SmokingMIND-THE-GAPNCT02601599

Medical Student INtervention to Promote Effective Nicotine Dependence and Tobacco HEalthcare

A study testing Motivational interviewing in people with Smoking, run by Royal College of Surgeons, Ireland at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Background: Smoking counselling during hospitalisation with post-discharge follow-up increases quitting. However, provision of cessation care for hospitalised patients is suboptimal. Students are potentially an untapped resource for providing cessation advice, but no studies have investigated this. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Smoking
What is being tested?: Motivational interviewing
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 67 participants
Where: 1 siteIreland
Study dates: Nov 2015to Dec 2016
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

All identified inpatient smokers at Connolly Hospital.

Who cannot join

Advised by ward manager that patient is too unwell or cognitively impaired, or otherwise unsuitable;
Death during hospitalisation;
Receiving palliative care;
Under 18 years of age;
To be transferred to another hospital;
Not English speaking;
Refusal to participate;
Inpatient in psychiatric ward

Trial locations and contacts

1 site in 1 country.

Ireland1 site

Connolly Hospital Blanchardstown
Dublin

Other trials in Ireland

About this study

Official title: Medical Student INtervention to Promote Effective Nicotine Dependence and Tobacco HEalthcare: GrAduate Entry Programme (MIND-THE-GAP) Feasibility Randomised Trial

Aim: To determine if medical students can encourage motivation to stop smoking (MTSS; primary outcome) in hospitalised smokers .

Design: 2-arm RCT Setting: RCSI (www.rcsi.ie) and Connolly Hospital (www.hse.ie/eng/services/list/3/hospitals/Connolly/).

Participants: Inpatient smokers. Intervention and procedures: 60 graduate medical students will receive standardised motivational interviewing training in the provision of cessation advice. Each student will be randomly assigned to counsel ~1-3 smokers each, including an individual in-hospital, face-to-face session and post-discharge phone counselling. Training and implementation will cover Sept-2015-May-2016. Smokers will be randomised to 'usual care' (n~90), or intervention (n~90, student-delivered motivational interviewing). A researcher will enable recruitment and follow-up, and conduct a qualitative evaluation of programme participants.

Conditions: Smoking
Being tested: Motivational interviewing
Keywords: Smoking Cessation, Tobacco Use Cessation, Motivational Interviewing, Students, Medical, Randomized Controlled Trial
Medical subject headings: Smoking, Smoking Cessation, Tobacco Use Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Motivational interviewingBehavioural
The medical student will deliver a brief (approximately 15 minute) consultation with the patient that is based on principles of social cognitive theory and motivational interviewing. The goals of this consultation will be to enhance the patient's motivation and self-efficacy regarding quitting, and collaboratively elicit a plan to stay quit after discharge. Patients will be offered the opportunity to receive a consultation from the attending physician to determine eligibility for pharmacotherapy (via a chart sticker).
Each student will counsel 1-3 smokers each over the 8-month academic period, with student training and intervention staggered over this time. Students will also re-contact the smoker at 1-week post-discharge via telephone or personal follow-up, to provide further support.

Study groups in NCT02601599
Study group	Role	What they receive
Intervention	Experimental	Motivational interviewing The medical student will deliver a 15 minute consultation with the patient. The goals of this consultation will be to enhance the patient's motivation and self-efficacy regarding quitting, educate the patient about effective behavioral and pharmacological cessation strategies, and collaboratively elicit a plan to stay quit after discharge. Patients will be offered the opportunity to receive a consultation from the attending physician to determine eligibility for pharmacotherapy. Patients who elect to receive this consult with have a coloured sticker placed by the medical student on the medical chart requesting a consultation. Receives: Behavioral: Motivational interviewing
Usual care	No intervention	This group will not receive student contact, but may be counselled by the smoking cessation officer or other Connolly staff as per normal procedures.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Motivation to Stop Smoking Scale (MTSS)
Repeated measures: MTSS scores at baseline, 1-week, 3- and 6-month follow-up.
Measured: Repeated measures: MTSS scores at baseline, 1-week, 3- and 6-month follow-up.
Change in motivation to quit
If, on a scale of 1 to 10, 1 is not at all motivated to give up smoking and 10 is 100% motivated to give up, what number would you give yourself at the moment?
Measured: Repeated measures: single item scores at baseline, 1-week, 3- and 6-month follow-up.

