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

Primary Purpose

Smoking

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Motivational interviewing
Sponsored by
Royal College of Surgeons, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Smoking focused on measuring Smoking Cessation, Tobacco Use Cessation, Motivational Interviewing, Students, Medical, Randomized Controlled Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Connolly Hospital Blanchardstown

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Usual care

Arm Description

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.

This group will not receive student contact, but may be counselled by the smoking cessation officer or other Connolly staff as per normal procedures.

Outcomes

Primary Outcome Measures

Change in Motivation to Stop Smoking Scale (MTSS)
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?

Secondary Outcome Measures

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;
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
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);
7-day point prevalent abstinence rates
7-day point prevalent abstinence rates assessed at both 3- and 6-months by self-report

Full Information

First Posted
November 3, 2015
Last Updated
March 9, 2017
Sponsor
Royal College of Surgeons, Ireland
Collaborators
Health Service Executive, Ireland, University of Memphis, Connolly Hospital Blanchardstown
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1. Study Identification

Unique Protocol Identification Number
NCT02601599
Brief Title
Medical Student INtervention to Promote Effective Nicotine Dependence and Tobacco HEalthcare
Acronym
MIND-THE-GAP
Official Title
Medical Student INtervention to Promote Effective Nicotine Dependence and Tobacco HEalthcare: GrAduate Entry Programme (MIND-THE-GAP) Feasibility Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal College of Surgeons, Ireland
Collaborators
Health Service Executive, Ireland, University of Memphis, Connolly Hospital Blanchardstown

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking
Keywords
Smoking Cessation, Tobacco Use Cessation, Motivational Interviewing, Students, Medical, Randomized Controlled Trial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
This group will not receive student contact, but may be counselled by the smoking cessation officer or other Connolly staff as per normal procedures.
Intervention Type
Behavioral
Intervention Name(s)
Motivational interviewing
Intervention Description
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 Outcome Measure Information:
Title
Change in Motivation to Stop Smoking Scale (MTSS)
Description
Repeated measures: MTSS scores at baseline, 1-week, 3- and 6-month follow-up.
Time Frame
Repeated measures: MTSS scores at baseline, 1-week, 3- and 6-month follow-up.
Title
Change in motivation to quit
Description
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?
Time Frame
Repeated measures: single item scores at baseline, 1-week, 3- and 6-month follow-up.
Secondary Outcome Measure Information:
Title
Proportion of patients who receive a prescription for a cessation medication at the time of discharge
Description
The proportion of patients who receive a prescription for a cessation medication at the time of discharge, assessed via medical chart audit;
Time Frame
By discharge, an average of 5-10 days post-admission
Title
proportion of patients who report any use of a prescribed or over-the-counter cessation medication
Description
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
Time Frame
at 3- and 6-months discharge
Title
proportion of attending physicians who prescribe cessation medication during the hospitalisation
Description
the proportion of attending physicians who prescribe cessation medication during the hospitalisation (to be obtained by medical chart audit);
Time Frame
During hospitalisation (baseline)
Title
7-day point prevalent abstinence rates
Description
7-day point prevalent abstinence rates assessed at both 3- and 6-months by self-report
Time Frame
3- and 6-months
Other Pre-specified Outcome Measures:
Title
Perceived student efficacy
Description
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]?"
Time Frame
3- and 6-months
Title
Perceived student knowledge
Description
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]
Time Frame
3- and 6-months
Title
Quit attempts
Description
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? ______
Time Frame
3- and 6-months
Title
Professional advice
Description
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?
Time Frame
3- and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seamus Sreenan
Organizational Affiliation
RCSI and Connolly Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Liam Cormican
Organizational Affiliation
RCSI and Connolly Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ken Ward
Organizational Affiliation
University of Memphis
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lisa Mellon, PhD
Organizational Affiliation
RCSI
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ronan Conroy
Organizational Affiliation
RCSI
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anne Hickey, PhD
Organizational Affiliation
RCSI
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sinead Stynes
Organizational Affiliation
Connolly Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Frank Doyle, PhD
Organizational Affiliation
RCSI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
GEP IC1
Organizational Affiliation
RCSI students
Official's Role
Study Director
Facility Information:
Facility Name
Connolly Hospital Blanchardstown
City
Dublin
Country
Ireland

12. IPD Sharing Statement

Citations:
Citation
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Medical Student INtervention to Promote Effective Nicotine Dependence and Tobacco HEalthcare

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