Pilot Randomised Controlled Trial of Cardiac Rehabilitation vs. Standard Care after Aortic Aneurysm Repair to reduce Adverse Cardiovascular Events

ObjectivesThis study aimed to investigate if the use of a transition team was feasible for patients with diabetes being discharged from hospital on injectable diabetes therapies.DesignPilot, randomised controlled trial.SettingThe trial was conducted between 2014 and 2016 conjointly by a tertiary referral hospital and a community healthcare provider.ParticipantsHospital inpatients (n=105) on new injectable diabetes therapies were randomised 1:1 to transition team or standard care. The transition team received in-home diabetes education 24–48 hours postdischarge, with endocrinologist review 2–4 weeks and 16 weeks postdischarge.Main outcome measuresThe primary outcome was feasibility, defined by percentage of patients successfully receiving the intervention. Secondary outcomes included safety, defined by hospital readmission and emergency department presentations within 16 weeks postrandomisation, and treatment satisfaction, measured using Diabetes Treatment Satisfaction Questionnaire (DTSQ). Exploratory outcomes included length of stay (LOS) and change in haemoglobin A1c (HbA1c) throughout the study.ResultsThe intervention was deemed feasible (85% (95% CI 73% to 94%)). No difference in safety between groups was detected. No difference in change in HbA1c between groups was detected (standard care median HbA1c −1.5% (IQR −3.7% to −0.2%) vs transition team median HbA1c −1.9% (IQR −3.8% to −0.2%), p=0.83). There was a trend towards reduced LOS in the transition team group (per protocol, standard care median LOS 8 (IQR 5.5–12); transition team median LOS 6 (IQR 3–12), p=0.06). There was a significant improvement in patient satisfaction in the transition team (standard care median 10.5 (IQR 8.5–16); transition team DTSQ change version median 15 (IQR 10–17.5), p=0.047), although interpretability is limited by missing data.ConclusionThis study demonstrated that the use of a novel transition diabetes team is a feasible alternative model of care.

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PP28 ‘They are not silly people – they know the difference’: clinician focus group views on a pilot randomised controlled trial of prehospital continuous positive airway pressure (CPAP)

Emergency Medicine Journal ◽

10.1136/emermed-2019-999abs.28 ◽

2019 ◽

Vol 36 (10) ◽

pp. e12.2-e13

Author(s):

Joshua Miller ◽

Samuel Keating ◽

Alex Scott ◽

Gordon Fuller ◽

Steve Goodacre

Keyword(s):

Continuous Positive Airway Pressure ◽

Randomised Controlled Trial ◽

Focus Groups ◽

Airway Pressure ◽

Standard Care ◽

Positive Airway Pressure ◽

Controlled Trial ◽

Trial Participation ◽

Pilot Randomised Controlled Trial ◽

Randomised Controlled

BackgroundContinuous positive airway pressure (CPAP) is not in widespread use in UK ambulance services, but could benefit patients with acute respiratory failure (ARF). As a new treatment in this context, clinician acceptability is an important factor in the feasibility of conducting definitive research in the prehospital arena.MethodsAs part of a pilot randomised controlled trial (the ACUTE study), nine trial-trained paramedics took part in three semi-structured focus groups. 204 trained staff had been given the opportunity to take part. The sample included six staff who had recruited to the trial, one who had not, and two who had withdrawn from it. Audio-recordings were transcribed and analysed thematically.ResultsParticipants described facilitators to trial participation including: clear eligibility criteria and patient documentation, access to demonstration equipment, training away from the work environment, and repeated patient recruitment. Barriers to taking part included: the lack of protected time for training, inadequate workplace facilities for the electronic learning package used, adverse responses by receiving hospital staff, and infrequent patient exposure. Both paramedics who withdrew cited the inconvenience of carrying packs each shift. Some participants described anxiety and distress when opening packs to find a standard-care mask, and reported patients having similar reactions.ConclusionsFuture researchers could promote improved workplace computing facilities and increased provision of face-to-face training days, which were praised by participants in these focus groups, but limited to a single event distant from some staff. Greater stakeholder engagement by researchers could reduce the difficulties at hospital handover reported by some ambulance staff. Where blinding is not possible, the perceptions of clinicians and patients should be considered carefully, as this study shows both may have adverse emotional responses to being treated with standard care, particularly when prospective consent discussions describe the trial intervention as potentially beneficial.

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