Hospital to Home, Smoker Support Trial

NCT02767908 | Completed

• 2 other identifiers: 16022RP-PG-0608-10020
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 1

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

Conditions

Smoking Cessation

Keywords

Tobacco; Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Self-reported continuous smoking cessation since discharge

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

  4 weeks

Secondary Outcomes (6)

• Self-reported continuous cessation at three months post-discharge, validated by exhaled CO less than 6ppm

  12

• 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

Study Arms (2)

Usual Care

NO INTERVENTION

Participants in the usual care group will be offered and, if accepted, provided with smoking cessation support that meets the recommendations of NICE PH48 guidance including pharmacotherapy and behavioural support before leaving hospital, referral to NHS SSS for continued care after discharge, and ascertainment of smoking status at 4 weeks; participants will also be asked to consent to smoking status ascertainment at three months. Those who report cessation at 4 weeks and/or three months will be requested to agree to a home visit for CO validation. All will be asked at four weeks and 3 months to list the cessation support, in terms of pharmacotherapy and behavioural support from local or other services, delivered since the last contact.

Intervention

ACTIVE COMPARATOR

A home visit will be carried out as soon as practicable after discharge and typically within 48 hours, to deliver a multi-component intervention. Intervention components all have an existing evidence base proving or suggesting potential efficacy for smoking cessation and/or relapse prevention, though their feasibility and importance when delivered as a combined package have not been tested.

Other: Intervention

Interventions

Intervention OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Methods

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• John Britton, MD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 11, 2016
• Study Start: June 28, 2016
• Primary Completion: October 30, 2017
• Study Completion: February 28, 2018
• Last Updated: June 21, 2018

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)