Program SustainabilityNCT03598114

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

A study testing Program Sustainability Action Planning Model and Training Curricula in people with Program Sustainability and Tobacco Use, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Program Sustainability, Tobacco Use
What is being tested?: Program Sustainability Action Planning Model and Training Curricula
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 255 participants
Where: 1 siteUnited States
Study dates: 29 Jun 2018to 26 Jan 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Prevention Research Center in St. Louis
St Louis, Missouri, 63130

Other trials in United States

About this study

Official title: Program Sustainability Action Planning Training Project

Read the 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.

Conditions: Program Sustainability, Tobacco Use
Being tested: Program Sustainability Action Planning Model and Training Curricula
Medical subject headings: Tobacco Use

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Program Sustainability Action Planning Model and Training CurriculaBehavioural
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.

Study groups in NCT03598114
Study group	Role	What they receive
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 Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 0 months,12 months, 24 months

Secondary outcomes (4)

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."
Measured: 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."
Measured: 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.
Measured: 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).
Measured: 0 months, 12 months, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jun 201826 Jan 2022

First posted26 Jul 2018
Study start29 Jun 2018
Primary completion26 Jan 2022
Study completion26 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Program SustainabilityStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 255 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03598114
Sponsor's protocol ID: 201801196
Other IDs: R01CA203844
Status last verified: Apr 2023
First submitted: 2 Jul 2018
Last updated: 5 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 38365656
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.
PubMed 38308331
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.
PubMed 37292588
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.
PubMed 37063373
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.
PubMed 30257695

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Program Sustainability Action Planning Training Project
ClinicalTrials.gov ID: NCT03598114
Acronym / sponsor ID: 201801196
Conditions: Program Sustainability, Tobacco Use
Study type: Interventional
Recruitment status: Completed
Enrolment: 255 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 29 Jun 2018 (actual)
Primary completion: 26 Jan 2022 (actual)
Study completion: 26 Jan 2022 (actual)
First posted: 26 Jul 2018 (actual)
Results: Posted 5 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study defines program sustainability as the ability to maintain programming and its benefits over time.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Program Sustainability Training	Experimental	Behavioral: Program Sustainability Action Planning Model and Training Curricula* 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
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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Program Sustainability Action Planning Model and Training CurriculaThe 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.	Behavioural	Program Sustainability Training

Primary outcome

Change in Program Sustainability Assessment Tool (PSAT) Sustainability Scores
Time frame: 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.

4 secondary outcomes

Number of State Tobacco Control Programs Present in Law, Regulation, or Rule
Time frame: 0 months, 12 months, 24 months
State Tobacco Control Program is Included as Part of Regular Budget
Time frame: 0 months, 12 months, 24 months
Change in Percentage of Organizational Budget Allotted to Tobacco Control Program
Time frame: 0 months, 12 months, 24 months
Change in Percentage of CDC-recommended Tobacco Control Funding Level Actually Spent
Time frame: 0 months, 12 months, 24 months

Results and safety

Results posted to the registry on 5 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Program Sustainability Training	127	124
Control Condition	128	89

Primary outcome: Change in Program Sustainability Assessment Tool (PSAT) Sustainability Scores

Time frame: 0 months,12 months, 24 months. Median (Standard Deviation). Unit: score on a scale

Measure	State 1 - Program Sustainability Training n = 31	State 2 - Control Condition n = 22	State 3 - Control Condition n = 9	State 4 - Program Sustainability Training n = 24	State 5 - Control Condition n = 14	State 6 - Program Sustainability Training n = 22	State 7 - Control Condition n = 12	State 8 - Program Sustainability Training n = 20	State 9 - Program Sustainability Training n = 20	State 10 - Control Condition n = 31	State 11 - Program Sustainability Training n = 31	State 12 - Control Condition n = 14	State 13 - Program Sustainability Training n = 25	State 14 - Control Condition n = 31	State 15 - Program Sustainability Training n = 40	State 16 - Control Condition n = 24	State 17 - Control Condition n = 18	State 18 - Program Sustainability Training n = 19	State 19 - Program Sustainability Training n = 11	State 20 - Control Condition n = 25	State 21 - Program Sustainability Training n = 17	State 22 - Control Condition n = 28	State 23 - Control Condition n = 11
0 months	4.9 (0.7)	5.1 (0.4)	3.8 (0.5)	4.2 (0.5)	5.1 (0.8)	5.0 (0.5)	5.3 (0.6)	5.2 (0.5)	4.4 (0.7)	4.5 (0.5)	4.5 (0.4)	3.8 (1.1)	4.7 (0.5)	5.4 (0.5)	4.3 (0.4)	4.5 (0.6)	4.4 (0.6)	4.0 (0.4)	4.3 (0.6)	4.2 (0.6)	4.1 (0.5)	4.2 (0.4)	2.9 (0.6)
12 months	5.2 (0.6)	5.4 (0.6)	5.0 (0.8)	4.0 (0.4)	5.1 (0.8)	5.0 (0.5)	6.0 (0.5)	5.7 (0.2)	3.5 (0.7)	4.3 (0.4)	4.3 (0.2)	3.4 (0.6)	4.9 (0.5)	4.9 (0.4)	3.6 (0.6)	5.5 (0.4)	4.9 (0.5)	3.9 (0.4)	4.6 (0.3)	4.5 (0.9)	4.5 (0.8)	4.4 (0.4)	2.8 (0.5)
24 months	5.4 (0.7)	5.2 (0.4)	4.5 (1.3)	4.2 (0.3)	5.8 (1.0)	5.3 (0.5)	5.5 (0.8)	5.7 (0.5)	3.7 (0.5)	4.5 (0.7)	4.7 (0.4)	3.7 (0.6)	5.2 (0.5)	5.0 (0.2)	4.5 (0.3)	5.0 (0.5)	4.7 (0.5)	4.0 (0.5)	5.7 (0.7)	4.1 (0.7)	4.0 (0.8)	4.6 (0.3)	3.5 (0.7)

Population analysed: The results are the state's tobacco control program PSAT sustainability scores at each timepoint.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality, serious adverse events, and adverse events were collected from the start of trial through 24 month follow-up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Program Sustainability Training	0 of 127 (0%)	0 of 127 (0%)	0 of 127
Control Condition	0 of 128 (0%)	0 of 128 (0%)	0 of 128

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38365656Gannon 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.
Derived from this study: PubMed 38308331Moreland-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.
Derived from this study: PubMed 37292588Moreland-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.
Derived from this study: PubMed 37063373Moreland-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.
Derived from this study: PubMed 30257695Vitale 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.
This website provides a general project description.Link provided by the sponsor.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine.Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Douglas Luke, PhD study chair

Center for Public Health Systems Science

Ross C Brownson, PhD study chair

Prevention Research Center in St. Louis

Sarah Moreland-Russell, PhD, MPH principal investigator

Prevention Research Center in St. Louis

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Program Sustainability Assessment Tool (PSAT) Sustainability Scores (time frame: 0 months,12 months, 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03598114, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.