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Policy Document

Institutional end-of-life care policy for inpatients at a tertiary care centre in India: A way forward to provide a system for a dignified death

Bhatnagar, ASushma1,; Biswas, Swagata1; Kumar, Abhishek1; Gupta, Raghav1; Sarma, Riniki1; Yadav, Himanshu Prince1; Karthik, A.R. Dr.1; Agarwal, Akshat2; Ratre, Brajesh Kumar1; Sirohiya, Prashant1

Author Information
Indian Journal of Medical Research: February 2022 - Volume 155 - Issue 2 - p 232-242
doi: 10.4103/ijmr.IJMR_902_21
  • Open

Abstract

A peaceful and dignified death is the right of every person with a life-limiting illness1. A ‘good death’ can be an outcome of a holistic approach towards the patients, taking into account their wishes, cultural background, ethical considerations alongside symptom management2. As per the World Health Organization report in 2014, worldwide 68 per cent of the deaths are due to chronic non-communicable diseases3. India shares 15 per cent of this global burden4. Despite this high death rate due to chronic terminal illnesses, India seemingly lacks the capacity to provide end-of-life care (EOLC). As per the Economist Intelligence Unit report in 2015 India ranks 67th out of 80 countries which were studied for quality of death5. According to the Global Atlas of Palliative care, 2nd edition in 2020, India was found to be at the stage of the isolated palliative care provision (level 3a)6. The major factors that act as a barrier for practicing EOLC in developing countries include failure to recognize EOLC as a requirement of public health, lack of related systematic data, and lack of a national-level policy7. To top it off legal ambiguity further deters physicians from initiating EOLC discussions, resulting in the initiation and continuation of invasive life-sustaining procedures at end-of-life. However, the duty of care for the physician is bound not only by the national laws but also the principles of professional ethics (autonomy, non-maleficence, beneficence, and justice). The physician bears the duty to save a patient’s life, but this duty does not mean continuing a potentially non-beneficial or harmful treatment which can further increase the suffering of the patient and their caregivers89.

To date, only a few studies are available which give an idea of the EOLC scenario in India101112. Mani et al13 concluded that only a small proportion of terminally sick patients in the intensive care unit (ICU) had an end-of-life decision (EOLD). Despite a shift in a few legal paradigms over the past few years, still many questions prevail among physicians regarding patient selection, difficult communication, legal dilemma, etc. Thus, it is important to find solutions according to the resources available at the individual institutional level so that EOLC can be provided keeping in mind the medical ethical principles9. This article discusses the journey of formulation and initial training strategies for the implementation of an EOLC policy at a tertiary care hospital in India and may provide a road map for other institutions in India and possibly in other developing countries.

End-of-life care (EOLC) policies in India: How far we have come?

The first Indian policy document on EOLC was published in 2005 by the Indian Society of Critical Care Medicine (ISCCM)14. It focussed primarily on minimizing non-beneficial or harmful treatments and initiated a standard process to forego life support. The summary of legal solutions that could be used by physicians for their defense was published in the same year by ISCCM13. They revised and updated their guidelines in 2012 because of the landmark judgment of the Aruna Shanbaug case in 201115. These were followed by a few more position statements and consensus guidelines by different societies in India16171819. The document by the Indian Council of Medical Research (ICMR) described regarding the principles of do not attempt resuscitation, as well as focussed on algorithm for its implementation20. A critical analysis focusing on these policy documents has been presented in Table I. Though the Federation of Indian Chamber of Commerce Industry and End-of-Life Care in India Taskforce (ELICIT) comprising of members from ISCCM, Indian Association of Palliative Care, and Indian Academy of Neurology released an information guide in 201921, providing sequential strategies for implementation of EOLC for the first time, it, however, lacked a documentation format for the process.

T1
Table I:
Summary of important landmark policies in India for the end-of-life care

The BLUE MAPLE protocol22 published in March 2019 was the first document developed in India that provided procedural guidance for the limitation of life-sustaining treatment and EOLC at an institutional level. It provided an algorithmic approach, sequential steps, and guidance documents and templates for; (i) recognition of medical futility in various clinical settings; (ii) developing physician consensus on medical futility and template for endorsement of medical futility; (iii) providing a framework for communication and a family meeting while discussing prognosis and template for documentation of a family meeting; (iv) consenting and template consent forms for withholding and withdrawing life-sustaining treatment; (v) ratification of futility, withholding/withdrawing decision by the hospital clinical ethics committee and template for ratification; (vi) procedure for implementing withholding and withdrawing life-sustaining treatments; and (vii) EOLC plan (initial and ongoing assessment and management), and after death care protocol.

In November 2019, the Vidhi Centre for Legal Policy and the ELICIT drafted a bill on EOLC which adopted a rights-based perspective, in context to the reality of the healthcare system of India23.

