Chronic Pain Clinical Trial
Official title:
Supporting Self-management in Chronic Pain: a Collaborative Approach Providing Relevant Tools to Healthcare Professionals and People With Pain.
Does the Navigator Tool Intervention improve communication regarding self-management during
consultations between healthcare professionals and people with chronic pain?
As there is usually no cure for chronic pain, healthcare professionals are increasingly
turning to methods of treatment that emphasise management of symptoms rather than elimination
of pain. However, as Pain Concern's previous research has shown, there are several barriers
to self-management that both healthcare professionals and people with pain face in their
consultations in primary care. The Navigator Tool Intervention has been designed to overcome
the majority of these barriers through improving the quality of communication regarding
self-management during consultations.
In line with the House of Care Model, where care relies on engaged and informed patients,
healthcare professionals committed to partnership working, and organisational processes that
support this, our intervention prepares both the healthcare professionals and patients for
their consultation. By providing a training session for the healthcare professionals in how
supported self-management can be brought into the consultation room, and by providing the
patients with a paper-based tool that allows them to organise their concerns and questions
prior to the consultation, the intervention aims to steer the conversation toward the aspects
that the patient needs to discuss in order to better manage their pain.
This study will launch the intervention and evaluate its effectiveness in improving
self-management support through conversation. It will be launched over a 3 month period in 4
sites across Scotland; 24 patients will be using the tool with a trained healthcare
professional and 24 will act as a control group, receiving standard care without the tool.
Questionnaires assessing the satisfaction with the consultation(s) and communication, as well
as confidence in managing one's pain, will be analysed and compared between the two groups.
Interviews will be carried out with healthcare professionals and a sample of patients having
used the tool to gain a deeper understanding of the usefulness of the intervention and how it
may be improved in the future.
This study will involve 4 primary care sites across Scotland, 4-8 healthcare professionals
(HCPs) who will administer the intervention, and 48 patient participants (1-2 HCPs and 12
patients at each site). Half of the patient participants will act as the control group and
receive no intervention.
4 sites within primary care will be recruited through Pain Concern's current network of
healthcare professionals. The sites will consists of general practitioners, physiotherapists
and pharmacists, to ensure that the study reflects the usefulness of the intervention across
primary care. Each site will nominate 1-2 healthcare professionals who will undergo a
training session to learn about supported self-management and how to use the paper-based
Navigator Tool effectively. This training will be developed as a collaboration between Pain
Concern and the Thistle Foundation, an organisation specializing in supporting
self-management for people living with chronic conditions.
Each site will identify 12 patients from their practice who will be asked to participate in
the study. With their consent, the patient's contact details will be passed to the researcher
who will contact them over the phone and inform them of what the study entails. Prior to this
phone call, the patients will have received a written information and a consent sheet through
email, post or in person at their practice. The signed consent sheet can be returned the in
same way. Once recruited, the participants will be randomly allocated to either the
intervention group (24 patients) or the control group (24 patients).
Once allocated to a group, the participant will be sent a pre-intervention pack. There will
be two versions of this pack, one for the intervention group and one for the control group.
Both packs will contain a Pain Self-Efficacy Questionnaire (PSEQ), and the pack for the
intervention group will contain a copy of the Navigator Tool. The participants will be
instructed to fill out the questionnaire straight away and return it to the researcher
through email or post.
During the active research period (3months), the intervention group will have 2-3
consultations using the tool with a healthcare professional who has undergone the training
session. The control group will receive "standard care", i.e. they will not have access to
the paper-based tool, and they will be allocated whatever healthcare professional they would
have seen if they had not been in the study. There will be no regulation of how many
consultations these control participants will have during the research period.
After the 3 month active research period, all patient participants be sent a
post-intervention pack. The intervention and control group will be sent identical packs,
consisting of a demographics questionnaire, another PSEQ, and a Consultation Quality Index -2
(CQI-2) (which includes the CARE measure).
The scores will be compared between the control and active group and indicate the effect
intervention has on our outcome measures. The two most important outcome measures are
improvement in communication (measured by CQI-2) and improvement in confidence of pain
management (PSEQ). Other outcome measures include engagement with the intervention, perceived
participation in decision making, consultations and relational satisfaction and
patient-centeredness, extent to which GP was enabling to the patients and perceived efficacy
for self-management, scores of which will also be derived from the above questionnaires.
A more in-depth follow-up interview will be conducted with all HCPs and a sample of patient
participants (8 patients) spread out over the 4 sites. These interviews will provide a more
specific, nuanced and individual understanding of the patients' and healthcare professionals'
satisfaction with the intervention and quality of consultations. Possible topics include ease
of use, impact on consultation length, effectiveness of communication, required changes to
the intervention, and extent to which the intervention achieved aims. These interviews will
take place 1-2 months after the last consultation with the tool has taken place, last for
around 30-45 minutes, and will be conducted in a venue close to the primary care site the
participant was recruited from.
The interviews will be recorded and the researcher will then transcribe the interviews and
code them using N-vivo. Themes will be elicited and cross-compared between the participants
to establish prevalent experiences, views and attitudes.
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