Yael Schenker

Interventions to improve patient comprehension in informed consent for medical and surgical procedures: a systematic review

Background. Patient understanding in clinical informed consent is often poor. Little is known about the effectiveness of interventions to improve comprehension or the extent to which such interventions address different elements of understanding in informed consent. Purpose. To systematically review communication interventions to improve patient comprehension in informed consent for medical and surgical procedures. Data Sources. A systematic literature search of English-language articles in MEDLINE (1949–2008) and EMBASE (1974–2008) was performed. In addition, a published bibliography of empirical research on informed consent and the reference lists of all eligible studies were reviewed. Study Selection. Randomized controlled trials and controlled trials with nonrandom allocation were included if they compared comprehension in informed consent for a medical or surgical procedure. Only studies that used a quantitative, objective measure of understanding were included. All studies addressed informed consent for a needed or recommended procedure in actual patients. Data Extraction. Reviewers independently extracted data using a standardized form. All results were compared, and disagreements were resolved by consensus. Data Synthesis. Forty-four studies were eligible. Intervention categories included written information, audiovisual/multimedia, extended discussions, and test/feedback techniques. The majority of studies assessed patient understanding of procedural risks; other elements included benefits, alternatives, and general knowledge about the procedure. Only 6 of 44 studies assessed all 4 elements of understanding. Interventions were generally effective in improving patient comprehension, especially regarding risks and general knowledge. Limitations. Many studies failed to include adequate description of the study population, and outcome measures varied widely. Conclusions. A wide range of communication interventions improve comprehension in clinical informed consent. Decisions to enhance informed consent should consider the importance of different elements of understanding, beyond procedural risks, as well as feasibility and acceptability of the intervention to clinicians and patients. Conceptual clarity regarding the key elements of informed consent knowledge will help to focus improvements and standardize evaluations.

Association Between Palliative Care and Patient and Caregiver Outcomes: A Systematic Review and Meta-analysis

Importance The use of palliative care programs and the number of trials assessing their effectiveness have increased. Objective To determine the association of palliative care with quality of life (QOL), symptom burden, survival, and other outcomes for people with life-limiting illness and for their caregivers. Data Sources MEDLINE, EMBASE, CINAHL, and Cochrane CENTRAL to July 2016. Study Selection Randomized clinical trials of palliative care interventions in adults with life-limiting illness. Data Extraction and Synthesis Two reviewers independently extracted data. Narrative synthesis was conducted for all trials. Quality of life, symptom burden, and survival were analyzed using random-effects meta-analysis, with estimates of QOL translated to units of the Functional Assessment of Chronic Illness Therapy-palliative care scale (FACIT-Pal) instrument (range, 0-184 [worst-best]; minimal clinically important difference [MCID], 9 points); and symptom burden translated to the Edmonton Symptom Assessment Scale (ESAS) (range, 0-90 [best-worst]; MCID, 5.7 points). Main Outcomes and Measures Quality of life, symptom burden, survival, mood, advance care planning, site of death, health care satisfaction, resource utilization, and health care expenditures. Results Forty-three RCTs provided data on 12 731 patients (mean age, 67 years) and 2479 caregivers. Thirty-five trials used usual care as the control, and 14 took place in the ambulatory setting. In the meta-analysis, palliative care was associated with statistically and clinically significant improvements in patient QOL at the 1- to 3-month follow-up (standardized mean difference, 0.46; 95% CI, 0.08 to 0.83; FACIT-Pal mean difference, 11.36] and symptom burden at the 1- to 3-month follow-up (standardized mean difference, -0.66; 95% CI, -1.25 to -0.07; ESAS mean difference, -10.30). When analyses were limited to trials at low risk of bias (n = 5), the association between palliative care and QOL was attenuated but remained statistically significant (standardized mean difference, 0.20; 95% CI, 0.06 to 0.34; FACIT-Pal mean difference, 4.94), whereas the association with symptom burden was not statistically significant (standardized mean difference, -0.21; 95% CI, -0.42 to 0.00; ESAS mean difference, -3.28). There was no association between palliative care and survival (hazard ratio, 0.90; 95% CI, 0.69 to 1.17). Palliative care was associated consistently with improvements in advance care planning, patient and caregiver satisfaction, and lower health care utilization. Evidence of associations with other outcomes was mixed. Conclusions and Relevance In this meta-analysis, palliative care interventions were associated with improvements in patient QOL and symptom burden. Findings for caregiver outcomes were inconsistent. However, many associations were no longer significant when limited to trials at low risk of bias, and there was no significant association between palliative care and survival.

