Medical Student INtervention to Promote Effective Nicotine Dependence and Tobacco HEalthcare

Smoking Clinical Trial

— MIND-THE-GAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02601599
• Other study ID #: REC1126
• Status: Completed
• Phase: N/A
• First received: November 3, 2015
• Last updated: March 9, 2017
• Start date: November 2015
• Est. completion date: December 2016

Study information

• Verified date: April 2016
• Source: Royal College of Surgeons, Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All identified inpatient smokers at Connolly Hospital.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Smoking
• Tobacco Use Disorder

Intervention

Behavioral:
• Motivational interviewing
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.

Locations

Country	Name	City	State
Ireland	Connolly Hospital Blanchardstown	Dublin

Sponsors (4)

Lead Sponsor	Collaborator
Royal College of Surgeons, Ireland	Connolly Hospital Blanchardstown, Health Service Executive, Ireland, University of Memphis

Country where clinical trial is conducted

Ireland, 

References & Publications (19)

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.

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.

19. Freidman LM, Furberg CD, DeMets DL: Fundamentals of Clinical Trials, 4th Edition edn. New York: Springer; 2010.

2. Department of Health: Tobacco Free Ireland: Report of the Tobacco Policy Review Group. In. Dublin: Department of Health; 2013.

4. Bridgehead International: EQUIPP: Europe Quitting: Progress and Pathways. In. London; 2011.

Arora NK, Gustafson DH. Perceived helpfulness of physicians' communication behavior and breast cancer patients' level of trust over time. J Gen Intern Med. 2009 Feb;24(2):252-5. doi: 10.1007/s11606-008-0880-x. — View Citation

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. — View Citation

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;(5):CD000214. doi: 10.1002/14651858.CD000214.pub2. Review. — View Citation

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. — View Citation

Heatherton TF, Kozlowski LT, Frecker RC, Fagerström KO. The Fagerström Test for Nicotine Dependence: a revision of the Fagerström Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rigotti NA, Clair C, Munafò MR, Stead LF. Interventions for smoking cessation in hospitalised patients. Cochrane Database Syst Rev. 2012 May 16;(5):CD001837. doi: 10.1002/14651858.CD001837.pub3. Review. — View Citation

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. — View Citation

West R, Hajek P, Stead L, Stapleton J. Outcome criteria in smoking cessation trials: proposal for a common standard. Addiction. 2005 Mar;100(3):299-303. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perceived student efficacy	Single items survey: How helpful was the support that you received from the medical student?" [not at all, a little bit, somewhat, quite a bit, or very much]?"	3- and 6-months
Other	Perceived student knowledge	Single item survey: How knowledgeable was the medical student about quitting smoking? [not at all, a little bit, somewhat, quite a bit, or very much]	3- and 6-months
Other	Quit attempts	Three questionnaire items: In the past one/six months, have you quit smoking? Yes/No; If no, in the past one/six months have you attempted to quit smoking? Yes/No; If yes, how many times have you tried to quit in the past three/six months? ______	3- and 6-months
Other	Professional advice	One questionnaire item: In the past 3/6 months since your hospital admission, did a doctor or health professional discuss ways of giving up smoking with you?	3- and 6 months
Primary	Change in Motivation to Stop Smoking Scale (MTSS)	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.
Primary	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?	Repeated measures: single item scores at baseline, 1-week, 3- and 6-month follow-up.
Secondary	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;	By discharge, an average of 5-10 days post-admission
Secondary	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	at 3- and 6-months discharge
Secondary	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);	During hospitalisation (baseline)
Secondary	7-day point prevalent abstinence rates	7-day point prevalent abstinence rates assessed at both 3- and 6-months by self-report	3- and 6-months