PMID- 30345068
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240402
IS  - 2055-5784 (Print)
IS  - 2055-5784 (Electronic)
IS  - 2055-5784 (Linking)
VI  - 4
DP  - 2018
TI  - Supporting general practitioner-based care for poorly controlled type 2 diabetes 
      mellitus (the DECIDE study): feasibility study and protocol for a pilot cluster 
      randomised controlled trial.
PG  - 159
LID - 10.1186/s40814-018-0352-y [doi]
LID - 159
AB  - BACKGROUND: Poorly controlled type 2 diabetes mellitus (T2DM) is associated with 
      significant morbidity, mortality and healthcare costs. Control of T2DM can be 
      challenging for healthcare professionals for a number of reasons, including poor 
      concordance with medications, difficulties modifying lifestyle behaviour and also 
      clinical inertia, which is defined as a reluctance among health professionals to 
      intensify medications. A complex intervention, called ComputeriseD dECisIonal 
      support for poorly controlleD typE 2 Diabetes mellitus in Irish General Practice 
      (DECIDE), was developed, identifying T2DM patients with poor glycaemic and blood 
      pressure control and aiming to target clinical inertia, by supporting therapeutic 
      action, including GP-led medication intensification where appropriate. A 
      small-scale, uncontrolled, non-randomised feasibility study highlighted the 
      acceptability of the DECIDE intervention within Irish General Practice. This 
      paper presents a protocol for a pilot cluster randomised controlled trial (RCT) 
      of the DECIDE intervention. METHODS/DESIGN: The pilot cluster RCT will involve 14 
      practices and 140 patients in Irish General Practice. Intervention GPs will 
      participate in the DECIDE intervention, comprising (a) a training programme for 
      the practices and (b) a web-based clinical decision support system supporting 
      treatment escalation, tailored to specific patient information. Only patients who 
      have poorly controlled T2DM (defined as HbA1c > 70 mmol/mol and/or BP > 150/95) 
      will be included. The primary outcomes will include measures of feasibility such 
      as recruitment and retention of practices and acceptability of the intervention 
      and also HbA1c. Secondary outcomes will include medication intensification, blood 
      pressure and lipids. Control GPs will continue to provide usual care. A process 
      evaluation will be performed to determine whether the intervention is delivered 
      as intended and treatment fidelity assessed to monitor and enhance the 
      reliability and validity of interventions. An exploratory health economic 
      analysis will examine the potential costs and cost effectiveness of the 
      intervention relative to the control. DISCUSSION: A pilot cluster RCT will 
      establish the feasibility of a complex intervention which aims to support primary 
      care for patients with poorly controlled T2DM in Irish General Practice. TRIAL 
      REGISTRATION: The protocol for the pilot cluster RCT is registered on the ISRCTN 
      Registry at: ISRCTN69498919.
FAU - Murphy, Mark E
AU  - Murphy ME
AUID- ORCID: 0000-0002-4240-5327
AD  - 1HRB Centre for Primary Care Research, Royal College of Surgeons, Dublin, 
      Ireland. ISNI: 0000 0004 0488 7120. GRID: grid.4912.e
FAU - Byrne, Molly
AU  - Byrne M
AD  - 2Health Behaviour Change Research Group, School of Psychology, National 
      University of Ireland, Galway, Ireland. ISNI: 0000 0004 0488 0789. GRID: 
      grid.6142.1
FAU - Boland, Fiona
AU  - Boland F
AD  - 1HRB Centre for Primary Care Research, Royal College of Surgeons, Dublin, 
      Ireland. ISNI: 0000 0004 0488 7120. GRID: grid.4912.e
FAU - Corrigan, Derek
AU  - Corrigan D
AD  - 1HRB Centre for Primary Care Research, Royal College of Surgeons, Dublin, 
      Ireland. ISNI: 0000 0004 0488 7120. GRID: grid.4912.e
FAU - Gillespie, Paddy
AU  - Gillespie P
AD  - 3Health Economics and Policy Analysis Centre (HEPAC), National University of 
      Ireland, Galway, Ireland. ISNI: 0000 0004 0488 0789. GRID: grid.6142.1
FAU - Fahey, Tom
AU  - Fahey T
AD  - 1HRB Centre for Primary Care Research, Royal College of Surgeons, Dublin, 
      Ireland. ISNI: 0000 0004 0488 7120. GRID: grid.4912.e
FAU - Smith, Susan M
AU  - Smith SM
AD  - 1HRB Centre for Primary Care Research, Royal College of Surgeons, Dublin, 
      Ireland. ISNI: 0000 0004 0488 7120. GRID: grid.4912.e
LA  - eng
PT  - Journal Article
DEP - 20181013
PL  - England
TA  - Pilot Feasibility Stud
JT  - Pilot and feasibility studies
JID - 101676536
PMC - PMC6186054
COIS- Ethical approval has been granted by the ICGP Research Ethics Committee.Not 
      applicableThe authors declare that they have no competing interests.Springer 
      Nature remains neutral with regard to jurisdictional claims in published maps and 
      institutional affiliations.
EDAT- 2018/10/23 06:00
MHDA- 2018/10/23 06:01
PMCR- 2018/10/13
CRDT- 2018/10/23 06:00
PHST- 2018/09/03 00:00 [received]
PHST- 2018/10/02 00:00 [accepted]
PHST- 2018/10/23 06:00 [entrez]
PHST- 2018/10/23 06:00 [pubmed]
PHST- 2018/10/23 06:01 [medline]
PHST- 2018/10/13 00:00 [pmc-release]
AID - 352 [pii]
AID - 10.1186/s40814-018-0352-y [doi]
PST - epublish
SO  - Pilot Feasibility Stud. 2018 Oct 13;4:159. doi: 10.1186/s40814-018-0352-y. 
      eCollection 2018.