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NCT03598114

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

Completed NA Results posted Last updated 5 April 2023
What this trial tests

NA trial testing Program Sustainability Action Planning Model and Training Curricula in Program Sustainability in 255 participants. Completed in 26 January 2022.

Timeline
29 June 2018
Primary endpoint
26 January 2022
26 January 2022

Quick facts

Lead sponsorWashington University School of Medicine
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment255
Start date29 June 2018
Primary completion26 January 2022
Estimated completion26 January 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Program Sustainability or Tobacco Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Program Sustainability Assessment Tool (PSAT) Sustainability Scores Primary · 0 months,12 months, 24 months

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
GroupValue95% CI
State 1 - Program Sustainability Training4.9± 0.7
State 2 - Control Condition5.1± 0.4
State 3 - Control Condition3.8± 0.5
State 4 - Program Sustainability Training4.2± 0.5
State 5 - Control Condition5.1± 0.8
State 6 - Program Sustainability Training5.0± 0.5
State 7 - Control Condition5.3± 0.6
State 8 - Program Sustainability Training5.2± 0.5
State 9 - Program Sustainability Training4.4± 0.7
State 10 - Control Condition4.5± 0.5
State 11 - Program Sustainability Training4.5± 0.4
State 12 - Control Condition3.8± 1.1
12 months
GroupValue95% CI
State 1 - Program Sustainability Training5.2± 0.6
State 2 - Control Condition5.4± 0.6
State 3 - Control Condition5.0± 0.8
State 4 - Program Sustainability Training4.0± 0.4
State 5 - Control Condition5.1± 0.8
State 6 - Program Sustainability Training5.0± 0.5
State 7 - Control Condition6.0± 0.5
State 8 - Program Sustainability Training5.7± 0.2
State 9 - Program Sustainability Training3.5± 0.7
State 10 - Control Condition4.3± 0.4
State 11 - Program Sustainability Training4.3± 0.2
State 12 - Control Condition3.4± 0.6
24 months
GroupValue95% CI
State 1 - Program Sustainability Training5.4± 0.7
State 2 - Control Condition5.2± 0.4
State 3 - Control Condition4.5± 1.3
State 4 - Program Sustainability Training4.2± 0.3
State 5 - Control Condition5.8± 1.0
State 6 - Program Sustainability Training5.3± 0.5
State 7 - Control Condition5.5± 0.8
State 8 - Program Sustainability Training5.7± 0.5
State 9 - Program Sustainability Training3.7± 0.5
State 10 - Control Condition4.5± 0.7
State 11 - Program Sustainability Training4.7± 0.4
State 12 - Control Condition3.7± 0.6
Number of State Tobacco Control Programs Present in Law, Regulation, or Rule Secondary · 0 months, 12 months, 24 months

-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
GroupValue95% CI
State 1 - Program Sustainability Training1
State 2 - Control Condition1
State 3 - Control Condition0
State 4 - Program Sustainability Training0
State 5 - Control Condition1
State 6 - Program Sustainability Training1
State 7 - Control Condition0
State 8 - Program Sustainability Training1
State 9 - Program Sustainability Training0
State 10 - Control Condition0
State 11 - Program Sustainability Training0
State 12 - Control Condition1
12 months
GroupValue95% CI
State 1 - Program Sustainability Training1
State 2 - Control Condition1
State 3 - Control Condition0
State 4 - Program Sustainability Training0
State 5 - Control Condition1
State 6 - Program Sustainability Training1
State 7 - Control Condition1
State 8 - Program Sustainability Training1
State 9 - Program Sustainability Training0
State 10 - Control Condition1
State 11 - Program Sustainability Training0
State 12 - Control Condition1
24 months
GroupValue95% CI
State 1 - Program Sustainability Training1
State 2 - Control Condition1
State 3 - Control Condition0
State 4 - Program Sustainability Training0
State 5 - Control Condition1
State 6 - Program Sustainability Training1
State 7 - Control Condition1
State 8 - Program Sustainability Training1
State 9 - Program Sustainability Training0
State 10 - Control Condition1
State 11 - Program Sustainability Training0
State 12 - Control Condition1
State Tobacco Control Program is Included as Part of Regular Budget Secondary · 0 months, 12 months, 24 months

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
GroupValue95% CI
State 1 - Program Sustainability Training1
State 2 - Control Condition1
State 3 - Control Condition0
State 4 - Program Sustainability Training0
State 5 - Control Condition1
State 6 - Program Sustainability Training0
State 7 - Control Condition1
State 8 - Program Sustainability Training1
State 9 - Program Sustainability Training1
State 10 - Control Condition1
State 11 - Program Sustainability Training1
State 12 - Control Condition1
12 months
GroupValue95% CI
State 1 - Program Sustainability Training1
State 2 - Control Condition1
State 3 - Control Condition0
State 4 - Program Sustainability Training0
State 5 - Control Condition1
State 6 - Program Sustainability Training0
State 7 - Control Condition1
State 8 - Program Sustainability Training1
State 9 - Program Sustainability Training1
State 10 - Control Condition1
State 11 - Program Sustainability Training1
State 12 - Control Condition1
24 months
GroupValue95% CI
State 1 - Program Sustainability Training1
State 2 - Control Condition1
State 3 - Control Condition0
State 4 - Program Sustainability Training0
State 5 - Control Condition1
State 6 - Program Sustainability Training0
State 7 - Control Condition1
State 8 - Program Sustainability Training1
State 9 - Program Sustainability Training1
State 10 - Control Condition1
State 11 - Program Sustainability Training1
State 12 - Control Condition1
Change in Percentage of Organizational Budget Allotted to Tobacco Control Program Secondary · 0 months, 12 months, 24 months

