Barriers and facilitators to healthcare professional behaviour change in clinical trials using the Theoretical Domains Framework: a case study of a trial of individualized temperature-reduced haemodialysis

Background Implementing the treatment arm of a clinical trial often requires changes to healthcare practices. Barriers to such changes may undermine the delivery of the treatment making it more likely that the trial will demonstrate no treatment effect. The ‘Major outcomes with personalized dialysate temperature’ (MyTEMP) is a cluster-randomised trial to be conducted in 84 haemodialysis centres across Ontario, Canada to investigate whether there is a difference in major outcomes with an individualized dialysis temperature (IDT) of 0.5 °C below a patient’s body temperature measured at the beginning of each haemodialysis session, compared to a standard dialysis temperature of 36.5 °C. To inform how to deploy the IDT across many haemodialysis centres, we assessed haemodialysis physicians’ and nurses’ perceived barriers and enablers to IDT use. Methods We developed two topic guides using the Theoretical Domains Framework (TDF) to assess perceived barriers and enablers to IDT ordering and IDT setting (physician and nurse behaviours, respectively). We recruited a purposive sample of haemodialysis physicians and nurses from across Ontario and conducted in-person or telephone interviews. We used directed content analysis to double-code transcribed utterances into TDF domains, and inductive thematic analysis to develop themes. Results We interviewed nine physicians and nine nurses from 11 Ontario haemodialysis centres. We identified seven themes of potential barriers and facilitators to implementing IDTs: (1) awareness of clinical guidelines and how IDT fits with local policies (knowledge; goals), (2) benefits and motivation to use IDT (beliefs about consequences; optimism; reinforcement; intention; goals), (3) alignment of IDTs with usual practice and roles (social/professional role and identity; nature of the behaviour; beliefs about capabilities), (4) thermometer availability/accuracy and dialysis machine characteristics (environmental context and resources), (5) impact on workload (beliefs about consequences; beliefs about capabilities), (6) patient comfort (behavioural regulation; beliefs about consequences; emotion), and (7) forgetting to prescribe or set IDT (memory, attention, decision making processes; emotion). Conclusions There are anticipatable barriers to changing healthcare professionals’ behaviours to effectively deliver an intervention within a randomised clinical trial. A behaviour change framework can help to systematically identify such barriers to inform better delivery and evaluation of the treatment, therefore potentially increasing the fidelity of the intervention to increase the internal validity of the trial. These findings will be used to optimise the delivery of IDT in the MyTEMP trial and demonstrate how this approach can be used to plan intervention delivery in other clinical trials. Trial registration ClinicalTrials.gov NCT02628366. Registered November 16 2015. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1965-9) contains supplementary material, which is available to authorized users.

Coding instructions: 1. The framework used for data analysis is a combination of the 12-Domain Theoretical Domains Framework (TDF1; Michie et al., 2005) and the 14-Domain TDF2 (Cane et al., 2012) with one additional theme relevant to broader trial implementation but not specific to the TACT-specified behaviour of interest; note: this may eventually be an emergent theme(s). 2. Code into domains, and wherever possible use its corresponding constructs to justify coding the text into a domain (Definitions of constructs and domains are included below). Note to double coder: the double coding is at the domain level, but use constructs to inform the decision of which domain to code. 3. Code all responses (both positive and negative, clarifying the directionality of the quote wherever possible, using verbatim quotes if possible). 4. Code all relevant text into each domain (i.e. provide context to demonstrate how the text is associated with a domain), but also highlight the specific sections of the text within that are specifically related to the domain. Note to double coder: only code the highlighted text, but use the broader context text to inform the coding. Can code un-highlighted text if deemed relevant. 5. Please use the "Decision Rule" columns to supplement the description of the domains and constructs for this context. Also see the decision rule column for information regarding text that could be justifiably coded into multiple domains. Can code highlighted text to multiple domains if necessary. 6. Note that definitions are from Cane et al. (2012) unless otherwise indicated. Wherever possible, use the definitions provided in this codebook to justify coding 7. Code "No" answers along with the corresponding question into the appropriate domains.

