Evaluating and Improving the Sustainability of State-level Tobacco Control Programs in the United States

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to empirically develop, test, and disseminate sustainability training to improve the institutionalization of evidence-based state tobacco control (TC) programs, and thus, tobacco-related health outcomes.

Detailed Description
-----------------
This study defines program sustainability as the ability to maintain programming and its benefits over time. The project builds upon the empirically-developed Program Sustainability Action Planning Model and Training Curricula. The training will incorporate experiential learning methods and includes: action planning workshops, development of action plans with measurable objectives to foster institutional changes, and technical assistance. The goal is to demonstrate change in sustainability outcomes in states who receive the Program Sustainability Action Planning Training compared to states that do not. After conclusion of the study, the sustainability training curriculum will be disseminated to all participating state TC programs. Additionally, the curriculum will be adapted for the use by any public health program in need of building sustainability capacity.

Official Title
-----------------
Program Sustainability Action Planning Training Project

Conditions
-----------------
Program Sustainability, Tobacco Use

Intervention / Treatment
-----------------
* Behavioral: Program Sustainability Action Planning Model and Training Curricula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All participants will be non-institutionalized adults ages 18 and older. Exclusion Criteria: Participants must be involved in their state's tobacco control program and must be selected by their state's Program Manager to participate.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Program Sustainability Training<br>Selected publicly funded tobacco control programs receive the intervention in the form of custom training curricula designed to identify and enable sustainable tobacco control programming at a state-organizational level. Sustainability is assessed at t=12 months and 1=24 months to capture potential impact of the training and curricula. The intervention group will receive a follow-up survey inviting them to evaluate the training and their progress on executing their sustainability plan. The intervention group will also receive a follow-up survey inviting them to evaluate the technical assistance they have received from the research team. Responses on neither follow-up survey impact participants standing in the study | Behavioral: Program Sustainability Action Planning Model and Training Curricula<br>* The Program Sustainability Action Planning Model and Training Curricula's conceptual model is driven by the theory of change and incorporates aspects of Kolb's experiential learning theory to produce a six step process: defining the program, assessing the program, developing an action plan, executing the action plan, evaluating sustainability, and reassessing and modifying. The study team will deliver in-person, hand-on workshops incorporating each of these aspects of the conceptual model. Following the workshop, intervention states will partake in technical assistance activities with the study team to track progress and troubleshooting challenges.<br>|
| No Intervention: Control Condition<br>In this condition, publicly funded tobacco control programs do not receive the designated program sustainability training and proceed with standard operations. Sustainability is assessed at t=12 months and t=24 months to compare against tobacco control programs receiving sustainability training The control group will receive a follow-up survey inviting them to evaluate their progress on creating their sustainability plan. Responses on the follow-up survey do not impact participants' standing in the study | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Program Sustainability Assessment Tool (PSAT) Sustainability Scores | The Program Sustainability Assessment Tool (PSAT) allows stakeholders to rate their programs on the extent to which they have processes and structures in place that will increase the likelihood of sustainability. The minimum score is 1 and the maximum score is 7. A higher score indicates greater program capacity for sustainability. Assessment results can be used to identify next steps in building program capacity for sustainability in order to position efforts for long term success. | 0 months,12 months, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of State Tobacco Control Programs Present in Law, Regulation, or Rule | -This measure is defined as whether a state's tobacco control program is established or continued through state statute or regulation and/or if the program is stated in organizational doctrine as a permanent component of the auspice organization. This is a direct measure of formal institutionalization of tobacco control programs and will be measured as a simple binary quantity, zero (0) for not present in law, regulation, or rule and one (1) for present in law, regulation, or rule. | 0 months, 12 months, 24 months | 
| State Tobacco Control Program is Included as Part of Regular Budget | Defined as whether a state's tobacco control program is a regular (annual, quarterly, or otherwise) item of the budget of its auspice organization. It directly indicated formal institutionalization and will take one of two possible values, zero (0) for not included in budget and one (1) for included in budget. | 0 months, 12 months, 24 months | 
| Change in Percentage of Organizational Budget Allotted to Tobacco Control Program | Defined as the percentage of the state health department budget garnered by its tobacco control program. The measure will be continuous and theoretically range from 0% (no funding) to 100% (entire health department budget). This quantity measures institutionalization of a program both individually and relative to other state health programs. | 0 months, 12 months, 24 months | 
| Change in Percentage of CDC-recommended Tobacco Control Funding Level Actually Spent | Defined as the amount of program funding as a percentage of the amount recommended by the CDC. This quantity measures institutionalization of a program relative to an objective level of funding computed uniformly from state characteristics by the CDC. The measure ranges from 0% (no funding) to over 100% (above CDC-recommended level). | 0 months, 12 months, 24 months |