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
GroupValue95% CI
State 1 - Program Sustainability Training31.80
State 2 - Control Condition12.30
State 3 - Control Condition0.80
State 4 - Program Sustainability Training1.70
State 5 - Control Condition2.50
State 6 - Program Sustainability Training3.90
State 7 - Control Condition6.30
State 8 - Program Sustainability Training18.10
State 9 - Program Sustainability Training3.70
State 10 - Control Condition9.00
State 11 - Program Sustainability Training5.30
State 12 - Control Condition16.20
12 months
GroupValue95% CI
State 1 - Program Sustainability Training13.10
State 2 - Control Condition22.30
State 3 - Control Condition5.10
State 4 - Program Sustainability Training3.40
State 5 - Control Condition8.50
State 6 - Program Sustainability Training20.40
State 7 - Control Condition18.20
State 8 - Program Sustainability Training17.00
State 9 - Program Sustainability Training4.90
State 10 - Control Condition7.40
State 11 - Program Sustainability Training13.30
State 12 - Control Condition22.00
24 months
GroupValue95% CI
State 1 - Program Sustainability Training12.10
State 2 - Control Condition19.80
State 3 - Control Condition0.90
State 4 - Program Sustainability Training4.00
State 5 - Control Condition7.90
State 6 - Program Sustainability Training13.20
State 7 - Control Condition13.60
State 8 - Program Sustainability Training16.50
State 9 - Program Sustainability Training4.80
State 10 - Control Condition7.10
State 11 - Program Sustainability Training10.80
State 12 - Control Condition19.00
Change in Percentage of CDC-recommended Tobacco Control Funding Level Actually Spent Secondary · 0 months, 12 months, 24 months

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
GroupValue95% CI
State 1 - Program Sustainability Training31.93
State 2 - Control Condition102.22
State 3 - Control Condition3.43
State 4 - Program Sustainability Training8.54
State 5 - Control Condition20.92
State 6 - Program Sustainability Training45.0
State 7 - Control Condition42.99
State 8 - Program Sustainability Training36.22
State 9 - Program Sustainability Training8.90
State 10 - Control Condition13.14
State 11 - Program Sustainability Training51.27
State 12 - Control Condition58.89
12 months
GroupValue95% CI
State 1 - Program Sustainability Training28.20
State 2 - Control Condition102.20
State 3 - Control Condition10.20
State 4 - Program Sustainability Training6.90
State 5 - Control Condition20.90
State 6 - Program Sustainability Training58.50
State 7 - Control Condition43.00
State 8 - Program Sustainability Training36.70
State 9 - Program Sustainability Training9.0
State 10 - Control Condition14.0
State 11 - Program Sustainability Training36.20
State 12 - Control Condition53.50
24 months
GroupValue95% CI
State 1 - Program Sustainability Training28.20
State 2 - Control Condition98.10
State 3 - Control Condition2.0
State 4 - Program Sustainability Training8.40
State 5 - Control Condition21.10
State 6 - Program Sustainability Training43.40
State 7 - Control Condition32.40
State 8 - Program Sustainability Training37.60
State 9 - Program Sustainability Training8.90
State 10 - Control Condition13.90
State 11 - Program Sustainability Training30.70
State 12 - Control Condition45.70

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Developing an evidence-based program sustainability training curriculum: a group randomized, multi-phase approach.
    Vitale R, Blaine T, Zofkie E, Moreland-Russell S, et al · · 2018 · cited 15× · PMID 30257695 · DOI 10.1186/s13012-018-0819-5
  2. Action planning for building public health program sustainability: results from a group-randomized trial.
    Moreland-Russell S, Combs T, Gannon J, Jost E, et al · · 2024 · cited 5× · PMID 38308331 · DOI 10.1186/s13012-024-01340-4
  3. 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.
    Moreland-Russell S, Jost E, Gannon J. · · 2023 · cited 3× · PMID 37063373 · DOI 10.3389/frhs.2023.1026484
  4. A qualitative study examining the impact of COVID-19 on capacity for sustainability of tobacco control programs.
    Gannon J, Moreland-Russell S. · · 2024 · cited 1× · PMID 38365656 · DOI 10.1186/s12913-024-10633-9
  5. A qualitative study examining the impact of COVID-19 on capacity for sustainability of tobacco control programs
    Gannon J, Moreland-Russell S. · · 2023 · DOI 10.21203/rs.3.rs-3001544/v1
  6. Action Planning for Building Program Sustainability: Results from a Group-Randomized Trial
    Moreland-Russell S, Combs T, Gannon J, Jost E, et al · · 2023 · DOI 10.21203/rs.3.rs-2783056/v1

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