Project ACTIVE a Clinical Intervention

NCT04211883 | Completed DMC

• 1 other identifier: 14-01865
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alcohol Abuse; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in life expectancy including smoking, hypertension, hyperlipidemia, quality of life.

  Visits 4 weeks, 8 weeks, 12 weeks, 16 weeks, 28 weeks, 40 weeks

Study Arms (2)

Active intervention

EXPERIMENTAL

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.

Behavioral: ACTIVE intervention

Standard Clinical Treatment

NO INTERVENTION

Participants will continue with their usual clinic care.

Interventions

ACTIVE intervention BEHAVIORAL

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 .

Active intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age \>65
• Pregnant
• Dominant comorbidity (one that disproportionately impacts care plans and/or life expectancy).

Sponsors & Collaborators

• NYU Langone Health: lead

Related Publications (1)

• 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.

  PMID: 33443695 DERIVED

MeSH Terms

Conditions

Alcoholism; Obesity

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ronald Braithwaite, MD

  NYU Langone

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 26, 2019
• Study Start: January 20, 2016
• Primary Completion: May 2, 2018
• Study Completion: May 2, 2018
• Last Updated: January 3, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.