Clinical trial NCT02767908: Hospital to Home, Smoker Support Trial
Official title: Randomised Controlled Trial to Test the Effectiveness of an Intensive Home Support Intervention for Newly Abstinent Smokers Leaving Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Tobacco
Smoking Cessation
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Detailed 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).

Eligibility criteria: 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).

Primary outcomes:
measure: Self-reported continuous smoking cessation since discharge
timeFrame: 4 weeks
Secondary outcomes:
measure: Self-reported continuous cessation at three months post-discharge, validated by exhaled CO less than 6ppm
timeFrame: 12
measure: Un-validated self-reported continuous smoking cessation at four weeks
timeFrame: 4 weeks
measure: Un-Validated Self-reported continuous cessation at three months post-discharge
timeFrame: 12 weeks
measure: Self-report of having a smoke-free home at 4 weeks post discharge
timeFrame: 4 weeks
measure: Acceptance and utilization of the different components of enhance intervention
timeFrame: 12 weeks
measure: Reduction in number of cigarettes smoked per day at four weeks post-discharge compared to before hospital admission
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
Study officials:
affiliation: University of Nottingham
name: John Britton, MD
role: PRINCIPAL_INVESTIGATOR
References: