Tobacco SmokingIMPACTNCT04796961
Promoting Evidenced-Based Tobacco Smoking Cessation Treatment in Community Mental Health Clinics
A study testing Implementation Intervention in people with Tobacco Smoking, run by Johns Hopkins University at 1 site in United States.
Trial summary
This pilot study will examine whether an implementation intervention will improve delivery of evidence-based treatment for tobacco smoking cessation for patients in community mental health clinics. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking
- What is being tested?
- Implementation Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2021to 31 Jul 2023
- 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
- study population: community mental health clinic staff and providers
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
This pilot study will examine whether an implementation intervention will improve delivery of evidence-based treatment for tobacco smoking cessation for patients in community mental health clinics.
Read the detailed description
In this pilot study, the investigators will work with community mental health clinical and pilot test an implementation intervention to improve mental health providers' delivery of evidence-based tobacco smoking cessation treatment in community mental health clinics.
- Conditions
- Tobacco Smoking
- Being tested
- Implementation Intervention
- Medical subject headings
- Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation InterventionOther
The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.
| Study group | Role | What they receive |
|---|---|---|
| Implementation Intervention | Other | All participants will receive the implementation intervention. Receives: Other: Implementation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider (Staff) Knowledge of Smoking Cessation Treatment as Assessed by a 16-item Scale
Knowledge of evidence-based smoking cessation treatment: 16-item scale developed by our team. Items are true/false and score reflects number answered correctly. Average score range 0-16 with a higher score signifies an increased knowledge of smoking cessation treatment.
Measured: Baseline, 12 months
Provider Self-efficacy to Deliver Evidence-based Smoking Cessation Treatment
Self-efficacy for a four components of the smoking cessation intervention were evaluated using an instrument adapted from Compeau and Higgins' task-focused self-efficacy scale. Responses for items are on a Likert scale of 1-10. Average score range 1-10 and higher scores signify greater self-efficacy for the smoking cessation task.
Measured: Baseline, 12 months
Secondary outcomes (10)
Number of Clients Recieved Smoking Status Assessment
Assessment of smoking status measured by clinic documentation during client visits with the number below indicating the number of clients who had a smoking status assessment during the 12 month study period.
Measured: Baseline through 12 months
Number of Clients Willing to Quit Smoking That Received a Willingness to Quit Assessment
Assessment of willingness to quit measured by clinic documentation during client visits, with the number below indicating the number of clients who reported smoking during a smoking status assessment who had a willingness to quit assessment during the 12 month study period.
Measured: Baseline through 12 months
Number of Clients Interested in Quitting Smoking Who Received Smoking Cessation Behavioral Counseling
Receipt of behavioral counseling measured by clinic documentation during client visits, with the number below indicating the number of clients interested in quitting smoking that reported smoking during a smoking status assessment who staff reported as receiving behavioral counseling during the 12 months study period.
Data is reported in two groups based upon whether the client had a recorded interest in quitting smoking or not, and only includes clients who reported smoking at some point during the study period. Clients can be reported in both groups if they responded differently to this question at two points over the course of the 12 months.
Measured: Baseline through 12 months
Number of Clients Interested in Quitting Smoking That Received Smoking Cessation Pharmacotherapy
Measured by clinic documentation during client visits with the number below indicating the number of clients interested in quitting smoking, that reported smoking during a smoking status assessment who staff reported as receiving smoking cessation pharmacotherapy during the 12 months study period.
Clients can be reported in both groups (Interested in quitting, not interested in quitting) if they responded differently to this question at two points over the course of the 12 months.
Measured: Baseline through 12 months
Acceptability of Evidence-based Practices Based on Adaptation of Acceptability of Intervention Measure
An adaptation of the Acceptability of Intervention Measure was used. Each of the items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater acceptability.
Measured: Post Training (up to 2 weeks), 12 months
Appropriateness of Evidence-based Practices Based on Adaptation of the Intervention Appropriateness Measure
An adaptation of the Intervention Appropriateness Measure was used. Each of the items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater appropriateness.
Measured: Post Training (up to 2 weeks), 12 Months
Feasibility of Evidence-based Practices Based on Adaptation of the Feasibility of Intervention Measure
An adaptation of the Feasibility of Intervention Measure was used. Each of the items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater feasibility.
Measured: Post Training (up to 2 weeks), 12 Months
Acceptability of Implementation Intervention Based on Adaptation of Acceptability of Intervention Measure
An adaptation of the Acceptability of Intervention Measure was used. Each of the items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater acceptability.
Measured: Post Training (up to 2 weeks), 12 Months
Appropriateness of Implementation Intervention Based on Adaptation of the Intervention Appropriateness Measure
An adaptation of the Intervention Appropriateness Measure was used. Each of the items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater appropriateness.
Measured: Post Training (up to 2 weeks), 12 Months
Feasibility of Implementation Intervention Based on Adaptation of the Feasibility of Intervention Measure
An adaptation of the Feasibility of Intervention Measure was used. Each of the items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater feasibility.
