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

Program Sustainability Action Planning Training Project

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use; Program Sustainability
• Intervention / Treatment: Behavioral: Program Sustainability Action Planning Model and Training Curricula

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.

• Study Type: Interventional
• Enrollment (Actual): 255
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63130
      • Prevention Research Center in St. Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Program Sustainability Training; 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; 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.
No Intervention: Control Condition; 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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General Publications

• Vitale R, Blaine T, Zofkie E, Moreland-Russell S, Combs T, Brownson RC, Luke DA. Developing an evidence-based program sustainability training curriculum: a group randomized, multi-phase approach. Implement Sci. 2018 Sep 26;13(1):126. doi: 10.1186/s13012-018-0819-5.

Helpful Links

• This website provides a general project description.
• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine.

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2018
• Primary Completion (Actual): January 26, 2022
• Study Completion (Actual): January 26, 2022

Study Registration Dates

• First Submitted: July 2, 2018
• First Submitted That Met QC Criteria: July 13, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 201801196; R01CA203844 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No