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

March 9, 2017 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland
        • Connolly Hospital Blanchardstown

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Repeated measures: MTSS scores at baseline, 1-week, 3- and 6-month follow-up.
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?
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
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;
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
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
at 3- and 6-months discharge
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);
During hospitalisation (baseline)
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
3- and 6-months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]?"
3- and 6-months
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- and 6-months
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? ______
3- and 6-months
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?
3- and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal College of Surgeons, Ireland

Collaborators

Connolly Hospital Blanchardstown
University of Memphis
Health Service Executive, Ireland

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 3, 2015

First Submitted That Met QC Criteria

November 9, 2015

First Posted (Estimate)

November 10, 2015

Study Record Updates

Last Update Posted (Actual)

March 10, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC1126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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