Smoking CessationEarly Phase 1HiQuitNCT01108432
DPBRN Hygienists Internet Quality Improvement in Tobacco Cessation (HiQuit)
A Early Phase 1 study testing Electronic Referral in people with Smoking Cessation, run by Dental Practice-Based Research Network at 2 sites in United States.
Trial summary
Our overall goal is to advance science related to using the Internet in health services delivery, and specifically smoking cessation by targeting dental hygienists. Our proposed intervention is the first Internet-delivered intervention to target the dental microsystem for smoking cessation-providing access to… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Electronic Referral
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2010to Jun 2011
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community-based practices with internet access available in the office seeing an average of five or more smokers in a week.
Who cannot join
- Exclude practices that have ongoing computer-based smoking cessation programs for patients.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Health Partners Research Foundation
Minneapolis, Minnesota
About this study
Official title: Hygienists Internet Tobacco Cessation Study (HiQuit)
Our overall goal is to advance science related to using the Internet in health services delivery, and specifically smoking cessation by targeting dental hygienists. Our proposed intervention is the first Internet-delivered intervention to target the dental microsystem for smoking cessation-providing access to hygienists and patients.
Read the detailed description
This study is designed to allow dental hygienists and dentists to provide additional tobacco cessation counseling with little additional marginal effort. This would be done using an Internet-based referral to external resources. This system, termed "ReferASmoker", will allow hygienists and dentists to refer patients to a patient education, self-management website, "Decide2Quit" and accompanying Quitline, while the patient is still in the dental office. We anticipate that hygienists will be the primary drivers of this intervention. Our intervention has several innovations designed to support the dental practice in their tobacco cessation activities and maximize patient cessation rates. We will randomize 80 community-based primary dental practices into a clinical trial.
Aim 1. To test hypothesis 1(H1)that the number of patients REFERRED to the self-management resource website will be larger in the intervention practices compared to control practices.
Aim 2. To test hypothesis 2 (H2) that the proportion of patients referred who GO to the patient self-management website will be larger in intervention practices compared to control practices
Aim 3. To test hypothesis 3 (H3) that the proportion of smokers who are referred who QUIT at six months will be larger among intervention compared to control because of the additional connectivity of the intervention.
- Conditions
- Smoking Cessation
- Being tested
- Electronic Referral
- Keywords
- Tobacco cessation counseling
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic ReferralOther
Dental practices in this arm will be able to have option of making electronic patient referrals to the Decide2Quit website.
| Study group | Role | What they receive |
|---|---|---|
| Electronic Referrals | Experimental | Dental practices randomized to the experimental group will have options on how to refer patients to the tobacco cessation website. Receives: Other: Electronic Referral |
| Routine Referral | No intervention | Dental practices in this arm will refer patients to the Decide2Quit website by using an information prescription. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of smokers referred to tobacco cessation website
We will asses the number of patient referrals that the dental hygienists make to the tobacco cessation website.
Measured: 12 months
Secondary outcomes (2)
Proportion of smokers who go to the tobacco cessation website
We will assess the proportion of smokers who were referred to the tobacco cessation website to the number of patients who registered on the website.
Measured: 12 months
Point prevalence smoking cessation
Tobacco cessation behaviors will be assessed by follow-up email and/or telephone interviews at six months from website enrollment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dental Practice-Based Research Network
- Sponsor type
- Research network
- Collaborators
- University of Alabama at Birmingham, University of Massachusetts, Worcester, HealthPartners Institute
- Responsible party
- Sponsor
- Investigators
- Gregg H. GIlbert, DDS, MBA, Study chair, Dental Practice-Based Research Network (DPBRN)Midge N. Ray, RN, MSN, CCS, Principal investigator, University of Alabama School of Health Professons at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108432
- Sponsor's protocol ID
- 122286
- Other IDs
- U01DE016747
- Acronym
- HiQuit
- Status last verified
- Jan 2013
- First submitted
- 20 Apr 2010
- Last updated
- 25 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.
PubMed 33605440Ray MN, Funkhouser E, Williams JH, Sadasivam RS, Gilbert GH, Coley HL, Rindal DB, Houston TK; National Dental PBRN Collaborative Group. Smoking-cessation e-referrals: a national dental practice-based research network randomized controlled trial. Am J Prev Med. 2014 Feb;46(2):158-65. doi: 10.1016/j.amepre.2013.10.018.
