Impact of Cognitive Load on Family Decision Makers' Recall and Understanding of Donation Requests for the Genotype-Tissue Expression (GTEx) Project.

Genomic research projects that collect tissues from deceased organ and tissue donors must obtain the authorization of family decision makers under difficult circumstances that may affect the authorization process. Using a quasi-experimental design, the Ethical, Legal, and Social Issues (ELSI) substudy of the Genotype-Tissue Expression (GTEx) project compared the recall and understanding of the donation authorization process of two groups: family members who had authorized donation of tissues to the GTEx project (the comparison group) and family members who had authorized organ and tissue donations in years previous, who subsequently participated in two different mock-authorization processes that mimicked the GTEx authorization process (the intervention groups). Participants in the comparison and intervention groups were matched on key demographic characteristics. We found that participants in the intervention groups who experienced a mock-authorization process demonstrated better recall of the tissue donation request than members of the comparison group. Our data indicate that the stress associated with the loss of a loved one limited the ability of family members to recall details about the GTEx project. However, we found a similar lack of knowledge in both the comparison and the intervention group participants, suggesting lack of knowledge may be due to the complexity and unfamiliarity of the information presented to them during the authorization process. We discuss these findings in the context of everyday clinical decision making in cognitively challenging conditions.

Communicating About Choices in Transplantation (COACH).

INTRODUCTION: Previous research highlights the difficulties patients with end-stage renal disease awaiting kidney transplant experience while attempting to manage both the logistical and the content-related aspects of discussions about transplantation. This article presents pilot results of the behavioral communication intervention program, Communicating about Choices in Transplantation (COACH), designed to improve transplant candidates' communication about transplantation. RESEARCH QUESTIONS: As compared to matched controls, increases in knowledge of deceased and living donor transplantation, communication self-efficacy, intentions to hold conversations about transplantation, and self-reported discussion were expected for pilot participants from pre- and postassessment; decreases in conversational difficulties were also posited. DESIGN: Using a nonrandomized quasi-experimental design, we compared transplant knowledge and communication between patients completing a 2-hour COACH session (pilot sample) to a sample of matched controls (n = 10). Data were collected via semi-structured telephone interviews upon enrollment and 1 month after enrollment or attendance at a COACH program session. RESULTS: The results revealed significant differences in knowledge from pre- to postassessment between the pilot and control samples ( P = .02). Although no other statistically significant between-group differences were found, paired-sample t tests revealed significant pre-post increases in transplant knowledge (7.6 [standard deviation, SD = 2.0] to 9.5 [SD =1.8]; P = .05) and communication self-efficacy (1255.8 [SD = 239.7] to 1513.8 [SD = 114.3]; P = .009) for pilot participants. Decreases in perceived conversational difficulties were also observed ( P = .53). DISCUSSION: Results provide preliminary support for the program's impact. Moreover, participant evaluations of the COACH were overwhelmingly positive. A more definitive program evaluation with a larger, more diverse sample is currently underway.

Family decision maker perspectives on the return of genetic results in biobanking research.

PURPOSE: There are many ethical considerations regarding the return of genetic results to biobanking participants, especially when biobanks collect samples from deceased organ and tissue donors that require the authorization of a family decision maker (FDM). This article explores FDM knowledge and opinions regarding return of genetic results in the context of the Genotype-Tissue Expression (GTEx) Project, which does not return results to participants. METHODS: Data collection included a survey completed by Organ Procurement Organization requesters (n = 22) and semistructured telephone interviews with FDM (n = 55). RESULTS: Nearly every FDM wanted some form of genetic results returned. Information regarding treatable diseases (94.3%) and diseases that could affect their children (84.9%) were more desirable than that regarding untreatable diseases (71.7%). Sixty percent of FDMs understood that GTEx would not return genetic results. FDMs were four times more likely to have correct knowledge of the GTEx policy when their GTEx requester reported discussing the topic with them. CONCLUSION: FDMs from the GTEx project were interested in receiving genetic test results. Marked changes in the infrastructure of the GTEx would be required to alter the policy. Regardless, care must be taken to ensure that the return policy is clearly communicated with FDMs to dispel misconceptions.Genet Med 18 1, 82-88.

Keep it going: maintaining health conversations using relational and instrumental approaches.