Patterns of Interpreter Use for Hospitalized Patients with Limited English Proficiency

ABSTRACTBACKGROUNDProfessional interpreter use improves the quality of care for patients with limited English proficiency (LEP), but little is known about interpreter use in the hospital.OBJECTIVEEvaluate interpreter use for clinical encounters in the hospital.DESIGNCross-sectional.PARTICIPANTSHospitalized Spanish and Chinese-speaking LEP patients.MAIN MEASURESPatient reported use of interpreters during hospitalization.KEY RESULTSAmong 234 patients, 57% reported that any kind of interpreter was present with the physician at admission, 60% with physicians during hospitalization, and 37% with nurses since admission. The use of professional interpreters with physicians was infrequent overall (17% at admission and 14% since admission), but even less common for encounters with nurses (4%, p < 0.0001). Use of a family member, friend or other patient as interpreter was more common with physicians (28% at admission, 23% since admission) than with nurses (18%, p = 0.008). Few patients reported that physicians spoke their language well (19% at admission, 12% since admission) and even fewer reported that nurses spoke their language well (6%, p = 0.0001). Patients were more likely to report that they either “got by” without an interpreter or were barely spoken to at all with nurses (38%) than with physicians at admission (14%) or since admission (15%, p < 0.0001).CONCLUSIONSInterpreter use varied by type of clinical contact, but was overall more common with physicians than with nurses. Professional interpreters were rarely used. With physicians, use of ad hoc interpreters such as family or friends was most common; with nurses, patients often reported, “getting by” without an interpreter or barely speaking at all.

Oncologist factors that influence referrals to subspecialty palliative care clinics.

PURPOSE Recent research and professional guidelines support expanded use of outpatient subspecialty palliative care in oncology, but provider referral practices vary widely. We sought to explore oncologist factors that influence referrals to outpatient palliative care. METHODS Multisite, qualitative interview study at three academic cancer centers in the United States with well-established palliative care clinics. Seventy-four medical oncologists participated in semistructured interviews between February and October 2012. The interview guide asked about experiences and decision making regarding outpatient palliative care use. A multidisciplinary team analyzed interview transcripts using constant comparative methods to inductively develop and refine themes related to palliative care referral decisions. RESULTS We identified three main oncologist barriers to subspecialty palliative care referrals at sites with comprehensive palliative care clinics: persistent conceptions of palliative care as an alternative philosophy of care incompatible with cancer therapy, a predominant belief that providing palliative care is an integral part of the oncologists role, and a lack of knowledge about locally available services. Participants described their views of subspecialty palliative care as evolving in response to increasing availability of services and positive referral experiences, but emphasized that views of palliative care as valuable in addition to standard oncology care were not universally shared by oncologists. CONCLUSIONS Improving provision of palliative care in oncology will likely require efforts beyond increasing service availability. Raising awareness of ways in which subspecialty palliative care complements standard oncology care and developing ways for oncologists and palliative care physicians to collaborate and integrate their respective skills may help.

Informed Consent in Clinical Care: Practical Considerations in the Effort to Achieve Ethical Goals

INFORMED CONSENT IS A FUNDAMENTAL TENET OF THE US health care system, rooted in the ethical principles of respect for patient autonomy and enhanced patient wellbeing. As famously stated in a pivotal court case, “every human being of adult years and sound mind has a right to determine what shall be done with his own body.” Over the past century, that has come to mean that patients should be able to participate in decisions about their medical care, weighing the risks, benefits, and alternatives of a proposed intervention to ensure that the care they receive reflects their goals, preferences, and values. Although practice varies widely, the current reality of informed consent for medical and surgical interventions often falls far short of stated goals. In many settings clinical informed consent involves a laundry list of potential risks recited to a patient who has already committed to a procedure, followed by the requisite signatures on a form. It is not surprising that patient comprehension is often poor. In a recent study of patients who had just provided informed consent for elective diagnostic cardiac catheterization with possible percutaneous coronary intervention, 88% had mistaken beliefs about the benefits of the procedure. Without a basic understanding of risks, benefits, and alternatives, patients cannot meaningfully participate in decision making (although providing such information does not guarantee that patients will understand the information, use it, and use it wisely). Although failures of informed consent can have disastrous consequences, more commonly the process simply takes up valuable time and does little to promote patient autonomy or well-being, leading to cynicism of some physicians and patients who view informed consent as a legal nuisance without true meaning, and the conclusion of some scholars that expectations for patient understanding and involvement in medical care are unreasonable. Accumulating evidence suggests that the informed consent process can be improved. A recent systematic review identified 44 controlled trials of a wide range of interventions designed to improve patient comprehension in informed consent for medical and surgical procedures. While standardized measures of understanding in informed consent are lacking, the majority of these studies showed some benefit. The challenge lies in how to implement these research findings to achieve an agreed-on minimum standard of comprehension, with the overall goal of elevating the process of informed consent in clinical care to fulfill the ethical principles on which the process was founded. In this pursuit, 3 practical issues bear special consideration.

