“How do I keep this live in my mind?” Allied Health Professionals’ perspectives of barriers and enablers to implementing Good Clinical Practice in research: A qualitative exploration guided by behaviour change theory

doi:10.21203/rs.3.rs-1503347/v1

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“How do I keep this live in my mind?” Allied Health Professionals’ perspectives of barriers and enablers to implementing Good Clinical Practice in research: A qualitative exploration guided by behaviour change theory

https://doi.org/10.21203/rs.3.rs-1503347/v1

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BACKGROUND

Allied health professionals (AHPs) engaged in research are encouraged to comply with Good Clinical Practice (GCP) principles to protect participant safety and wellbeing and enhance data integrity. Currently, there is limited exploration into health professionals’ perceptions of implementing and adhering to GCP standards in research. Such knowledge is vital to guide future interventions to increase GCP adherence.

METHODS

This qualitative descriptive study, guided by behaviour change theory, aimed to identify the barriers and enablers AHPs experience when applying GCP principles to research conduct in a public hospital and health service, as well as their perceived support needs. AHPs currently undertaking ethically approved research within a public health service in Queensland, Australia were interviewed to explore barriers and enablers to GCP adherence and support needs, with interview questions guided by the Theoretical Domains Framework.

RESULTS

Ten AHPs across six professions were interviewed. Participants identified several enablers to implementing GCP. These included strong beliefs about the importance of GCP in increasing research rigour and participant safety; existing clinical skills and personal attributes they can apply when implementing, available training and support; and alignment with their moral sense to ‘do the right thing’. Barriers to GCP implementation were generally less commonly reported but included reduced time to implement GCP and a sense of ‘red tape’, a lack of knowledge of GCP principles and a fear of making mistakes, and varying relevance to individual projects. Several suggestions for support were identified beyond training, such as physical resources (e.g., prescriptive checklists, templates and scripts), additional time, and regular one-on-one mentoring support.

CONCLUSIONS

This study provides important insights into AHP experiences of implementing GCP principles in research, to guide the development of targeted interventions. Findings suggest clinicians require support beyond standard GCP training to implement GCP on a practical basis and adapt relevant principles to their research designs. Other strategies to enhance GCP implementation and adherence should be further investigated.

Research conduct

allied health

Good Clinical Practice

Conducting research in a way that protects participants and yields credible and reliable results is central to the Good Clinical Practice (GCP) guidelines produced by the International Conference on Harmonisation (ICH, 2016). While the GCP guidelines were originally designed for drug or investigational product clinical trials, they are now widely applied to other intervention types (Symons, Webb, & Zalcberg, 2021), including behavioural interventions. Due to this broad definition of what constitutes a clinical trial, an increasing number of investigators involved in healthcare research are required to ensure their research adheres to GCP principles.

Allied health professionals (AHPs), who include physiotherapists, occupational therapists, psychologists, speech pathologists, audiologists, social workers, dietitians and podiatrists, among others, make up at least a third of the healthcare workforce (Nancarrow et al., 2017), and are being increasingly encouraged to participate in and lead research (Cooke, Gardois, & Booth, 2018; Hulcombe, Sturgess, Souvlis, & Fitzgerald, 2014). Clinician engagement in research can produce multiple benefits at individual, organisational and societal levels (Harding, Lynch, Porter, & Taylor, 2017; Hulcombe, Sturgess, Souvlis, & Fitzgerald, 2014; Slade, Philip, & Morris, 2018). AHPs engaged in research frequently use designs that fit the World Health Organization’s definition of a clinical trial. Research designs that prospectively assign human participants to an intervention including observational cohort studies or qualitative designs are recommended to comply with GCP principles (Australian Commission on Safety and Quality in Health Care, 2022). However currently, there is limited exploration into health professionals’ perceptions and experiences of adhering to GCP standards, including the barriers and enablers that influence adherence in the conduct of research.

