Clinical trial NCT04211883: Project ACTIVE a Clinical Intervention
Official title: Project ACTIVE: A Randomized Controlled Trial of Personalized and Patient-Centered Preventive Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Obesity
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Change in number of unfulfilled health care goals resulting from USPSTF recommendations over the course of one year
timeFrame: Visits 4 weeks, 8 weeks, 12 weeks, 16 weeks, 28 weeks, 40 weeks
Secondary outcomes:
measure: Change in life expectancy including smoking, hypertension, hyperlipidemia, quality of life.
timeFrame: Visits 4 weeks, 8 weeks, 12 weeks, 16 weeks, 28 weeks, 40 weeks
Other outcomes:
Locations:
Study officials:
affiliation: NYU Langone
name: Ronald Braithwaite, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.