The Next Era of Palliative Care

In 1995, the pivotal SUPPORT (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatment), involving more than 4000 patients, documented “substantial shortcomings in care for seriously ill hospitalized patients” while demonstrating no improvement in outcomes with a nurse-led communication intervention.1 These negative results—published in JAMA and referenced in more than 1000 peer-reviewed publications—galvanized efforts to improve advanced illness care. Champions of these efforts became leaders in palliative care—an emerging field focused on improving quality of life and alleviating physical and psychological symptoms for patients with complex serious illness and their families.

The Ethics of Advertising for Health Care Services

Advertising by health care institutions has increased steadily in recent years. While direct-to-consumer prescription drug advertising is subject to unique oversight by the Federal Drug Administration, advertisements for health care services are regulated by the Federal Trade Commission and treated no differently from advertisements for consumer goods. In this article, we argue that decisions about pursuing health care services are distinguished by informational asymmetries, high stakes, and patient vulnerabilities, grounding fiduciary responsibilities on the part of health care providers and health care institutions. Using examples, we illustrate how common advertising techniques may mislead patients and compromise fiduciary relationships, thereby posing ethical risks to patients, providers, health care institutions, and society. We conclude by proposing that these risks justify new standards for advertising when considered as part of the moral obligation of health care institutions and suggest that mechanisms currently in place to regulate advertising for prescription pharmaceuticals should be applied to advertising for health care services more broadly.

Care Management by Oncology Nurses To Address Palliative Care Needs: A Pilot Trial To Assess Feasibility, Acceptability, and Perceived Effectiveness of the CONNECT Intervention

BACKGROUND Specialty palliative care is not accessible for many patients with advanced cancer. There is a need to find alternative palliative care strategies in oncology clinics. OBJECTIVE The objective of the study was to assess the feasibility, acceptability, and perceived effectiveness of an oncology nurse-led care management approach to improve primary palliative care. METHODS The study design was a single-arm pilot trial of the Care Management by Oncology Nurses (CONNECT) intervention, in which registered oncology nurses receive specialized training and work closely with oncologists to (1) address symptom needs; (2) engage patients and caregivers in advance care planning; (3) provide emotional support; and (4) coordinate care. The subjects were 23 patients with advanced cancer, 19 caregivers, and 5 oncologists from a community oncology clinic in western Pennsylvania. Feasibility was assessed through enrollment rates, outcome assessment rates, and visit checklists. Patients, caregivers, and oncologists completed three-month assessments of acceptability and perceived effectiveness. RESULTS The consent-to-approach rate was 86% and enrolled-to-consent rate, 77%. CONNECT was implemented according to protocol for all participants. No participants withdrew after enrollment. Four patients died during the study; three-month outcome assessments were completed with all remaining participants (83%). Patients and caregivers reported high satisfaction with CONNECT and perceived the intervention as helpful in addressing symptoms (85%), coping (91%), and planning for the future (82%). Oncologists unanimously agreed that CONNECT improved the quality of care provided for patients with advanced cancer. CONCLUSION An oncology nurse-led care management intervention is feasible, acceptable, and was perceived to be effective for improving provision of primary palliative care. A randomized trial of CONNECT is warranted.

“Her Husband Doesn't Speak Much English”: Conducting a Family Meeting with an Interpreter

A growing percentage of critically ill patients and their families in the United States speak limited English. We present the case of a palliative care consult conducted across language barriers to frame a discussion about the use of interpreters for family meetings, including the evidence for using a professional interpreter, the burden experienced by interpreters involved in end-of-life discussions, potential challenges encountered when conducting a family meeting with an interpreter, and recommended best practices for interpreter use in these settings.

A cluster randomized trial of a primary palliative care intervention (CONNECT) for patients with advanced cancer: Protocol and key design considerations

BACKGROUND The addition of specialty palliative care to standard oncology care improves outcomes for patients with advanced cancer and their caregivers, but many lack access to specialty care services. Primary palliative care-meaning basic palliative care services provided by clinicians who are not palliative care specialists-is an alternative approach that has not been rigorously evaluated. METHODS A cluster randomized, controlled trial of the CONNECT (Care management by Oncology Nurses to address supportive care needs) intervention, an oncology nurse-led care management approach to providing primary palliative care for patients with advanced cancer and their family caregivers, is currently underway at 16 oncology practices in Western Pennsylvania. Existing oncology nurses are trained to provide symptom management and emotional support, engage patients and families in advance care planning, and coordinate appropriate care using evidence-based care management strategies. The trial will assess the impact of CONNECT versus standard oncology care on patient quality of life (primary outcome), symptom burden, and mood; caregiver burden and mood; and healthcare resource use. DISCUSSION This trial addresses the need for more accessible models of palliative care by evaluating an intervention led by oncology nurses that can be widely disseminated in community oncology settings. The design confronts potential biases in palliative care research by randomizing at the practice level to avoid contamination, enrolling patients prior to informing them of group allocation, and conducting blinded outcome assessments. By collecting patient, caregiver, and healthcare utilization outcomes, the trial will enable understanding of the full range of a primary palliative care interventions impact.