Smoking CessationQUIT-PRIMONCT00797628
Web-delivered Provider Intervention for Tobacco Control
A study testing Decide2Quit and Smoking Coach in people with Smoking Cessation, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
This is a randomized control trial to determine the efficacy of a multi-modal intervention in improving smoking cessation processes of care and patient outcomes in community-based primary care practices. 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?
- Decide2Quit and Smoking Coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Aug 2013
- Phase
- Interventional
- 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 primary care practices who have:
- Internet access in office
- Sees 4 - 5 smokers per week
Who cannot join
- Practices with more than five providers
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: QUIT-PRIMO: Web-Delivered Clinical Microsystem Intervention for Tobacco Control
This is a randomized control trial to determine the efficacy of a multi-modal intervention in improving smoking cessation processes of care and patient outcomes in community-based primary care practices. Our Overall Goal is to advance science related to the use and impact of the Internet in health services delivery, specifically smoking cessation, by targeting primary care clinical microsystems. A clinical microsystem is defined as the smallest functional healthcare unit. A clinical microsystem is not simply equivalent to a clinical team of doctors and nurses, but also the panel of patients cared for by the providers and the processes of care that are used.
- Conditions
- Smoking Cessation
- Being tested
- Decide2Quit, Smoking Coach
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decide2QuitBehavioural
Patient intervention website that includes 1) interactive calculators to assess readiness to quit, symptoms and quit plan, 2) motivational content, and 3) links to other high quality information.
Smoking CoachBehavioural
Control Patients will be referred by paper prescription to the control- "Smoking Coach" website.
| Study group | Role | What they receive |
|---|---|---|
| Information Prescription | Experimental | Providers will give usual care to patients who smoke and a paper prescription with the name and url of the "Smoking Coach" website. The smoking coach website is a tailored, public health intervention for smoking cessation. Receives: Behavioral: Smoking Coach |
| QUIT-PRIMO | Experimental | Providers will give usual care to patients who smoke and then refer patients to the online smoking cessation system electronically. Receives: Behavioral: Decide2Quit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician performance on refering patients that smoke cigarettes to the web intervention
Measured: pre-intervention, 6 months, 12 months and 24 months
Of the smokers who are referred to the web intervention, the number who go to the site
Measured: preintervention, 6 months, 12 months, 24 months
Point prevalence smoking cessation
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 posted25 Nov 2008 (estimated)
- Study startMar 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, University of Alabama at Birmingham
- Responsible party
- Principal investigator, Thomas Houston, University of Massachusetts, Worcester
- Investigators
- Thomas K Houston, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797628
- Sponsor's protocol ID
- X071211009
- Other IDs
- NIH R01CA129091
- Acronym
- QUIT-PRIMO
- Status last verified
- Aug 2013
- First submitted
- 24 Nov 2008
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
DeLaughter KL, Sadasivam RS, Kamberi A, English TM, Seward GL, Chan SW, Volkman JE, Amante DJ, Houston TK. Crave-Out: A Distraction/Motivation Mobile Game to Assist in Smoking Cessation. JMIR Serious Games. 2016 May 26;4(1):e3. doi: 10.2196/games.4566.
PubMed 27229772Houston TK, Sadasivam RS, Allison JJ, Ash AS, Ray MN, English TM, Hogan TP, Ford DE. Evaluating the QUIT-PRIMO clinical practice ePortal to increase smoker engagement with online cessation interventions: a national hybrid type 2 implementation study. Implement Sci. 2015 Nov 2;10:154. doi: 10.1186/s13012-015-0336-8.
PubMed 26525410Coley 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 24139766Sadasivam RS, Kinney RL, Delaughter K, Rao SR, Williams JH, Coley HL, Ray MN, Gilbert GH, Allison JJ, Ford DE, Houston TK; National Dental PBRN Group; QUIT-PRIMO Collaborative Group. Who participates in Web-assisted tobacco interventions? The QUIT-PRIMO and National Dental Practice-Based Research Network Hi-Quit studies. J Med Internet Res. 2013 May 1;15(5):e77. doi: 10.2196/jmir.2385.
PubMed 23635417Sadasivam RS, Delaughter K, Crenshaw K, Sobko HJ, Williams JH, Coley HL, Ray MN, Ford DE, Allison JJ, Houston TK. Development of an interactive, Web-delivered system to increase provider-patient engagement in smoking cessation. J Med Internet Res. 2011 Oct 18;13(4):e87. doi: 10.2196/jmir.1721.
PubMed 22011394Houston TK, Sadasivam RS, Ford DE, Richman J, Ray MN, Allison JJ. The QUIT-PRIMO provider-patient Internet-delivered smoking cessation referral intervention: a cluster-randomized comparative effectiveness trial: study protocol. Implement Sci. 2010 Nov 17;5:87. doi: 10.1186/1748-5908-5-87.
