Streamlined versus traditional consent for low-risk comparative effectiveness trials: a randomized experimental study to measure patients' and public attitudes.

Aim: Streamlining consent for low-risk comparative effectiveness research (CER) could facilitate research, while safeguarding patients' rights. Materials & methods: 2618 adults were randomized to one of seven consent approaches (six streamlined and one traditional) for a hypothetical, low-risk CER study. A survey measured understanding, voluntariness, and feelings of respect. Results: Participants in all arms had a high understanding of the trial and positive attitudes toward the consent interaction. Highest satisfaction was with a streamlined approach showing a video before the medical appointment. Participants in streamlined were more likely to mistakenly think a signature was required. Conclusion: Streamlined consent was no less acceptable than traditional, signed consent. Streamlined and traditional approaches achieved similar levels of understanding, voluntariness and a feeling that the doctor-patient interaction was respectful.

Integrated Digital Health System Tools to Support Decision Making and Treatment Preparation in CKD: The PREPARE NOW Study.

RATIONALE & OBJECTIVE: Digital health system tools to support shared decision making and preparation for kidney replacement treatments for patients with chronic kidney disease (CKD) are needed. STUDY DESIGN: Descriptive study of the implementation of digital infrastructure to support a patient-centered health system intervention. SETTING & PARTICIPANTS: 4 CKD clinics within a large integrated health system. EXPOSURE: We developed an integrated suite of digital engagement tools to support patients' shared decision making and preparation for kidney failure treatments. Tools included an automated CKD patient registry and risk prediction algorithm within the electronic health record (EHR) to identify and prioritize patients in need of nurse case management to facilitate shared decision making and preparation for kidney replacement treatments, an electronic patient-facing values clarification tool, a tracking application to document patients' preparation for treatments, and an EHR work flow to broadcast patients' treatment preferences to all health care providers. OUTCOMES: Uptake and acceptability. ANALYTIC APPROACH: Mixed methods. RESULTS: From July 1, 2017, through June 30, 2018, the CKD registry identified 1,032 patients in 4 nephrology clinics, of whom 243 (24%) were identified as high risk for progressing to kidney failure within 2 years. Kidney Transitions Specialists enrolled 117 (48%) high-risk patients by the end of year 1. The values tool was completed by 30/33 (91%) patients who attended kidney modality education. Nurse case managers used the tracking application for 100% of patients to document 287 planning steps for kidney replacement therapy. Most (87%) high-risk patients had their preferred kidney replacement modality documented and displayed in the EHR. Nurse case managers reported that the tools facilitated their identification of patients needing support and their navigation activities. LIMITATIONS: Single institution, short duration. CONCLUSIONS: Digital health system tools facilitated rapid identification of patients needing shared and informed decision making and their preparation for kidney replacement treatments. FUNDING: This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Project Program Award (IHS-1409-20967). TRIAL REGISTRATION: ClinicalTrials.gov NCT02722382.

Geisinger's effort to realize its potential as a learning health system: A progress report.

OBJECTIVES: In the last two decades, several organizational initiatives have moved Geisinger into closer alignment with the key characteristics of the learning health system (LHS) model. The intent of this experience report is to provide a firsthand view of the potential of the model and of the complex, multifaceted nature of any endeavor designed and implemented to realize that potential. METHODS: After describing Geisinger, we offer a critical self-assessment of our progress toward the goal of becoming an LHS, followed by an account of the challenges. RESULTS: Geisinger has made incremental but measurable progress in implementing the LHS model, especially in two key domains: in patient-clinician engagement and science and informatics. Other challenges, however, present significant opportunities for additional forward movement, especially with respect to incentives, culture, and leadership. CONCLUSION: Becoming a fully realized LHS is and will be a long-term challenge for any organization that embraces this aspiration.

Validation of a brief scale to assess ambulatory patients' perceptions of reading visit notes: a scale development study.

