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Clinical Trials/NCT02767908
NCT02767908
Completed
N/A

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

University of Nottingham1 site in 1 country404 target enrollmentJune 28, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Smoking Cessation
Sponsor
University of Nottingham
Enrollment
404
Locations
1
Primary Endpoint
Self-reported continuous smoking cessation since discharge
Status
Completed
Last Updated
7 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
June 28, 2016
End Date
February 28, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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).

Outcomes

Primary Outcomes

Self-reported continuous smoking cessation since discharge

Time Frame: 4 weeks

At four weeks post-discharge, validated by exhaled CO less than 6ppm

Secondary Outcomes

  • Un-validated self-reported continuous smoking cessation at four weeks(4 weeks)
  • Un-Validated Self-reported continuous cessation at three months post-discharge(12 weeks)
  • Self-report of having a smoke-free home at 4 weeks post discharge(4 weeks)
  • Acceptance and utilization of the different components of enhance intervention(12 weeks)
  • Reduction in number of cigarettes smoked per day at four weeks post-discharge compared to before hospital admission(4 weeks)
  • Self-reported continuous cessation at three months post-discharge, validated by exhaled CO less than 6ppm(12)

Study Sites (1)

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