Informed consent has become one of the primary means for protecting the legal rights of patients and guiding the ethical practice of medicine. [1] In most countries, it is an ethical and legal requirement for healthcare providers to obtain informed consent from patients prior to providing medical care. Additionally, informed consent facilitates trust between healthcare providers and patients and supports shared decision making, a fundamental principle of patient centered care. Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care.
Although it is easy to think of informed consent as a document a patient must sign prior to treatment, it’s not the document but the discussion between the healthcare professional and the patient that constitutes informed consent. While the practice of informed consent has legal, ethical and administrative implications,[2] ultimately, to achieve informed consent, healthcare providers must first provide adequate information to patients and secondly, patients must understand the information they receive in order to make an informed decision regarding their treatment. The signed document is the official confirmation that all the elements of the discussion have taken place. Those elements include:
- The diagnosis (when known), and a description of the medical issue and the commonly suggested treatment
- The nature and purpose of recommended interventions, as well as alternatives
- The burdens, risks, and expected benefits of all options, including forgoing treatment[3]
- The patient’s role in the decision-making process — emphasizing that it is, ultimately, their choice
- The risks and benefits of the suggested treatment, as well as the risks and benefits of the alternatives, and compare those with the patient’s goals and preferences
- Uncertainties — rather than making the patient less sure, this full disclosure will build trust
- Assessment of the patient’s understanding of the information provided
- Eliciting the patient’s preference and the treatment they’re consenting to, and confirm this with the signing of the informed consent document.[4]
In medical travel, the practice of informed consent may be complicated by numerous factors which may not be apparent at first glance. Healthcare providers wishing to target traveling patient populations should strive to develop a clear written policy on informed consent that addresses these challenges.
Challenges facing medical travel patients
A 2011 study[5] of Canadian broker websites looked at risk communication and informed consent in the context of medical travel and highlighted the following challenges:
· The addition of more parties offering health advice – such as medical tourism facilitators and multiple destination providers, may complicate how effectively potential risks are communicated to medical travelers, thus compromising their ability to achieve informed consent.
· Language barriers may compromise communication between medical travelers and healthcare professionals abroad, thus limiting risk-related communication.
· Medical travelers may experience more difficulty in verifying the credentials and training of destination physicians, further complicating the patient’s understanding of risk.
· In some instances, medical travel may strain relationships with the patient's primary care physician and other local medical professionals, hindering the gathering of medical advice.
· Follow up care back home for medical tourists can be challenging as they may have difficulty contacting the destination physician should complications or questions arise post-operatively, which can poses a post-operative health risk.
Other potential challenges not highlighted in the study include:
· Cultural or religious norms as potential barriers to achieve informed consent. For example, some groups may forbid certain medical procedures or treatments – even in emergency situations – due to cultural or religious beliefs.[6] Other cultural groups may involve people in the decision making process that may not traditionally be involved in the making of a medical decision. Still others may have different views on who it is that should be informed of the patient's condition.[7]
· If the procedure or treatment is performed in a foreign country (with different laws and regulations), traveling patients may not have a clear understanding of their legal recourse if unanticipated events were to occur.
· Patients who have traveled long distances over multiple time zones may feel disoriented and fatigued (especially if the treatment is scheduled shortly after arrival), which could hinder the patient’s understanding of risk.
· Patients who travel alone may feel stress and anxiety without the emotional support of a family member or close friend.
Taking a closer look at these factors it is clear that they fall primarily under four major themes:
· Communication challenges that impact patient understanding
· Difficulty accessing information
· Cultural or religious beliefs that challenge conventional protocol
· Travel related stressors
Strategies for improving informed consent in medical travel
What can healthcare providers do to adequately address these challenges? Under each of these factors we have included some general principals and strategies that healthcare providers may want to consider in order to facilitate the achievement of informed consent in their medical travel programs.
Communication challenges that impact patient understanding.
It is not uncommon for medical travelers to seek health advice from multiple sources such as other healthcare providers or even medical travel facilitators (most of whom are not qualified to provide medical advice and therefore should not be offering medical advice); consequently, there is the potential for the patient to receive incomplete or erroneous health advice or at least experience information overload and confusion - particularly if different views on treatments, risks versus benefits or outcomes are espoused. Language barriers also pose challenges for the patient to achieve informed consent.
· The destination physician can mitigate these risks by communicating with the patient prior to travel to evaluate patient understanding and address miscommunications.
· Additionally, healthcare providers should be very selective about the medical travel facilitators they choose to work with and set clear boundaries and expectations regarding their role as intermediaries as opposed to providers of healthcare services.
· To minimize the impact of language barriers, appropriate communication tools and materials should be made available based on the patient’s language preferences. For example, interpreters need to be readily available and consent forms may need to be translated into the languages of the primary patient target markets.[8]
Difficulty accessing information.
