Inpatient Smoking Cessation Pilot Program

Smoking Cessation Pilot Program on 9 South

The investigators are implementing a stepwise approach to cessation with a public health focus to improve health outcomes for the investigators' pediatric patients. The investigators are focusing on addressing caregiver smoking as a modifiable risk factor during time of child's hospitalization as a window of opportunity to provide counseling and education to families on secondhand and third hand smoke exposure as well as information on NRT products to heighten caregiver contemplation for quitting. One of the central goals of the investigators' project is to increase immediate access to Nicotine Replacement Therapy (NRT) resources for families during hospitalization which pediatric providers could potentially dose and prescribe to caregivers who are screened positive for smoking. Long-term cessation care is provided by referrals to both the MD Quitline and the John Hopkins Tobacco Treatment Clinic. Both are provided to allow participants options that the participants would find preferable from an insurance and provider perspective.

Study Overview

• Status: Withdrawn
• Conditions: Tobacco Use Cessation
• Intervention / Treatment: Drug: Nicotine lozenge; Drug: Nicotine gum; Drug: Nicotine patch; Other: Maryland Quitline; Other: John Hopkins Tobacco Treatment Clinic

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Aysha Jawed; Phone Number: 6677763777; Email: ajawed1@jhmi.edu
• Study Contact Backup: Name: Mandeep S. Jassal; Phone Number: 4109552035; Email: mjassal1@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Caregivers of patients on an inpatient unit at Johns Hopkins Children's Center who self-identify as tobacco users and wish to initiate tobacco cessation

Exclusion Criteria:

• Pregnant or breast feeding maternal caregivers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cessation intervention; All participants will receive nicotine replacement therapy and a referral to both Maryland Quitline and Johns Hopkins Tobacco Treatment Clinic for continued cessation care. Nicotine replacement therapy: Nicoderm patches, gum, lozenges; Low nicotine dependence: Lozenge (2 mg) or Gum (2 mg) or Patch (7 mg); Moderate nicotine dependence: Patch (14 mg) and Lozenge (2 mg) or Gum (2 mg); High nicotine dependence: Patch (21 mg) and Lozenge (4 mg) or Gum (4 mg) Regardless of the level of nicotine addiction and subsequent dose of nicotine replacement therapy (NRT), participants of this trials are described as "recipients of NRT products".

Drug: Nicotine lozenge; Nicotine replacement therapy; Drug: Nicotine gum; Nicotine replacement therapy; Drug: Nicotine patch; Nicotine replacement therapy; Other: Maryland Quitline; Telephone-based tobacco cessation service; Other: John Hopkins Tobacco Treatment Clinic; Clinic-based tobacco cessation service

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-reported attempts to quit smoking	Change in caregiver self-reported tobacco cessation attempt in the past 14-days.	Baseline, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Frequency of usage of outpatient tobacco cessation services	Change in frequency of caregiver self-reported usage of outpatient tobacco cessation services (Maryland Quitline or Johns Hopkins Tobacco Treatment Clinic).	Baseline, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months
Change in Usage of nicotine replacement therapy products	Change in caregiver self-reported usage of nicotine replacement therapy in the past 14-days.	Baseline, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Mandeep S. Jassal, MD, MPH, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Estimated): April 1, 2023
• Study Completion (Estimated): April 1, 2023

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 29, 2021

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: IRB00208192

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified participant data will be shared with researchers or sponsor upon review of a written request. The request will require a detailed description of the usage of the data and will require approval by the principal investigator. A data use agreement will be set-up and a plan for data removal (including timeline) will be established.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No