The initial moments of conversations, particularly discussions addressing difficult or unexpected health topics, establish the context and tone of the entire discussion. We examined how elements of relational and instrumental communication occurring within the first five minutes of the request impacted the length of the discussion. A sample of 16 U.S. tissue banking organizations and their staff (n = 226) making telephone requests for donation to families of tissue-donation eligible patients (n = 1,465) agreed to participate in the research. The first five minutes of 430 (29.4%) audiorecorded request conversations were qualitatively coded and analyzed. The primary outcome measure was whether the conversation continued beyond the first five minutes (yes/no). Aspects of both relational and instrumental communication were associated with discussion length. A logistic regression analysis found that the total number of distinct topics disclosed and requesters' vocal affect during the discussion as well as characteristics of the family member approached about donation predicted conversational maintenance. This research demonstrates that "thin slices" of effective relational and instrumental communication can have a significant, positive impact on conversation length.

Utility and Usability of the Rapid Assessment of Hospital Procurement Barriers in Donation (RAPiD) as a Tool for OPO Hospital Development Staff.

CONTEXT: Few systematic assessment tools are available to organ procurement organizations (OPOs) for evaluating donation climates of hospitals in their donation service areas (DSAs). The Rapid Assessment of hospital Procurement barriers in Donation (RAPiD) was developed for OPO hospital development staff to assess the organ donation climate of hospitals. OBJECTIVE: To implement a national test of the RAPiD to examine its efficacy and usability by OPO hospital development staff. DESIGN: Two-arm randomized design, comparing implementation of RAPiD protocol between qualitatively trained researchers (n = 7) and OPO hospital development staff (n = 24); all evaluators received the same training assessments of high-yield hospitals. SETTING: A total of 77 hospitals in DSAs of 8 OPOs. PARTICIPANTS: A total of 2552 health-care providers (HCPs) in high organ donor potential units. MAIN OUTCOME MEASURES: Twenty-four donation-related attitudes, knowledge, and behaviors. RESULTS: More HCPs interviewed in the autonomous condition were positive toward the concept of organ donation. However, HCPs in the assisted condition were more candid about and critical of the OPO. As for knowledge, fewer HCPs in the autonomous condition reported familiarity with the donation process, need for donors, and generally accepted timely referral criteria. With respect to behaviors, more respondents in the autonomous condition reported frequent or occasional contact with the OPO and routine or occasional referral criteria use. Due to issues of bias, inadequate research experience, conflicts of interest, and ongoing OPO hospital development initiatives, the RAPiD's usability by OPO-based hospital development staff is questionable and not recommended in its current form. A next generation of the RAPiD is described for future consideration.

Living Kidney Donors' Information Needs and Preferences.

INTRODUCTION: Past research suggests the information exchanged from transplant centers to potential living kidney donors is, in many cases, suboptimal. The purpose of this study was to assess donors' perceptions of the information provided while considering living donation. METHODS: Semistructured telephone interviews conducted with 81 past living donors seen at 1 mid-Atlantic transplant center assessed the extent to which living kidney donors deemed Centers for Medicare and Medicaid Services (CMS)-mandated information useful to making a decision about donation and to which more information was or would have been desired before donating. Understanding of and satisfaction with the information was also assessed. RESULTS: Participants were primarily white (67.9%), females (67.9%), with an average age of 57.8 years. Perceived usefulness ranged from a mean of 3.1 for the confidentiality of the transplant center's communication to 4.1 for postoperative care and short-term medical risks of donation. Donors of minority descent as well as those with more education and less income found the information provided most useful. Few donors desired additional information about the right to opt out of (8.6%) or decline (13.6%) donation; however, most wanted more information regarding the risk of being refused health, disability and/or life insurance after donating (77.8%), and insurance coverage for future health problems (66.7%). DISCUSSION: This study revealed limited usefulness of certain CMS-mandated topics and a desire for additional information about donation. Efforts to standardize the informed consent process should incorporate donors' perspectives as to the specific topics, quantity of information, and the mode of communication found most useful when considering living donation.

Consent to organ donation: a review.

Successful transplant medicine hinges on consent to deceased organ donation. Yet rates of consent remain suboptimal. To increase the availability of transplantable organs, several policy strategies along with a rich body of evidence aimed at identifying best practices for obtaining consent have accumulated. This review describes past and current policies and practices, presents evidence illustrating the impact of these policies and practices on consent, and summarizes future directions and recommendations for the field. Key findings include evidence that although past policies such as required request have been unsuccessful, the recent policy, first-person authorization, shows promise. Additionally, practices such as decoupling and detailed discussions of brain death are unwarranted. On the other hand, the Organ Donation Breakthrough Collaboration was successful. We also underscore the impact of alternative procedures such as donation after cardiac death. Last, effective communication that is delivered by trained, caring requesters at the appropriate time, in a supportive environment, and allows sufficient time for families to make an informed decision, optimizes the request process. Organ procurement organizations' adoption of such request practices, implementation of evidence-based policies regarding donation after cardiac death, and further investigations of the medical basis for dual brain death examinations are recommended.

