RECRUITING

Smoking Cessation Pharmacotherapy-Nurse Practitioner Led Tobacco Treatment Team Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Tobacco use remains the leading cause of death in the United States and contributes to more than 7 million hospitalizations annually. Being admitted to the hospital offers the perfect opportunity to support smoking cessation. Patients are motivated to quit because of their current illness and societal guidelines recommend clinicians should counsel patients and prescribe smoking cessation pharmacotherapy (SCP) to virtually all smokers. However, only 22% of patients are prescribed SCP while hospitalized, and only 1% are prescribed medications compatible with current guidelines. This failure is part of the reason 70-80% of hospitalized smokers eventually relapse. The relapse typically occurs within a few days of hospital discharge - well before outpatient follow-up can occur. The investigators aim to improve smoking cessation treatment and guideline adherence by utilizing the opportunity that hospitalization provides. The investigators have created a tobacco treatment team (T3) to overcome physicians' and patients' low use of current guideline smoking cessation medications. The team members are trained in tobacco treatment and will be led by a nurse practitioner (NPT3). The team will work together and 1) prescribe individually tailored and guideline-concordant SCP; 2) counsel and motivate patients to use SCP properly; and 3) manage a mobile phone-based text-messaging system to keep patients motivated and adherent to SCP. Our preliminary data suggest that such an approach is workable and acceptable to patients, physicians, and hospital administrators. The investigators will recruit 424 patients in the hospital who smoke with cardiopulmonary disease. These patients will be randomized to receive either usual care or personalized care with the NPT3 team. The investigators will compare rates of guideline-concordant SCP use at 1 week and exhaled carbon monoxide (eCO) verified smoking cessation at 6 months between patients randomized to the NPT3 team vs. usual care. The investigators will also measure the project's economic value from a hospital and payer perspective. Understanding the economic value will better inform hospital and insurance policies and sustainability. Finally, acceptability, generalizability, and sustainability measures will be assessed through qualitative interviews with patients, providers, and hospital leadership.

Official Title

Implementing Effective Smoking Cessation Pharmacotherapy for Hospitalized Smokers With Cardiopulmonary Disease

Quick Facts

Study Start:2022-11-03
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05733767

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Admitted to Baystate Medical Center in Springfield, MA with a cardiac or pulmonary disease diagnosis will be eligible to participate in this trial.
  2. * Patients who smoke cigarettes
  3. * Speak English
  4. * myocardial infarction
  5. * coronary artery bypass grafting surgery
  6. * heart valve surgery
  7. * percutaneous coronary intervention (PCI)
  8. * acute coronary syndrome
  9. * heart failure
  10. * chronic obstructive pulmonary disease (COPD)
  11. * asthma exacerbation.
  1. * We will exclude pregnant or nursing women, patients with current suicidal ideation, planned discharge to hospice or expected survival \<6 months, or concurrent use of daily smoked marijuana, because this can increase exhaled carbon monoxide levels, which would confound biochemical confirmation.

Contacts and Locations

Study Contact

Quinn R Pack, MD
CONTACT
413-794-4490
quinn.pack@baystatehealth.org
Karen L Riska, PhD
CONTACT
413-795-7115
karen.riska@baystatehealth.org

Principal Investigator

Quinn R Pack, MD
PRINCIPAL_INVESTIGATOR
Baystate Medical Center

Study Locations (Sites)

Baystate Medical Center
Springfield, Massachusetts, 01199
United States

Collaborators and Investigators

Sponsor: Baystate Medical Center

  • Quinn R Pack, MD, PRINCIPAL_INVESTIGATOR, Baystate Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-03
Study Completion Date2027-12

Study Record Updates

Study Start Date2022-11-03
Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

  • Cardiopulmonary Disease
  • Smoking Cessation
  • Inpatient