Project ACTIVE a Clinical Intervention
Primary Purpose
Alcohol Abuse, Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ACTIVE intervention
Sponsored by

About this trial
This is an interventional prevention trial for Alcohol Abuse
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).
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
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
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Project ACTIVE a Clinical Intervention
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