Medical Student INtervention to Promote Effective Nicotine Dependence and Tobacco HEalthcare

Study Overview
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Brief Summary
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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.

Official Title
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Medical Student INtervention to Promote Effective Nicotine Dependence and Tobacco HEalthcare: GrAduate Entry Programme (MIND-THE-GAP) Feasibility Randomised Trial

Conditions
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Smoking

Intervention / Treatment
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* Behavioral: Motivational interviewing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>|
| No Intervention: Usual care<br>This group will not receive student contact, but may be counselled by the smoking cessation officer or other Connolly staff as per normal procedures. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who receive a prescription for a cessation medication at the time of discharge | 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 | 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 | 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 | 7-day point prevalent abstinence rates assessed at both 3- and 6-months by self-report | 3- and 6-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation, Tobacco Use Cessation, Motivational Interviewing, Students, Medical, Randomized Controlled Trial