NCT00797628

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2008

Completed
1.3 years until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 28, 2013

Status Verified

August 1, 2013

Enrollment Period

3.4 years

First QC Date

November 24, 2008

Last Update Submit

August 27, 2013

Conditions

Outcome Measures

Primary Outcomes (3)

  • Physician performance on refering patients that smoke cigarettes to the web intervention

    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

    preintervention, 6 months, 12 months, 24 months

  • Point prevalence smoking cessation

    6 months

Study Arms (2)

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.

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.

Behavioral: Decide2Quit

Interventions

Decide2QuitBEHAVIORAL

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.

QUIT-PRIMO
Smoking CoachBEHAVIORAL

Control Patients will be referred by paper prescription to the control- "Smoking Coach" website.

Information Prescription

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community based primary care practices who have:
  • Internet access in office
  • Sees 4 - 5 smokers per week

You may not qualify if:

  • Practices with more than five providers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (6)

  • 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.

  • Houston 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.

  • Coley 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.

  • Sadasivam 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.

  • Sadasivam 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.

  • Houston 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.

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Thomas K Houston, MD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 24, 2008

First Posted

November 25, 2008

Study Start

March 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

August 28, 2013

Record last verified: 2013-08

Locations