India demonstrates inequality in terms of delivery of healthcare facilities24. Cultural and economic diversities make the implementation of these existing policy guidelines even more difficult, especially for patients with terminal illnesses in the general wards of hospitals. Thus, implementation of EOLC is still a challenge even for the tertiary care institutes, and formulation of institutional guidelines seems to be a reasonable solution in the absence of a uniform national policy.

Initial assessment of the EOLC scenario at the institute level: Identifying the barriers and scope

At our tertiary care health centre (Dr. BRAIRCH, AIIMS, New Delhi), total outpatients in the year 2019-2020 were 44,14,490 and total admissions were 2,68,14425. The department of Palliative Medicine provides EOLC services in a palliative care ward and attends all the referrals from other departments for EOLC. The referral data of the Palliative Medicine department for EOLC over 14 months (January 2018-February 2019) were analyzed to assess the baseline service provision at the institute. It was found that only 49 out of 239 (18%) patients with life-limiting illnesses, attending the emergency department and 19 out of 197 patients in general wards (9.64%) received EOLC counseling (regarding potentially non-beneficial or harmful treatment, supportive care, and symptom management).

An EOLC service needs many support systems to sustain, like space and availability of palliative care physicians, guidelines or policy for implementation, and standardized documentation of the process26. So, the first step of formulation of the policy was to explore the adequacy of these different components at the institutional level. An initial meeting was arranged under the chairmanship of the director of the institute, involving representative faculties from a total of 15 departments, including Oncology, Pulmonary Medicine, Neurology, Nephrology, Emergency Medicine, and Palliative Medicine. The major factors which were found to be responsible for the lack of EOLC practice at the institutional level are schematically shown in Figure 1

F1
Fig. 1:
The existing barriers for practicing end-of-life care at our institution, as perceived by the physicians of the expert committee.

Based on these, the committee had a consensus opinion regarding the evident scope and need of an institutional policy to guide the healthcare providers in practicing the process of EOLC and standardized documentation.

Formulation of policy

The major goals of the policy were to cover the following purposes: (i) Identify the terminal stage of illness and facilitation early discussions about prognosis promoting realistic expectations of the patient and family; (ii) enable patients to have a dignified dying process ensuring care at all levels – physical, emotional, social, spiritual, and ethical; (iii) empowering the patients in deciding their treatment. This will include a patient-centered holistic approach with the inclusion of family and the clinical team in the decision-making process; and (iv) create awareness among staff for dignified death for terminally ill patients, empowering them with skills of communication, knowledge about the steps of EOLC practice, and its documentation.

The major steps of formulation of the policy included defining the steps of EOLC, designing consent forms for disclosures, and developing documentation strategies for the daily progress of EOLC. A team of the legal advisory was included in the committee to clarify the legal questions and doubts prevailing in our country regarding the practice of EOLC. The initial draft of the policy was circulated amongst all the faculty members of the institute for feedback. After the necessary corrections, the final draft was putup on the institutional website for public opinion. In the end, the committee members again scrutinized the final document and after approval by them, it was uploaded to the institutional website.

The policy document includes the following four steps as also shown descriptively in Figure 2; (i) recognition of potentially non-beneficial or harmful treatment by the physicians; (ii) the consensus among all the caregivers on potentially non-beneficial or harmful treatment and initiation of the best supportive care pathway; (iii) initiation of EOLC pathway; and (iv) symptom management and ongoing supportive care till death.

F2
Fig. 2:
Summary of end-of-life care policy.

Recognition of potentially non-beneficial or harmful treatment by the physicians: Potentially non-beneficial or harmful treatment should be recognized initially by primary physicians based on some general as well as disease-specific criteria. The general criteria include (i) shortened survival expected to be in days to weeks; (ii) any condition where the clinicians predict a low chance of achieving an acceptable quality of life according to the patients’ values; and (iii) post-cardiac arrest status with poor neurological outcomes. The general criteria mentioned helps us in recognition of non-beneficial or harmful treatment.

In different specialities, (i.e., critical care units, pulmonary medicine, paediatric medicine, neurology, neurosurgery, oncology, etc.) the specific criteria for further potentially non-beneficial or harmful treatment can be decided by the team of clinicians of the concerned speciality considering the disease-specific details.

Once the potentially non-beneficial or harmful treatment has been identified by the primary clinician, the same must be confirmed by another clinician of the same speciality who is not directly involved in the care of the patient. After the consensus, a mandatory referral has to be made to palliative care services. The consensus among the clinicians must be documented in proper format (Supplementary Enclosure I).

Consensus among all the caregivers on potentially non-beneficial or harmful treatment and initiation of the best supportive care pathway: Four basic steps should be followed to reach a consensus:

(i) Assess the mental competence of the patient for taking an informed decision: Check for the ability to understand, appreciate, reasoning and expression of choices. If a patient is not found to be mentally capacitated to give valid informed consent, a surrogate decision-maker should be identified.

