Medical Student INtervention to Promote Effective Nicotine Dependence and Tobacco HEalthcare (MIND-THE-GAP)
9. mars 2017 oppdatert av: 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.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
67
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Dublin, Irland
- Connolly Hospital Blanchardstown
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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. |
|
Ingen inngripen: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Motivation to Stop Smoking Scale (MTSS)
Tidsramme: 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.
|
Repeated measures: MTSS scores at baseline, 1-week, 3- and 6-month follow-up.
|
|
Change in motivation to quit
Tidsramme: 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?
|
Repeated measures: single item scores at baseline, 1-week, 3- and 6-month follow-up.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of patients who receive a prescription for a cessation medication at the time of discharge
Tidsramme: By discharge, an average of 5-10 days post-admission
|
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
|
|
proportion of patients who report any use of a prescribed or over-the-counter cessation medication
Tidsramme: at 3- and 6-months discharge
|
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
|
|
proportion of attending physicians who prescribe cessation medication during the hospitalisation
Tidsramme: During hospitalisation (baseline)
|
the proportion of attending physicians who prescribe cessation medication during the hospitalisation (to be obtained by medical chart audit);
|
During hospitalisation (baseline)
|
|
7-day point prevalent abstinence rates
Tidsramme: 3- and 6-months
|
7-day point prevalent abstinence rates assessed at both 3- and 6-months by self-report
|
3- and 6-months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Perceived student efficacy
Tidsramme: 3- and 6-months
|
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
|
|
Perceived student knowledge
Tidsramme: 3- and 6-months
|
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
|
|
Quit attempts
Tidsramme: 3- and 6-months
|
Three questionnaire items:
|
3- and 6-months
|
|
Professional advice
Tidsramme: 3- and 6 months
|
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Studieleder: Seamus Sreenan, RCSI and Connolly Hospital
- Studieleder: Liam Cormican, RCSI and Connolly Hospital
- Studieleder: Ken Ward, University of Memphis
- Studieleder: Lisa Mellon, PhD, RCSI
- Studieleder: Ronan Conroy, RCSI
- Studieleder: Anne Hickey, PhD, RCSI
- Studieleder: Sinead Stynes, Connolly Hospital
- Hovedetterforsker: Frank Doyle, PhD, RCSI
- Studieleder: GEP IC1, RCSI students
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. november 2015
Primær fullføring (Faktiske)
1. desember 2016
Studiet fullført (Faktiske)
1. desember 2016
Datoer for studieregistrering
Først innsendt
3. november 2015
Først innsendt som oppfylte QC-kriteriene
9. november 2015
Først lagt ut (Anslag)
10. november 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. mars 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. mars 2017
Sist bekreftet
1. april 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- REC1126
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .