Preventing disease through opportunistic, rapid engagement by primary care teams using behaviour change counselling (PRE-EMPT): protocol for a general practice-based cluster randomised trial

Background: Smoking, excessive alcohol consumption, lack of exercise and an unhealthy diet are the key
modifiable factors contributing to premature morbidity and mortality in the developed world. Brief interventions in
health care consultations can be effective in changing single health behaviours. General Practice holds
considerable potential for primary prevention through modifying patients’ multiple risk behaviours, but feasible,
acceptable and effective interventions are poorly developed, and uptake by practitioners is low. Through a process
of theoretical development, modeling and exploratory trials, we have developed an intervention called Behaviour
Change Counselling (BCC) derived from Motivational Interviewing (MI). This paper describes the protocol for an
evaluation of a training intervention (the Talking Lifestyles Programme) which will enable practitioners to routinely
use BCC during consultations for the above four risk behaviours.
Methods/Design: This cluster randomised controlled efficacy trial (RCT) will evaluate the outcomes and costs of
this training intervention for General Practitioners (GPs) and nurses. Training methods will include: a practice-based
seminar, online self-directed learning, and reflecting on video recorded and simulated consultations. The
intervention will be evaluated in 29 practices in Wales, UK; two clinicians will take part (one GP and one nurse)
from each practice. In intervention practices both clinicians will receive training. The aim is to recruit 2000 patients
into the study with an expected 30% drop out. The primary outcome will be the proportion of patients making
changes in one or more of the four behaviours at three months. Results will be compared for patients seeing
clinicians trained in BCC with patients seeing non-BCC trained clinicians. Economic and process evaluations will
also be conducted.
Discussion: Opportunistic engagement by health professionals potentially represents a cost effective medical
intervention. This study integrates an existing, innovative intervention method with an innovative training model to
enable clinicians to routinely use BCC, providing them with new tools to encourage and support people to make
healthier choices. This trial will evaluate effectiveness in primary care and determine costs of the intervention.
Trial Registration: ISRCTN22495456