Journal of General Practice

ISSN: 2329-9126

Journal of General Practice
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Why it Remains Difficult for Remote Cardiologist to Obtain the Locus of Control for Ambulatory Health Care Conditions Such as Congestive Heart Failure?

Iyngkaran P1*, Brown A2, Cass A3, Battersby M4, Nadarajan K5 and Ilton M6
1 Cardiologist Royal Darwin Hospital, Senior Lecturer Flinders University, Research Fellow FHBHRU, Darwin Private Hospital, Australia
2 New Theme Leader, Indigenous Health, SAHMRI, Australia
3 Director Menzies School of Health Research, Australia
4 Head, Flinders Human Behaviour and Health Research Unit (FHBHRU) Margaret Tobin Centre, Flinders University, Australia
5 Cardiologist and Co-Director Division of Medicine, Royal Darwin Hospital, Australia
6 Director of Cardiology, Darwin Private Hospital, Australia
Corresponding Author : Dr Pupalan Iyngkaran
Cardiologist Royal Darwin Hospital
Senior Lecturer Flinders University
Research Fellow FHBHRU
Darwin Private Hospital, Rocklands Drive
Tiwi, NT 0811, Australia
Tel: +61884042323
Received January 07, 2014; Accepted January 20, 2014; Published January 25, 2014
Citation: Iyngkaran P, Brown A, Cass A, Battersby M, Nadarajan K, et al. (2014) Why it Remains Difficult for Remote Cardiologist to Obtain the Locus of Control for Ambulatory Health Care Conditions Such as Congestive Heart Failure? A Tug of War between General Practice, Administrators and Implementable Research Findings. J Gen Pract 2:146. doi:10.4172/2329-9126.1000146
Copyright: © 2014 Iyngkaran P, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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“…it is essential that those held accountable have the processes of care being assessed under their locus of control…”
Harlan Krumholz
Clinicians and researchers aiming to improve congestive heart failure (CHF) services need to invest in quality assurance research. In this regard standards of accountability can be met for the goals set within any particular programme. Part of this process involves gathering evidence, which is the basis for audit and observational research. Implementing these findings can be straight forward when the issues are limited to resources. In all cases the responses can be negative, positive or somewhat positive where certain measures are taken within the constraints of that system. The issue becomes more difficult when findings involve implementing a new strategy or if there are more than one choice available. We have previously discussed some of these challenges and potential solutions for the NT [1-5]. In this short commentary, we discuss briefly some issues on the implementation strategies for CHF best practice in the Northern Territory (NT) of Australia and why it remains difficult for the cardiologists who are held to account to also maintain a degree of control on the process. The position statement on performance measures complemented with the above statement was designed to encourage clinician led research practice [6,7]. The advantage of this approach is that those who are providing a service, being assessed on that service are able to assert a certain degree of control on this process, which has greater relevance in areas where local knowledge plays a part in best practice. This statement was probably, not intended to encourage unilateral decisions or a hierarchical approach. However without collaborative approaches it may appear that way. In the acute setting regardless of environment the locus of control is often within the cardiologist grasp as most decision are made at the bedside. The grey areas start at discharge and extend further with ambulatory conditions. CHF can be largely managed in the community with more intensive specialist care during periods of decompensation. In the NT hospital cardiology focused acute care is only possible in one hospital, the Royal Darwin Hospital, while cardiology supervised subacute care is only possible in Darwin. In the NT the locus of control for a significant number of acute care cases and greater number of subacute cases are not within cardiology control. In stable cases, while the urgency of specialty consultation is less there are still challenges. In this regard we have set up early measures to collect prospective data [4] and pilot supporting intervention tools [5]a .
In the end obtainingb data is not sufficient. Adequate strategies to implement the research findings are also important. To do so the evidence gathered needs to be robust, wide reaching, durable, explore measures of cost economics and remain externally valid for a broad demographic. We have to be convincing in our findings to influence other prescribers (general practitioners, other subspecialists, nurse practitioners) and policy makers who can determine the success of HF management programmes. Additional challenges that necessitate research strategies with broad aims are the funding and staffing availabilities. In a sense research funding needs to be multidimensional and staff multitask, which will have consequences for the depth of information and validity of findings. Unfortunately efficiency in the research sense is synonymous in economic terms due to issues of validity.
Collecting research data in the NT has become relatively easier. Research infrastructure has been strengthened and assistance from partners has helped. An area we highlight are the performance measures that were added or rested. The questions we anticipate when results are available: Firstly, will the rationale for the decisions made be free from scrutiny, i.e. without significant precedence from trials in the region significant assumptions have to me made; and
secondly, the application of results to a larger audience outside the NT i.e will federal policy makers be persuaded about the cost effectiveness of strategies for this populations. This first hurdle usually does not greatly affect strategies that call for increased resources in staffing and infrastructure. As we have previously highlighted this onedimensional strategy may not however in the long term achieve the programme goals. In our case it remains to be seen how the data will affect views on intervention strategies particularly therapeutics, chronic disease self-management programmes (CDSMP) and technology assisted programmes, to name a few, should they be required. It is likely moving forward will thus require further research in multifaceted interventional studies. It is fortunate in Australia the NHMRCc does encourage such efforts and a more likely to support collaborative efforts between clinicians, research institutes and local health department who provide in kind funding for the interventional study.