Swezey et al. (2020) interviewed 13 research sponsors and 10 medical investigators on their perceptions of good clinical conduct and training needs in GCP. This United States (US) study highlighted that GCP training should be presented in a way that is engaging to participants and focuses on daily application in practice (Swezey et al., 2020). A follow up study suggested that a more tailored rather than “one-size fits all” approach to GCP training may be indicated to meet the needs of investigators (Bechtel et al., 2020). In a descriptive editorial piece, Cronin et al. similarly described a more tailored approach used in a US paediatric medical setting to improve understanding and application of GCP into everyday work for their investigator group (Cronin, Hamblin, & Goldenberg, 2020). While limited studies from US-based medical teams are emerging, there is a need to more systematically explore the barriers and enablers that other health professionals (such as AHPs) face when using GCP, within different healthcare contexts. This understanding will help inform targeted approaches that support the application of GCP in daily research practice.

Applying behaviour change theory may be of value when developing tailored approaches to enhance GCP adherence. It can also guide the systematic evaluation of health professionals’ needs, for example by identifying their perceived barriers and enablers to implementing GCP. Our team has previously used the Theoretical Domains Framework (TDF) and COM-B system of behaviour change to explore barriers and enablers to research participation among AHPs (Wenke, Noble, Weir, & Mickan, 2020). That study found implementation science frameworks may provide a more systematic and holistic understanding of factors that influence AHPs’ engagement in research (Wenke et al., 2020), and could be applied in the context of GCP.

Local context

Gold Coast Health is a public, regional tertiary health service in Queensland, Australia that employs approximately 1,200 allied health staff. Local audits have found increasing research engagement among AHPs, with the number of ethically approved research projects being led by AHPs tripling from 2013 to 2017 and continuing to grow. Three part time Research Fellows currently work within the health service, mentoring AHPs throughout the research cycle. The health service encourages clinician researchers to undertake GCP training and provide GCP training workshops (Sophie Mepham GCP™, TransCelerate accredited to ICH GCP E6 R2), however the uptake of this recommendation within allied health is unclear. Anecdotal reports also suggest variability in how GCP principles are being adhered to and operationalised in the day-to-day conduct of clinical research projects. As such, there is a need to better understand which factors currently influence adherence and implementation of GCP principles in allied health research, to inform the development of tailored interventions and mechanisms to encourage ongoing GCP adherence. This could help optimise the standard of conduct and quality of clinical research undertaken by AHPs, and ultimately lead to improved patient and service outcomes. This research will also contribute to the limited evidence base regarding AHPs’ perceptions and experiences of implementing GCP.

Aim

This study aimed to identify the barriers and enablers AHPs face in implementing GCP principles when conducting research in a public health service, and their perceived support needs. This study formed part of a larger project aiming to develop, implement and evaluate a tailored, theory-informed intervention to encourage adherence to GCP principles in allied health research within a tertiary health service. It was approved by the Gold Coast Hospital and Health Service (GCHHS) Human Research Ethics Committee (LNR/2021/QGC/73671), with all methods performed in accordance with the relevant guidelines and regulations including the Declaration of Helsinki.

This study used a qualitative descriptive design (Bradshaw, Atkinson, & Doody, 2017) guided by behaviour change theory (Cane, O’Connor, & Michie, 2012a) and is reported according to the reporting standards for qualitative research (COREQ) (Tong, Sainsbury, & Craig, 2007).

Participants

Allied Health Professionals working at GCHHS were invited to participate if they: 1) worked within Audiology, Dietetics, Music Therapy, Occupational Therapy, Physiotherapy, Podiatry, Psychology, Social Work, or Speech Pathology; and 2) were listed as a Principal or Lead Investigator on an ethically approved research project (or a project in preparation) at GCHHS in the past three years (2018 onwards). Clinicians who met the above criteria were identified through internal information sources on current ethically approved research (i.e., research metric registers). AHPs were emailed an invitation to participate and a Participant Information and Consent form by the Principal Investigator. Participants were recruited using convenience sampling to firstly identify clinicians who met the criteria, and purposive sampling to ensure a diverse sample was selected (i.e., varying in profession and research experience). Informed written consent was obtained from all participants.