OBJECTIVES: To develop and evaluate the validity of a scale to assess patients' perceived benefits and risks of reading ambulatory visit notes online (open notes). DESIGN: Four studies were used to evaluate the construct validity of a benefits and risks scale. Study 1 refined the items; study 2 evaluated underlying factor structure and identified the items; study 3 evaluated study 2 results in a separate sample; and study 4 examined factorial invariance of the developed scale across educational subsamples. SETTING: Ambulatory care in three large health systems in the USA. PARTICIPANTS: Participants in three US health systems who responded to one of two online surveys asking about benefits and risks of reading visit notes: a psychometrics survey of primary care patients, and a large general survey of patients across all ambulatory specialties. Sample sizes: n=439 (study 1); n=439 (study 2); n=500 (study 3); and n=250 (study 4). PRIMARY AND SECONDARY OUTCOME MEASURES: Questionnaire items about patients' perceived benefits and risks of reading online visit notes. RESULTS: Study 1 resulted in the selection of a 10-point importance response option format over a 4-point agreement scale. Exploratory factor analysis (EFA) in study 2 resulted in two-factor solution: a four-item benefits factor with good reliability (alpha=0.83) and a three-item risks factor with poor reliability (alpha=0.52). The factor structure was confirmed in study 3, and confirmatory factor analysis of benefit items resulted in an excellent fitting model, X2(2)=2.949; confirmatory factor index=0.998; root mean square error of approximation=0.04 (0.00, 0.142); loadings 0.68-0.86; alpha=0.88. Study 4 supported configural, measurement and structural invariance for the benefits scale across high and low-education patient groups. CONCLUSIONS: The findings suggest that the four-item benefits scale has excellent construct validity and preliminary evidence of generalising across different patient populations. Further scale development is needed to understand perceived risks of reading open notes.

Patients Evaluate Visit Notes Written by Their Clinicians: a Mixed Methods Investigation.

BACKGROUND: Patients actively involved in their care demonstrate better health outcomes. Using secure internet portals, clinicians are increasingly offering patients access to their narrative visit notes (open notes), but we know little about their understanding of notes written by clinicians. OBJECTIVE: We examined patients' views on the clarity, accuracy, and thoroughness of notes, their suggestions for improvement, and associations between their perceptions and willingness to recommend clinicians to others. DESIGN: We conducted an online survey of patients in 3 large health systems, June-October 2017. We performed a mixed methods analysis of survey responses regarding a self-selected note. PARTICIPANTS: Respondents were 21,664 patients aged 18 years or older who had read at least 1 open note in the previous 12 months. MAIN MEASURES: We asked to what degree the patient recalled understanding the note, whether it described the visit accurately, whether anything important was missing, for suggestions to improve the note, and whether they would recommend the authoring clinician to others. KEY RESULTS: Nearly all patients (96%) reported they understood all or nearly all of the self-selected note, with few differences by clinician type or specialty. Overall, 93% agreed or somewhat agreed the note accurately described the visit, and 6% reported something important missing from the note. The most common suggestions for improvement related to structure and content, jargon, and accuracy. Patients who reported understanding only some or very little of the note, or found inaccuracies or omissions, were much less likely to recommend the clinician to family and friends. CONCLUSIONS: Patients overwhelmingly report understanding their visit notes and usually find them accurate, with few disparities according to sociodemographic or health characteristics. They have many suggestions for improving their quality, and if they understand a note poorly or find inaccuracies, they often have less confidence in their clinicians.

Frequency and Types of Patient-Reported Errors in Electronic Health Record Ambulatory Care Notes.

