NCT03598114

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
255

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 29, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 5, 2023

Completed
Last Updated

April 5, 2023

Status Verified

April 1, 2023

Enrollment Period

3.6 years

First QC Date

July 2, 2018

Results QC Date

January 13, 2023

Last Update Submit

April 3, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Number of State Tobacco Control Programs Present in Law, Regulation, or Rule

    0 months, 12 months, 24 months

  • State Tobacco Control Program is Included as Part of Regular Budget

    0 months, 12 months, 24 months

  • Change in Percentage of Organizational Budget Allotted to Tobacco Control Program

    0 months, 12 months, 24 months

  • Change in Percentage of CDC-recommended Tobacco Control Funding Level Actually Spent

    0 months, 12 months, 24 months

Study Arms (2)

Program Sustainability Training

EXPERIMENTAL

* 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

Control Condition

NO INTERVENTION

* 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

Interventions

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.

Program Sustainability Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All participants will be non-institutionalized adults ages 18 and older.

You may not qualify if:

  • Participants must be involved in their state's tobacco control program and must be selected by their state's Program Manager to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prevention Research Center in St. Louis

St Louis, Missouri, 63130, United States

Location

Related Publications (5)

  • Gannon J, Moreland-Russell S. A qualitative study examining the impact of COVID-19 on capacity for sustainability of tobacco control programs. BMC Health Serv Res. 2024 Feb 16;24(1):215. doi: 10.1186/s12913-024-10633-9.

  • Moreland-Russell S, Combs T, Gannon J, Jost E, Farah Saliba L, Prewitt K, Luke D, Brownson RC. Action planning for building public health program sustainability: results from a group-randomized trial. Implement Sci. 2024 Feb 2;19(1):9. doi: 10.1186/s13012-024-01340-4.

  • Moreland-Russell S, Combs T, Gannon J, Jost E, Saliba LF, Prewitt K, Luke D, Brownson RC. Action Planning for Building Program Sustainability: Results from a Group-Randomized Trial. Res Sq [Preprint]. 2023 May 19:rs.3.rs-2783056. doi: 10.21203/rs.3.rs-2783056/v1.

  • Moreland-Russell S, Jost E, Gannon J. A conceptual model for building program sustainability in public health settings: Learning from the implementation of the program sustainability action planning model and training curricula. Front Health Serv. 2023 Mar 29;3:1026484. doi: 10.3389/frhs.2023.1026484. eCollection 2023.

  • 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.

Related Links

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Sarah Moreland-Russell, Ph.D., MPH
Organization
Washington University School of Medicine

Study Officials

  • Douglas Luke, PhD

    Center for Public Health Systems Science

    STUDY CHAIR
  • Ross C Brownson, PhD

    Prevention Research Center in St. Louis

    STUDY CHAIR
  • Sarah Moreland-Russell, PhD, MPH

    Prevention Research Center in St. Louis

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

July 2, 2018

First Posted

July 26, 2018

Study Start

June 29, 2018

Primary Completion

January 26, 2022

Study Completion

January 26, 2022

Last Updated

April 5, 2023

Results First Posted

April 5, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations