Smoking CessationHTHNCT02767908
Hospital to Home, Smoker Support Trial
A study testing Intervention in people with Smoking Cessation, run by University of Nottingham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jun 2016to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- • 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial to Test the Effectiveness of an Intensive Home Support Intervention for Newly Abstinent Smokers Leaving Hospital
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
Read the 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).
- Conditions
- Smoking Cessation
- Being tested
- Intervention
- Keywords
- Tobacco, Smoking Cessation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported continuous smoking cessation since discharge
At four weeks post-discharge, validated by exhaled CO less than 6ppm
Measured: 4 weeks
Secondary outcomes (6)
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
Measured: 12
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
Measured: 4 weeks
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
Measured: 12 weeks
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
Measured: 4 weeks
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"
Measured: 12 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study start28 Jun 2016
- Primary completion30 Oct 2017
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Britton, MD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767908
- Sponsor's protocol ID
- 16022
- Other IDs
- RP-PG-0608-10020
- Acronym
- HTH
- Status last verified
- Aug 2017
- First submitted
- 6 May 2016
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial to Test the Effectiveness of an Intensive Home Support Intervention for Newly Abstinent Smokers Leaving Hospital
- ClinicalTrials.gov ID
- NCT02767908
- Acronym / sponsor ID
- HTH / 16022
- Conditions
- Smoking Cessation
- Keywords
- Tobacco, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 28 Jun 2016 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: InterventionA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- • 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionParticipants 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. | Other | Intervention |
Primary outcome
Self-reported continuous smoking cessation since discharge
Time frame: 4 weeks
At four weeks post-discharge, validated by exhaled CO less than 6ppm
6 secondary outcomes
Self-reported continuous cessation at three months post-discharge, validated by exhaled CO less than 6ppm
Time frame: 12
Un-validated self-reported continuous smoking cessation at four weeks
Time frame: 4 weeks
Un-Validated Self-reported continuous cessation at three months post-discharge
Time frame: 12 weeks
Self-report of having a smoke-free home at 4 weeks post discharge
Time frame: 4 weeks
Acceptance and utilization of the different components of enhance intervention
Time frame: 12 weeks
Reduction in number of cigarettes smoked per day at four weeks post-discharge compared to before hospital admission
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Britton, MD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Smoking Cessation, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported continuous smoking cessation since discharge (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2018.