Strengths and limitations of this study
To the best of our knowledge, this is the first randomised controlled trial to examine the impact of holistic needs assessment (HNA) on the dynamics of conversation and any subsequent impact on shared decision-making and self-efficacy.
We are only collecting data from one consultation per patient. However, it is recommended that HNA should be administered across the patient pathway (at diagnosis, pretreatment, and then post-treatment). Therefore, we are unable to comment on the impact of HNA on the patient–clinician dynamic over time.
Applying a holistic approach to patient care has many benefits, but only around 25% of cancer survivors in the UK receive a HNA and care plan. Gaining a greater insight into the delivery and experience of HNA in the clinical environment will support evidence-based implementation of HNA in the UK and internationally.
Introduction
Background and rationale
There is currently a concerted political, ethical and philosophical push towards improving patient experience and care in the UK National Health Service.1 ,2 Government initiatives such as ‘Better Cancer Care: An Action Plan’,3 and policy guidelines such as ‘Improving supportive and palliative care for adults with cancer’4 address the need to improve satisfaction, reduce distress, offer support and save money by facilitating self-care. Improved collaboration between patient and clinician is central to this agenda.5 However, it is not clear how collaboration is optimised, who should be sharing what decisions, or how this may or may not impact on outcomes.6 Therefore, evidence grounded in the systematic analysis of the process and impact of collaboration is rare as well as important.
Communication in cancer care is a well-researched field. Effective communication between the health professional and the patient is associated with improved psychological functioning of the patient,7 ,8 adherence to treatment and pain control,9 and higher quality of life and satisfaction.10 By contrast, it has been suggested11 that poor communication may have a number of negative effects on the patient and the treatment process, including the nature and quality of information transmission, decision-making, and the psychosocial experience of the patient.
There are inherent methodological and philosophical challenges attached to this line of enquiry. Most notably the idea of ‘poor’ or ‘effective’ communication is subjective, with factors such as patient behaviour, time, resources and previous training all affecting clinician communication style.12 The aim of the current study is to understand more about the factors that may impact on the quality of communication within the clinical consultation.
The intervention in this study is holistic needs assessment (HNA). HNA is a checklist completed by the patient prior to consultation. It signposts issues of emotional, practical, financial and clinical concern. The purpose of HNA is to identify a patient's individual needs in order to facilitate better collaboration.13 During consultation, the HNA facilitates a dialogue that will have the patient's concerns at the centre. In conjunction with a subsequent care plan, the process supports timely intervention based on a collaborative, person-centred discussion.13
In order to gather pertinent data, we are going to audio record clinical consultations. We recognise that this action may have an impact in itself, potentially changing the subtle dynamics of the consultation we intend to study. Nevertheless, this is the same for both arms of the study and a valuable method of analysis.14 Through detailed examination of communication patterns within the consultation, we intend to ascertain if and how a structured conversation derived from personally identified patient needs impacts on subsequent outcomes. To the best of our knowledge this is the first randomised controlled trial to examine the impact of HNA on patient–clinician communication, and the subsequent impact on shared decision-making and patient-reported self-efficacy.
Objectives
The objectives are to examine
The impact of HNA on consultation style;
The impact of HNA on shared decision-making;
The impact of HNA on patient-reported self-efficacy.
In order to meet these objectives, the study will test the following hypotheses:
Use of HNA within clinical consultation will facilitate increased levels of patient participation.
Use of HNA within clinical consultation will facilitate increased levels of shared decision-making.
Use of HNA within clinical consultation will facilitate increased feelings of self-efficacy.
Method
Study design and setting
This protocol follows SPIRIT15 2013 guidelines.
It is a randomised controlled trial. The randomisation pertains to the patients within each clinic. Data collection will occur within a post-treatment, outpatient cancer clinic. Ten clinics from the West of Scotland and