PubMed 24439349Coley HL, Sadasivam RS, Williams JH, Volkman JE, Schoenberger YM, Kohler CL, Sobko H, Ray MN, Allison JJ, Ford DE, Gilbert GH, Houston TK; National Dental PBRN and QUITPRIMO Collaborative Group. Crowdsourced peer- versus expert-written smoking-cessation messages. Am J Prev Med. 2013 Nov;45(5):543-50. doi: 10.1016/j.amepre.2013.07.004.
PubMed 24139766
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hygienists Internet Tobacco Cessation Study (HiQuit)
- ClinicalTrials.gov ID
- NCT01108432
- Acronym / sponsor ID
- HiQuit / 122286
- Conditions
- Smoking Cessation
- Keywords
- Tobacco cessation counseling
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Dental Practice-Based Research NetworkResearch network
- Collaborators
- University of Alabama at Birmingham, University of Massachusetts, Worcester, HealthPartners Institute
- Study start
- Apr 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 22 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our overall goal is to advance science related to using the Internet in health services delivery, and specifically smoking cessation by targeting dental hygienists. Our proposed intervention is the first Internet-delivered intervention to target the dental microsystem for smoking cessation-providing access to hygienists and patients.
Detailed description
This study is designed to allow dental hygienists and dentists to provide additional tobacco cessation counseling with little additional marginal effort. This would be done using an Internet-based referral to external resources. This system, termed "ReferASmoker", will allow hygienists and dentists to refer patients to a patient education, self-management website, "Decide2Quit" and accompanying Quitline, while the patient is still in the dental office. We anticipate that hygienists will be the primary drivers of this intervention. Our intervention has several innovations designed to support the dental practice in their tobacco cessation activities and maximize patient cessation rates. We will randomize 80 community-based primary dental practices into a clinical trial.
Aim 1. To test hypothesis 1(H1)that the number of patients REFERRED to the self-management resource website will be larger in the intervention practices compared to control practices.
Aim 2. To test hypothesis 2 (H2) that the proportion of patients referred who GO to the patient self-management website will be larger in intervention practices compared to control practices
Aim 3. To test hypothesis 3 (H3) that the proportion of smokers who are referred who QUIT at six months will be larger among intervention compared to control because of the additional connectivity of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic Referrals | Experimental | Other: Electronic ReferralDental practices randomized to the experimental group will have options on how to refer patients to the tobacco cessation website. |
| Routine Referral | No intervention | –Dental practices in this arm will refer patients to the Decide2Quit website by using an information prescription. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Community-based practices with internet access available in the office seeing an average of five or more smokers in a week.
Key exclusion criteria (1 listed)
- Exclude practices that have ongoing computer-based smoking cessation programs for patients.
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 |
|---|---|---|
| Electronic ReferralDental practices in this arm will be able to have option of making electronic patient referrals to the Decide2Quit website. | Other | Electronic Referrals |
Primary outcome
Number of smokers referred to tobacco cessation website
Time frame: 12 months
We will asses the number of patient referrals that the dental hygienists make to the tobacco cessation website.
2 secondary outcomes
Proportion of smokers who go to the tobacco cessation website
Time frame: 12 months
Point prevalence smoking cessation
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2013.
- Derived from this study: PubMed 33605440Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.
- Derived from this study: PubMed 24439349Ray MN, Funkhouser E, Williams JH, Sadasivam RS, Gilbert GH, Coley HL, Rindal DB, Houston TK; National Dental PBRN Collaborative Group. Smoking-cessation e-referrals: a national dental practice-based research network randomized controlled trial. Am J Prev Med. 2014 Feb;46(2):158-65. doi: 10.1016/j.amepre.2013.10.018.
- Derived from this study: PubMed 24139766Coley HL, Sadasivam RS, Williams JH, Volkman JE, Schoenberger YM, Kohler CL, Sobko H, Ray MN, Allison JJ, Ford DE, Gilbert GH, Houston TK; National Dental PBRN and QUITPRIMO Collaborative Group. Crowdsourced peer- versus expert-written smoking-cessation messages. Am J Prev Med. 2013 Nov;45(5):543-50. doi: 10.1016/j.amepre.2013.07.004.
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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.
Gregg H. GIlbert, DDS, MBA study chair
Dental Practice-Based Research Network (DPBRN)
Midge N. Ray, RN, MSN, CCS principal investigator
University of Alabama School of Health Professons at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Electronic Referral in people with Smoking Cessation, run by Dental Practice-Based Research Network at 2 sites 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 25 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of smokers referred to tobacco cessation website (time frame: 12 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 NCT01108432, which also lists 3 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 25 Jan 2013; AzTrials last refreshed its copy on 8 Nov 2026.