Integrating the Quit and Stay Quit Monday Model Into Smoking Cessation Services for Smokers With Mental Health Conditions

• ClinicalTrials.gov Identifier: NCT04512248
• Recruitment Status: Completed
• First Posted: August 13, 2020
• Last Update Posted: January 5, 2022
• Sponsor: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

Tracking Information

• First Submitted Date: August 11, 2020
• First Posted Date: August 13, 2020
• Last Update Posted Date: January 5, 2022
• Actual Study Start Date: October 1, 2020
• Actual Primary Completion Date: October 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 11, 2020)

• Incidence of 3-month quit attempts [ Time Frame: 3 months ]
  Phone surveys will be conducted to obtain information
• Incidence of smoking cessation [ Time Frame: 3 months ]
  Phone surveys will be conducted to obtain information
• Number of participants who report satisfaction in intervention [ Time Frame: 3 months ]
  Phone surveys will be conducted to obtain information

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Integrating the Quit and Stay Quit Monday Model Into Smoking Cessation Services for Smokers With Mental Health Conditions
• Official Title: Integrating the Quit and Stay Quit Monday Model Into Smoking Cessation Services for Smokers With Mental Health Conditions
• Brief Summary: The Quit and Stay Quit Monday model is an innovative smoking cessation approach that guides smokers' behavior without requiring additional resources. The investigator will conduct a randomized control trial evaluating the effectiveness of this model as compared to usual smoking cessation care in a population of smokers with a mental health condition.

Detailed Description

The overall objective of this proposal is to innovate the tobacco treatment paradigm for smokers with mental health conditions (MHC) by integrating the Quit and Stay Quit Monday Model into smoking cessation services for this vulnerable population.

The investigator will conduct a two-group, parallel-randomized controlled trial (RCT). The target population will be generated by the NYU Langone electronic medical record (EMR). The investigator will proactively contact patients to offer enrollment and randomize participants 1:1 to one of two groups (n=50/group): (1) Quit and Stay Quit Monday Model or (2) Usual Care. For evaluation, phone surveys will be conducted at baseline and 3-months to assess quit attempts, intervention satisfaction, and smoking cessation.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Two-group, parallel-randomized controlled trial

Masking: None (Open Label)
Primary Purpose: Supportive Care

• Condition: Smoking Cessation

Intervention

Behavioral: Quit and Stay Quit Monday Model

Participants randomized to the study intervention will receive: (1) 2 telephone smoking cessation coaching calls; (2) enrollment into SmokefreeTXT; and (3) enrollment in the iquitmonday.org weekly email newsletter. The telephone coaches will ask these participants to identify a future Monday as their quit date and provide coaching to achieve a Monday quit. The coaches will also enter the selected Monday as the patient's quit day when enrolling the patient into SmokefreeTXT.

Study Arms

• Experimental: Quit and Stay Quit Monday Model
  Intervention: Behavioral: Quit and Stay Quit Monday Model
• No Intervention: Usual Care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 14, 2021): 70
• Original Estimated Enrollment (submitted: August 11, 2020): 100
• Actual Study Completion Date: October 30, 2021
• Actual Primary Completion Date: October 30, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. age ≥ 18 years old
2. Has smoked a cigarette in the past 30 days, even a puff
3. Has been diagnosed with a mental health condition or received care from a mental health clinic within the NYU Langone Health system in the prior 12 months
4. Interested in quitting smoking
5. English language
6. Has a phone that can receive text messages
7. Able to provide informed consent

Exclusion Criteria:

1. age < 18 years of age
2. Non-smoker

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04512248
• Other Study ID Numbers: 20-01247
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Time Frame: Data will become available beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to ERIN.ROGERS@NYULANGONE.ORG. To gain access, data requestors will need to sign a data access agreement.

• Current Responsible Party: NYU Langone Health
• Original Responsible Party: Same as current
• Current Study Sponsor: NYU Langone Health
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Erin Rogers, DrPH; NYU Langone Health

• PRS Account: NYU Langone Health
• Verification Date: December 2021