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Completed

NCT Number: NCT02601599

Medical Student INtervention to Promote Effective Nicotine Dependence and Tobacco HEalthcare

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Connolly Hospital Blanchardstown

Dublin, Ireland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Interviewing

Behavioral

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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:

    • In the past one/six months, have you quit smoking? Yes/No
    • If no, in the past one/six months have you attempted to quit smoking? Yes/No
    • 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?

Sponsors and collaborators

Lead sponsor

Royal College of Surgeons, Ireland

Other

Collaborators

  • Connolly Hospital Blanchardstown
  • Health Service Executive, Ireland
  • University of Memphis

Registry information

Official study title

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

Acronym: MIND-THE-GAP

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 10, 2015
Registry last updated
Mar 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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