PubMed 21080972
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QUIT-PRIMO: Web-Delivered Clinical Microsystem Intervention for Tobacco Control
- ClinicalTrials.gov ID
- NCT00797628
- Acronym / sponsor ID
- QUIT-PRIMO / X071211009
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Johns Hopkins University, University of Alabama at Birmingham
- Study start
- Mar 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 25 Nov 2008 (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.
This is a randomized control trial to determine the efficacy of a multi-modal intervention in improving smoking cessation processes of care and patient outcomes in community-based primary care practices. Our Overall Goal is to advance science related to the use and impact of the Internet in health services delivery, specifically smoking cessation, by targeting primary care clinical microsystems. A clinical microsystem is defined as the smallest functional healthcare unit. A clinical microsystem is not simply equivalent to a clinical team of doctors and nurses, but also the panel of patients cared for by the providers and the processes of care that are used.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Information Prescription | Experimental | Behavioral: Smoking CoachProviders will give usual care to patients who smoke and a paper prescription with the name and url of the "Smoking Coach" website. The smoking coach website is a tailored, public health intervention for smoking cessation. |
| QUIT-PRIMO | Experimental | Behavioral: Decide2QuitProviders will give usual care to patients who smoke and then refer patients to the online smoking cessation system electronically. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Community based primary care practices who have:
Key exclusion criteria (1 listed)
- Practices with more than five providers
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 |
|---|---|---|
| Decide2QuitPatient intervention website that includes 1) interactive calculators to assess readiness to quit, symptoms and quit plan, 2) motivational content, and 3) links to other high quality information. | Behavioural | QUIT-PRIMO |
| Smoking CoachControl Patients will be referred by paper prescription to the control- "Smoking Coach" website. | Behavioural | Information Prescription |
Primary outcome
Physician performance on refering patients that smoke cigarettes to the web intervention
Time frame: pre-intervention, 6 months, 12 months and 24 months
Of the smokers who are referred to the web intervention, the number who go to the site
Time frame: preintervention, 6 months, 12 months, 24 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 28 Aug 2013.
- Derived from this study: PubMed 27229772DeLaughter KL, Sadasivam RS, Kamberi A, English TM, Seward GL, Chan SW, Volkman JE, Amante DJ, Houston TK. Crave-Out: A Distraction/Motivation Mobile Game to Assist in Smoking Cessation. JMIR Serious Games. 2016 May 26;4(1):e3. doi: 10.2196/games.4566.
- Derived from this study: PubMed 26525410Houston TK, Sadasivam RS, Allison JJ, Ash AS, Ray MN, English TM, Hogan TP, Ford DE. Evaluating the QUIT-PRIMO clinical practice ePortal to increase smoker engagement with online cessation interventions: a national hybrid type 2 implementation study. Implement Sci. 2015 Nov 2;10:154. doi: 10.1186/s13012-015-0336-8.
- 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.
- Derived from this study: PubMed 23635417Sadasivam RS, Kinney RL, Delaughter K, Rao SR, Williams JH, Coley HL, Ray MN, Gilbert GH, Allison JJ, Ford DE, Houston TK; National Dental PBRN Group; QUIT-PRIMO Collaborative Group. Who participates in Web-assisted tobacco interventions? The QUIT-PRIMO and National Dental Practice-Based Research Network Hi-Quit studies. J Med Internet Res. 2013 May 1;15(5):e77. doi: 10.2196/jmir.2385.
- Derived from this study: PubMed 22011394Sadasivam RS, Delaughter K, Crenshaw K, Sobko HJ, Williams JH, Coley HL, Ray MN, Ford DE, Allison JJ, Houston TK. Development of an interactive, Web-delivered system to increase provider-patient engagement in smoking cessation. J Med Internet Res. 2011 Oct 18;13(4):e87. doi: 10.2196/jmir.1721.
- Derived from this study: PubMed 21080972Houston TK, Sadasivam RS, Ford DE, Richman J, Ray MN, Allison JJ. The QUIT-PRIMO provider-patient Internet-delivered smoking cessation referral intervention: a cluster-randomized comparative effectiveness trial: study protocol. Implement Sci. 2010 Nov 17;5:87. doi: 10.1186/1748-5908-5-87.
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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.
Thomas K Houston, MD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decide2Quit and Smoking Coach in people with Smoking Cessation, run by University of Massachusetts, Worcester 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 3 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 28 Aug 2013. 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?
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?
Physician performance on refering patients that smoke cigarettes to the web intervention (time frame: pre-intervention, 6 months, 12 months and 24 months). The study lists 3 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 NCT00797628, which also lists 6 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 28 Aug 2013.