Secondary outcomes (4)

Proportion of patients who receive a prescription for a cessation medication at the time of discharge
The proportion of patients who receive a prescription for a cessation medication at the time of discharge, assessed via medical chart audit;
Measured: By discharge, an average of 5-10 days post-admission
proportion of patients who report any use of a prescribed or over-the-counter cessation medication
the proportion of patients who report any use of a prescribed or over-the-counter cessation medication, of an approved cessation pharmacotherapy, including nicotine patch, gum, lozenge, inhaler, mouth spray, Champix, or Zyban at 1- and 6-months discharge
Measured: at 3- and 6-months discharge
proportion of attending physicians who prescribe cessation medication during the hospitalisation
the proportion of attending physicians who prescribe cessation medication during the hospitalisation (to be obtained by medical chart audit);
Measured: During hospitalisation (baseline)
7-day point prevalent abstinence rates
7-day point prevalent abstinence rates assessed at both 3- and 6-months by self-report
Measured: 3- and 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2015Dec 2016

First posted10 Nov 2015 (estimated)
Study startNov 2015
Primary completionDec 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for SmokingStudies of the same condition, open and under way.
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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02601599
Sponsor's protocol ID: REC1126
Acronym: MIND-THE-GAP
Status last verified: Apr 2016
First submitted: 3 Nov 2015
Last updated: 10 Mar 2017
Results posted: No
Data monitoring committee: No

Publications

1. Hickey P, Evans DS: Smoking in Ireland 2014: Synopsis of key patterns. In. HSE National Tobacco Control Office, Health and Wellbeing Division: Health Services Executive; 2015.
2. Department of Health: Tobacco Free Ireland: Report of the Tobacco Policy Review Group. In. Dublin: Department of Health; 2013.
National Center for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and Health. The Health Consequences of Smoking-50 Years of Progress: A Report of the Surgeon General. Atlanta (GA): Centers for Disease Control and Prevention (US); 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK179276/
PubMed 24455788
4. Bridgehead International: EQUIPP: Europe Quitting: Progress and Pathways. In. London; 2011.
Carson KV, Verbiest ME, Crone MR, Brinn MP, Esterman AJ, Assendelft WJ, Smith BJ. Training health professionals in smoking cessation. Cochrane Database Syst Rev. 2012 May 16;2012(5):CD000214. doi: 10.1002/14651858.CD000214.pub2.
PubMed 22592671
Rigotti NA, Clair C, Munafo MR, Stead LF. Interventions for smoking cessation in hospitalised patients. Cochrane Database Syst Rev. 2012 May 16;5(5):CD001837. doi: 10.1002/14651858.CD001837.pub3.
PubMed 22592676
Rigotti NA, Regan S, Levy DE, Japuntich S, Chang Y, Park ER, Viana JC, Kelley JH, Reyen M, Singer DE. Sustained care intervention and postdischarge smoking cessation among hospitalized adults: a randomized clinical trial. JAMA. 2014 Aug 20;312(7):719-28. doi: 10.1001/jama.2014.9237.
PubMed 25138333
O'Donovan G. Smoking prevalence among qualified nurses in the Republic of Ireland and their role in smoking cessation. Int Nurs Rev. 2009 Jun;56(2):230-6. doi: 10.1111/j.1466-7657.2008.00700.x.
PubMed 19646173
Bartels C, Abuhaliga AR, McGee H, Morgan K, McElvaney NG, Doyle F. A survey of the prevalence of smoking and smoking cessation advice received by inpatients in a large teaching hospital in Ireland. Ir J Med Sci. 2012 Sep;181(3):445-9. doi: 10.1007/s11845-011-0792-3. Epub 2012 Jan 6.
PubMed 22223193
Fitzpatrick P, Gilroy I, Doherty K, Corradino D, Daly L, Clarke A, Kelleher CC. Implementation of a campus-wide Irish hospital smoking ban in 2009: prevalence and attitudinal trends among staff and patients in lead up. Health Promot Int. 2009 Sep;24(3):211-22. doi: 10.1093/heapro/dap020. Epub 2009 Jun 16.
PubMed 19531558
11. Ohakim A, Mellon L, Jafar B, O'Byrne C, McElvaney NG, Cormican L, McDonnell R, Doyle F: Smoking, attitudes to smoking and provision of smoking cessation advice in two teaching hospitals in Ireland: do smoke-free policies matter? Health Psychology and Behavioral Medicine: An Open Access Journal 2015, 3(1):142-153.
12. Mellon L, McElvaney NG, Cormican L, Hickey A, Conroy R, Ekpotu L, Oghenejobo O, Atteih S, McDonnell R, Doyle F: Determining rates of smoking cessation advice delivered during hospitalisation and smoking cessation rates 3-months post discharge: a two-hospital survey. manuscript submitted for publication.
Raupach T, Shahab L, Baetzing S, Hoffmann B, Hasenfuss G, West R, Andreas S. Medical students lack basic knowledge about smoking: findings from two European medical schools. Nicotine Tob Res. 2009 Jan;11(1):92-8. doi: 10.1093/ntr/ntn007. Epub 2009 Jan 27.
PubMed 19246446
Raupach T, Merker J, Hasenfuss G, Andreas S, Pipe A. Knowledge gaps about smoking cessation in hospitalized patients and their doctors. Eur J Cardiovasc Prev Rehabil. 2011 Apr;18(2):334-41. doi: 10.1177/1741826710389370. Epub 2011 Feb 11.
PubMed 21450679
Kotz D, Brown J, West R. Predictive validity of the Motivation To Stop Scale (MTSS): a single-item measure of motivation to stop smoking. Drug Alcohol Depend. 2013 Feb 1;128(1-2):15-9. doi: 10.1016/j.drugalcdep.2012.07.012. Epub 2012 Sep 1.
PubMed 22943961

