search
Back to results

Project ACTIVE a Clinical Intervention

Primary Purpose

Alcohol Abuse, Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ACTIVE intervention
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Abuse

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Active intervention

    Standard Clinical Treatment

    Arm Description

    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.

    Participants will continue with their usual clinic care.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    December 5, 2019
    Last Updated
    December 31, 2019
    Sponsor
    NYU Langone Health
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04211883
    Brief Title
    Project ACTIVE a Clinical Intervention
    Official Title
    Project ACTIVE: A Randomized Controlled Trial of Personalized and Patient-Centered Preventive Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 20, 2016 (Actual)
    Primary Completion Date
    May 2, 2018 (Actual)
    Study Completion Date
    May 2, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NYU Langone Health

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Abuse, Obesity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    140 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Standard Clinical Treatment
    Arm Type
    No Intervention
    Arm Description
    Participants will continue with their usual clinic care.
    Intervention Type
    Behavioral
    Intervention Name(s)
    ACTIVE intervention
    Intervention Description
    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 .
    Primary Outcome Measure Information:
    Title
    Change in number of unfulfilled health care goals resulting from USPSTF recommendations over the course of one year
    Description
    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.
    Time Frame
    Visits 4 weeks, 8 weeks, 12 weeks, 16 weeks, 28 weeks, 40 weeks
    Secondary Outcome Measure Information:
    Title
    Change in life expectancy including smoking, hypertension, hyperlipidemia, quality of life.
    Description
    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.
    Time Frame
    Visits 4 weeks, 8 weeks, 12 weeks, 16 weeks, 28 weeks, 40 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ronald Braithwaite, MD
    Organizational Affiliation
    NYU Langone
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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.
    Citations:
    PubMed Identifier
    33443695
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Project ACTIVE a Clinical Intervention

    We'll reach out to this number within 24 hrs