Domain
Construct Descriptions of how confident a participant feels that they would be able to set or prescribe an ICDT "It's easy and I can basically just do it [prescribe a cooler dialysate temperature] and it'll get done." (Physician#1) Perceived competence: An individual's belief in her or her ability to learn and execute skills Self-efficacy: An individual's capacity to act effectively to bring about desired results, as perceived by the individual Perceived behavioural control: an individual's perception of the ease or difficulty of performing the behaviour of interest Beliefs: The thing believed; the proposition or set of propositions held true Self-esteem: The degree to which the qualities and characteristics contained in one's selfconcept are perceived to be positive Empowerment: The promotion of the skills, knowledge and confidence necessary to take great control of one's life as in certain educational or social schemes; the delegation of increase decision-making powers to individuals or groups in a society or organization Professional confidence: An individual's beliefs in his or her repertoire of skills, and ability, especially as it is applied to a task or set of tasks.

Optimism
The confidence that things will happen for the best or that desired goals will be attained Optimism: The attitude that outcomes will be positive and that people's wishes or aims will be ultimately fulfilled Can also include hypothetical reinforcement/reward e.g. patient and nurse satisfaction with treatment: "Oh, yes because the patients are very satisfied when they say, "Oh…" Like last treatment I was unable to remove a lot of fluids but this treatment I was and there's no complication. As long as they're comfortable, no complications during dialysis and I'm able to make them comfortable after and make them happy. That's rewarding." Incentives: An external stimulus, such as condition or object, that enhances or serves as a motive for behaviour Punishment: The process in which the relationship between as response and some stimulus or circumstance results in the response becoming less probable; a painful, unwanted or undesired event or circumstance imposed as a penalty on a wrongdoer Consequents: An outcome of behaviour in a given situation Reinforcement: A process in which the frequency of a response is increased by a dependent relationship or contingency with a stimulus Contingencies: A conditional probabilistic relation between two events. Contingencies may be arranged via dependencies or they may emerge by accident Sanctions: A punishment or other coercive measure, usually administered by a recognized authority, that is used to penalise and deter inappropriate or unauthorized actions.

Importance of staff buy-in
Inappropriate coding to this domain: this is different from how effective they think using individualized and/or cooler dialysate temperatures will be or that cooler dialysate temperatures help manage hypotension and help with fluid removal during treatment ('Beliefs About Consequences') and different from how much of a priority prescribing/setting individualized and/or cooler dialysate temperatures is for them ('Goals'). Be careful not to code the reasons for the intention (focus on statements that directly reflect their intention and motivation) "having the core temperature as your baseline and as your guide really ensures that everybody's going to get a bit of cooler dialysate rather than something a bit more random. I personally would love to do it." (Physician#1) Descriptions of how setting/prescribing individualized cooler dialysate temperatures are (or are not) in conflict with guidelines/local policies currently used (also code this at 'Knowledge') or in conflict with other aspects of the care they provide (goal conflict) Unit standards (double coded at knowledge) "Interviewer: How much of a priority is prescribing individualized cooler dialysate temperatures in the grand scheme of everything you do?

Respondent:
Very low" (Physician#1) Goal priority: Order of importance or urgency of end state toward which one is striving Goal/target setting: A process that establishes specific time based behavioural targets that are measureable, achievable and realistic Goals (autonomous/controlled): The end state toward which one is striving: the purpose of an activity or endeavour. It can be identified by observing that a person ceases or changes their behaviour upon attaining this state; proficiency in a task to be achieved within a set period of time. Action planning: The action or process of forming a plan regarding a thing to be done or a deed Implementation intention: The plan that one creates in advance of when, where an how one will enact a behaviour 10. Memory,

