As mentioned in the introduction (seeMethodology for the design of a new intervention), we approached the design of the intervention on the basis of the principles of implementation science and user-centred design. The former suggests the need for a‘programme theory’as the basis of implementation and evaluation; the latter suggests starting with high-level (conceptual) design before moving on to low-level design (the actual working of the system and the‘look and feel’of the system). The three phases inform each other as propositions/ideas are discussed, and mock-ups are tested and evaluated (Figure 5). We completed the first steps of the first two phases by developing the foundations for a programme theory (Table 12, further developed in the proposal for the PADDS system) and the requirements specifications document (version 1; seeAppendix 6). These were based on the discussions and analytic work done by the team, written up by the senior research fellow (VL), with documents circulated for comments among the team. The requirement specification document was written with reference to the requirements specifications for electronic prescribing systems published by NHS Connecting for Health.111
(a)
(b) (c)
(d) (e)
(f)
FIGURE 4 Design team analysis workshop: working out components, rationales, expected outcomes and assumptions (the‘programme theory’). Potential interventions and related elements were mapped with
(a) sticky notes and organised into key components; (b) how pain is understood; (c) components; (d) mechanisms; (e) outcomes; and (f) conditions.
FOUNDATIONS FOR THE DEVELOPMENT OF THE DECISION SUPPORT TOOL
NIHR Journals Library www.journalslibrary.nihr.ac.uk
1. Intervention programme theory
Why, how, when, who, in what contexts
2. High-level design
What does the system do, what data, who are the users/stakeholders
3. Low-level design
What does the system look like, how does it work . . .
Discuss, revise Discuss, revise
Test, evaluate the design (usability, clinical utility) Test, evaluate feasibility and cost-effectiveness
FIGURE 5 Three phases for the design of a theory-based intervention.
TABLE 12 Foundations for the programme theory for the PADDS system
Conceptual elements of the
programme theory Findings, propositions, hypotheses
The problem we aim to address The decision-making problem we identified is multidimensional and it involves:
l pain in patients with dementia not being noticed and understood as pain
l lack of integration of relevant information required for collective sense-making of the patient’s pain
l poor feedback mechanisms to inform the empirical (trial) approach to pain management
The components of our intervention intended to mitigate or solve the problems
Our intervention entails a new documentation process and chart or electronic space that enables connecting all available information about the presence or absence of pain to make a patient-specific pain picture that can provide an overview to inform collective decision-making. The intervention will include these components:
l a documentation chart/electronic space
l guidance on use and information materials
l a training package on the use of the tool
l guidance on adoption including how to integrate this into routine workflow, identification of existing systems to replace or augment (if electronic) and practices to change, and aspects of change management strategy
This will need to be digital. We are aware of the inherent risks associated with a pain medication chart that is separate from the drug chart: a new documentation process and chart dedicated to a patient’s pain that also includes pain medication data cannot be physically separated from the documentation of the patient’s other medical prescriptions. For reasons of patient safety, and given the design constraints of paper, the new documentation process and information space we propose will augment existing electronic patient record/electronic prescribing systems
TABLE 12 Foundations for the programme theory for the PADDS system (continued)
Conceptual elements of the
programme theory Findings, propositions, hypotheses
The intervention’s expected outcomes The intervention is expected to have direct and indirect, and immediate and medium-term outcomes
Direct and immediate outcomes:
l improved documentation of pain assessment. This includes, for example, narrative from carers about individual pain cues, documentation of absence of pain as well as presence, and whether or not the assessment is based on clinician’s inference from the patient’s behaviour or from the patient’s verbal report
l improved documentation of the therapy. This includes information on clinical effectiveness of the therapy (e.g. patient is feeling better); performance of medicine management (e.g. drug was administered at a given time); outcome of therapy (e.g. strategy abandoned, change in prescription); personalisation of the pain management (i.e. what helps the individual with their pain). Note that the therapy can include forms of intervention other than medicines
l improved shared understanding of patients’pain and the best ways to manage it
