Medical Student INtervention to Promote Effective Nicotine Dependence and Tobacco HEalthcare

NCT02601599 | Completed

• 1 other identifier: REC1126
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking

Keywords

Smoking Cessation; Tobacco Use Cessation; Motivational Interviewing; Students, Medical; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (4)

• Proportion of patients who receive a prescription for a cessation medication at the time of discharge

  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

  at 3- and 6-months discharge

• proportion of attending physicians who prescribe cessation medication during the hospitalisation

  During hospitalisation (baseline)

• 7-day point prevalent abstinence rates

  3- and 6-months

Other Outcomes (4)

• Perceived student efficacy

  3- and 6-months

• Perceived student knowledge

  3- and 6-months

• Quit attempts

  3- and 6-months

Study Arms (2)

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.

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.

Interventions

Motivational interviewing BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All identified inpatient smokers at Connolly Hospital.

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead
• Health Service Executive, Ireland: collaborator
• University of Memphis: collaborator
• Connolly Hospital Blanchardstown: collaborator

Study Sites (1)

Connolly Hospital Blanchardstown

Dublin, Ireland

Location

Related Publications (20)

• 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.

  BACKGROUND

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

  BACKGROUND

• 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/

  PMID: 24455788 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 22592671 BACKGROUND

• 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.

  PMID: 22592676 BACKGROUND

• 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.

  PMID: 25138333 BACKGROUND

• 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.

  PMID: 19646173 BACKGROUND

• 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.

  PMID: 22223193 BACKGROUND

• 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.

  PMID: 19531558 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 19246446 BACKGROUND

• 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.

  PMID: 21450679 BACKGROUND

• 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.

  PMID: 22943961 BACKGROUND

• 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. doi: 10.1111/j.1360-0443.2004.00995.x.

  PMID: 15733243 BACKGROUND

• 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. Epub 2008 Dec 17.

  PMID: 19089501 BACKGROUND

• Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.

  PMID: 1932883 BACKGROUND

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

  BACKGROUND

• Kumar A, Ward KD, Mellon L, Gunning M, Stynes S, Hickey A, Conroy R, MacSweeney S, Horan D; Graduate Entry Programme 2014-18 Class; Cormican L, Sreenan S, Doyle F. Medical student INtervention to promote effective nicotine dependence and tobacco HEalthcare (MIND-THE-GAP): single-centre feasibility randomised trial results. BMC Med Educ. 2017 Dec 11;17(1):249. doi: 10.1186/s12909-017-1069-y.

  PMID: 29233157 DERIVED

MeSH Terms

Conditions

Smoking; Smoking Cessation; Tobacco Use Cessation

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Seamus Sreenan

  RCSI and Connolly Hospital

  STUDY DIRECTOR

• Liam Cormican

  RCSI and Connolly Hospital

  STUDY DIRECTOR

• Ken Ward

  University of Memphis

  STUDY DIRECTOR

• Lisa Mellon, PhD

  RCSI

  STUDY DIRECTOR

• Ronan Conroy

  RCSI

  STUDY DIRECTOR

• Anne Hickey, PhD

  RCSI

  STUDY DIRECTOR

• Sinead Stynes

  Connolly Hospital

  STUDY DIRECTOR

• Frank Doyle, PhD

  RCSI

  PRINCIPAL INVESTIGATOR

• GEP IC1

  RCSI students

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 10, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 10, 2017

Record last verified: 2016-04

Locations

IE (1)