Project ACTIVE a Clinical Intervention

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04211883
• Other study ID #: 14-01865
• Status: Completed
• Phase: N/A
• Start date: January 20, 2016
• Est. completion date: May 2, 2018

Study information

• Verified date: December 2019
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 2, 2018
• Est. primary completion date: May 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Obesity

Intervention

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 .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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