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Medical Student INtervention to Promote Effective Nicotine Dependence and Tobacco HEalthcare (MIND-THE-GAP)

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ClinicalTrials.gov Identifier: NCT02601599
Recruitment Status : Completed
First Posted : November 10, 2015
Last Update Posted : March 10, 2017
Sponsor:
Collaborators:
Health Service Executive, Ireland
University of Memphis
Connolly Hospital Blanchardstown
Information provided by (Responsible Party):
Royal College of Surgeons, Ireland

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.


Condition or disease Intervention/treatment Phase
Smoking Behavioral: Motivational interviewing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Medical Student INtervention to Promote Effective Nicotine Dependence and Tobacco HEalthcare: GrAduate Entry Programme (MIND-THE-GAP) Feasibility Randomised Trial
Actual Study Start Date : November 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: 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.
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.


No Intervention: 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.



Primary Outcome Measures :
  1. Change in Motivation to Stop Smoking Scale (MTSS) [ Time Frame: 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.

  2. Change in motivation to quit [ Time Frame: 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?


Secondary Outcome Measures :
  1. Proportion of patients who receive a prescription for a cessation medication at the time of discharge [ Time Frame: 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;

  2. proportion of patients who report any use of a prescribed or over-the-counter cessation medication [ Time Frame: 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

  3. proportion of attending physicians who prescribe cessation medication during the hospitalisation [ Time Frame: During hospitalisation (baseline) ]
    the proportion of attending physicians who prescribe cessation medication during the hospitalisation (to be obtained by medical chart audit);

  4. 7-day point prevalent abstinence rates [ Time Frame: 3- and 6-months ]
    7-day point prevalent abstinence rates assessed at both 3- and 6-months by self-report


Other Outcome Measures:
  1. Perceived student efficacy [ Time Frame: 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]?"

  2. Perceived student knowledge [ Time Frame: 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. Quit attempts [ Time Frame: 3- and 6-months ]

    Three questionnaire items:

    1. In the past one/six months, have you quit smoking? Yes/No
    2. If no, in the past one/six months have you attempted to quit smoking? Yes/No
    3. If yes, how many times have you tried to quit in the past three/six months? ______

  4. Professional advice [ Time Frame: 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?



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601599


Locations
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Ireland
Connolly Hospital Blanchardstown
Dublin, Ireland
Sponsors and Collaborators
Royal College of Surgeons, Ireland
Health Service Executive, Ireland
University of Memphis
Connolly Hospital Blanchardstown
Investigators
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Study Director: 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
Principal Investigator: Frank Doyle, PhD RCSI
Study Director: GEP IC1 RCSI students

Publications:
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.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier: NCT02601599     History of Changes
Other Study ID Numbers: REC1126
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: April 2016

Keywords provided by Royal College of Surgeons, Ireland:
Smoking Cessation
Tobacco Use Cessation
Motivational Interviewing
Students, Medical
Randomized Controlled Trial

Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action