Conference Lectures
Does the Outcome become better with Protocol-Driven Care? Pro
Col (Dr) Deepak Kumar Sreevastava, MD, DNB, MNAMS, PGDHCM.
Senior Adviser (Anaesthesia and Paediatric Anaesthesia)
Army Hospital (R & R), New Delhi – 110010.
Introduction
Protocol-based care is a mechanism for facilitating the standardisation of care and streamlining decision-making through rationalisation of information.A protocol is based onguidelines on various topics which are prepared after literature review, critical appraisal, multidisciplinary consultation, and grading of recommendations by level of evidence (1). However in order to translate these guidelines into clinical usage, management protocols need to be prepared and then implemented through what is known as Integrated care pathways.Integrated care pathways are task orientated care planswhich detail essential steps in the care of patients witha specific clinical problem and describe the patient'sexpected clinical course.These pathways offer a structuredmeans of developing and implementing localprotocols of care.They are designed to support clinical management, clinical and non-clinical resource management, clinical audit and also financial management.
The need of protocols and clinical care pathways has received adequate emphasis by various governing agencies. Clinical care pathways were introduced in the early 1990s in the UK and the USA. For example, in many NHS trusts throughout the UK, critical pathways are being used as a method of managing patient care, enabling trusts to ensure that patients receive appropriate, high quality, cost-effective care (2). European Pathway Association is an international network of clinical pathway/care pathway networks, user groups, academic institutions, supporting organisations and individuals who want to support the development, implementation and evaluation of clinical/care pathways (3).
This article will discuss the need of a protocol, how it is developed and its relevance in current perspective with special emphasis in the area of anaesthesia and critical care.
Protocol Based Care
The final aim of any protocol is to benefit the patient, the end-user of our hospital service. These local protocols are based on the standards to be achieved by a department, hospital or the state. For example, Department ofAnaesthesia may want to eliminate incidence of drug administration errors. This can be achieved by making a local protocol which will list out all that can be done to attain the goal. An effective example is National Institute for Clinical Excellence (NICE) in UK which sets a standard in a particular clinical area which has to be enforced in an institution through a local protocol. As described above, there are already protocols in place for a variety of clinical conditions in NHS hospitals in UK (4). These include protocols for the management of coronary heart disease etc. However, it must be reiterated that even in absence of national standards, protocols when prepared by using the best available evidence, enable the staff to determine standard of care and allow them to deliver care in accordance with the standard.
Protocols can be made for almost anything such as how to make staffing arrangements, or how to administer a service (dietary or radiology service) or protocols could direct how to deliver effective clinical care by identifying important steps of the treatment by acting as decision support systems.
How protocols should be developed
NICE in its booklet on “A Step-by-Step Guide to Developing Protocols” mentioned that a protocol can improve care in almost any setting (5). The protocols must be developed to fulfil a need which has to be clearly identified. For a protocol to have the necessary impact, a methodical approach is essential. Iiott et al undertook an interpretative review of thirty three studies about protocol-based care in the United Kingdom. They noted that protocol-based care was developed in a non-linear, idiosyncratic process, with steps omitted, repeated or completed in a different order. There were multiple purposes of developing such protocols without mentioning how the same would be implemented and sustained (1). It is felt that protocols developed in this manner have inadequate potential for making any positive difference.
In order to make a protocol, one can refer to the guidance issued by NICE in this regard (5). The process is briefly reviewed in the following section.
- Developing protocols: The nuances
The topic to be covered by the protocol should be selected through twomain routes:
• The publication of national standards
• The identification of local service improvement priorities
The process of development of protocol can be reinforced by gathering more information from established standards such as NICE guidelines, published evidence of good practice and experiences and protocols of other organisations. Usually protocols need to be developed when local service improvement priorities have been identified e.g. pathways with a high variation.
The protocols are especially helpful when following characteristics are noted:
- The condition or disease follows a relatively predictable course and the process of care is relatively standardised
- Large numbers of people require care for the condition or disease
- The procedure is high cost
- The area represents a high risk to the organisation
- Clinical governance considerations indicate that action is necessary
The first step towards preparation of any protocol is identification and confirmation of objectives or topic by all the stake-holders. One should aim at establishing objectives which are precise, quantifiable and should have distinct targets for achievement.It is essential to prepare a document which guides the staff through the process. It should not be a document with detailed description of each procedure.
