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Comparing an Opt-out to an opt-in Approach for Smoking Cessation in VA Primary Care Clinics

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ClinicalTrials.gov Identifier: NCT03477435
Recruitment Status : Not yet recruiting
First Posted : March 26, 2018
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The investigators propose a Type I hybrid effectiveness/implementation study to evaluate two population-based approaches for increasing use of Quitlines and text messaging at two VA sites. Specifically, the investigators will test the default bias, examining whether an opt-out approach to referral is more effective than an opt-in approach. The investigators will randomly assign teams to either an opt-out or opt-in approach to referring smokers to treatment. In the opt-out approach, the default is that everyone is referred to treatment unless they actively choose not to be. In the opt-in approach, people are offered treatment but must actively choose to enroll in it.

Condition or disease Intervention/treatment Phase
Tobacco Use Behavioral: Staff training and academic detailing Not Applicable

Detailed Description:
This project is a Type 1 hybrid effectiveness/implementation study to evaluate two population-based approaches for increasing use of specific evidence-based approaches for behavioral tobacco dependence treatment, Quitlines and text messaging, at the Manhattan and Brooklyn campuses of the VA New York Harbor Healthcare System (NYHHS). The project will test the default bias, examining whether an opt-out approach to referral is more effective than an opt-in approach. Researchers will randomly assign clinical care teams at each VA campus to either an opt-out or an opt-in approach to referring smokers to treatment. In the opt-out approach, the default is that everyone is referred to treatment unless they actively choose not to be. In the opt-in approach, people are offered treatment but must actively choose to enroll in it.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5274 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Type 1 hybrid effectiveness/implementation study to evaluate two population-based approaches
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Comparing an Opt-out to an opt-in Approach for Smoking Cessation in VA Primary Care Clinics
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Opt-in clinical reminder
As the investigators have done previously, the reminder will be self-explanatory, and will walk staff through each step of referral. The reminder will include the following domains: normative advice, referral to treatment, handout
Behavioral: Staff training and academic detailing
Both arms will receive training at baseline to help their patients quit smoking. The training will be a mix of content and process education. We will provide brief updates to staff every 6 months throughout the intervention period, which will focus primarily on process education. We will monitor which staff attend and reach out separately to staff who did not. During the month after implementation of the clinical reminders, two study investigators will make a brief outreach visit to each staff member. We will follow a script, using the seven steps recommended by the National Resource Center for Academic Detailing: 1) Introduction; 2) Needs Assessment; 3) Key Messages/Features/Benefits; 4) Understanding Barriers and Enablers; 5) Identifying and Handling Objections; 6) Summary; and 7) Close. The key message (Step 3) will include demonstration of the clinical reminder, review of the evidence for telephone counseling and text messaging and how to refer patients.

Experimental: Opt-out tobacco treatment
The investigators will directly change the treatment status quo by implementing a clinical reminder that automatically initiates tobacco treatment referral at the time the reminder is activated.
Behavioral: Staff training and academic detailing
Both arms will receive training at baseline to help their patients quit smoking. The training will be a mix of content and process education. We will provide brief updates to staff every 6 months throughout the intervention period, which will focus primarily on process education. We will monitor which staff attend and reach out separately to staff who did not. During the month after implementation of the clinical reminders, two study investigators will make a brief outreach visit to each staff member. We will follow a script, using the seven steps recommended by the National Resource Center for Academic Detailing: 1) Introduction; 2) Needs Assessment; 3) Key Messages/Features/Benefits; 4) Understanding Barriers and Enablers; 5) Identifying and Handling Objections; 6) Summary; and 7) Close. The key message (Step 3) will include demonstration of the clinical reminder, review of the evidence for telephone counseling and text messaging and how to refer patients.




Primary Outcome Measures :
  1. Proportion of smokers who accept referral to treatment (Quitline or text messaging) [ Time Frame: 2-year intervention period ]
    This outcome will be based on intervention process data. Note that we will measure both offering and accepting referral, but our outcome will be accepting referral.

  2. Proportion of smokers who engage in treatment with the Quitline or text messaging service [ Time Frame: 2-year intervention period ]
    This outcome will be based on data from the Quitline and SmokefreeTXT.

  3. Abstinence at the end of the 2-year intervention period [ Time Frame: 7-day abstinence ]
    Abstinence will be based on self-report, as is recommended for population-level studies


Secondary Outcome Measures :
  1. Cost-effectiveness of the two approaches (opt-out vs opt-in) [ Time Frame: 2-year intervention period ]
    This outcome will be based on cost data at the end of the intervention

  2. Use of smoking cessation medications [ Time Frame: 2-year intervention period ]
    This outcome will be based on VA administrative data



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Survey Cohort -- Have been seen by an NA on the PACT team in the past 12 months at the Manhattan or Brooklyn VA campus AND Current smoker
  • Nursing Assistants/Registered Nurses -- Work on a PACT at the Manhattan or Brooklyn VA campus
  • Administrative Cohort -- Have been seen by a PACT team at the Manhattan or Brooklyn VA campus AND Current smoker
  • Patient Post-Visit Survey Population -- Had a visit with an NA/RN included in the study AND Current smoker

Exclusion Criteria:

  • Survey Cohort -- Non-English speaking
  • Nursing Assistants/Registered Nurses -- None
  • Administrative Cohort -- None
  • Patient Post-Visit Survey Population -- Non-English speaking

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): NCT03477435


Contacts
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Contact: Scott E Sherman, MD MPH (212) 686-7500 ext 7386 Scott.Sherman@va.gov
Contact: Hilary F Oliphant, MHA MA BA (212) 686-7500 ext 3131 Hilary.Oliphant@va.gov

Locations
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United States, New York
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY Not yet recruiting
New York, New York, United States, 10010
Contact: Scott E Sherman, MD MPH    212-686-7500 ext 7386    Scott.Sherman@va.gov   
Contact: Hilary F Oliphant, MHA MA BA    (212) 686-7500 ext 3131    Hilary.Oliphant@va.gov   
Principal Investigator: Scott E. Sherman, MD MPH         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Scott E. Sherman, MD MPH Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03477435     History of Changes
Other Study ID Numbers: IIR 17-056
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by VA Office of Research and Development:
smoking
tobacco dependence
quitline
smoking cessation