Clinical trial NCT02601599: Medical Student INtervention to Promote Effective Nicotine Dependence and Tobacco HEalthcare
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
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Smoking Cessation
Tobacco Use Cessation
Motivational Interviewing
Students, Medical
Randomized Controlled Trial
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
Collaborators: name: Health Service Executive, Ireland
name: University of Memphis
name: Connolly Hospital Blanchardstown
First posted: 2015-11-10
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in Motivation to Stop Smoking Scale (MTSS)
timeFrame: Repeated measures: MTSS scores at baseline, 1-week, 3- and 6-month follow-up.
measure: Change in motivation to quit
timeFrame: Repeated measures: single item scores at baseline, 1-week, 3- and 6-month follow-up.
Secondary outcomes:
measure: Proportion of patients who receive a prescription for a cessation medication at the time of discharge
timeFrame: By discharge, an average of 5-10 days post-admission
measure: proportion of patients who report any use of a prescribed or over-the-counter cessation medication
timeFrame: at 3- and 6-months discharge
measure: proportion of attending physicians who prescribe cessation medication during the hospitalisation
timeFrame: During hospitalisation (baseline)
measure: 7-day point prevalent abstinence rates
timeFrame: 3- and 6-months
Other outcomes:
measure: Perceived student efficacy
timeFrame: 3- and 6-months
measure: Perceived student knowledge
timeFrame: 3- and 6-months
measure: Quit attempts
timeFrame: 3- and 6-months
measure: Professional advice
timeFrame: 3- and 6 months
Locations:
city: Dublin
country: Ireland
facility: Connolly Hospital Blanchardstown
Study officials:
affiliation: RCSI and Connolly Hospital
name: Seamus Sreenan
role: STUDY_DIRECTOR
affiliation: RCSI and Connolly Hospital
name: Liam Cormican
role: STUDY_DIRECTOR
affiliation: University of Memphis
name: Ken Ward
role: STUDY_DIRECTOR
affiliation: RCSI
name: Lisa Mellon, PhD
role: STUDY_DIRECTOR
affiliation: RCSI
name: Ronan Conroy
role: STUDY_DIRECTOR
affiliation: RCSI
name: Anne Hickey, PhD
role: STUDY_DIRECTOR
affiliation: Connolly Hospital
name: Sinead Stynes
role: STUDY_DIRECTOR
affiliation: RCSI
name: Frank Doyle, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: RCSI students
name: GEP IC1
role: STUDY_DIRECTOR
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citation: Kumar A, Ward KD, Mellon L, Gunning M, Stynes S, Hickey A, Conroy R, MacSweeney S, Horan D; Graduate Entry Programme 2014-18 Class; Cormican L, Sreenan S, Doyle F. Medical student INtervention to promote effective nicotine dependence and tobacco HEalthcare (MIND-THE-GAP): single-centre feasibility randomised trial results. BMC Med Educ. 2017 Dec 11;17(1):249. doi: 10.1186/s12909-017-1069-y.