Project ACTIVE: A Randomized Controlled Trial of Personalized and Patient-Centered Preventive Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 140
- Primary Endpoint
- Change in number of unfulfilled health care goals resulting from USPSTF recommendations over the course of one year
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Dominant comorbidity (one that disproportionately impacts care plans and/or life expectancy).
Arms & Interventions
Active intervention
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.
Intervention: ACTIVE intervention (Behavioral)
Standard Clinical Treatment
Participants will continue with their usual clinic care.
Outcomes
Primary Outcomes
Change in number of unfulfilled health care goals resulting from USPSTF recommendations over the course of one year
Time Frame: Visits 4 weeks, 8 weeks, 12 weeks, 16 weeks, 28 weeks, 40 weeks
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 Outcomes
- Change in life expectancy including smoking, hypertension, hyperlipidemia, quality of life.(Visits 4 weeks, 8 weeks, 12 weeks, 16 weeks, 28 weeks, 40 weeks)