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Strategies to Connect Patients at Federally Qualified Health Clinics With Evidence Based Tobacco Cessation Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03900767
Recruitment Status : Not yet recruiting
First Posted : April 3, 2019
Last Update Posted : April 3, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Utah

Brief Summary:
This trial aims to connect tobacco using patients of Community Health Centers (CHCs) and Federally Qualified Health Centers (FQHCs) with evidence-based treatment to help them quit. The trial will evaluate multiple strategies, that target both clinics and for patients, to increase the number of patients who enroll in Utah Tobacco Quit Line treatment.

Condition or disease Intervention/treatment Phase
Current Smoker Tobacco Smoking Tobacco Use Other: Electronic Health Record intervention Behavioral: Smoking Cessation Intervention Behavioral: Telephone-Based Intervention Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate clinic and patient level interventions with respect to increasing the reach of evidence-based treatment for tobacco use (delivered via the Utah Quitline).

II. To evaluate clinic and patient level interventions with respect to increasing the impact of Quitline treatment. Impact is defined as Reach X Efficacy. In calculating impact, efficacy is defined as the proportion of smokers who enroll in Quitline delivered treatment that successfully quit.

III. To evaluate characteristics of both clinics and patients that may influence tobacco use outcomes.

OUTLINE:

PHASE I: Clinics are randomized to 1 of 2 groups.

GROUP I: Clinics participate in Ask, Advise, Connect-Opt Out (AAC-Out) intervention consisting of an electronic health record (EHR)-based point of care alert that requires clinic staff to Advise and Connect tobacco users to the Utah Quitline, or to "opt out" (i.e. the default requires an action- Advise and Connect, or Opt Out).

GROUP II: Clinics participant in Ask, Advise, Connect-Opt in (AAC-In) intervention consisting of an EHR based point of care reminder that allows medical staff to choose when to perform Advise and Connect (i.e. the default does not require a connection).

PHASE II: Tobacco users who do not enroll in Quitline treatment in response to AAC-Out or AAC-In, will be individually randomized to one of two groups in a 4:1 ratio (4 to Group 1 for every 1 to Group II):

GROUP I: Patients receive a monthly text message (TM) for 6 months following each tobacco user's clinic visit that includes a simple one-touch response to directly connect to the Quitline. Patients receive continued clinic level electronic health record (EHR) intervention following each tobacco user's clinic visit.

GROUP II: Patients receive continued clinic level electronic health record (EHR) intervention following each tobacco user's clinic visit.

PHASE III: Nonresponders (i.e., did not engage in Quitline treatment at 6 months) in Group 1 of Phase II (i.e., text messaging condition) will be randomized to 1 of 2 groups.

GROUP I: Patients continue to receive a monthly text message with a simple one-touch response to directly connect to the Quitline during months 6-12 following each tobacco user's clinic visit

GROUP II: Patients receive a monthly text message plus 2 brief telephone calls from patient navigators/health educators for 6-12 months following each tobacco user's clinic visit.

After completion of study, patients are followed up at 12 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Multi-Level Interventions for Increasing Tobacco Cessation at Federally Qualified Health Clinics (FQHCs)
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 1, 2023

Arm Intervention/treatment
Experimental: Phase I Group I (AAC-Out)
GROUP I: Clinics participate in AAC-Out intervention consisting of an EHR-based point of care alert that requires clinic staff to Advise and Connect tobacco users to the Utah Quitline, or to "opt out" (i.e. the default requires an action- Advise and Connect, or Opt Out).
Other: Electronic Health Record intervention
AAC-Out

Experimental: Phase I Group II (AAC-In)
Clinics participant in AAC-In intervention consisting of an EHR based point of care reminder that allows medical staff to choose when to perform Advise and Connect (i.e. the default does not require a connection).
Other: Electronic Health Record intervention
AAC-In

Experimental: Phase II Group I (Continued EHR and text messages)
Patients receive a monthly text message for 6 months following each tobacco user's clinic visit that includes a simple one-touch response to directly connect to the Quitline.
Behavioral: Smoking Cessation Intervention
Receive standard Utah Quitline treatment
Other Name: Smoking and Tobacco Use Cessation Interventions

Behavioral: Telephone-Based Intervention
Receive text messages

Experimental: Phase II Group II (Continued EHR)
Patients receive continued clinic level EHR intervention following each tobacco user's clinic visit.
Behavioral: Smoking Cessation Intervention
Receive standard Utah Quitline treatment
Other Name: Smoking and Tobacco Use Cessation Interventions

Experimental: Phase III Group I (Continued EHR and text messages)
Patients receive a monthly text message for 6-12 months following each tobacco user's clinic visit that includes a simple one-touch response to directly connect to the Quitline.
Behavioral: Smoking Cessation Intervention
Receive standard Utah Quitline treatment
Other Name: Smoking and Tobacco Use Cessation Interventions

Behavioral: Telephone-Based Intervention
Receive text messages

Experimental: Phase III Group II (Text messages, Counseling call)
Patients receive a monthly text message plus 2 brief telephone calls from patient navigators/health educators for 6-12 months following each tobacco user's clinic visit.
Behavioral: Smoking Cessation Intervention
Receive standard Utah Quitline treatment
Other Name: Smoking and Tobacco Use Cessation Interventions

Behavioral: Telephone-Based Intervention
Receive text messages

Behavioral: Telephone-Based Intervention
Receive phone calls




Primary Outcome Measures :
  1. Reach [ Time Frame: Up to 12 months ]
    Defined as the proportion of tobacco users who enter Quitline treatment.

  2. Impact [ Time Frame: At 12 months ]
    Defined as reach x efficacy. Efficacy is defined as the proportion of tobacco users entering Quitline treatment who quit (i.e., achieve abstinence).

  3. Abstinence from tobacco use [ Time Frame: At 12 months ]
    Abstinence assessments are based on recommendations for cessation induction trials (i.e., 7 and 30 day point prevalence abstinence).

  4. Health-related quality of life [ Time Frame: At 12 months ]
    Assessed with the Short Form Health Survey.


Secondary Outcome Measures :
  1. Abstinence from tobacco use (biochemical validation) [ Time Frame: At 12 months ]
    We will randomly select a subset of participants who report abstinence at 12 months to complete biochemical validation of abstinence via saliva samples. The saliva sample will be used to test for cotinine, a metabolite of nicotine.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants will be current tobacco users.
  • Participants who speak English or Spanish.
  • Participants will have a working cellphone that can accept texts and calls.
  • Participants who present at participating community health center (CHC) clinics.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03900767


Contacts
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Contact: Chelsey Schlechter, PhD, MPH 801-213-5704 chelsey.schlechter@hci.utah.edu

Locations
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United States, Utah
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Contact: David Wetter    801-213-6178      
Principal Investigator: David Wetter         
Sponsors and Collaborators
University of Utah
National Cancer Institute (NCI)
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: David Wetter Huntsman Cancer Institute/ University of Utah

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT03900767    
Other Study ID Numbers: HCI111985
NCI-2019-00502 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
HCI111985 ( Other Identifier: Huntsman Cancer Institute/University of Utah )
P30CA042014 ( U.S. NIH Grant/Contract )
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No