(ii) Identify the responsible surrogate decision-makers: If the patient does not have the capacity to make healthcare decisions or is unable to participate in the healthcare decision making, the process of decision-making rests on patient surrogates, which is usually the patient’s family who makes the medical decision in consultation with the treating team in best interests of the patient. If there are no documented surrogate decision-makers, the hierarchy for surrogate decision-makers as described in Table II are to be followed2728. The list is valid only if the patients’ advance directive, if any, has not named a surrogate decision-maker.

T2
Table II:
Summary of the training strategie

(iii) Appropriate communication to disclose the potentially non-beneficial or harmful treatment and options for best supportive care: The primary clinician along with the palliative care physician and nursing officer should communicate to the patient and/or all concerned family members together in a meeting. The communication should take place in a language, with which they are comfortable. The communicating team must introduce themselves to all the family members present in the meeting.

The communication should include explanations related to the terminal nature of illness with an emphasis on conveying empathy, short life expectancy, burden versus benefit of further aggressive management, option of EOLC as an alternative, change of goals of treatment from cure to care, symptoms expected in the last few days or hours and their comfort measuring strategies, clarification of the patient’s values and beliefs by the patient or surrogate, clarification of any myths or misunderstandings regarding illness and treatment and recheck and ensure the understanding of the prognosis and process of EOLC among all the caregivers.

At the end of communication, the checklist for communication should be filled by communicating team’s clinicians (Supplementary Checklist I).

(iv) Documentation: If the patient is mentally capacitated to take an informed decision, the patient’s wishes for withholding of life supporting measures should be recorded and signed (Supplementary Enclosure II).

If the patient does not have the capacity to make informed decisions, then once consensus amongst all family members is established, a written disclosure of further potentially non-beneficial or harmful treatment and withdrawal or withholding of life supporting measures should be obtained (Supplementary Enclosure III). ‘Do Not Attempt Resuscitation’ Form, if applicable, to be filled (Supplementary Enclosure IV). The form has been adopted from the ICMR Consensus Guidelines on ‘Do Not Attempt Resuscitation’19.

Initiation of EOLC pathway: Once consensus for initiating EOLC is achieved among all the caregivers and physicians, palliative care physicians must ensure all the prerequisites have been adequately addressed (Supplementary Checklist II).

Symptom management and ongoing supportive care till death: This includes: (i) daily assessment of the patient to be done for holistic palliative needs, e.g., psychological, spiritual along with symptoms management at the end of life (e.g., pain, breathlessness, delirium, vomiting), (ii) daily supportive care plans and treatments given should be documented for all in-hospital EOLC (Supplemantary Enclosure IV). Any change in plan (Care to Cure) must be documented, and (iii) if the patient is not already on any life-sustaining support, patient/surrogate decision-makers may be given an option for home-based/hospice-based care.

The oversight committee is the Institutional Ethics Committee which will be referred to in case of any discrepancy related to this policy.

Navigating India’s uncertain legal framework around the end-of-life decision (EOLD)-making

While euthanasia and physician-assisted suicide remain illegal in India, the Supreme Court gave legal recognition to withholding and withdrawing life-sustaining treatment with strict guidelines in the Aruna Shanbaug’s case in 201115. Court of law, however, required all such decisions to be approved by the jurisdictional High Courts before being implemented. In 2018, Supreme Court made the EOCL refusal of life-sustaining treatment as a part of the fundamental right to liberty and dignity. The court also recognized the legal validity of advance directives2930. However, it laid down a restrictive process to implement such decision-making, involving multiple rounds of approval by multiple authorities31. These practical difficulties made it difficult to follow the court’s guidelines in real-life critical care settings. The ICMR clarified the confusion that was created by the use of the phrase ‘passive euthanasia’ in the supreme court verdict of 2018. It says ‘‘euthanasia cannot be passive and withholding or withdrawing a potentially inappropriate treatment in a patient dying with a terminal illness that only prolongs the dying process, cannot be construed as an intention to kill’’323334. The government of India sought public comments on the draft bill posted on their website before making a law of passive euthanasia in 2016. The government, however, did not proceed with this proposed legislation35.

In response to these legal restrictions, hospitals are coming up with their own EOLC policies, which, while capturing the essence of the Supreme Court’s declarations around patient autonomy and the role of physicians in the best interest of the patients, also incorporate principles of transparency and accountability. This institutional policy proceeds on this understanding and seeks to create practical standards of EOLC decision-making. Two key innovations that the policy brings about are: (i) proposing a clear hierarchy for identifying surrogate decision-makers, who will participate in EOLC decision making and (ii) creating an institutional advisory EOLC committee. Hierarchy includes spouse or de facto spouse or a partner with whom the patient has a relationship in the nature of marriage or a friend of long-standing who regularly attends to the patient in the hospital; available adult children; available parents; available siblings and any other lineal ascendants or descendants of the patient who are present in the hospital and regularly attend to the patient.