Measured: Post Training (up to 2 weeks), 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start12 Mar 2021
- Primary completion18 Jul 2023
- Study completion31 Jul 2023
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 (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Gail Daumit, MD, MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796961
- Sponsor's protocol ID
- IRB00231836
- Other IDs
- 1P50MH115842-01
- Acronym
- IMPACT
- Status last verified
- Aug 2025
- First submitted
- 10 Mar 2021
- Last updated
- 3 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dickerson F, Goldsholl S, Yuan CT, Dalcin A, Eidman B, Minahan E, Gennusa Rd JV, Mace E, Cullen B, Evins AE, Cather C, Wang NY, McGinty EM, Daumit GL. Promoting Evidence-Based Tobacco Cessation Treatment in Community Mental Health Clinics: Protocol for a Prepost Intervention Study. JMIR Res Protoc. 2023 May 12;12:e44787. doi: 10.2196/44787.
PubMed 37171851
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Evidenced-Based Tobacco Smoking Cessation Treatment in Community Mental Health Clinics
- ClinicalTrials.gov ID
- NCT04796961
- Acronym / sponsor ID
- IMPACT / IRB00231836
- Conditions
- Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Posted 24 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study will examine whether an implementation intervention will improve delivery of evidence-based treatment for tobacco smoking cessation for patients in community mental health clinics.
Detailed description
In this pilot study, the investigators will work with community mental health clinical and pilot test an implementation intervention to improve mental health providers' delivery of evidence-based tobacco smoking cessation treatment in community mental health clinics.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implementation Intervention | Other | Other: Implementation InterventionAll participants will receive the implementation intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- study population: community mental health clinic staff and providers
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Implementation InterventionThe implementation intervention involves training, coaching, expert consultation, organizational strategy meetings. | Other | Implementation Intervention |
Primary outcome
Provider (Staff) Knowledge of Smoking Cessation Treatment as Assessed by a 16-item Scale
Time frame: Baseline, 12 months
Knowledge of evidence-based smoking cessation treatment: 16-item scale developed by our team. Items are true/false and score reflects number answered correctly. Average score range 0-16 with a higher score signifies an increased knowledge of smoking cessation treatment.
Provider Self-efficacy to Deliver Evidence-based Smoking Cessation Treatment
Time frame: Baseline, 12 months
Self-efficacy for a four components of the smoking cessation intervention were evaluated using an instrument adapted from Compeau and Higgins' task-focused self-efficacy scale. Responses for items are on a Likert scale of 1-10. Average score range 1-10 and higher scores signify greater self-efficacy for the smoking cessation task.
10 secondary outcomes
Number of Clients Recieved Smoking Status Assessment
Time frame: Baseline through 12 months
Number of Clients Willing to Quit Smoking That Received a Willingness to Quit Assessment
Time frame: Baseline through 12 months
Number of Clients Interested in Quitting Smoking Who Received Smoking Cessation Behavioral Counseling
Time frame: Baseline through 12 months
Number of Clients Interested in Quitting Smoking That Received Smoking Cessation Pharmacotherapy
Time frame: Baseline through 12 months
Acceptability of Evidence-based Practices Based on Adaptation of Acceptability of Intervention Measure
Time frame: Post Training (up to 2 weeks), 12 months
Appropriateness of Evidence-based Practices Based on Adaptation of the Intervention Appropriateness Measure
Time frame: Post Training (up to 2 weeks), 12 Months
Feasibility of Evidence-based Practices Based on Adaptation of the Feasibility of Intervention Measure
Time frame: Post Training (up to 2 weeks), 12 Months
Acceptability of Implementation Intervention Based on Adaptation of Acceptability of Intervention Measure
Time frame: Post Training (up to 2 weeks), 12 Months
Appropriateness of Implementation Intervention Based on Adaptation of the Intervention Appropriateness Measure
Time frame: Post Training (up to 2 weeks), 12 Months
Feasibility of Implementation Intervention Based on Adaptation of the Feasibility of Intervention Measure
Time frame: Post Training (up to 2 weeks), 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37171851Dickerson F, Goldsholl S, Yuan CT, Dalcin A, Eidman B, Minahan E, Gennusa Rd JV, Mace E, Cullen B, Evins AE, Cather C, Wang NY, McGinty EM, Daumit GL. Promoting Evidence-Based Tobacco Cessation Treatment in Community Mental Health Clinics: Protocol for a Prepost Intervention Study. JMIR Res Protoc. 2023 May 12;12:e44787. doi: 10.2196/44787.
- 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.
Gail Daumit, MD, MHS principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation Intervention in people with Tobacco Smoking, run by Johns Hopkins University at 1 site in United States.
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 3 Sep 2025. 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 24 Aug 2025). 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?
Provider (Staff) Knowledge of Smoking Cessation Treatment as Assessed by a 16-item Scale (time frame: Baseline, 12 months). The study lists 2 primary outcomes in all. 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 NCT04796961, which also lists 1 linked publication.
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 3 Sep 2025.