Structuring interventional research studies is not a difficult process when funding has been secured. The gold standard RCT may unfortunately not be the most suitable study to conduct. While maintaining a strong internal validity two issues are worth highlighting. Firstly, the NT population is vulnerable and a placebo arm may not receive ethics committee support. An example here was the SHARP study on Vytorin, where there was concern of the effects of placebo on an already at risk group. Secondly, are the issues of the comparator. Non-inferiority studies would be supported, this will however require a baseline study to compare and agreement on the comparator. This may be less contentious for hospital based therapeutics, but more so for community based interventions. An example we highlight here has been in shaping a CDSMP, as part of a CHF disease management programme. The locally generated and federal government supported CFPId , has had some stumbling blocks in the NT due to concerns of time and user friendliness and application to a broad clientele e.g. Indigenous Australians. Thus any study on CDSMP will require trialing several strategies some favored by administrators, others by clinicians and/or allied health, who implements these strategies. Furthermore there is a need to convince general practitioners, who appear to be the key for CDSMP success [8,9], to participate, while there remain concerns on remuneration, practice staffing to complete and followup along with individual practice preferences. Finally, while some may argue that community based strategies are not within the domain of cardiologist, it may be that in remote strategies the distinction and boundaries between primary care and tertiary care will actually become less defined purely from the sheer numbers of patients, the illness burden with comorbidities and staffing shortfalls. In this case community strategies for ambulatory conditions could receive some primary care at tertiary centers and followed through remotely and vice-versa, as a measure in efficiency. A consensus on the approach and sharing of information will be part of this new paradigm.
The ideal study for this region would have the primary aims of patient and staff self-reported satisfaction (or technology uptake) and health economics, with secondary aims of outcomes and within a quasi-experimental design. This will address issues of compliance, staff user friendliness and whether the system will invest in this approach for the long term. While outcomes are the primary aims of many RCT, we have to accept that merely implementing RCT findings has not generated the desired clinical outcomes. Furthermore, regional phase 4 post-marketing data is also limited. It is thus important that we explore step lock measures in research; for e.g. many systems readily implement findings from RCT when questions of external validity still remain. In this should we not assume that if we implement a strategy that improves compliance and delivery i.e meeting the RCT design, would these also not equate to outcomes, thus negating the need for outcome measures in this study. Alternatively exploring quasi-experimental trial designs. To date there have been no such trials on a large scale for CHF, nor has any such trial significantly influenced policy, to our knowledge. Benefits of this approach is that the results are likely to have high external validity, allow for a broad experimental intervention and replicate real world clinical conditions [9-11]. Asch et al. using this design was able to demonstrate the benefits of a collaborative organizational care intervention in CHF [12]. Only limited small studies were conducted in CHF [12-15]. Similar large studies for cardiovascular disease are reported mostly positive1 [6-24] although longer term translation in those systems is unknown. Failures have also been seen with this approach in the British NHS [25]. Findings from other studies are also awaited 25. It remains to be seen that if we choose to go down this pathway when more data becomes available [4,5] would the funding bodies and policy makers will equally support collaborative programme funding with this design.
Optimizing CHF care in remote settings remain difficult, but not from lack of intent. Cardiology control over the process is variable but accountability is still required. Local interpretation of evidence and experimental trial designs are probably required. Whether this is a good way forward is also uncertain however it allows for us to maximize the information we gain, implement collaborative strategies and measure results. General acceptability away from RCT as the gold standard for all regions and populations still remains until there are further efforts to define:
• Principles on interpreting external validity of studies [3]
• Importance of physiological based study prescribing principles to therapeutics particularly in CHF with comorbidities [2,3]
• The axis of control for subspecialty ambulatory health care conditions that require collaborative and multifaceted approaches to research practice [1]
It would appear to improve CHF care; there is a need for a broader range of interventional research tools that focus on implementation in a heterogeneous group and allow a broader range of questions to be answered, that can similarly steer policy. We would encourage clinician in similar clinical settings to contribute further in this area. Thus the locus of control for CHF in remote practice lies within the system broadly, however it is important that cardiologist take a leading role in steering the discussion and ensuring accountability for this subspecialty ambulatory care condition (Figure 1).
All co-authors have won independent and governmental research funding. None pose a conflict of interest for this paper. Dr Iyngkaran is supported by the RACP Fellow Contribution research award.
a Northern Territory Heart Failure Initiative - 2 Worlds Study (NTHFI -2Worlds) – a third study in progress, aimed at assessing an Indigenous patient journey mapping tool in a prospective pilot. Study details are in preparation and will be published when completed.
b Providing evidenced based best practice in remote areas such as the NT has proved challenging predominately from service and infrastructure shortfalls, geographical distances and compounded by socio-cultural issues and rigid treatment policies. We have previously described issues on the external validity and allied health input in improving care. We have previously published on the issues surrounding implementing heart failure care in the NT. Primary Care: In this regard the treatment is easy so long as every member in the chain plays their part.
c National Health and Medical Research Council – Collaboration and Programme Grants
d The Flinders ProgramTM for Chronic Condition Management: Information Paper



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