Attention and Decision Processes
The ability to retain information, focus selectively on aspects of the environment and choose between two or more alternatives Memory: The ability to retain information or a representation of a past experience, based on the mental processes of learning or encoding retention across some interval of time, and retrieval or reactivation of the memory; specific information of a specific task Consider coding to this domain: When/why would it be easy to forget.
Descriptions of decision processes regarding dialysate temperature (reasons why dialysate temperature chosen) Due the hypothetical nature of the interviews, please also code participant's descriptions of when they think they would forget as well as reasons why they don't think they would forget at this domain Descriptions of how more time will be required for setting/prescribing ICDT.
Descriptions of how environmental/contextual factors can influence the accuracy of temperature measure (Also code these descriptions at 'Beliefs about Consequences') Patient clinical factors that would influence whether or not a cooler dialysate temperature was prescribed/set for a patient (Also code at 'Beliefs about Consequences') Note: clinical factors include fever, hypo/hypertension, cardiac issues, feeling cold etc. as well as descriptions of patients doing well on dialysis (i.e. have a lack of clinical features) and patient comfort e.g. equipment used to set/prescribe temperature, thermometers, blankets, electronic recording "EMR" software used "Well, so equipment might be a limitation depending on the patient's core temperature. The equipment has maximum and minimum setting of temperature." (Physician#1) "However, with the temperature outside now and then when they come, what we normally do predialysis is we want to settle them a little bit because it's cold outside. When they come in and we check their temperature, they're already cold because we normally check the ear temperature. Yes, tympanic temperature. Because they come from outside and they never cover their ears, normally, it's low already. " (Nurse#1) Discussion about how others influence whether or not a cooler dialysate temperature is set/prescribed. Includes patient influence, and influence of other healthcare professionals.

Resources/material resources: Commodities and human resources used in enacting a behaviour
Descriptions of patient's complaints related to feeling cold, resistance to having cooler dialysate temperatures set.
Discussing the importance of patient buy-in Discussion of the need for other's activity "We need a doctor's order" (e.g., nurse describing how they would need a physician order)

Descriptions of how nurses follow doctor's orders
Recommending a medical directive/protocol so nurses can set ICDTs without requiring a doctor's order For physicians/nurse practitioner/prescriber: descriptions of notifying nurses of changes in prescription in person or notes etc.
Descriptions of unit-wide pattern of thought related to cooler dialysate temperatures (considered social norms) Inappropriate coding to this domain: Specific descriptions of the roles of others i.e. what someone else is doing "Physicians prescribe" "Nurses set" should be coded at 'Social Professional Role and Identity.' "R:They are, they are because sometimes mind over matter and they say, "Okay, set this up." Then they disagree with you but they still set it up and then they'll say, "I'm really cold. I'm really cold. I'm really cold." They won't stop.
I:Then in that case their temperature…?
R:Yes, in that case you have to increase the temperature, and show it to them, in the machine that, "Look, I did it." (Nurse#1) "I think everyone, most people in Ottawa do. I'll be very honest. Most people use cooler than core temperature. Well assuming core temperature is 37, most people use cooler than core temperature." (Physician#1) Self-monitoring: A method used in behavioural management in which individuals keep a record of their behaviour, especially in connection with efforts to changes or regulate the self; a personality trait reflecting an ability to modify one's behaviour in response to a situation Consider coding to this domain: Self-regulatory strategies already in place that would influence the prescription/setting of cooler dialysate temperatures. Focus on selfregulatory strategies only (not all strategies) Coping plans, problem solving scripts/strategies used in response to patients' resistance to cooler dialysate temperatures (including providing blankets) Descriptions of dialysate temperatures being increased in response to patients' complaints of being cold or in response to other clinical factors (e.g. hypertension) Descriptions of auditing or spot-checks recommended for implementation Inappropriate coding to this domain: strategies suggested by the participant as being useful to implement the setting/prescription of cooler dialysate temperatures (not currently done). This would be 'Strategies Suggested for Implementation.' e.g. prompts that already exist to prescribe a dialysate "Right now when we enter our orders whether it's for an inpatient or an outpatient, in your prompts you have to put in a temperature." (Physician#1) "You tell them, "Look, we're doing this because A, B and C and if you feel cold we'll give you an extra blanket." to have some mitigating factors for the subjective symptoms of being cold. Hopefully you can convince a fair amount of patients to actually agree to that." (Physician#1) Breaking habit: to discontinue a behaviour or sequence of behaviours that is automatically activated by relevant situational cues Action planning: The action or process of forming a plan regarding a thing to be done or a deed. Descriptions of how dialysate temperature is currently an automatic/default setting on machine.

Nature of
Descriptions of how often cooler dialysate temperatures are prescribed or set in usual "I have to say that at least not in my practice and I don't think in many practices there's not a lot of people who actually look at the core patient's temperature to decide what they're going to set the dialysis temperature. It's more, let's say patients having recurrent low blood pressure. You look at their prescription. They're at 36.5. You'll say let's drop it to 36. We're not going to look at what their core temperature is. We're just going to say, "Let's drop them by a .5 or a one degree towards the