Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients

Smoking Cessation Clinical Trial

Official title:

Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01363245
• Other study ID #: CHART NYU
• Secondary ID: 1U01HL105229013U
• Status: Completed
• Phase: N/A
• First received: January 31, 2011
• Last updated: July 1, 2015
• Start date: July 2011
• Est. completion date: April 2015

Study information

• Verified date: July 2015
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators plan to compare the effectiveness and cost effectiveness of an inpatient smoking cessation intervention for all smokers hospitalized at two urban public hospitals.

Description:

Our sites are: Bellevue Hospital Center (a New York City public hospital) and the Manhattan campus of the VA New York Harbor Healthcare System. During hospitalization, all smokers will receive usual care. At the time of discharge, patients will be randomized to one of two arms: multisession telephone counseling by their hospital's smoking cessation staff, or faxed referral to the state Quitline (which will then perform phone outreach as per Quitline protocol). All patients enrolled in the study will receive nicotine replacement therapy.

The primary aims are:

Aim 1: To compare the effectiveness of the intervention (proactive multisession telephone counseling by in-hospital staff) versus control ('fax-to-quit' Quitline referral).

Aim 2: To evaluate and compare the cost-effectiveness of these interventions from a societal perspective and from a payer perspective.

The secondary aims are:

Secondary Aim 1: To compare outcomes by race/ethnicity, immigrant status, inpatient diagnosis, and location of patient hospitalization Secondary Aim 2: To compare outcomes of the interventions at 6 and 12 months post-discharge Secondary Aim 3: To compare biochemically-verified abstinence rates at 6 months post-discharge Secondary Aim 4: To compare cessation outcomes between those who are known HIV-seropositive and those who are not, and explore possible mediators of cessation in HIV-seropositive patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1618
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age = 18 years

• smoked tobacco during the prior 30 days

• have an active phone number

• provide consent in English, Spanish or Mandarin

Exclusion Criteria:

• Patients will be excluded if they use only smokeless tobacco or products such as betel (since there is not yet efficacy data for treating use of these tobacco products in the inpatient setting)

• are pregnant or breastfeeding

• are discharged to an institution (e.g. jail/prison, nursing home, long-term psychiatric facility).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Telephone Counseling
Telephone counseling: 7 calls over 6 weeks
• Fax-to-quit
referral to state smoking cessation 'quitline' for counseling - 1 call over 2 weeks

Locations

Country	Name	City	State
United States	Bellevue Hospital Center	New York	New York
United States	VA New York Harbor Healthcare System	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of counseling intervention vs. control intervention on smoking cessation rates of participants enrolled in study	To compare the effectiveness of a phone counseling intervention (proactive multisession telephone counseling by in-hospital staff) versus control intervention ('fax-to-quit' Quitline referral)	4 yrs	No
Secondary	Comparison of cessation outcomes by sociodemographic subgroups	To compare smoking abstinence rates by race/ethnicity, immigrant status, inpatient diagnosis, and location of patient hospitalization	4yrs	No
Secondary	Comparison of cessation rates at 6 and 12 months post-discharge	To compare smoking abstinence rates in the two arms at 6 months and 12 months post-discharge	4yrs	No
Secondary	Comparison of biochemically-verified smoking cessation	To compare rates of biochemically-verified smoking abstinence measured at 6 months post-discharge	4 years	No
Secondary	Comparison of cessation outcomes between participants who are HIV-seropositive vs. those who are not	To compare cessation outcomes between those who are known HIV-seropositive and those who are not, and explore possible mediators of cessation in HIV-seropositive patients.	2 years	No
Secondary	Cost Effectiveness comparison of two smoking cessation interventions.	Evaluate and compare the cost-effectiveness of these interventions from a societal perspective and from a payor perspective. Our hypotheses are that the intervention will have incremental cost-effectiveness ratios consistent with current standards of healthcare value in the United States.	4 yrs	No