Web-delivered Provider Intervention for Tobacco Control (QUIT-PRIMO)

This study is currently recruiting participants.

Verified February 2013 by University of Massachusetts, Worcester

Sponsor:

Collaborators:

Johns Hopkins University

University of Alabama at Birmingham

Information provided by (Responsible Party):

Thomas Houston, University of Massachusetts, Worcester

ClinicalTrials.gov Identifier:

NCT00797628

First received: November 24, 2008

Last updated: February 19, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 24, 2008

Last Updated Date

February 19, 2013

Start Date ^ICMJE

March 2010

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Physician performance on refering patients that smoke cigarettes to the web intervention [ Time Frame: pre-intervention, 6 months, 12 months and 24 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Point prevalence smoking cessation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00797628 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Web-delivered Provider Intervention for Tobacco Control

Official Title ^ICMJE

QUIT-PRIMO: Web-Delivered Clinical Microsystem Intervention for Tobacco Control

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 0

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research

Condition ^ICMJE

Smoking Cessation

Intervention ^ICMJE

Behavioral: Decide2Quit
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.
Behavioral: Smoking Coach
Control Patients will be referred by paper prescription to the control- "Smoking Coach" website.

Study Arm (s)

Experimental: Information Prescription
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.

Intervention: Behavioral: Smoking Coach
Experimental: QUIT-PRIMO
Providers will give usual care to patients who smoke and then refer patients to the online smoking cessation system electronically.

Intervention: Behavioral: Decide2Quit

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

160

Estimated Completion Date

September 2013

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Practices with more than five providers

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Thomas K Houston, MD

508-856-8995

thomas.houston@umassmed.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00797628

Other Study ID Numbers ^ICMJE

X071211009, NIH R01CA129091

Has Data Monitoring Committee

Yes

Responsible Party

Thomas Houston, University of Massachusetts, Worcester

Study Sponsor ^ICMJE

University of Massachusetts, Worcester

Collaborators ^ICMJE

Johns Hopkins University
University of Alabama at Birmingham

Investigators ^ICMJE

Principal Investigator:

Thomas K Houston, MD

University of Massachusetts, Worcester

Information Provided By

University of Massachusetts, Worcester

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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