Medical Student INtervention to Promote Effective Nicotine Dependence and Tobacco HEalthcare (MIND-THE-GAP)
9 marzo 2017 aggiornato da: Royal College of Surgeons, Ireland
Medical Student INtervention to Promote Effective Nicotine Dependence and Tobacco HEalthcare: GrAduate Entry Programme (MIND-THE-GAP) Feasibility Randomised Trial
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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
67
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Dublin, Irlanda
- Connolly Hospital Blanchardstown
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Intervention
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.
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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. |
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Nessun intervento: Usual care
This group will not receive student contact, but may be counselled by the smoking cessation officer or other Connolly staff as per normal procedures.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Motivation to Stop Smoking Scale (MTSS)
Lasso di tempo: Repeated measures: MTSS scores at baseline, 1-week, 3- and 6-month follow-up.
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Repeated measures: MTSS scores at baseline, 1-week, 3- and 6-month follow-up.
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Repeated measures: MTSS scores at baseline, 1-week, 3- and 6-month follow-up.
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Change in motivation to quit
Lasso di tempo: Repeated measures: single item scores at baseline, 1-week, 3- and 6-month follow-up.
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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?
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Repeated measures: single item scores at baseline, 1-week, 3- and 6-month follow-up.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Proportion of patients who receive a prescription for a cessation medication at the time of discharge
Lasso di tempo: By discharge, an average of 5-10 days post-admission
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The proportion of patients who receive a prescription for a cessation medication at the time of discharge, assessed via medical chart audit;
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By discharge, an average of 5-10 days post-admission
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proportion of patients who report any use of a prescribed or over-the-counter cessation medication
Lasso di tempo: at 3- and 6-months discharge
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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
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at 3- and 6-months discharge
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proportion of attending physicians who prescribe cessation medication during the hospitalisation
Lasso di tempo: During hospitalisation (baseline)
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the proportion of attending physicians who prescribe cessation medication during the hospitalisation (to be obtained by medical chart audit);
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During hospitalisation (baseline)
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7-day point prevalent abstinence rates
Lasso di tempo: 3- and 6-months
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7-day point prevalent abstinence rates assessed at both 3- and 6-months by self-report
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3- and 6-months
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Perceived student efficacy
Lasso di tempo: 3- and 6-months
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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]?"
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3- and 6-months
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Perceived student knowledge
Lasso di tempo: 3- and 6-months
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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]
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3- and 6-months
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Quit attempts
Lasso di tempo: 3- and 6-months
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Three questionnaire items:
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3- and 6-months
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Professional advice
Lasso di tempo: 3- and 6 months
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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?
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3- and 6 months
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Direttore dello studio: Seamus Sreenan, RCSI and Connolly Hospital
- Direttore dello studio: Liam Cormican, RCSI and Connolly Hospital
- Direttore dello studio: Ken Ward, University of Memphis
- Direttore dello studio: Lisa Mellon, PhD, RCSI
- Direttore dello studio: Ronan Conroy, RCSI
- Direttore dello studio: Anne Hickey, PhD, RCSI
- Direttore dello studio: Sinead Stynes, Connolly Hospital
- Investigatore principale: Frank Doyle, PhD, RCSI
- Direttore dello studio: GEP IC1, RCSI students
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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/
- 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.
- 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.
- 4. Bridgehead International: EQUIPP: Europe Quitting: Progress and Pathways. In. London; 2011.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 19. Freidman LM, Furberg CD, DeMets DL: Fundamentals of Clinical Trials, 4th Edition edn. New York: Springer; 2010.
- 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.
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Studia le date principali
Inizio studio (Effettivo)
1 novembre 2015
Completamento primario (Effettivo)
1 dicembre 2016
Completamento dello studio (Effettivo)
1 dicembre 2016
Date di iscrizione allo studio
Primo inviato
3 novembre 2015
Primo inviato che soddisfa i criteri di controllo qualità
9 novembre 2015
Primo Inserito (Stima)
10 novembre 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
10 marzo 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 marzo 2017
Ultimo verificato
1 aprile 2016
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- REC1126
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