Study Procedure

Semi-structured interviews were conducted to explore the barriers, enablers, and support needs of AHPs in implementing GCP principles in their research. The interviews were audio-recorded and conducted either in person in a quiet office in the hospital or via videoconference (i.e., Microsoft TEAMs). Interview questions were guided by the 14 domains of the Theoretical Domains Framework (TDF), an integrative framework of behaviour change theories used to understand barriers and enablers to implementation (Cane, O’Connor, & Michie, 2012b). The 14 domains include: knowledge; skills; social/professional role/identity; belief about capability; optimism; belief about consequences; reinforcement; intentions; goals; memory, attention and decision processes; environmental context and resources; social influence; emotion; and behavioural regulation (defined in Supplementary File 1). Additional questions regarding support needs were also included (Supplementary File 2: Interview guide).

Interviews were conducted by the lead investigator RW, except for one where there was a mentoring relationship between RW and the clinician (subsequently conducted by RA). In all other occasions, RW had a working professional relationship with the interviewees but was not actively mentoring them on any research projects. Both interviewers were experienced researchers with an AHP background and were employed by the same health service as the interview participants.

Demographic data collected included years of clinical experience, gender, professional background, and previous research experience including any post-graduate research qualifications.

Data analysis

All interview data were transcribed using a professional transcription service and analysed using NVIVO software (version 12). Deductive analysis was used to categorize barriers and enablers identified in the interview data into one or more of the 14 TDF domains, combined with a general inductive approach to identify emergent subcategories within each domain (Graneheim & Lundman, 2004). Support needs were coded using inductive coding and content analyses. The analysis was led by RW, with all codes reviewed by a second project team member (KW, SR, or RA). Any discrepancies were discussed until a consensus was reached. Following these analyses, the key barriers and enablers were further synthesized by RW mapping them onto the three constructs of the COM-B system: capability, opportunity, or motivation (Michie et al., 2011). The COM-B system, a model of behaviour change, cites these three factors are necessary to change behaviour (Michie et al., 2011), thereby providing a useful theoretical framework to guide future intervention development to change health professionals’ behaviour in relation to GCP implementation. While a convenience sample was used, data saturation was achieved with no new categories being found when analysing the final two participants.

Participants

A total of 24 AHPs were identified as meeting inclusion criteria. Thirteen AHPs were invited to participate via email, with 10 consenting. Three clinicians did not respond due to being on leave or having left the health service. Interviews took on average 32 minutes (range 18–42 minutes). Participant demographics are reported in Table 1.

Barriers and Enablers to implementing GCP

Participants generally reported more enablers than barriers towards implementing GCP within their research. Although participants cited barriers and enablers across all 14 TDF domains, most comments related to nine of the domains, which will be described under the categories capability, opportunity, and motivation; of the COM-B system. A summary of these factors mapped according to the COM-B can be found in Figure 1.

Capability

Knowledge

Most participants reported sound knowledge of what constitutes good research conduct: “Good conduct in research obviously means conducting research that's been ethically approved and complying with how you got it approved with the protocol, making sure you're considering patient safety, confidentiality, all of that” (P09). Several participants reported increased knowledge from participating in GCP training: “It was a four-hour workshop that we had to do, which was fantastic in just introducing me to all of these concepts that I didn't even know about” (P10). Fewer reported gaining this knowledge from university courses or completing a higher research degree: “I guess it’s just been drummed through my graduate training…” (P03).

A number of participants were unfamiliar with the term GCP, despite reporting adherence to its concepts: “I would say that the senior researchers that I work with don’t use the same language about Good Clinical Practice and this definition…I don’t think that they label it that way but they’re concepts they talk about all the time” (P01), while others were unclear what the principles of GCP were: “I wouldn’t say that I’m actually overly familiar if there are any certain guidelines or principles.” (P04). Another knowledge-related barrier to using GCP was a lack of awareness, coined by participants as “you don't know what you don't know” (P02), which impacted their ability to source information: “I don't know what I don't know, so being able to find information to make it easier to adhere to these [GCP principles]” (P07).

Skills

Clinicians reported personal attributes that were helpful in implementing GCP: “I'm quite detail-orientated, a little bit perfectionistic, so that probably helps me to ensure that these things are met each time I design a research project.” (P09). Clinicians also said their current clinical skills transferred into useful skills when adhering to GCP: “As a hospital clinician, we already are thinking about confidentiality, and assuring that our work is confidential and it's stored and managed correctly. So I bring that skill set to this - which is transferable to these principles” (P02). Clinicians however reported barriers in specific skills of implementing GCP principles, for example, “how to recruit ethically because I found that tricky. I feel it was a bit of a sales pitch and I'm not like that at all in my personality” (P08).