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Medical Student INtervention to Promote Effective Nicotine Dependence and Tobacco HEalthcare: GrAduate Entry Programme (MIND-THE-GAP) Feasibility Randomised Trial
ClinicalTrials.gov ID: NCT02601599
Acronym / sponsor ID: MIND-THE-GAP / REC1126
Conditions: Smoking
Keywords: Smoking Cessation, Tobacco Use Cessation, Motivational Interviewing, Students, Medical, Randomized Controlled Trial
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Royal College of Surgeons, IrelandUniversity, hospital or other
Collaborators: Health Service Executive, Ireland, University of Memphis, Connolly Hospital Blanchardstown
Study start: Nov 2015 (actual)
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 10 Nov 2015 (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.

Aim: To determine if medical students can encourage motivation to stop smoking (MTSS; primary outcome) in hospitalised smokers .

Design: 2-arm RCT Setting: RCSI (www.rcsi.ie) and Connolly Hospital (www.hse.ie/eng/services/list/3/hospitals/Connolly/).

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Behavioral: Motivational interviewingMotivational interviewing The medical student will deliver a 15 minute consultation with the patient. The goals of this consultation will be to enhance the patient's motivation and self-efficacy regarding quitting, educate the patient about effective behavioral and pharmacological cessation strategies, and collaboratively elicit a plan to stay quit after discharge. Patients will be offered the opportunity to receive a consultation from the attending physician to determine eligibility for pharmacotherapy. Patients who elect to receive this consult with have a coloured sticker placed by the medical student on the medical chart requesting a consultation.
Usual care	No intervention	–This group will not receive student contact, but may be counselled by the smoking cessation officer or other Connolly staff as per normal procedures.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

All identified inpatient smokers at Connolly Hospital.

Key exclusion criteria (8 listed)

Advised by ward manager that patient is too unwell or cognitively impaired, or otherwise unsuitable;
Death during hospitalisation;
Receiving palliative care;
Under 18 years of age;
To be transferred to another hospital;

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
Motivational interviewingThe medical student will deliver a brief (approximately 15 minute) consultation with the patient that is based on principles of social cognitive theory and motivational interviewing. The goals of this consultation will be to enhance the patient's motivation and self-efficacy regarding quitting, and collaboratively elicit a plan to stay quit after discharge. Patients will be offered the opportunity to receive a consultation from the attending physician to determine eligibility for pharmacotherapy (via a chart sticker). Each student will counsel 1-3 smokers each over the 8-month academic period, with student training and intervention staggered over this time. Students will also re-contact the smoker at 1-week post-discharge via telephone or personal follow-up, to provide further support.	Behavioural	Intervention

Primary outcome

Change in Motivation to Stop Smoking Scale (MTSS)
Time frame: Repeated measures: MTSS scores at baseline, 1-week, 3- and 6-month follow-up.
Repeated measures: MTSS scores at baseline, 1-week, 3- and 6-month follow-up.
Change in motivation to quit
Time frame: Repeated measures: single item scores at baseline, 1-week, 3- and 6-month follow-up.
If, on a scale of 1 to 10, 1 is not at all motivated to give up smoking and 10 is 100% motivated to give up, what number would you give yourself at the moment?

