Frequent Utilisers of Urgent Medical Care Who Have High Health Anxiety Clinical Trial
Official title:
Helping Urgent Care Users Cope With Distress About Physical Complaints: A Randomised Controlled Trial
To determine the cost and clinical effectiveness of offering 6-10 sessions of remotely
delivered cognitive behaviour therapy (CBT) via video calling or over the telephone for
health anxiety in repeated utilisers of unscheduled/urgent care versus treatment as usual.
To optimise the delivery of CBT for health anxiety delivered remotely by systematically
identifying and then acting on barriers and enablers to the intervention through a network of
practice.
Background: Health anxiety costs £3 billion per year in unnecessary expenditure, much of it
on unscheduled care and in-patient admission. CCGs are incentivised to reduce emergency care
use and the Department of Health is spending up to an additional £400 million per year to
provide psychological treatment for this problem. Yet patients with health anxiety are
reluctant to accept face to face psychological treatment. There is strong evidence that
delivered in secondary acute care as a liaison psychiatry service psychological therapy it
can be clinically and cost effective for two years. Government policy is to deliver this
intervention in primary or community care where there is little evidence of clinical or cost
effectiveness. Face to face delivery of this intervention through secondary care mental
health and IAPT services has not been acceptable to these service users. Remotely delivered
psychological treatment designed to assist coping with symptoms can be delivered by mental
health services and may be both more acceptable to service users than face to face treatment
in IAPT services and just as effective as in secondary acute care.
Aims: To determine the clinical and cost effectiveness of remotely delivered cognitive
behaviour therapy for health anxiety in repeated users of unscheduled primary or secondary
care for physical symptoms without a physical health cause. To determine barriers and drivers
to delivering such remote treatment and how such treatment might fit into a wider care
pathway to enhance patient experience of care.
Methods of research: Randomised controlled trial of 6-10 sessions of cognitive behaviour
therapy for health anxiety delivered by telephone or through the internet versus treatment as
usual. Primary outcome is change in health anxiety from baseline to 6 months; secondary
outcomes are persisting change in health anxiety to 12 months, emergency care use,
generalised anxiety, depression, somatic distress, work and social adjustment and quality of
life. We will assess economic outcome and qualitative analysis of barriers and drivers to
delivery of intervention and view the intervention as part of an overall care pathway to
provide alternatives to emergency care use. This will help network leads, practitioners and
service users to shape the research so that it can provide the most information to enable
putting the intervention into practice.
Methods of implementation (putting into practice). A network lead, a networking practitioner
and an associated network of practice will bridge work between the research team and
practitioners, commissioners, strategic clinical networks, Health England (education) and the
Academic Health Science Networks (AHSN) across the East Midlands to put the intervention into
practice. The process will be iterative, identifying core features of the intervention that
should not be varied and those parts of the intervention that may be adapted allowing a
degree of adaptation to local requirements.
Research plan:
Design: Pragmatic individually randomised controlled trial (RCT) of CBT versus treatment as
usual, stratified by site. Economic evaluation and qualitative analysis of barriers and
drivers to the research, intervention and its implementation into practice will also be
performed. There may be differences in the uptake and retention to both the intervention and
the trial if the service user is recruited to the study through their own practice or through
an urgent care service. In order to refine the efficiency of recruitment and retention into
the RCT and the intervention, we will conduct a 12 month feasibility phase in two parts of
the East Midlands, then roll out the study within the East Midlands before starting the study
in other AHSN areas.
Setting. Recruitment of service users from primary care, unscheduled primary or secondary
care in the East Midlands, including rapid access services for problems such as chest pain.
Delivery of intervention remotely by mental health services.
Interventions. CBT delivered remotely. We will use an experienced CBT therapist, who was
trained in the engagement and delivery of CBT to health anxious patients in primary care to
deliver CBT and to supervise up to four therapists also delivering the same intervention one
day per week, one from each mental health trust in the East Midlands (lead from
Nottinghamshire Healthcare NHS Trust). The lead therapist will receive supervision from the
lead therapist in the CHAMP study (Tyrer, 2013) to ensure consistency with the approach in
that study and to understand any adaptations that are necessary to deliver this intervention
remotely and to high utilisers of care. The number of sessions is dependent on the pace of
engagement with the patient and the complexity of their problems, and is tailored to the
individual formulation of the patient's problems by the therapist (Tyrer, 2013). The
treatment intervention will address health anxiety with reassurance seeking and/or phobic
avoidance with or without management of panic attacks, generalised anxiety or depression,
communication with health professionals, current psychosocial problems and differentiation
from other physical health problems.
Treatment as usual will be that decided by the patient with their general practitioner and
health professionals they consult for unscheduled care.
Outcomes. Outcomes will be assessed single blind at baseline, 6 and 12 months. The primary
clinical outcome is change in the 14 item self-rated short week Health Anxiety Inventory
(Salkovskis et al, 2002) from baseline to 6 months. Secondary clinical outcomes are contacts
with unscheduled or emergency care, change from baseline to 12 months on the short week the
14 item HAI, 7 item GAD-7 (generalised anxiety; Spitzer et al, 2006), 15 item PHQ-15 (somatic
distress; Kroenke et al, 2002), 9 item PHQ-9 (depression; Kroenke et al, 2001), 8 item social
function (WASA; Mundt et al, 2002), and 5 item quality of life (EQ5D; EuroQol Group, 1990).
Economic analysis. A detailed resource profile will be established for the intervention
versus usual care. A cost profile will then be attached to each arm. Cost utility and cost
effectiveness assessment will be made from health and social care perspectives as recommended
by NICE.
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