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

Tobacco Use Clinical Trial

Official title:

Program Sustainability Action Planning Training Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03598114
• Other study ID #: 201801196
• Secondary ID: R01CA203844
• Status: Completed
• Phase: N/A
• Start date: June 29, 2018
• Est. completion date: January 26, 2022

Study information

• Verified date: April 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: January 26, 2022
• Est. primary completion date: January 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Program Sustainability
• Tobacco Use

Intervention

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.

Locations

Country	Name	City	State
United States	Prevention Research Center in St. Louis	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

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