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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 3, 2015
First Posted Date  ICMJE November 10, 2015
Last Update Posted Date March 10, 2017
Actual Study Start Date  ICMJE November 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2015)
  • 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.
  • 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?
Original Primary Outcome Measures  ICMJE
 (submitted: November 9, 2015)
Change in Motivation to Stop Smoking Scale (MTSS) [ Time Frame: Repeated measures: MTSS scores at baseline, 1-week, 1- and 6-month follow-up. ]
Repeated measures: MTSS scores at baseline, 1-week, 1- and 6-month follow-up.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2016)
  • 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;
  • 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
  • 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);
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2015)
  • 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;
  • proportion of patients who report any use of a prescribed or over-the-counter cessation medication [ Time Frame: at 1- 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
  • 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);
  • 7-day point prevalent abstinence rates [ Time Frame: 1- and 6-months ]
    7-day point prevalent abstinence rates assessed at both 1- and 6-months by self-report, and verified at 6-months by expired carbon monoxide level of <10ppm as per guidelines
Current Other Pre-specified Outcome Measures
 (submitted: December 3, 2015)
  • 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]?"
  • 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]
  • 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? ______
  • 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?
Original Other Pre-specified Outcome Measures
 (submitted: November 9, 2015)
  • Perceived student efficacy [ Time Frame: 1- 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]?"
  • Perceived student knowledge [ Time Frame: 1- 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]
  • Quit attempts [ Time Frame: 1- 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? ______
  • Professional advice [ Time Frame: 1- and 6 months ]
    One questionnaire item: In the past 1/6 months since your hospital admission, did a doctor or health professional discuss ways of giving up smoking with you?
 
Descriptive Information
Brief Title  ICMJE Medical Student INtervention to Promote Effective Nicotine Dependence and Tobacco HEalthcare
Official Title  ICMJE Medical Student INtervention to Promote Effective Nicotine Dependence and Tobacco HEalthcare: GrAduate Entry Programme (MIND-THE-GAP) Feasibility Randomised Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Smoking
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Motivational interviewing
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2017)
67
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2015)
180
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ireland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02601599
Other Study ID Numbers  ICMJE REC1126
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Royal College of Surgeons, Ireland
Study Sponsor  ICMJE Royal College of Surgeons, Ireland
Collaborators  ICMJE
  • Health Service Executive, Ireland
  • University of Memphis
  • Connolly Hospital Blanchardstown
Investigators  ICMJE
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
PRS Account Royal College of Surgeons, Ireland
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP