Hospital to Home, Smoker Support Trial

Smoking Cessation Clinical Trial

— HTH  

Official title:

Randomised Controlled Trial to Test the Effectiveness of an Intensive Home Support Intervention for Newly Abstinent Smokers Leaving Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02767908
• Other study ID #: 16022
• Secondary ID: RP-PG-0608-10020
• Status: Completed
• Phase: N/A
• Start date: June 28, 2016
• Est. completion date: February 28, 2018

Study information

• Verified date: August 2017
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study is proposed to build on the investigators demonstration of the effectiveness of default delivery of smoking interventions in hospital inpatients by testing a multi-component intervention to prevent relapse to smoking after hospital discharge. The proposed intervention is designed to integrate easily with existing services, and hence be widely implemented if shown to be effective

Description:

The Investigators analysis of electronic primary care records has recently estimated that approximately 1.1 million smokers are admitted to English hospitals every year . Every one of these admissions represents a prime opportunity to intervene to promote smoking cessation, particularly since most smokers abstain from smoking while in hospital. Recent NICE guidance (PH48) recommends that smoking cessation interventions should be provided in routine care pathways for all smokers admitted to hospital; The Investigators earlier work (Evaluation of the impact of a systematic delivery of cessation interventions on delivery of smoking cessation in secondary care. REC Reference Number:10/H0403/34) in this Programme (RP-PG-0608-10020) has demonstrated that default delivery of cessation support to all smokers in hospital significantly increases uptake of support and doubles the proportion of smokers who quit long term. Clinical experience indicates that many smokers admitted to hospital, particularly those with an illness caused or exacerbated by smoking, are motivated not to smoke again after discharge but are also likely to be heavily dependent on smoking and in many cases are disabled by lung or heart disease, socially isolated, and socio-economically deprived. On leaving hospital, many participants returned to a home environment where smoking has been an integral part of daily life for many years. It is therefore not surprising that whilst many participants managed to stay smoke-free during their hospital stay, relapse after discharge is common.

The Investigators previous study, among smokers who received care similar to that now recommended by NICE, 62% of participants abstinent at discharge had relapsed by 4 weeks, and 81% by 6 months. The Investigators hypothesise that many of these relapses could be prevented by interventions that help to sustain cessation and the maintenance of smoke-free home after discharge.

The investigators therefore propose to test the effectiveness of an intensive home support intervention for newly-abstinent smokers leaving hospital and involving home visits to support cessation and establishment of a smoke-free home; ensure receipt and correct use of smoking cessation pharmacotherapy; deliver behavioural support or else, where local services are preferred, transfer to local community Stop Smoking Services (SSS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: February 28, 2018
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients aged 18 and over (with no upper age limit).

• Have been admitted for 24 hours or more to any participating inpatient ward at Nottingham City Hospital.

• Who report that they are current smokers, or had smoked within 7 days before the current admission.

• Are capable of understanding and consenting to the trial.

Exclusion Criteria:

• • If they are pregnant; Pregnant smokers (of whom very few are admitted to medical wards) will be offered cessation advice in line with NICE PH48 guidance.

• If they do not consent to participate,

• If they are too ill or otherwise lack capacity to understand the information and consent forms.

• If they live more than 50 miles from the City Hospital (these patients will be referred to their local community cessation services, in line with NICE recommendations).

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Other:
• Intervention
Participants will receive a tailored support package which will include; Nicotine replacement products, behavioural support, including telephone support, Carbon dioxide measurements, home air quality measurements, signposting to support groups, and self-help materials.For participants who decline a home visit, the above support options will be offered as far as possible through telephone contact and delivered to the extent accepted by the participant. Those who report cessation at 4 weeks and/or three months will be requested to agree to a home visit for CO validation.

Locations

Country	Name	City	State
United Kingdom	Nottingham City Hospital	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported continuous smoking cessation since discharge	At four weeks post-discharge, validated by exhaled CO less than 6ppm	4 weeks
Secondary	Self-reported continuous cessation at three months post-discharge, validated by exhaled CO less than 6ppm	At 12 weeks post-discharge, validated by exhaled CO less than 6ppm	12
Secondary	Un-validated self-reported continuous smoking cessation at four weeks	Individual declares "No" to smoking any form of tobacco product since being discharged from hospital	4 weeks
Secondary	Un-Validated Self-reported continuous cessation at three months post-discharge	Individual declares "No" to smoking any form of tobacco product since being discharged from hospital	12 weeks
Secondary	Self-report of having a smoke-free home at 4 weeks post discharge	Individual declares "No" to anyone ever smoking inside home (even by the door or window) at 4 weeks post-discharge	4 weeks
Secondary	Acceptance and utilization of the different components of enhance intervention	Individual declares to have used the different components of the enhanced intervention (has not ticked "didn't use") and declared them to be "1 Very helpful" or "2"	12 weeks
Secondary	Reduction in number of cigarettes smoked per day at four weeks post-discharge compared to before hospital admission	Reduction in number of self reported cigarettes smoked per day at four weeks post-discharge, compared to baseline.	4 weeks