The EOLC policy’s hierarchy of surrogate decision-makers accounts for societal shifts in India by going beyond relationships in heteronormative family structures and giving primacy to the principal caregiver. The institutional advisory EOLC committee has been set up with the twin objectives of resolving conflicts and giving ethical guidance during difficult decisions. It also complies with the spirit of the Supreme Court’s directions to set up institutional expert committees that can oversee decisions regarding the withdrawal or withholding of life-supporting measures.

Implementation of the policy: Strategies we adopted: After vigorous feedback by the 15 committee members, the policy was finalized and uploaded to the institutional website for faculty and public opinion for a month. For strengthening the implementation process of the policy, some major steps were initiated (Table II).

Impact on the practice of EOLC by various departments after implementation of the policy: Our initial experience

The journey of formulation of policy and implementation of training programmes started in July 2019. This showed a sharp and consistent increase in the specialist palliative care referral rate from various departments for EOLC over the next seven months (Fig. 3). Data from the Palliative Medicine departmental audit revealed that after formulation of policy (September 2019 to February 2020) the total number of EOLC referrals for the malignant and non-malignant diseases increased by 110 and 83.3 per cent, respectively compared to before (March to August 2019) (Fig. 4). Thus, this policy document has shown a positive change in awareness and attitude regarding EOLC among physicians.

F3
Fig. 3:
Trend showing end-of-life care referral over one year (March, 2019- February, 2020).
F4
Fig. 4:
Bar chart showing the break-down of end-of-life care referrals between malignant and non-malignant cases six months before and six months after institutional end-of-life care policy discussion.

Limitations

Although many legal complexities were answered in the policy by involving the legal expert and proposing a hierarchy of surrogate decision-makers, the medicolegal sanction of such an approach is still pending. The exhaustive communication checklist and structured documentations are expected to minimize future conflicts but a clear legal defense is still unavailable. As our initial pre-policy barrier assessment was solely based on feedback from the expert committee members, some of the important perspectives of patients and relatives may have been overlooked. Furthermore, the efficacy of the policy is yet to be ascertained by assessing the quality of deaths with validated questionnaires. Spiritual support and structured bereavement care services are the arena with great challenges for us given the extreme diversities in the population base. Also situations like acute catastrophic illnesses where there was no or limited time to initiate EOLC were excluded from our policy.

Future direction

Implementation of the policy is a long process and we are still enroute. The outcome of this policy will serve as a framework for the revision of the EOLC policy. For future assessment of the quality of the EOLC process, postgraduate dissertations of palliative medicine students have been allotted to many departments, e.g., Oncology, pulmonary medicine, neurology, nephrology, etc. Another goal of these dissertations is to develop and validate robust disease-specific criteria for EOLC. This will be helpful in resolving conflicts of choosing patients. The ongoing training programmes for staff and physicians will further be intensified by arranging more frequent communication workshops and focussed sessions in individual specialties. Privacy is often lacking when a terminally ill patient is admitted to the general ward and ICUs. To overcome such problems in the future, a dedicated EOLC ward under the palliative medicine department is planned to be set up. Hospices or homes are usually the preferred places of death for the patients instead of hospitals36. The development of a service system for those patients who are willing to undergo home-based EOLC can be integrated with this policy in the future. Hospice centres should be roped in for all those who do not want to spend their last days in the hospital and do not have good home care facilities.

Conclusion

Institutional policies are the need of the hour in developing countries like India, where a ‘dignified death’ is still a myth for most of the terminally ill patients in the hospital. It should focus on patient selection, documentation of the whole process, and resolution of the conflicts arising in the process. The inclusion of legal experts in the institutional advisory EOLC committee will facilitate identifying and providing solutions for some of the legal lacunae. Aggressive and repeated training and educational workshops for the health staff are needed to implement the policy. Although a wide-scale assessment of the quality of deaths provided under the policy is still pending, it can act as a working plan for other institutes in developing countries with poor awareness and knowledge about EOLC. The outcomes of policy implementation whether anticipated or unanticipated will influence future policy-making or its modification. One may also hope that it may stimulate the national level policy making to standardize the practice of EOLC across India.

Financial support & sponsorship: None.

Conflicts of Interest: None

Acknowledgment:

Authors acknowledge the efforts and contributions of all our staff, residents, and faculties of various departments who participated in our training sessions and helped in making this Institutional policy for EOLC. Authors also acknowledge the ‘BLUE MAPLE’ document prepared by Dr Naveen Salins and the team of Kasturba Hospital, Manipal, India, from where we have taken inspiration throughout policymaking.

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Keywords:

EOLC policy; end-of-life care; formulation; implementation; India; institution

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