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

9. marts 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

67

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Irland
      • Dublin, Irland
        • Connolly Hospital Blanchardstown

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Motivation to Stop Smoking Scale (MTSS)
Tidsramme: 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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of patients who receive a prescription for a cessation medication at the time of discharge
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 3- and 6-months
7-day point prevalent abstinence rates assessed at both 3- and 6-months by self-report
3- and 6-months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Perceived student efficacy
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Royal College of Surgeons, Ireland

Samarbejdspartnere

Connolly Hospital Blanchardstown
University of Memphis
Health Service Executive, Ireland

Efterforskere

  • Studieleder: Seamus Sreenan, RCSI and Connolly Hospital
  • Studieleder: Liam Cormican, RCSI and Connolly Hospital
  • Studieleder: Ken Ward, University of Memphis
  • Studieleder: Lisa Mellon, PhD, RCSI
  • Studieleder: Ronan Conroy, RCSI
  • Studieleder: Anne Hickey, PhD, RCSI
  • Studieleder: Sinead Stynes, Connolly Hospital
  • Ledende efterforsker: Frank Doyle, PhD, RCSI
  • Studieleder: GEP IC1, RCSI students

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2015

Primær færdiggørelse (Faktiske)

1. december 2016

Studieafslutning (Faktiske)

1. december 2016

Datoer for studieregistrering

Først indsendt

3. november 2015

Først indsendt, der opfyldte QC-kriterier

9. november 2015

Først opslået (Skøn)

10. november 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. marts 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. marts 2017

Sidst verificeret

1. april 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • REC1126

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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