Project ACTIVE a Clinical Intervention

NYU Langone Health

Status: Completed

Conditions: Obesity; Alcohol Abuse

Treatments: Behavioral: ACTIVE intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04211883

14-01865

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Active intervention

Experimental group

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.

Treatment:

Behavioral: ACTIVE intervention

Standard Clinical Treatment

No Intervention group

Description:

Participants will continue with their usual clinic care.