Memory, Attention and Decision Processes

Enablers to GCP implementation in this domain included “having processes set up and ready to go” (P08) such as “scripts” (P08) and detailed instructions “that you need to follow” (P04). The use of reminders or other strategies to bring GCP principles to the forefront of the busy clinician’s mind were also reported: “when life gets busy and the years go on, probably just having some sort of process that just jogs your memory along the way would be good” (P03). Some clinicians said it became more automatic to implement GCP over time as they became used to applying the principles: “I think when you start out in research, and it's like a whole different world of things that you just try and navigate and possibly not doing things correctly all the time, but once you know what you need to do it just makes it easier. So being able to stick to GCP principles just becomes second nature I guess.” (P07).

Barriers to implementing GCP in this domain included difficulty remembering what was learnt in GCP training and keeping that at the forefront of your mind: “When things are really busy, and you're rushing between things, I still haven't figured out ‘how do I keep this live in my mind?’ (P02).

Opportunity

Environmental Context and Resources

Most comments under this domain described barriers related to inadequate time or funding to attend training and implement the principles in their projects: “The biggest barrier to me is time. So if I don’t have time to be able to do these things, I’m probably not going to do it, or I’m going to rush it, and possibly something would get missed” (P03). Other barriers related to physical resources including not knowing where current resources or templates are located: “coming in as a clinician…there's nowhere to go to find this information. I know there's that website that's meant to have lots of things on it like templates and forms but it's not super easy to find things” (P08) and comments regarding current training not being relevant to their project design: “I found a lot of it seemed very specific to clinical trials, which was I think a lot less relevant to the work in particular that I do” (P05).

Existing research infrastructure within the health service including training and resources from the Research Office were described as enablers to GCP implementation, “especially now that the Research Office has got people employed …who are giving us GCP training and support and resources. I think that's really important. (P09).

Social Influences

Several clinicians noted the benefit of support from more experienced researchers including local Research Fellows and PhD supervisors to implement GCP: “I think having support people and people that are experienced in research does make it a lot easier (P09). Support from peers or colleagues also enabled GCP implementation: “In terms of support…we have a good research peer environment here at Gold Coast, so there are people who are there to ask questions and to learn from experience” (P06) and “having teams share responsibility and have regular communication” (P02). A smaller number of clinicians reported that there was a lack of support from their professional teams due to limited research experience: “I think the fact that our… department is really evolving in their interest in research, it's not, from my perspective, well established; it's quite new, and foreign… so not a lot of local support, but I know it's not far away” (P10).

Motivation

Beliefs about consequences

Almost half of AHPs felt implementing GCP principles could restrict the logistics of some projects: “There is risk that good research might not be started in the fear of... too much red tape or too many hoops to jump over” (P04), while some felt there was a risk of implementing the principles in a superficial way: “I just think generally, when we have standards and principles, it's possible to tick boxes without really engaging with what we're doing.” (P02)

Almost all clinicians reported two enabling beliefs about the consequences of implementing GCP, being improved rigour, replicability, and ethical conduct of the research: “It means that you get good quality research as well, like good rigour” (P03), and improved participant safety: “Hopefully it means that the studies are safer, that the participants' privacy or confidentiality is protected, that there's fewer adverse events, that there's just fewer issues in general” (P09). Some AHPs said implementing GCP was important to avoid other negative consequences: “There's serious consequences if you don't, as well as it doesn't make you a reputable researcher if you're dodgy [laughs]. So yeah, it has consequences for the organisation as well and for yourself and obviously for participants, so yeah, it's kind of important that you stick to it” (P07).

Emotions

While some perceived consequences encouraged GCP implementation, clinicians commonly reported anxiety or fear of negative consequences as a result of making a mistake: “It does make you a little bit anxious. There's lots of things that maybe you haven't considered and the consequences for not adhering to it” (P07). Clinicians also reported feeling pressured or overwhelmed amidst their other priorities: “because there is a lot to consider, it can be overwhelming because you’re thinking ‘oh gosh, when am I going to get time within the constraints of what I’m already doing and the research?’” (P04).