Importance: As health information transparency increases, patients more often seek their health data. More than 44 million patients in the US can now readily access their ambulatory visit notes online, and the practice is increasing abroad. Few studies have assessed documentation errors that patients identify in their notes and how these may inform patient engagement and safety strategies. Objective: To assess the frequency and types of errors identified by patients who read open ambulatory visit notes. Design, Setting, and Participants: In this survey study, a total of 136 815 patients at 3 US health care organizations with open notes, including 79 academic and community ambulatory care practices, received invitations to an online survey from June 5 to October 20, 2017. Patients who had at least 1 ambulatory note and had logged onto the portal at least once in the past 12 months were included. Data analysis was performed from July 3, 2018, to April 27, 2020. Exposures: Access to ambulatory care open notes through patient portals for up to 7 years (2010-2017). Main Outcomes and Measures: Proportion of patients reporting a mistake and how serious they perceived the mistake to be, factors associated with finding errors characterized by patients as serious, and categories of patient-reported errors. Results: Of 136 815 patients who received survey invitations, 29 656 (21.7%) responded and 22 889 patients (mean [SD] age, 55.16 [15.96] years; 14 447 [63.1%] female; 18 301 [80.0%] white) read 1 or more notes in the past 12 months and completed error questions. Of these patients, 4830 (21.1%) reported a perceived mistake and 2043 (42.3%) reported that the mistake was serious (somewhat serious: 1563 [32.4%]; very serious: 480 [9.9%]). In multivariable analysis, female patients (relative risk [RR], 1.79; 95% CI, 1.72-1.85), more educated patients (RR, 1.38; 95% CI, 1.29-1.48), sicker patients (RR, 1.89; 95% CI, 1.84-1.94), those aged 45 to 64 years (RR, 2.23; 95% CI, 2.06-2.42), those 65 years or older (RR, 2.00; 95% CI, 1.73-2.32), and those who read more than 1 note (2-3 notes: RR, 1.82; 95% CI, 1.34-2.47; ≥4 notes: RR, 3.09; 95% CI, 2.02-4.73) were more likely to report a mistake that they found to be serious compared with their reference groups. After categorization of patient-reported very serious mistakes, those specifically mentioning the word diagnosis or describing a specific error in current or past diagnoses were most common (98 of 356 [27.5%]), followed by inaccurate medical history (85 of 356 [23.9%]), medications or allergies (50 of 356 [14.0%]), and tests, procedures, or results (30 of 356 [8.4%]). A total of 23 (6.5%) reflected notes reportedly written on the wrong patient. Of 433 very serious errors, 255 (58.9%) included at least 1 perceived error potentially associated with the diagnostic process (eg, history, physical examination, tests, referrals, and communication). Conclusions and Relevance: In this study, patients who read ambulatory notes online perceived mistakes, a substantial proportion of which they found to be serious. Older and sicker patients were twice as likely to report a serious error compared with younger and healthier patients, indicating important safety and quality implications. Sharing notes with patients may help engage them to improve record accuracy and health care safety together with practitioners.

Correction: OpenNotes After 7 Years: Patient Experiences With Ongoing Access to Their Clinicians' Outpatient Visit Notes.

[This corrects the article DOI: 10.2196/13876.].

The Views and Experiences of Clinicians Sharing Medical Record Notes With Patients.

Importance: The 21st Century Cures Act of 2016 requires that patients be given electronic access to all the information in their electronic medical records. The regulations for implementation of this law give patients far easier access to information about their care, including the notes their clinicians write. Objective: To assess clinicians' views and experiences with sharing clinical notes (open notes) with patients. Design, Setting, and Participants: Web-based survey study of physicians, advanced practice nurses, registered nurses, physician assistants, and therapists at 3 health systems in Boston, Massachusetts; Seattle, Washington; and rural Pennsylvania where notes have been shared across all outpatient specialties for at least 4 years. Participants were clinicians in hospital-based offices and community practices who had written at least 1 note opened by a patient in the year prior to the survey, which was administered from May 21, 2018, to August 31, 2018. Main Outcomes and Measures: Clinicians' experiences with and perceptions of sharing clinical notes with patients. Results: Invitations were sent to 6064 clinicians; 1628 (27%) responded. Respondents were more likely than nonrespondents to be female (65% vs 55%) and to be younger (mean [SD] age, 42.1 [12.6] vs 44.9 [12.7] years). The majority of respondents were physicians (951 [58%]), female (1023 [65%]), licensed to practice in 2000 or later (940 [61%]), and spent fewer than 40 hours per week in direct patient care (1083 [71%]). Most viewed open notes positively, agreeing they are a good idea (1182 participants [74%]); of 1314 clinicians who were aware that patients were reading their notes, 965 (74%) agreed that open notes were useful for engaging patients. In all, 798 clinicians (61%) would recommend the practice to colleagues. A total of 292 physicians (37%) reported spending more time on documentation, and many reported specific changes in the way they write their notes, the most frequent of which related to use of language that could be perceived as critical of the patient (422 respondents [58%]). Most physicians (1234 [78%]) favored being able to determine readily that their notes had been read by their patients. Conclusions and Relevance: In this survey of clinicians in a wide range of specialties who had several years of experience offering their patients ready access to their notes, more than two-thirds supported this new practice. Even among subgroups of clinicians who were less enthusiastic, most endorsed the idea of sharing notes and believed the practice could be helpful for engaging patients more actively in their care.

