Enhanced Care for Smoking Cessation

Recruiting at 5 trial locations

Overseen By Kenneth M Cummings, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: No phone, Non-English speakers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Duration of hospitalization

1122 Participants Needed

Trial Summary

What is the purpose of this trial?

The modest goal of this study is to replicate the behavioral outcomes of the opt out MUSC-Tobacco Treatment Program in the following three patient groups: 1) psychiatric inpatients housed in the Institute of Psychiatry (IOP) in Charleston; 2) non-IOP patients seen in Charleston; and 3) patients seen in the other four MUSC affiliated hospitals combined (i.e., Chester, Florence, Lancaster, and Marion). The aims and the design/methods utilized for evaluation will be the same for each of the three patient groups.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Enhanced Care treatment for smoking cessation?

Research shows that enhanced care, which includes additional support and resources, can improve smoking cessation outcomes. For example, a study found that more patients in an enhanced care program were asked about their smoking status and advised to quit compared to usual care, leading to better engagement in quitting efforts. ^{1 2 3 4 5}

Is the Enhanced Care for Smoking Cessation treatment safe for humans?

The studies reviewed focus on the feasibility and effectiveness of smoking cessation treatments, but they do not provide specific safety data for Enhanced Care or similar treatments. However, the use of FDA-approved smoking cessation medications in these studies suggests a level of safety, as these medications have been evaluated for human use. ^{6 7 8 9 10}

How does the Enhanced Care treatment for smoking cessation differ from other treatments?

Enhanced Care for smoking cessation may involve more intensive behavioral support compared to basic care, potentially delivered by primary care nurses or auxiliary healthcare workers. This approach could offer a more structured and frequent support system, which might be more effective than standard minimal interventions or pharmacological treatments like nicotine replacement therapy. ^{3 5 11 12 13}

Research Team

Kenneth M Cummings, PhD

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

This trial is for hospitalized cigarette smokers over the age of 18 who are being discharged back to their homes. Participants must have a phone number and be able to communicate in English. It's not open to those without a phone or who can't speak English.

Inclusion Criteria

I am 18 years old or older.

discharged from the hospital back to their home

I am a hospitalized smoker eligible for care.

Exclusion Criteria

Patients without a phone number

I cannot communicate in English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the opt-out MUSC-Tobacco Treatment Program during hospitalization

Duration of hospitalization

Follow-up

Participants are monitored for smoking behavior and use of cessation medication after discharge

6 weeks

Assessed post-discharge

Treatment Details

Interventions

• Basic Care
• Enhanced Care

Trial Overview The study is testing two types of smoking cessation services: Basic Care and Enhanced Care, across different patient groups including psychiatric inpatients and non-psychiatric patients at various hospitals affiliated with MUSC.

Participant Groups

Group I: Enhanced Care Condition Experimental Treatment 1 Intervention

Group II: Basic Care Condition Active Control 1 Intervention

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Findings from Research

The study evaluated an asynchronous smoking cessation e-visit for adult smokers in primary care, involving 51 participants, and found it to be acceptable and feasible, with high satisfaction rates among users.

The e-visit showed promising efficacy in improving smoking cessation outcomes compared to standard treatment, with participants having higher odds of quitting at both 1 month (ORs: 2.10-5.39) and 3 months (ORs: 1.31-4.67) post-enrollment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Proactive Smoking Cessation Electronic Visit to Extend the Reach of Evidence-Based Cessation Treatment via Primary Care. Dahne, J., Player, M., Carpenter, MJ., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Designing for Sustainability: An Approach to Integrating Staff Role Changes and Electronic Health Record Functionality Within Safety-Net Clinics to Address Provision of Tobacco Cessation Care. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Barriers and facilitators to implementing the CURE stop smoking project: a qualitative study. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Web-Based Intervention for Transitioning Smokers From Inpatient to Outpatient Care: An RCT. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Evaluation of an intervention to enhance the delivery of smoking cessation services to patients with cancer. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

12-Month Evaluation of an EHR-Supported Staff Role Change for Provision of Tobacco Cessation Care in 8 Primary Care Safety-Net Clinics. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Improving smoking cessation policy by assessing user demand for an inpatient smoking cessation service in adult psychiatric wards. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Proactive Smoking Cessation Electronic Visit to Extend the Reach of Evidence-Based Cessation Treatment via Primary Care. [2022]

8. Greece pubmed.ncbi.nlm.nih.gov

Feasibility of collecting computer-facilitated patient-reported tobacco use, interest, and preferences for smoking cessation in an outpatient thoracic surgery and oncology setting. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Rationale and protocol for a cluster randomized pragmatic clinical trial testing behavioral economic implementation strategies to improve tobacco treatment rates for cancer patients who smoke. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Identifying Targeted Strategies to Improve Smoking Cessation Support for Cancer Patients. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Weekly versus basic smoking cessation support in primary care: a randomised controlled trial. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Are Nurses and Auxiliary Healthcare Workers Equally Effective in Delivering Smoking Cessation Support in Primary Care? [2018]

13. Spain pubmed.ncbi.nlm.nih.gov

[Smoking cessation in primary and specialized care: a real opportunity and a public health necessity]. [2020]