Clinicians reported a sense of comfort or reassurance that GCP principles helped guide their research conduct: “I think it's reassuring to know that these structures are in place… that we as researchers should be adhering to these principles” (P02), as well as a sense of responsibility: “I certainly feel a sense of responsibility and a sense of duty to ensure that I'm conducting research in a way that's ethical and safe (P02).

Beliefs about Capabilities

While most clinicians felt confident about implementing GCP principles, with one commenting “I don't think there's anything that's too difficult to adhere to” (P07), several clinicians identified certain aspects of implementing GCP where they perceived they needed more development: “My protocol writing skills could be developed. Honestly, I could refine all of my research skills and there's probably not an area that doesn't need development if I'm 100 per cent honest” (P02). Training was seen to help confidence: “I just found it personally really valuable to attend the training and I’d say that helped increase my confidence in my research” (P08).

Social Professional Role and Identity

Other enablers to implementing GCP included it being part of clinicians’ responsibility as a Principal Investigator: “As an investigator I think everybody has a responsibility to adhere to…good clinical practice” (P06), and that it aligned with their values to do the right thing: “I like to have good principles in my everyday life, I don't like to…be unethical about things, so I'm not usually cutting corners (P07).

Support Needs

Seven categories emerged from the interviews regarding future suggestions of support needs to implement GCP. These are outlined in Table 2, with some of the key actions arising from these categories summarised in Figure 2.

The present study was the first to explore AHPs’ perceived barriers and enablers to implementing GCP standards in research projects as well as their support needs. This research highlights the usefulness of using behaviour change theory to understand the factors which influence health professionals in implementing GCP, and further demonstrates that factors beyond capability including opportunity and motivation can influence day to day implementation.

While training is identified as a useful strategy to enhance capability, in particular knowledge and skills (Michie, Atikins, & West, 2014), it may not address barriers to GCP implementation identified in the present study related to memory, attention and decision making; environmental context and resources; or fear of making mistakes. As such, supplementary strategies targeting these specific barriers may be required. Participants also suggested several strategies to improve traditional GCP training to enhance relevance. Previous research has identified similar enhancements, including incorporating more tailored practical discussion in the training and mentorship for new investigators (Swezey et al., 2020), however such tailored strategies to support GCP implementation have had limited investigation (Cronin et al., 2020). With an expanding range of investigators with varying levels of experience and support now expected to apply GCP (Symons et al., 2021), attention to strategies that address the unique enablers and barriers to GCP implementation for them individually and within their team must be considered. A “one size fits all” approach to support is unlikely to be effective (Bechtel et al., 2020; Cronin et al., 2020).

The present study also offers unique insights into AHPs’ perspectives of GCP in a range of research designs. AHP participants felt GCP was important; a finding that echoes previous research involving medical practitioners (Swezey et al., 2020). However, while AHPs generally had good knowledge about research conduct, drawing from some of their clinical knowledge, many reported a lack of confidence in their ability to apply their knowledge to specific aspects of their projects. Potentially addressing this lack of confidence, a key enabler to GCP implementation was the support of social influences including peers, colleagues, and more experienced researchers. This power of social influences, particularly peers, is consistent with an earlier study of AHPs’ research engagement (Wenke et al., 2020).

Limitations and Future Directions

Participants recruited in this study had varied research experience and professions, however came from a single health service. As such, future research should explore perspectives from other professional and geographical contexts to determine whether similar themes arise. Evaluation of the feasibility and effectiveness of some of the identified strategies reported by interviewees to enhance implementation and adherence of GCP would be useful.

