benefit from improvements in adherence to evidence-based preventive care, (2) use a validated mathematical model that was published in Annals of Internal Medicine to quantify and rank the estimated amount of health benefit that would arise from improved adherence to each USPSTF preventive care guideline, with estimates personalized based on that patient's risk factors and medical history, (3) communicate this information in a manner informed by risk communication studies relevant to patients from disparate cultural groups and with low literacy and numeracy, (4) engage the patient in a shared decision making process in which the patient identified which preventive health goals patient aimed to achieve, and (5) set particular action steps for the next visit that were congruent with these goals. The program supplements rather than substitutes for normally scheduled primary care visits, and is coordinated with these visits whenever possible.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Non-elderly non-pregnant adults already in care at Bellevue Ambulatory adult care clinic
• Subjects with at least one of twelve unfulfilled clinical management goals from USPSTF Grade A and B recommendations
• English or Spanish speaking
• Capable of understanding informed consent.

Exclusion Criteria:

• Age >65
• Pregnant
• Dominant comorbidity (one that disproportionately impacts care plans and/or life expectancy).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active intervention; Participants will come to the Project Active clinic and be asked questions about their health history, assist in their health goals, medications will be adjusted, lab work and screening tests will be ordered. At end of each visit, current health recommendations and goals as well as previous health changes will be given after each visit.	Behavioral: ACTIVE intervention; The Project ACTIVE intervention was adapted to suit workflow demands of our busy inner-city clinic: (1) identify patients who could most benefit from improvements in adherence to evidence-based preventive care, (2) use a validated mathematical model to quantify and rank the estimated amount of health benefit that would arise from improved adherence to each USPSTF preventive care guideline, (3) communicate this information in a manner informed by risk communication studies relevant to patients from disparate cultural groups and with low literacy and numeracy, (4) engage the patient in a shared decision making process in which the patient identified which preventive health goals aimed to achieve, and (5) set particular action steps for the next visit that were congruent with these goals .
No Intervention: Standard Clinical Treatment; Participants will continue with their usual clinic care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of unfulfilled health care goals resulting from USPSTF recommendations over the course of one year	At follow up visits the patient's data and goal achievement (or lack thereof) is updated into the model along with their new vital signs, lab work, screenings, and medication changes that occurred since their last visit, to enable the model to yield updated results. If the patient has made improvements to their health since the last visit, this is depicted graphically on an updated summary chart, demonstrating what they accomplished since their previous visit.	Visits 4 weeks, 8 weeks, 12 weeks, 16 weeks, 28 weeks, 40 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in life expectancy including smoking, hypertension, hyperlipidemia, quality of life.	Subject will meet with the health coach, who helps the patients meet their health goals in practical ways by setting corresponding behavioral goals. Motivational interviewing techniques are again used, and the patient ends the visit with clear behavioral goals they have created for the next visit. The goals are written out at the bottom of the patient's visual graph depicting the possible health gain. Educational materials and resources are also given to the patient depending on their specific needs, such as food logs to record their diets, lists of local gyms near their residence and lists of healthy foods to buy when grocery shopping. At the end of the visit, a copy of the patient's visual graph with their specific goals are left in the clinic mailbox of their primary care clinician, and notes are documented by the nurse practitioner and the health coach into the electronic medical record system.	Visits 4 weeks, 8 weeks, 12 weeks, 16 weeks, 28 weeks, 40 weeks

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Ronald Braithwaite, MD, NYU Langone

Publications and helpful links

General Publications

• Applegate M, Scott E, Taksler GB, Sanchez M, Duong N, Mark L, Caniglia E, Wallach A, Braithwaite RS. Project ACTIVE: a Randomized Controlled Trial of Personalized and Patient-Centered Preventive Care in an Urban Safety-Net Setting. J Gen Intern Med. 2021 Mar;36(3):606-613. doi: 10.1007/s11606-020-06359-z. Epub 2021 Jan 14.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2016
• Primary Completion (Actual): May 2, 2018
• Study Completion (Actual): May 2, 2018

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 23, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): January 3, 2020
• Last Update Submitted That Met QC Criteria: December 31, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: 14-01865

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data.Upon reasonable request Requests should be directed to melanie.applegate@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No