Consenting to donation: an examination of current practices in informed consent for tissue donation in the US.

Informed consent is the primary moral principle guiding the donation of human tissue for transplant purposes. When patients' donation wishes are not known, family members making the decision about tissue donation should be provided with requisite information needed to make informed donation decisions. Using a unique dataset of 1,016 audiotaped requests for tissue obtained from 15 US tissue banking organizations, we examined whether the information provided to families considering tissue donation met current standards for informed consent. The results indicated that many elements of informed consent were missing from the donation discussions, including the timeframe for procurement, autopsy issues, the involvement of both for-profit and nonprofit organizations, and the processing, storage and distribution of donated tissue. A multiple linear regression analysis also revealed that nonwhites and family members of increased age received less information regarding tissue donation than did younger, white decision makers. Recommendations for improving the practice of obtaining consent to tissue donation are provided.

An exploratory study of relational, persuasive, and nonverbal communication in requests for tissue donation.

This study explores the effects of tissue requesters' relational, persuasive, and nonverbal communication on families' final donation decisions. One thousand sixteen (N = 1,016) requests for tissue donation were audiotaped and analyzed using the Siminoff Communication Content and Affect Program, a computer application specifically designed to code and assist with the quantitative analysis of communication data. This study supports the important role of communication strategies in health-related decision making. Families were more likely to consent to tissue donation when confirmational messages (e.g., messages that expressed validation or acceptance) or persuasive tactics such as credibility, altruism, or esteem were used during donation discussions. Consent was also more likely when family members exhibited nonverbal immediacy or disclosed private information about themselves or the patient. The results of a hierarchical log-linear regression revealed that the use of relational communication during requests directly predicted family consent. The results provide information about surrogate decision making in end-of-life situations and may be used to guide future practice in obtaining family consent to tissue donation.

Determinants of family consent to tissue donation.

BACKGROUND: Family consent to tissue donation currently falls well below that for solid organ donation. Moreover, research suggests that Americans have limited understanding of tissue donation, an activity largely overshadowed by the more publicly visible organ donation. This research sought to identify determinants of families' consent to tissue donation. METHODS: Data collection included a brief, self-administered survey completed by tissue bank staff and telephone interviews with family for a sample of tissue donor-eligible deaths reported to a national sample of 16 United States Tissue banks from 2003 to 2006. Family members (N = 1,418) and tissue bank staff (n = 226) involved in the tissue donation decision participated in the research. RESULTS: The families of 1,015 (71.6%) tissue donor-eligible patients consented to tissue donation; 403 (26.8%) families refused. Results revealed a multitude of associations between study variables and the donation decision. A subsequent multivariable analysis identified determinants of family consent to tissue donation, including the discussion of key donation-related issues during the request (adjusted odds ratio [AOR], 17.22; 95% confidence interval [CI], 11.61-25.54), the quality of communication during the request (AOR, 12.39; CI, 7.76-20.02), families' tissue donation attitudes and knowledge (AOR, 10.01; CI, 6.47-15.50), families' initial reactions to the request (AOR, 7.86; CI, 5.13-12.05), families' advance notice of the request (AOR, 3.95; CI, 2.41-6.46), and patient and family sociodemographic characteristics (AOR, 3.32; CI, 2.01-5.48). CONCLUSIONS: Family consent to tissue donation is affected by many of the same variables influencing consent to solid organ donation. Recommendations for practice are provided.

Improving donation outcomes: hospital development and the Rapid Assessment of Hospital Procurement Barriers in Donation.

CONTEXT: Deficiencies in the donation process continue to contribute to the shortage of organs available for transplant. Continuous quality improvement of hospitals' donation processes is needed to identify and correct the problems. OBJECTIVE: To test the Rapid Assessment of Hospital Procurement Barriers in Donation (RAPiD), a direct observation technique with a focused ethnographic strategy, for assessing hospitals' donation processes and identifying areas in need of continuous quality improvement interventions. DESIGN: A pre-post assessment of hospitals' barriers to patient identification and referral, and family consent to donation. SETTING AND PARTICIPANTS: Seventeen hospitals within the catchment area of a Northeastern organ procurement organization were assessed by using the RAPiD method. Hospital administrators, health care providers, and staff (N = 537) were interviewed as part of the assessments. INTERVENTION: Interventions, including on-site training and education, and the use of in-house coordinators, were specifically tailored to each hospital's unique set of barriers to donation. The interventions were delivered to the hospitals in the form of recommendations. The participating organ procurement organization was responsible for implementation of the interventions. RESULTS: The RAPiD hospital evaluations revealed gaps in respondents' knowledge of organ donation, brain death, and referral criteria; a reluctance to declare brain death; and a rocky relationship between the hospitals and the organ procurement organization. As a result of the interventions, 9 hospitals' environments for organ donation improved, 7 showed no change, and 1 was worse.

