Medical Student INtervention to Promote Effective Nicotine Dependence and Tobacco HEalthcare (MIND-THE-GAP)
2017년 3월 9일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
67
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Dublin, 아일랜드
- Connolly Hospital Blanchardstown
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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간섭 없음: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Motivation to Stop Smoking Scale (MTSS)
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Proportion of patients who receive a prescription for a cessation medication at the time of discharge
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Perceived student efficacy
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Seamus Sreenan, RCSI and Connolly Hospital
- 연구 책임자: Liam Cormican, RCSI and Connolly Hospital
- 연구 책임자: Ken Ward, University of Memphis
- 연구 책임자: Lisa Mellon, PhD, RCSI
- 연구 책임자: Ronan Conroy, RCSI
- 연구 책임자: Anne Hickey, PhD, RCSI
- 연구 책임자: Sinead Stynes, Connolly Hospital
- 수석 연구원: Frank Doyle, PhD, RCSI
- 연구 책임자: GEP IC1, RCSI students
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2015년 11월 1일
기본 완료 (실제)
2016년 12월 1일
연구 완료 (실제)
2016년 12월 1일
연구 등록 날짜
최초 제출
2015년 11월 3일
QC 기준을 충족하는 최초 제출
2015년 11월 9일
처음 게시됨 (추정)
2015년 11월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 3월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 3월 9일
마지막으로 확인됨
2016년 4월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Motivational interviewing에 대한 임상 시험
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