Smoking Cessation After Hospitalization for a Cardiopulmonary Illness

Smoking Cessation Treatment of CardioPulmonary Hospitalized Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01791803

Acronym

STOPP

Enrollment

164

Registered

2013-02-15

Start date

2006-01-31

Completion date

2009-05-31

Last updated

2017-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

Smoking cessation, Tobacco abstinence, hypnotherapy, Nicotine replacement therapy

Brief summary

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

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.

Interventions

BEHAVIORALhypnotherapy

One 90 minute session within 2 weeks of hospital discharge

DRUGNicotine

free one month supply after hospital discharge

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Abstinence From Smoking	at 26 weeks after hospitalization	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.

Secondary

Measure	Time frame	Description
Smoking Cessation	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.
Smoking Abstinence Rate at 12 and 26 Weeks	12 weeks and 26 weeks after hospital discharge	Abstinence rates were calculated for patients hospitalized with a cardiac or a pulmonary diagnosis.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Hypnotherapy 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.	41
Nicotine Replacement Therapy 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.	41
Hypnotherapy and Nicotine Replacement 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.	40
Self-Quit Group 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.	42
Total	164

Withdrawals & dropouts

Period	Reason	FG001	FG002	FG003
Overall Study	Death	0	2	2
Overall Study	Physician Decision	2	0	1
Overall Study	Withdrawal by Subject	0	0	2

Baseline characteristics

Characteristic	Hypnotherapy	Total	Self-Quit Group	Hypnotherapy and Nicotine Replacement	Nicotine Replacement Therapy
Admitted with Cardiac Diagnosis	26 Participants	100 Participants	27 Participants	22 Participants	25 Participants
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	41 Participants	164 Participants	42 Participants	40 Participants	41 Participants
Age, Continuous	55.0 years STANDARD_DEVIATION 10.6	55.17 years STANDARD_DEVIATION 1.4	56.0 years STANDARD_DEVIATION 10.7	54.4 years STANDARD_DEVIATION 8.9	55.3 years STANDARD_DEVIATION 12.2
Living with a smoker	18 Participants	61 Participants	14 Participants	13 Participants	16 Participants
Lost to Follow up (Considered non-quitters)	14 Participants	56 Participants	17 Participants	13 Participants	12 Participants
Number of cigarettes smoked	19.8 Cigarettes smoked /day STANDARD_DEVIATION 12.6	19.12 Cigarettes smoked /day STANDARD_DEVIATION 11.12	15 Cigarettes smoked /day STANDARD_DEVIATION 10	20.5 Cigarettes smoked /day STANDARD_DEVIATION 9.3	21.2 Cigarettes smoked /day STANDARD_DEVIATION 12.6
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants	27 Participants	6 Participants	9 Participants	9 Participants
Race (NIH/OMB) White	38 Participants	137 Participants	36 Participants	31 Participants	32 Participants
Region of Enrollment United States	41 participants	164 participants	42 participants	40 participants	41 participants
Sex: Female, Male Female	25 Participants	73 Participants	16 Participants	14 Participants	18 Participants
Sex: Female, Male Male	16 Participants	91 Participants	26 Participants	26 Participants	23 Participants
Total years of smoking	36.5 years STANDARD_DEVIATION 12.7	34.55 years STANDARD_DEVIATION 12.4	33.2 years STANDARD_DEVIATION 10.8	34.3 years STANDARD_DEVIATION 11.7	34.2 years STANDARD_DEVIATION 14.4
Years of education	13 years STANDARD_DEVIATION 2	13 years STANDARD_DEVIATION 1.9	13.2 years STANDARD_DEVIATION 1.9	13.2 years STANDARD_DEVIATION 1.8	12.6 years STANDARD_DEVIATION 2

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	0 / 41	0 / 39	0 / 38	0 / 37
serious Total, serious adverse events	0 / 41	0 / 39	0 / 38	0 / 37

Outcome results

Primary

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.

Time frame: at 26 weeks after hospitalization

Arm	Measure	Value (NUMBER)
Hypnotherapy	Abstinence From Smoking	15 percentage of participants
Nicotine Replacement Therapy	Abstinence From Smoking	7 percentage of participants
Hypnotherapy and Nicotine Replacement	Abstinence From Smoking	13 percentage of participants
Self-Quit Group	Abstinence From Smoking	10 percentage of participants

95% CI: [1.1, 11.4]

95% CI: [1.04, 9.7]

Secondary

Smoking Abstinence Rate at 12 and 26 Weeks

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

Time frame: 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.

Arm	Measure	Group	Value (NUMBER)
Hypnotherapy	Smoking Abstinence Rate at 12 and 26 Weeks	% quit rate for pulmonary diagnosis at 26 weeks	20 percentage of smoking abstinence rate
Hypnotherapy	Smoking Abstinence Rate at 12 and 26 Weeks	% Quit rate for cardiac diagnosis at 12 weeks	52.1 percentage of smoking abstinence rate
Hypnotherapy	Smoking Abstinence Rate at 12 and 26 Weeks	% Quit rate for pulmonary diagnosis at 12 weeks	20 percentage of smoking abstinence rate
Hypnotherapy	Smoking Abstinence Rate at 12 and 26 Weeks	% Quit rate for cardiac diagnosis at 26 weeks	34 percentage of smoking abstinence rate

Comparison: Comparison of smoking status at 12 weeks after hospitalization for a cardiac or pulmonary diagnosisp-value: <0.001ANOVA

Comparison: Comparison of smoking stars at 26 weeks after hospitalization for a cardiac or a pulmonary illnessp-value: 0.07ANOVA

Secondary