Smoking Cessation After Hospitalization for a Cardiopulmonary Illness

Study Overview
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Brief Summary
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Smoking-related cardiopulmonary diseases account for a large number of hospital admissions. We investigated the efficacy of hypnotherapy as an aid to a counseling-based smoking cessation program in improving quit rates of hospitalized smoking patients at 12 and 26 weeks after hospital discharge. We compared outcomes with hospitalized patients who received more conventional therapy, namely nicotine replacement therapy, or patients who decided to quit on their own. We also compared smoking cessation rates at 12 and 26 weeks after hospitalization among patients admitted with a cardiac or a pulmonary diagnosis.

Detailed Description
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Hospitalized patients with a cardiopulmonary diagnosis who were contemplating quitting were recruited into 4 groups: Hypnotherapy, Nicotine replacement therapy (NRT), both hypnotherapy and NRT, and self-quit group. All patients received self-help brochures and in-hospital counseling. Intervention groups received more extensive counseling, free NRT supply for a month and/or a 90 minute hypnotherapy session within 2 weeks of discharge. They also had follow up telephone counseling at 1,2,4,8 and 12 weeks after discharge. 7 day prevalence of tobacco abstinence rates at 26 weeks after hospitalization were verified by self report and urinary Cotinine levels.

Official Title
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Smoking Cessation Treatment of CardioPulmonary Hospitalized Patients

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: hypnotherapy
* Drug: Nicotine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized patients with a Cardiopulmonary admission. Exclusion Criteria: Terminal illness, history of Serious Psychiatric illness or substance abuse, Pregnancy, Cognitive or language barriers.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnotherapy<br>Patients admitted with a cardiopulmonary illness received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use after the session. They also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge. | Behavioral: hypnotherapy<br>* One 90 minute session within 2 weeks of hospital discharge<br>* Other names: hypnosis;|
| Experimental: Nicotine Replacement Therapy<br>Patients recieved a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization. | Drug: Nicotine<br>* free one month supply after hospital discharge<br>* Other names: Nicotine replacement therapy;|
| Experimental: Hypnotherapy and Nicotine replacement<br>The group received similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nicotine replacement supplies for a month after discharge. | Behavioral: hypnotherapy<br>* One 90 minute session within 2 weeks of hospital discharge<br>* Other names: hypnosis;Drug: Nicotine<br>* free one month supply after hospital discharge<br>* Other names: Nicotine replacement therapy;|
| No Intervention: Self-Quit group<br>Patients were given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence From Smoking | Assessed by 7-day prevalence of verified tobacco abstinence at 26 weeks after hospitalization for a cardiopulmoanry illness. Verification was confirmed biochemically by urine Cotinine testing or by telephone and discussion with a household proxy. Patients lost to follow up were considered to be persistent smokers. | at 26 weeks after hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Cessation | Abstinence from smoking at 12 weeks after hospitalization was measured by self reported 7-day prevalence and verified urinary Cotinine test. This included participants in groups receiving hypnotherapy, NRT or both. Self quit group was not approached until 26 weeks after discharge. Patients lost to follow up were considered smokers. | at 12 weeks after hospitalization | 
| Smoking Abstinence Rate at 12 and 26 Weeks | Abstinence rates were calculated for patients hospitalized with a cardiac or a pulmonary diagnosis. | 12 weeks and 26 weeks after hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking cessation, Tobacco abstinence, hypnotherapy, Nicotine replacement therapy