The choice of a topic can be directed by the requirement of national or institutional standards or by local needs to improve a service/clinical care. A multi-disciplinary team which includes all clinical and non-clinical staff should be responsible to supervise all aspects of the protocol development. Also, development of protocols or integrated care pathways by a multidisciplinary group results in guidelines withgreater validity. Patient information is captured better because of structured approach which not only facilitates audit but also improves patient care. In addition, flow charts or check list which are developed by staff locally are more likely to be adopted in clinical practice. Active participation of patients and carers in aiding the decision making process should be ensured.
The implementation of any protocol requires high level support within the organisation. This can be achieved by raising awareness amongst the peers and staff about the need of such protocol.Once the protocol is produced, it should be subjected to pilot assessment to address any operational problems and amend if necessary. Finally the protocol should be implemented after adequate training of team members has been given and clear written instructions have been issued. Use of PDSA (Plan-Do-Study-Act) cycle is recommended to test any protocol.
Long term aim should be to integrate the protocol into daily practice. Once the protocol is set in motion, periodic review should be undertaken to monitor variation from the protocol and to incorporate appropriate changes. The protocol should be constantly revised on the basis of up-to-date evidence of effectiveness, realisation of intended benefits for patients and staff or the target group.
- Examples of types of protocols
S No |
Type of protocol |
Example |
1 |
Disease-based |
Preop screening for IHD, diabetes, asthma, stroke, cancer |
2 |
Problem-based |
Unanticipated difficult airway, chest pain, disturbed behaviour, Preventing inadvertent perioperative hypothermia |
3 |
Treatment-based |
Management of LA toxicity |
4 |
Client-group-based |
Paediatric age group, |
- Protocols madein the Deptat Army Hospital (Research & Referral):
At our institute, several protocols and care pathways are being followed though there is scope of expanding their application. Some of them have been listed below:-
Administrative |
Clinical Care |
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In Operation Theaters |
In Intensive Care Unit |
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Brief review of literature on protocols in various fields of medicine
Many institutions have their own protocol booklets. WHO has published a book of protocols on Surgical Care at the District Hospital.Several hospitals in the developed world have such booklets which serve as guidance for the health care staff. Protocols for medical or surgical conditions are already in place for NHS trust hospitals which are based on the recommendations of NICE. In the following paragraphs, few examples of protocols as relevant to our specialty, are given.
Drug labelling was amongst the recommendations to reduce drug administration error (6). In a recent study, implementation of a 10-point ICU intubation management protocol (‘care bundle’) led to a 30–60% reduction in complications (7). In the area of airway management, an audit demonstrated that following a difficult airway protocol clearly reduced the incidence of complications (7).
In the areas of ambulatory anaesthesia, it is essential to improve efficiency and maximize resources without compromising patient safety and satisfaction. Twersky et al were able to achieve a higher level of fast-tracking of patients after a process was implemented subsequent to a study of areas needing attention, and identification of variables which could affect the functioning of a day care surgery center. (8). In the areas of post-operative recovery, it is now clear that the use of patient recovery scoring systems for protocol-based decision making, can help in fast tracking (9). A “stop oxygen therapy protocol” led to not only shortening of the duration of O2 therapy but also prevented unnecessary therapy with oxygen (10).In a patients undergoing major abdominal surgery, it was demonstrated that hemodynamic goal-directed therapy using pulse pressure variation, cardiac index trending and mean arterial pressure as the key parameters leads to a decrease in postoperative infectious complications (11).
Checklists may help avoid missing crucial steps in highly pressurized situations. The WHO Surgical Safety Checklist has been designed for routine use in operating theatres as a ‘standard operating procedure’ (12). Marked reductions in postoperative complications after implementation of a surgical checklist have been reported. This was demonstrated by van Klei et al as well as Bliss et al who noted that implementation of the WHO Surgical Checklist reduced in-hospital 30-day mortality and morbidity (13,14).
Adoption of a protocol to select patients for early discharge after laparoscopic appendectomy resulted in a 45% reduction in the need for in-hospital beds as well as substantial financial savings when compared with standard care (15). Critical pathways were associated with a rapid reduction in postoperative length of stay after major procedures. coronary artery bypass graft (CABG) surgery, total knee replacement, colectomy, thoracic surgery, or hysterectomy before and after pathway implementation at a university hospital (16). Ehrlich et al demonstrated that fast-track protocols for patients undergoing colorectal surgery led to faster postoperative functional recovery, lower morbidity and readmission rates and shorter postoperative hospital stay (17).