OpenNotes After 7 Years: Patient Experiences With Ongoing Access to Their Clinicians' Outpatient Visit Notes.

BACKGROUND: Following a 2010-2011 pilot intervention in which a limited sample of primary care doctors offered their patients secure Web-based portal access to their office visit notes, the participating sites expanded OpenNotes to nearly all clinicians in primary care, medical, and surgical specialty practices. OBJECTIVE: The aim of this study was to examine the ongoing experiences and perceptions of patients who read ambulatory visit notes written by a broad range of doctors, nurses, and other clinicians. METHODS: A total of 3 large US health systems in Boston, Seattle, and rural Pennsylvania conducted a Web-based survey of adult patients who used portal accounts and had at least 1 visit note available in a recent 12-month period. The main outcome measures included patient-reported behaviors and their perceptions concerning benefits versus risks. RESULTS: Among 136,815 patients who received invitations, 21.68% (29,656/136,815) responded. Of the 28,782 patient respondents, 62.82% (18,081/28,782) were female, 72.90% (20,982/28,782) were aged 45 years or older, 76.94% (22,146/28,782) were white, and 14.30% (4115/28,782) reported fair or poor health. Among the 22,947 who reported reading 1 or more notes, 3 out of 4 reported reading them for 1 year or longer, half reported reading at least 4 notes, and 37.74% (8588/22,753) shared a note with someone else. Patients rated note reading as very important for helping take care of their health (16,354/22,520, 72.62%), feeling in control of their care (15,726/22,515, 69.85%), and remembering the plan of care (14,821/22,516, 65.82%). Few were very confused (737/22,304, 3.3%) or more worried (1078/22,303, 4.83%) after reading notes. About a third reported being encouraged by their clinicians to read notes and a third told their clinicians they had read them. Less educated, nonwhite, older, and Hispanic patients, and individuals who usually did not speak English at home, were those most likely to report major benefits from note reading. Nearly all respondents (22,593/22,947, 98.46%) thought Web-based access to visit notes a good idea, and 62.38% (13,427/21,525) rated this practice as very important for choosing a future provider. CONCLUSIONS: In this first large-scale survey of patient experiences with a broad range of clinicians working in practices in which shared notes are well established, patients find note reading very important for their health management and share their notes frequently with others. Patients are rarely troubled by what they read, and those traditionally underserved in the United States report particular benefit. However, fewer than half of clinicians and patients actively address their shared notes during visits. As the practice continues to spread rapidly in the United States and internationally, our findings indicate that OpenNotes brings benefits to patients that largely outweigh the risks.

Open Notes in Teaching Clinics: A Multisite Survey of Residents to Identify Anticipated Attitudes and Guidance for Programs.

BACKGROUND: Clinicians are increasingly sharing outpatient visit notes with patients through electronic portals. These open notes may bring about new educational opportunities as well as concerns to physicians-in-training and residency programs. OBJECTIVE: We assessed anticipatory attitudes about open notes and explored factors influencing residents' propensity toward note transparency. METHODS: Residents in primary care clinics at 4 teaching hospitals were surveyed prior to implementation of open notes. Main measures included resident attitudes toward open notes and the anticipated effect on patients, resident workload, and education. Data were stratified by site. RESULTS: A total of 176 of 418 (42%) residents responded. Most residents indicated open notes would improve patient engagement, trust, and education but worried about overwhelming patients, residents being less candid, and workload. More than half of residents thought open notes were a good idea, and 32% (56 of 176) indicated they would encourage patients to read these notes. More than half wanted note-writing education and more feedback, and 72% (126 of 175) indicated patient feedback on residents' notes could improve communication skills. Attitudes about effects of open notes on safety, quality, trust, and medical education varied by site. CONCLUSIONS: Residents reported mixed feelings about the anticipated effects of sharing clinical notes with patients. They advocate for patient feedback on notes, yet worry about workload, supervision, and errors. Training site was correlated with many attitudes, suggesting local culture drives resident support for open notes. Strategies that address resident concerns and promote teaching and feedback related to notes may be helpful.