Confidentiality in Biobanking Research: A Comparison of Donor and Nondonor Families' Understanding of Risks.

AIMS: Confidentiality of personal identifiers potentially linking the genetic results from biobanking participants back to the donor and donor relatives is a concern. The risks associated with a breach of confidentiality should be ascertained when biobanks collect samples requiring the consent of a family decision maker (FDM) from deceased organ and tissue donors. This article explores FDM knowledge and opinions regarding risks associated with participation in biobanking research in the context of the Genotype-Tissue Expression (GTEx) Project. METHODS: Data collection included a survey completed by organ procurement organization requesters (n = 37) and semistructured telephone interviews with the FDMs (n = 85). RESULTS: Donor families were more likely to know that there was a risk that a patient's identity could be revealed through a breach of confidentiality (p < 0.05). They also were more likely to understand that researchers using biobanked tissue would not have access to the patient's exact identity (p < 0.05). FDMs who refused donation were more concerned about risks than donors and reported lower levels of support for medical research in general. Finally, families were frequently interested in the return of results and willing to trade absolute confidentiality for participation. CONCLUSIONS: Clear discussion of the risk of breach of confidentiality is needed during the consent process. The risk and benefit equation could be equalized if studies such as GTEx offered genomic results to interested participants.

Communicating Effectively about Organ Donation: A Randomized Trial of a Behavioral Communication Intervention to Improve Discussions about Donation.

BACKGROUND: Families' refusal to authorize solid organ donation contributes to the organ deficit in the United States. The importance of communication to reducing refusal to requests for solid organ donation at the bedside and thus increasing the supply of transplantable organs cannot be overstated. This research compares two versions of an innovative communication skills training program for Organ Procurement Organization (OPO) request staff, Communicating Effectively About Donation (CEaD), designed to improve the quantity and quality of organ donation discussions with family decision makers (FDM) of deceased patients. METHODS: We conducted a parallel-group randomized controlled trial of the CEaD intervention, comparing an online only version of the training (CEaD1) with the online version bolstered with in-person practice and feedback (CEaD2). Survey and interview data were collected from 1,603 FDMs and 273 requesters to assess the impact of both versions of the CEaD on requesters' communication skills and behaviors; the rate of family authorization to solid organ donation were obtained from administrative data provided by 9 OPOs. RESULTS: Results revealed higher rates of authorization for requesters with less tenure (78% to 89%, p < .03) for both versions; however, CEaD1 also increased authorization rates for requesters with three or more years of experience (89% to 92%, p < .03). Both conditions resulted in an improvement in overall communication quality. CONCLUSIONS: We conclude that the CEaD was effective in improving requesters' communication skills, rates of family authorization to organ donation, and the overall quality of the donation experience.

A Comparison of the Request Process and Outcomes in Adult and Pediatric Organ Donation.

BACKGROUND AND OBJECTIVES: Although existing studies suggest that factors affecting families' decisions regarding pediatric organ donation mirror those for adult patients, health professionals working in this area maintain that pediatric and adult decision-makers differ in significant ways. This study compared the request process, experiences, and authorization decisions between family decision-makers (FDMs) of adult and pediatric donors and nondonors. METHODS: Perceptions of the donation request were collected via telephone interviews with 1601 FDMs approached by staff from 9 US organ procurement organizations (OPOs). Authorization regarding donation (ie, authorized/refused) was obtained from FDM reports and verified by using OPO records. Tests of association were used to estimate differences between FDMs of adult and pediatric patients. A logistic regression analysis was conducted to identify variables predicting FDM authorization. RESULTS: FDMs of children were significantly more likely to authorize donation than were FDMs of adults (89.7% vs 83.2%; χ(2) = 6.2, P = .01). Differences were found between pediatric and adult families' initial feelings toward donation, donation-related topics discussed, communication behaviors and techniques used, perceptions of the request, and receipt and preference of grief information. The likelihood of FDM authorization increased with the number of topics discussed and communication skills employed during requests. Authorization was not predicted by patient age (ie, adult versus pediatric). CONCLUSIONS: FDMs of children are willing to donate and experience no more psychological distress from the request for donation than do FDMs of adults. Communication emerged as a critical factor of family authorization, reinforcing its importance in requests for donation.