Practical implications

The present study suggests GCP training alone may not be sufficient for clinicians to implement GCP and assistance may need to be tailored to the research design utilised, context and experience of the researcher. For example, extending training beyond clinical trials to other research designs, including observational research, would be useful. Additional support and mentoring in GCP may be required across different research phases, particularly for novice researchers. This may include embedding periodic GCP audits or ‘check-ins’ by a more experienced researcher, such as a Research Fellow, in a non-threatening manner to minimize reported anxiety, particularly if it is seen as usual practice and a learning opportunity. This strategy may also identify any potential areas of non-adherence early before they become a breach in ethical conduct. Access to more prescriptive resources to support implementation (e.g., checklists, templates, scripts) may further address barriers related to confidence and fear of making mistakes whilst creating efficiencies; thus, potentially addressing barriers relating to reduced time and resources. A whole systems approach may be beneficial, whereby health services identify what other mechanisms are available to keep GCP at the forefront of researchers’ minds, and to ensure it is not simply considered a tick box exercise of attending the training and forgetting to implement daily. This may be in the form of reminders, further integration with existing systems, and embedding GCP into learning early when supported by research fellows or mentors.

This study has shown that while AHPs recognise the importance of GCP and express a desire to implement it, they report barriers in the practical implementation of its principles. These challenges may be addressed by supplementing the level of support in GCP implementation beyond standard training. Further clarification of these strategies and evaluation of their effectiveness should be investigated to support health professionals implementing GCP in research, to ultimately protect the safety and wellbeing of participants involved in research and the integrity of data being collected.

GCP= Good Clinical practice

AHP= Allied Health Professionals

Ethics approval and consent to participate

The research was approved by the Gold Coast Hospital and Health Service (GCHHS) Human Research Ethics Committee (LNR/2021/QGC/73671) with all participants providing written informed consent.

Consent for publication

Not applicable.

Availability of data and materials

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Competing interests

The authors declare that they have no competing interests.

Funding

No funding was received for this research.

Authors' contributions

All authors were involved in the design of the research with KW initiating the initial concept for the research and RW leading the protocol development and ethics application. RW and RA were involved in data collection. RW led data analyses with input from RA and SR. RW led the manuscript preparation with all authors involved in critically revising.

Acknowledgements

The authors acknowledge the participants involved in the research.

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Table 1: Participant Demographics

Variable	Number (or mean as indicated)
Gender
Female	9
Male	1
Years of clinical experience (mean)	12.6 (range 0.5-20)
No. of projects led (mean)	3.2 (range 0-10)
Current Clinical Level:
Entry level clinician	2
Senior clinician	5
Team leader	3
Research qualifications
Enrolled in PhD	4
Completed PhD	1
Research related Master’s Degree	2
Enrolled in Master of Philosophy	1
Nil formal qualifications	2
Profession
Dietetics	2
Occupational Therapy	1
Physiotherapy	2
Psychology	1
Social Work	2
Speech Pathology	2

Table 2: Summary of support needs

Support need categories	Number of Sources	Total number of mentions
Physical or Financial Resources
Checklist, flowchart or manual specific to research designs	9	15
List of resources you can go to	3	3
Examples of templates, applications, folders & protocols	3	5
Directory of who to go for support including GCP contact	3	3
Extra time to complete training and implement	3	4
Protocol with extra information about principles and _____ _____processes	2	4
Reminders when to do things (e.g., annual reports)	1	2
One on One support
Someone to check up on project in non-threatening way (i.e., ‘supportive’ auditing)	8	18
Research fellows or senior researcher to provide guidance/advice on how to implement principles	3	4
Increase awareness and visibility of GCP	6	11
Hearing other people's experiences	1	2
GCP Training recommendations	0	0
Training should be early	3	5
Tailor to research design or allied health	5	10
Need support how to implement what’s learnt from training	5	6
Being aware of training	3	5
Annual training refreshers	4	5
Format of resources	0	0
Having online resources, ‘one stop shop’	8	11
Videos	6	7
Simple and easy to understand, not too long	4	9
Relate it to being a clinician	2	3
Needs to be accessible	2	3
Easier if can read it	3	3
Suggestions to make GCP interventions sustainable
Make sure HHS values it (GCP) & invests in resources	3	7
Embed into critical part of planning and conducting research	3	3
Accessible & regularly updated	3	5

No competing interests reported.

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“How do I keep this live in my mind?” Allied Health Professionals’ perspectives of barriers and enablers to implementing Good Clinical Practice in research: A qualitative exploration guided by behaviour change theory

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