Trial Outcomes & Findings for Smoking Cessation After Hospitalization for a Cardiopulmonary Illness (NCT NCT01791803)

Last Updated: 2017-05-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

164 participants

Primary outcome timeframe

at 26 weeks after hospitalization

Results posted on

2017-05-19

Participant Flow

Participant milestones

Participant milestones
Measure	Hypnotherapy Patients admitted with a cardiopulmonary illness will receive 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 will also recieve self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge. hypnotherapy: One 90 minute session within 2 weeks of hospital discharge	Nicotine Replacement Therapy Patients will recieve a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients will receive self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization. Nicotine: free one month supply after hospital discharge	Hypnotherapy and Nicotine Replacement The group will recieve similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nictotine replacement supplies for a month after discharge. hypnotherapy: One 90 minute session within 2 weeks of hospital discharge Nicotine: free one month supply after hospital discharge	Self-Quit Group patients will be given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization.
Overall Study STARTED	41	41	40	42
Overall Study COMPLETED	41	39	38	37
Overall Study NOT COMPLETED	0	2	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Nicotine Replacement Therapy Patients will recieve a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients will receive self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization. Nicotine: free one month supply after hospital discharge	Hypnotherapy and Nicotine Replacement The group will recieve similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nictotine replacement supplies for a month after discharge. hypnotherapy: One 90 minute session within 2 weeks of hospital discharge Nicotine: free one month supply after hospital discharge	Self-Quit Group patients will be given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization.
Overall Study Withdrawal by Subject	0	0	2
Overall Study Physician Decision	2	0	1
Overall Study Death	0	2	2

Baseline Characteristics

Smoking Cessation After Hospitalization for a Cardiopulmonary Illness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hypnotherapy n=41 Participants Patients received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use . They also received counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.	Nicotine Replacement Therapy n=41 Participants Patients received a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays, self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization.	Hypnotherapy and Nicotine Replacement n=40 Participants patients recieved both a similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nictotine replacement supplies for a month after discharge.	Self-Quit Group n=42 Participants Patients were given brief counseling during hospitalization and were not contacted until 26 weeks after hospitalization. They received no telephone contact and or counseling after discharge.	Total n=164 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=93 Participants	41 Participants n=4 Participants	40 Participants n=27 Participants	42 Participants n=483 Participants	164 Participants n=36 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Age, Continuous	55.0 years STANDARD_DEVIATION 10.6 • n=93 Participants	55.3 years STANDARD_DEVIATION 12.2 • n=4 Participants	54.4 years STANDARD_DEVIATION 8.9 • n=27 Participants	56.0 years STANDARD_DEVIATION 10.7 • n=483 Participants	55.17 years STANDARD_DEVIATION 1.4 • n=36 Participants
Sex: Female, Male Female	25 Participants n=93 Participants	18 Participants n=4 Participants	14 Participants n=27 Participants	16 Participants n=483 Participants	73 Participants n=36 Participants
Sex: Female, Male Male	16 Participants n=93 Participants	23 Participants n=4 Participants	26 Participants n=27 Participants	26 Participants n=483 Participants	91 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) White	38 Participants n=93 Participants	32 Participants n=4 Participants	31 Participants n=27 Participants	36 Participants n=483 Participants	137 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants	9 Participants n=4 Participants	9 Participants n=27 Participants	6 Participants n=483 Participants	27 Participants n=36 Participants
Region of Enrollment United States	41 participants n=93 Participants	41 participants n=4 Participants	40 participants n=27 Participants	42 participants n=483 Participants	164 participants n=36 Participants
Years of education	13 years STANDARD_DEVIATION 2 • n=93 Participants	12.6 years STANDARD_DEVIATION 2 • n=4 Participants	13.2 years STANDARD_DEVIATION 1.8 • n=27 Participants	13.2 years STANDARD_DEVIATION 1.9 • n=483 Participants	13 years STANDARD_DEVIATION 1.9 • n=36 Participants
Number of cigarettes smoked	19.8 Cigarettes smoked /day STANDARD_DEVIATION 12.6 • n=93 Participants	21.2 Cigarettes smoked /day STANDARD_DEVIATION 12.6 • n=4 Participants	20.5 Cigarettes smoked /day STANDARD_DEVIATION 9.3 • n=27 Participants	15 Cigarettes smoked /day STANDARD_DEVIATION 10 • n=483 Participants	19.12 Cigarettes smoked /day STANDARD_DEVIATION 11.12 • n=36 Participants
Total years of smoking	36.5 years STANDARD_DEVIATION 12.7 • n=93 Participants	34.2 years STANDARD_DEVIATION 14.4 • n=4 Participants	34.3 years STANDARD_DEVIATION 11.7 • n=27 Participants	33.2 years STANDARD_DEVIATION 10.8 • n=483 Participants	34.55 years STANDARD_DEVIATION 12.4 • n=36 Participants
Living with a smoker	18 Participants n=93 Participants	16 Participants n=4 Participants	13 Participants n=27 Participants	14 Participants n=483 Participants	61 Participants n=36 Participants
Admitted with Cardiac Diagnosis	26 Participants n=93 Participants	25 Participants n=4 Participants	22 Participants n=27 Participants	27 Participants n=483 Participants	100 Participants n=36 Participants
Lost to Follow up (Considered non-quitters)	14 Participants n=93 Participants	12 Participants n=4 Participants	13 Participants n=27 Participants	17 Participants n=483 Participants	56 Participants n=36 Participants