Disparities in the completion of steps to kidney transplantation: protocol for a systematic review.

INTRODUCTION: Disparities in access to transplantation have been well documented. The extant literature, however, focuses largely on disparities and related barriers for African-American patients and none has used the steps to transplantation as a guiding framework. This review will catalogue disparities in the steps to transplantation as well as the barriers and facilitators to completion of each step identified in the extant literature. The results of the review will be used to generate recommendations for future research to improve equity in access to kidney transplantation. METHODS AND ANALYSIS: Standard procedures will be used in the conduct of the review. Searches will be performed using the following electronic databases: PubMed/Medline, PsycINFO, CINHAL, EMBASE, Cochrane library and Web of Science. Reports of original research will be eligible for inclusion if they are published from 2005 to present, written or available in English language, performed in the USA, enrol adult participants (18 years of age or more), and employ descriptive or observational designs. Two authors will independently screen retrieved articles for inclusion. MaxQDA will be used for data analysis and management. All included reports will be coded for article characteristics; disparities identified; barriers and motivators of completion of steps to transplantation; and proposed solutions to disparities and barriers. Each report will be coded independently by two authors and discrepancies resolved by discussion among the full team. A qualitative approach to data analysis is planned. Risk of bias will be assessed using standard procedures. ETHICS AND DISSEMINATION: The findings will provide crucial information on the current status of disparities in access to transplantation. PRISMA guidelines will be followed in reporting the results of the review. It is anticipated that these results will inform research which seeks to increase parity in access to transplantation. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42014015027.

Communication self-efficacy, perceived conversational difficulty, and renal patients' discussions about transplantation.

OBJECTIVE: Many patients with chronic and end-stage renal disease (ESRD) have reported difficulties initiating and managing discussions about kidney transplantation, particularly live donor transplantation (LDT). Limited communication has demonstrable impact on patients' access to transplantation, the duration of dialysis treatments, and the length of time awaiting a transplantable kidney. This formative study sought to identify the specific communicative and conversational elements impeding ESRD patients' discussions about transplantation to inform the design of an educational program facilitating transplant-related discussions. METHODS: From March to July 2012, semi-structured telephone interviews (n=63) were conducted with ESRD patients waitlisted for kidney transplantation at one mid-Atlantic transplant center. RESULTS: Although 85.7% (n=54) of patients reported holding discussions about transplantation, qualitative analyses of open-ended responses revealed that the majority (66.7%) had limited conversations. Patients reported difficulties managing a variety of logistical and content-related aspects of LDT discussions. Moderate levels of communication self-efficacy were also found (mean=19.2 out of 28); self-efficacy was highest among respondents having held discussions and was significantly related to perceived magnitude of difficulty handling conversational aspects. CONCLUSION: Results support comprehensive communication skills training for ESRD patients awaiting kidney transplantation. PRACTICE IMPLICATIONS: Potential topics to be included in such training are discussed.

Attitudes and acceptance of First Person Authorization: a national comparison of donor and nondonor families.

BACKGROUND: First Person Authorization (i.e., donor designation) legislation makes indicating one's intent to be a posthumous organ donor legally binding, much like a living will or advance directive. Such legislation is the most recent in a long history of organ donation policies in the United States and has received little attention in the literature. METHODS: This retrospective cohort study recruited nine US organ procurement organizations (OPOs) and their staff who make requests for organ donation as well as family decision makers approached by OPO staff about organ donation. Telephone interviews (N = 1,087) with family decision makers assessed the attitudes, perceptions, and behaviors regarding the request for organ donation of families of designated donors as compared with those of patients who did not formally designate themselves as donors. RESULTS: Almost two thirds (65.7%) of the families of registered donors were aware of the decedent's decision to register as a posthumous donor. Family decision makers who authorized donation and those of designated donors exhibited greater knowledge of organ donation and more positive attitudes than decision makers who refused to donate. Families of designated donors had more favorable perceptions of the request for organ donation and were more satisfied with both the time spent discussing donation and the request process; fewer donor designation families were surprised at the request for donation. CONCLUSION: The enactment of First Person Authorization legislation increases the likelihood of familial authorization and satisfaction with the final donation outcome. As compared with other families approached about the option of organ donation, families of designated donors report having a more positive experience with the organ donation request process overall and greater comfort and satisfaction with the donation decision. LEVEL OF EVIDENCE: Epidemiologic study, level II.