In ICU, weaning protocols are commonly followed. Roh et al found that protocol-based weaning administered by nurses was safe and it reduced the weaning time as well when compared with that administered by intensive care physicians (18). A Cochrane review concluded that there is evidence to suggest, though limited, that weaning protocols reduce the duration of mechanical ventilation in paediatric ICU (19). In a medical ICU, it was shown that implementation of a hyperglycemic crises protocol decreased times to resolution of diabetic ketoacidosis DKA without increasing the rate of hypoglycemia or hypokalemia. (20). Gardetto et al were able to achieve results which were comparable with top 10% of hospitals in USA when they introduced use of a critical pathway protocol for management of acute decompensated heart failure (21). Similar protocols are widely used for reducing catheter related infections ICU. End-of-life care in cancer patients could be improved significantly with a protocol-based pathway which was adapted from Liverpool Care Pathway (LCP) (22).
It is important to remember that any protocol needs further review. The EGDT therapy for sepsiswas extensively adopted by various institutions around the world. However a recent study concluded that protocol-based resuscitation of patients in whom septic shock was diagnosed in the emergency department did not improve outcomes (23).
Are protocols (integrated care pathways) effective in improving patient care?
In general, there is lack of strong and reliable scientific evidence as there are no randomised controlled trials. There are reports in literature which usually describe experience and perceived benefits or concerns associated with use of protocols. These reports may have publication bias.
Despite overall lack of strong evidence, some studies do show that the implementation of evidence based clinical guidelines improve patient care. The reported benefits include reduction in the length of stay in hospital reduction of costs of patient care, improved patient outcomes (improved quality of life, reduced complications), increased patient satisfaction with the service, improved communication between doctors and nurses, increased participation of patient or carer in patient care, and reduction in the time health staff spent carrying out paperwork. (24, 25, 26).
Advantages of protocols
Protocol based care allows the physician to apply the evidence into his routine clinical practice (1). The protocols act as decision support systems to augment appropriate care for specific clinical circumstances (27). A protocol usually addresses important questions of what should be done, when, where and by whom at the ground level. It particularly becomes important when situation has to be managed by a team from several disciplines. They improve multidisciplinary communication and care and allow attainment of existing quality standards. This standardisation of practice lessens needless deviation in the treatment of patients on the same pathways and improves the quality of patient care. This results in savings of time.
Besides clinicians, the staff is benefitted as well since they learn the key interventions for specific conditions quickly and are able to appreciate likely variations. Use of protocol-based care has the potential to impact on nurses' roles, increasing their autonomy, extending their roles and subsequently impacting on service delivery. Protocols also allow redesignation and extension of roles, for example nurse led discharge which can improve patient experience, reduce length of stay and releases some of the doctors’ capacity. It also helps reduction of the size of case notes and effort taken by staff on entering them.
Protocols facilitate introduction of guidelines and continuation of audit and research into clinical practice. Patient satisfaction is also enhanced since protocols promote more patient focused care and improve patient information by letting the patient see what is planned and what progress is expected.
Problems with Protocol based care
There are certain limitations of protocol based care. In a study which looked at the impact of protocols on decision making of nurses in medical wards, it was commented that other sources of information supported nurses' decision-making process and not just the protocols. Decision-making was observed to be a social activity and knowledge was exchanged during personal interaction. This implies that any protocol must include the factors which may affect decision making (28).
In another study, authors noted that protocol-based care approaches were commonly used as checklists and for reference; nurses and doctors expressed concern that such use could lead to a 'tick box mentality' and restricted judgement. Many consider these protocols to be a “nurses’ thing(29).
It certainly takes effort and time to develop protocols which, one can argue, could be spent in other clinical activities. Protocol development needs leadership, energy, good communication along with adequate resources and suitable evidence and standards. As protocols are broad –based, it may affect clinical judgment in individual cases. In case of complex diseases with multiple pathologies it may be difficult to develop a protocol or care pathway. It has been suggested that 25% of all hospital inpatients will not be able to be cared for with integrated care pathways. However it can be a counter-argued that these complex cases may benefit more subsequent to discussions by a group of patients. Protocols sometimes may appear to discourage personalised care and may not allow the health care staff to respond well to unexpected changes in a patient's condition.
Successful implementation too takes time as one may have to tackle barriers like reluctance to change, obstructive interpersonal politics, While protocols may benefit the patients clinically, they may not make much impact if there is limited potential for cost-savings. It is equally essential to ensure that the person responsible for coordinating any initiative must be sufficiently well informed and of high enough standing within the organisation.
It is also felt that protocol based care can restrain clinical freedom. This however can be addressed by integrating adequate flexibility within any protocol since clinical judgements are bound to vary to customize the needs of patients. In case of deviations from any step of protocol, a mention must be made to record the variations for future reference.