Distance, language, customs, local laws and even negative perceptions of medical travel can make it difficult for patients to gather information or get in touch with a destination physician. It is recommended that:
· Healthcare providers should be transparent about the qualifications of physicians and other medical staff and make their credentials available to the patient upon request.
· Patients should be informed in advanced regarding local laws and legal recourse options if unanticipated events were to occur.
· A discussion should take place with the patient or the patient’s primary care physician (pcp) before travel to ensure appropriate follow-up care is arranged with the pcp or another medical professional.
· A physician or another point of contact should be assigned to the patient to ensure appropriate follow-up once the patient returns home.
Cultural or religious beliefs that challenge conventional protocol.
Patient care outcomes can be improved when patients and, as appropriate, their families and/or those who make decisions on their behalf are well informed and involved in care decisions and processes in a way that matches their cultural expectations.
- The values, beliefs, spirituality, and other preferences of the target populations served by the healthcare provider should be identified and respected by leadership and staff, [9] even in instances where these may conflict with conventional protocol.
- Policies and procedures should be instituted to encompass situations where culture or religious norms might impact the treatment provided or those involved in the decision process.
- Patients should be educated about informed consent and other forms that must be signed and returned prior to travel and educated about when others may grant consent on behalf of the patient. [10]
- Staff members should be trained to understand and to respect patients’ beliefs and values and to provide considerate and respectful care that promotes and protects patients’ dignity and self-worth.[11]
Ultimately, how these processes are carried out in practice depends on a country’s local laws and regulations and any international conventions, treaties, or agreements on human rights endorsed by the country.[12]
Travel related stressors.
Few would argue that travel, more often than not, is stressful. In fact, studies suggest that international travelers are at an increased risk for physical health problems such as insomnia, respiratory problems and skin problems as well as psychological issues such as stress, anxiety, and culture shock.[13] Add to this the fear and anxiety that often accompany a surgical procedure and it is not surprising that some medical travelers may experience diminished cognitive function or even disorientation while being admitted to the hospital or meeting with the treating physician – both critical points in the process to achieve informed consent. Numerous studies have demonstrated that when it comes to cognitive behavior and thinking, anxiety can deteriorate your thought processes, memory and ability to make cognitive, rational decisions.[14]
· The healthcare provider should assign a patient advocate to personally assist the patient through the entire care experience, answering questions, monitoring patient understanding and ensuring the patient has discussed the elements of informed consent with the appropriate caregiver.
· For patients who travel long distances (especially if unaccompanied), the healthcare provider may want to consider instituting a policy whereby patients are encouraged to schedule the procedure or treatment at least a day or two after their arrival in the destination in order to allow sufficient time for rest and to adapt to the time change.
· The healthcare provider may want recommend that patients travel with a companion who can provide emotional and physical support during the care process.
Monitor the effectiveness of your informed consent process
Finally, it is important for healthcare providers to gather periodic feedback from traveling patients and medical staff to determine if improvements need to be made to the informed consent process. Are the right professionals involved? Are medical interpreters needed? Is the consent document written in easy-to-understand language? Does the consent form describe the patient's procedure, or is it a generic, one-size-fits-all document?
Ultimately, increasing compliance with the informed consent process has the potential to improve the patient experience across the medical travel care continuum, boost staff efficiency, and enhance physician-patient communication, all worthy goals for your medical travel program.
[1] Hall, D., et al. Informed Consent for Clinical Treatment. Canadian Medical Association Journal (2012). Retrieved at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3307558/ on July 25, 2018.
[2] Ibid.
[3] https://www.ama-assn.org/delivering-care/informed-consent
[4] https://www.scribeamerica.com/blog/best-practices-for-informed-consent/
[5] Penny, K., et al. Risk communication and informed consent in the medical tourism industry: A thematic content analysis of Canadian broker websites (2011). Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3189886/ on July 25, 2018
[6] Jenkins, ED. Informed consent: cultural and religious issues associated with the use of allogeneic and xenogeneic mesh products. (2010). Retrieved at https://www.ncbi.nlm.nih.gov/pubmed/20347731 on July 25, 2018
[7] Alvarado, M., et al. Cultural Differences and the Understanding of Informed Consent. A Worcester Polytechnic Institute Interactive Qualifying Project. (2015). Retrieved at https://web.wpi.edu/Pubs/E-project/Available/E-project-050415-135554/unrestricted/Informed_Consent_IQP_Final_Project_Report.pdf on July 25, 2018.
[8] GHA Standards 4.1, pre-publication version.
[9] Ibid.
[10] Ibid.
[11] Ibid.
[12] Ibid.
[13] Rodgers, HL., Reilly, SM. Health problems associated with international business travel. A critical review of the literature. (2000). Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/11760300 on July 30, 2018.
[14] D. Grant., E. White, Influence of Anxiety on Cognitive Control Processes. (2016). Retrieved at http://psychology.oxfordre.com/view/10.1093/acrefore/9780190236557.001.0001/acrefore-9780190236557-e-74 on July 30, 2018.
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