# Project 3: Evaluation of Comprehensive Optimized Care for Smokers in Primary Care: Two Randomized Clinical Trials (Optimized Care)

> **NIH NIH P01** · UNIVERSITY OF WISCONSIN-MADISON · 2021 · $632,101

## Abstract

Tobacco use is the leading preventable cause of premature death overall, as well as cancer death, in the US.
Although healthcare settings offer great opportunities to provide effective smoking treatment, too few smokers
receive such treatment in these settings. This project will address the two most pressing needs regarding the
treatment of smoking in primary care: to increase the effectiveness and reach of smoking treatment. We will do
this by evaluating two innovative types of intervention packages amongst primary care patients: 1) a health
system reach intervention package designed to markedly increase smoking cessation treatment use (reach) in
smokers initially unwilling to quit, and 2) two cessation treatment packages designed to increase smoking
abstinence in smokers willing to make a quit attempt. Both the health system reach intervention package and
the cessation treatment packages will have been previously engineered (i.e., optimized) using the Multiphase
Optimization Strategy (MOST) to contain especially effective intervention components. We will evaluate these
optimized reach and cessation intervention packages in two 3-arm randomized controlled trials (RCTs). One
RCT will randomize smokers willing to make a quit attempt (N = 600) to: 1) Optimized Varenicline Treatment,
2) Optimized Combination Nicotine Replacement Therapy Treatment (C-NRT; nicotine patch + nicotine minilozenge), or 3) Standard Care (quitline and physician referral). The second RCT will randomize smokers
initially unwilling to make a quit attempt (N = 900) to three groups. Over a 1-year period, two groups will
receive an optimized reach intervention package plus access to one of two optimized cessation treatment
packages when they are ready to make an aided quit attempt. These two groups will receive: 1) Optimized
Health System Reach Interventions + Optimized Varenicline Treatment, or 2) Optimized Health System Reach
Interventions + Optimized C-NRT Treatment. The third group will receive Standard Care: letters that
encourage smokers to quit using treatments provided by the quitline or their primary care provider. Primary
outcomes will be likelihood of 1-year abstinence, cost-effectiveness, and likelihood of treatment use (for those
initially unwilling to quit). Thus, this project will evaluate optimized care for smokers on its ability to boost
cessation treatment reach, effectiveness, and cost-effectiveness via rigorous RCTs conducted in healthcare
settings. It will yield a comprehensive chronic care smoking treatment package that is easily implemented in
primary care and that markedly increases the reach and effectiveness of smoking treatment so as to reduce
cancer-related morbidity and mortality.

## Key facts

- **NIH application ID:** 10215424
- **Project number:** 5P01CA180945-08
- **Recipient organization:** UNIVERSITY OF WISCONSIN-MADISON
- **Principal Investigator:** Jessica Megan Cook
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $632,101
- **Award type:** 5
- **Project period:** 2014-09-01 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10215424

## Citation

> US National Institutes of Health, RePORTER application 10215424, Project 3: Evaluation of Comprehensive Optimized Care for Smokers in Primary Care: Two Randomized Clinical Trials (Optimized Care) (5P01CA180945-08). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10215424. Licensed CC0.

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