4 secondary outcomes

Proportion of patients who receive a prescription for a cessation medication at the time of discharge
Time frame: By discharge, an average of 5-10 days post-admission
proportion of patients who report any use of a prescribed or over-the-counter cessation medication
Time frame: at 3- and 6-months discharge
proportion of attending physicians who prescribe cessation medication during the hospitalisation
Time frame: During hospitalisation (baseline)
7-day point prevalent abstinence rates
Time frame: 3- and 6-months

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 10 Mar 2017.
Background1. Hickey P, Evans DS: Smoking in Ireland 2014: Synopsis of key patterns. In. HSE National Tobacco Control Office, Health and Wellbeing Division: Health Services Executive; 2015.
Background2. Department of Health: Tobacco Free Ireland: Report of the Tobacco Policy Review Group. In. Dublin: Department of Health; 2013.
Background: PubMed 24455788National Center for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and Health. The Health Consequences of Smoking-50 Years of Progress: A Report of the Surgeon General. Atlanta (GA): Centers for Disease Control and Prevention (US); 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK179276/
Background4. Bridgehead International: EQUIPP: Europe Quitting: Progress and Pathways. In. London; 2011.
Background: PubMed 22592671Carson KV, Verbiest ME, Crone MR, Brinn MP, Esterman AJ, Assendelft WJ, Smith BJ. Training health professionals in smoking cessation. Cochrane Database Syst Rev. 2012 May 16;2012(5):CD000214. doi: 10.1002/14651858.CD000214.pub2.
Background: PubMed 22592676Rigotti NA, Clair C, Munafo MR, Stead LF. Interventions for smoking cessation in hospitalised patients. Cochrane Database Syst Rev. 2012 May 16;5(5):CD001837. doi: 10.1002/14651858.CD001837.pub3.
Background: PubMed 25138333Rigotti NA, Regan S, Levy DE, Japuntich S, Chang Y, Park ER, Viana JC, Kelley JH, Reyen M, Singer DE. Sustained care intervention and postdischarge smoking cessation among hospitalized adults: a randomized clinical trial. JAMA. 2014 Aug 20;312(7):719-28. doi: 10.1001/jama.2014.9237.
Background: PubMed 19646173O'Donovan G. Smoking prevalence among qualified nurses in the Republic of Ireland and their role in smoking cessation. Int Nurs Rev. 2009 Jun;56(2):230-6. doi: 10.1111/j.1466-7657.2008.00700.x.
Background: PubMed 22223193Bartels C, Abuhaliga AR, McGee H, Morgan K, McElvaney NG, Doyle F. A survey of the prevalence of smoking and smoking cessation advice received by inpatients in a large teaching hospital in Ireland. Ir J Med Sci. 2012 Sep;181(3):445-9. doi: 10.1007/s11845-011-0792-3. Epub 2012 Jan 6.
Background: PubMed 19531558Fitzpatrick P, Gilroy I, Doherty K, Corradino D, Daly L, Clarke A, Kelleher CC. Implementation of a campus-wide Irish hospital smoking ban in 2009: prevalence and attitudinal trends among staff and patients in lead up. Health Promot Int. 2009 Sep;24(3):211-22. doi: 10.1093/heapro/dap020. Epub 2009 Jun 16.
Background11. Ohakim A, Mellon L, Jafar B, O'Byrne C, McElvaney NG, Cormican L, McDonnell R, Doyle F: Smoking, attitudes to smoking and provision of smoking cessation advice in two teaching hospitals in Ireland: do smoke-free policies matter? Health Psychology and Behavioral Medicine: An Open Access Journal 2015, 3(1):142-153.
Background12. Mellon L, McElvaney NG, Cormican L, Hickey A, Conroy R, Ekpotu L, Oghenejobo O, Atteih S, McDonnell R, Doyle F: Determining rates of smoking cessation advice delivered during hospitalisation and smoking cessation rates 3-months post discharge: a two-hospital survey. manuscript submitted for publication.

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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.

Seamus Sreenan study director

RCSI and Connolly Hospital

Liam Cormican study director

RCSI and Connolly Hospital

Ken Ward study director

University of Memphis

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Motivational interviewing in people with Smoking, run by Royal College of Surgeons, Ireland at 1 site in Ireland.

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 1 inclusion and 8 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 10 Mar 2017. 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 Ireland. 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?

Change in Motivation to Stop Smoking Scale (MTSS) (time frame: Repeated measures: MTSS scores at baseline, 1-week, 3- and 6-month follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02601599, which also lists 20 linked publications.

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 10 Mar 2017.