Conclusion
There may not be a level I evidence to support the statement that protocols make a positive impact on health care. However there is sufficient reason to believe that adoption of such practice has an all-round salutary effect on patient care in OT (anaesthesia) and ICU where there is plenty of scope of omission and commission of critically important steps in a Care Pathway. There is a need to expand the application of protocol-based care given the advantages described in the preceding paragraphs.
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References:
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2.http://www.institute.nhs.uk/quality_and_service_improvement_tools/quality_and_service_improvement_ tools/protocol_based_care.html#sthash.cyz3ycEl.dpuf (accessed on 22 Oct 2014)
3. http://www.e-p-a.org/about-epa/index.html(accessed on 22 Oct 2014)
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5.National Institute for Clinical Excellence:A Step-by-Step Guide to Developing Protocols. 2003.
6. Kothari D1, Gupta S, Sharma C, Kothari S. Medication error in anaesthesia and critical care: A cause for concern. Indian J Anaesth. 2010 May;54(3):187-92.
7. Cook TM, Woodall N, Harper J, Benger J, Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 2: intensive care and emergency departments. Br J Anaesth. 2011 May;106(5):632-42.
8. Twersky RS. Risk factors associated with fast-track ineligibility after monitored anesthesiacare in ambulatory surgery patients. Anesth Analg. 2008 May;106(5):1421-6,
9. Abdullah HR, Chung F. Postoperative issues: discharge criteria. AnesthesiolClin. 2014 Jun;32(2):487-93.
10. Komara JJ, Stoller JK The impact of a postoperative oxygen therapy protocol on use of pulse oximetry and oxygen therapy. Respiratory care 1995; 40 (11): 1125-9.
11. Salzwedel C. Perioperative goal-directed hemodynamic therapy based on radial arterial pulse pressure variation and continuous cardiac index trending reduces postoperative complications after major abdominal surgery: a multi-center, prospective, randomized study. CritCare. 2013 Sep 8;17(5):R191.
12. Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP. A surgical safety checklist to reduce morbidity and mortality in a global population.N Engl J Med.2009 Jan 29;360(5):491-9.
13. Bliss LA, Ross-Richardson CB, Sanzari LJ, Shapiro DS, Lukianoff AE, Bernstein BA, Ellner SJ. Thirty-day outcomes support implementation of a surgical safety checklist. J Am Coll Surg. 2012 Dec;215(6):766-76.
14. van Klei WA, Hoff RG, van Aarnhem EE, Simmermacher RK, Regli LP, Kappen TH. Effects of the introduction of the WHO "Surgical Safety Checklist" on in-hospital mortality: a cohort study. Ann Surg. 2012 Jan;255(1):44-9.
15. Dubois L, Vogt KN, Davies W, Schlachta CM. Impact of an outpatient appendectomy protocol on clinical outcomes and cost: a case-control study. J Am Coll Surg. 2010 Dec;211(6):731-7.
16. Pearson SD, Kleefield SF, Soukop JR, Cook EF, Lee TH. Critical pathways intervention to reduce length of hospital stay. Am J Med. 2001 Feb 15;110(3):175-80.
17. Ehrlich A, Wagner B, Kairaluoma M, Mecklin JP, Kautiainen H, Kellokumpu I. Evaluation of a fast-track protocol for patients undergoing elective colorectal surgery.Scandinavian Journal of Surgery 2014;0: 1–7.
18. Roh JH, Synn A, Lim CM, Suh HJ, Hong SB, Huh JW, Koh Y. A weaning protocol administered by critical care nurses for the weaning of patients from mechanical ventilation. J CritCare. 2012 Dec;27(6):549-55.
19. Blackwood B, Murray M, Chisakuta A, Cardwell CR, O'Halloran P. Protocolized versus non-protocolized weaning for reducing the duration of invasive mechanical ventilation in critically ill paediatric patients. Cochrane Database Syst Rev. 2013 Jul 31;7:CD009082.
20. Hara JS, Rahbar AJ, Jeffres MN, Izuora KE.Impact of a hyperglycemic crises protocol.EndocrPract. 2013 Nov-Dec;19(6):953-62.
21. Gardetto NJ, Critical pathway for the management of acute heart failure at the Veterans Affairs San Diego Healthcare System: transforming performance measures into cardiac care. CritPathwCardiol. 2008 Sep;7(3):153-72.
22. Neo PS, Poon MC, Peh TY, Ong SY, Koo WH, Santoso U et al. Improvements in end-of-life care with a protocol-based pathway for cancer patients dying in a Singapore hospital. Ann Acad Med Singapore. 2012 Nov;41(11):483-93.
23. The ProCESS Investigators. A Randomized Trial of Protocol-Based Care for Early Septic Shock
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