Indirect, medium-term outcomes:
l greater patient well-being, for example less confusion, agitation, aggression
l better use of medication, for example by use of a wider variety of management methods beyond the use of drugs as well as more effective use of drugs
l increased involvement of carers whenever possible, for example in decision-making about pain management strategies
The metrics and methods for assessing these outcomes
Assessment clearly linked to prescription Administration clearly linked to assessment
Number of days patients appear content and are able to meaningfully engage
Shorter stays in hospital
Less recourse to specialist care in the community Carers’satisfaction
Involvement and shared decision-making documented in patient records Decreased use of neuroleptics
Greater variety and frequency of use of appropriate non-pharmacological pain management interventions
The mechanisms: from our input to expected outcomes
The chart is expected to change individual cognitive work and decision- making tasks from‘mental computation’to‘pattern recognition’, through:
l reducing fragmentation of information, centralising information into one place
l reconnecting assessment and management information into one place
l organising the information into visualisations of changes and patterns in the patient’s pain
l structuring the information related to the trial of therapy
l providing reminders of therapeutic options
This reorganisation of available information will facilitate the building of mental models (‘patterns of pain’or‘pain pictures’) both in general and for individual patients. It will therefore enable more effective triggering of the identification of pain and more effective use of pain management strategies Pattern recognition tasks are less error prone than mental computational tasks and therefore a change from computation to pattern recognition is expected to lead to improved quality and safety
FOUNDATIONS FOR THE DEVELOPMENT OF THE DECISION SUPPORT TOOL
NIHR Journals Library www.journalslibrary.nihr.ac.uk
The third stage, the low-level design, including codesign sessions with users and evaluation, required more time and different expertise than those available within the research team and was therefore left to further research. This third stage will incorporate a health economic evaluation, using the outcome measures developed in this study. However, given that the proposed intervention is more complex than anticipated, further development of this part of the evaluation will be essential.
At this point the high-level design envisages a ward-based electronic health record module designed to ‘slot into’existing systems, augmenting rather than replacing existing electronic or paper forms or records where a patient’s pain is documented. The actual design of this module will be strongly influenced by potential users during the codesign process.
TABLE 12 Foundations for the programme theory for the PADDS system (continued)
Conceptual elements of the
programme theory Findings, propositions, hypotheses
The conditions necessary for the intervention to work and outcomes to be achieved (context and implementation strategy)
There are prerequisites for the effectiveness of our intervention. We identified the following:
l Education (staff dementia training): understanding of dementia–causes, symptoms, behaviours–is prerequisite background knowledge for‘pain in dementia’to be understood
l Implementation strategy (do not add; replace or augment): the new documentation tool has to replace or augment existing ones–it must not add to it in terms of documentation burden. Otherwise, there is a risk that the new tool will be considered redundant and thus will not be adopted. There is also a risk that the new tool will add to time spent on documentation at the detriment of time for direct patient care
l Implementation strategy (integration into workflow/ownership for adoption): interventions introduced at the point of decision-making, integrated into clinical workflow and‘owned and championed’by staff are more successful
l Cost-effectiveness: the implementation and use of the PADDS system would have to demonstrate cost-effectiveness; appropriate research instruments will be needed to ascertain this
Chapter 8
Health economics
Background
There has been little research about the cost or cost-effectiveness of interventions to identify or manage pain for individuals with dementia. For example, a recent review112identified only five randomised controlled
studies published since 2003 targeting behavioural disturbances and behavioural interventions targeting pain; none of these considered the cost or cost-effectiveness of the interventions. Similarly, a systematic review, of the same year, considered the effectiveness of interventions targeting pain or behaviour in dementia. The study included 16 papers, but again none assessed cost or cost-effectiveness.113However,
evidence suggests that dementia is costly. The onset of behavioural disturbances such as agitation are often linked with pain114and result in more frequent medical examinations and hospitalisation, thus higher costs.115