PRIMARY outcome

Timeframe: at 26 weeks after hospitalization

Outcome measures

Outcome measures
Measure	Hypnotherapy n=41 Participants 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. hypnotherapy: One 90 minute session within 2 weeks of hospital discharge	Nicotine Replacement Therapy n=39 Participants Patients received 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. Nicotine: free one month supply after hospital discharge	Hypnotherapy and Nicotine Replacement n=38 Participants 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. hypnotherapy: One 90 minute session within 2 weeks of hospital discharge Nicotine: free one month supply after hospital discharge	Self-Quit Group n=37 Participants patients were given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization.
Abstinence From Smoking	15 percentage of participants	7 percentage of participants	13 percentage of participants	10 percentage of participants

SECONDARY outcome

Timeframe: at 12 weeks after hospitalization

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.

Outcome measures

Outcome measures
Measure	Hypnotherapy n=41 Participants 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. hypnotherapy: One 90 minute session within 2 weeks of hospital discharge	Nicotine Replacement Therapy n=39 Participants Patients received 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. Nicotine: free one month supply after hospital discharge	Hypnotherapy and Nicotine Replacement n=38 Participants 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. hypnotherapy: One 90 minute session within 2 weeks of hospital discharge Nicotine: free one month supply after hospital discharge	Self-Quit Group n=37 Participants patients were given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization.
Smoking Cessation	18 Participants	11 Participants	18 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 weeks and 26 weeks after hospital discharge

Population: Abstinence comparing the 2 admitting diagnoses was similar within each arm, thus analysis for admitting diagnosis was done combining the 4 arms.

Abstinence rates were calculated for patients hospitalized with a cardiac or a pulmonary diagnosis.

Outcome measures

Outcome measures
Measure	Hypnotherapy n=155 Participants 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. hypnotherapy: One 90 minute session within 2 weeks of hospital discharge	Nicotine Replacement Therapy Patients received 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. Nicotine: free one month supply after hospital discharge	Hypnotherapy and Nicotine Replacement 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. hypnotherapy: One 90 minute session within 2 weeks of hospital discharge Nicotine: free one month supply after hospital discharge	Self-Quit Group patients were given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization.
Smoking Abstinence Rate at 12 and 26 Weeks % Quit rate for cardiac diagnosis at 26 weeks	34 percentage of smoking abstinence rate	—	—	—
Smoking Abstinence Rate at 12 and 26 Weeks % Quit rate for cardiac diagnosis at 12 weeks	52.1 percentage of smoking abstinence rate	—	—	—
Smoking Abstinence Rate at 12 and 26 Weeks % Quit rate for pulmonary diagnosis at 12 weeks	20 percentage of smoking abstinence rate	—	—	—
Smoking Abstinence Rate at 12 and 26 Weeks % quit rate for pulmonary diagnosis at 26 weeks	20 percentage of smoking abstinence rate	—	—	—

Adverse Events

Hypnotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nicotine Replacement Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hypnotherapy and Nicotine Replacement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Self-Quit Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Faysal M. Hasan

North Shore Medical Center

Phone: 978-741-1200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place