An environmental scan of shared access to patient portals.

We sought to understand the comprehensiveness of consumer-oriented information describing the availability of shared access to adult patient portals from publicly reported information on institutional websites of 20 large and geographically diverse health systems. All 20 health systems reported that they offer patients the ability to share access to their patient portal account with a family member or friend; however, the comprehensiveness of information regarding registration procedures, features, and terminology varied widely. Half of the systems (n = 10) reported having shared access available on their patient portal registration webpage. Few systems (n = 2) reported affording patients the ability to differentiate specific role-based privileges. No systems reported uptake of shared access among adult patients, which was variably described as "proxy," "caregiver," "parental," or "delegate" access. Findings suggest that engaging families through health information technology will require greater efforts to promote awareness and differentiate privileges that respect patients' choice and control in information-sharing preferences.

Inviting patients and care partners to read doctors' notes: OpenNotes and shared access to electronic medical records.

We examined the acceptability and effects of delivering doctors' visit notes electronically (via OpenNotes) to patients and care partners with authorized access to patients' electronic medical records. Adult patients and care partners at Geisinger Health System were surveyed at baseline and after 12 months of exposure to OpenNotes. Reporting on care partner access to OpenNotes, patients and care partners stated that they had better agreement about patient treatment plans and more productive discussions about their care. At follow-up, patients were more confident in their ability to manage their health, felt better prepared for office visits, and reported understanding their care better than at baseline. Care partners were more likely to access and use patient portal functionality and reported improved communication with patients' providers at follow-up. Our findings suggest that offering patients and care partners access to doctors' notes is acceptable and improves communication and patients' confidence in managing their care.

Leadership Perspectives on Operationalizing the Learning Health Care System in an Integrated Delivery System.

INTRODUCTION: Healthcare leaders need operational strategies that support organizational learning for continued improvement and value generation. The learning health system (LHS) model may provide leaders with such strategies; however, little is known about leaders' perspectives on the value and application of system-wide operationalization of the LHS model. The objective of this project was to solicit and analyze senior health system leaders' perspectives on the LHS and learning activities in an integrated delivery system. METHODS: A series of interviews were conducted with 41 system leaders from a broad range of clinical and administrative areas across an integrated delivery system. Leaders' responses were categorized into themes. FINDINGS: Ten major themes emerged from our conversations with leaders. While leaders generally expressed support for the concept of the LHS and enhanced system-wide learning, their concerns and suggestions for operationalization where strongly aligned with their functional area and strategic goals. DISCUSSION: Our findings suggests that leaders tend to adopt a very pragmatic approach to learning. Leaders expressed a dichotomy between the operational imperative to execute operational objectives efficiently and the need for rigorous evaluation. Alignment of learning activities with system-wide strategic and operational priorities is important to gain leadership support and resources. Practical approaches to addressing opportunities and challenges identified in the themes are discussed. CONCLUSION: Continuous learning is an ongoing, multi-disciplinary function of a health care delivery system. Findings from this and other research may be used to inform and prioritize system-wide learning objectives and strategies which support reliable, high value care delivery.

Patients, care partners, and shared access to the patient portal: online practices at an integrated health system.

OBJECTIVE: To describe the characteristics and online practices of patients and "care partners" who share explicit access to a patient portal account at a large integrated health system that implemented shared access functionality in 2003. MATERIALS AND METHODS: Survey of 323 patients and 389 care partners at Geisinger Health System with linked information regarding access and use of patient portal functionality. RESULTS: Few (0.4%) registered adult patient portal users shared access to their account. Patients varied in age (range: 18-102); more than half had a high school education or less (53.6%). Patient motivations for sharing access included: to help manage care (41.9%), for emergency reasons (29.7%), lack of technology experience (18.4%), or care partner request (10.0%). Care partners were parents (39.8%), adult children (27.9%), spouses (26.2%), and other relatives (6.1%). Patients were more likely than care partners to have inadequate health literacy (54.8% versus 8.8%, P < .001) and less confident in their ability to manage their care (53.0% versus 88.1%; P < .001). Care partners were more likely than patients to perform health management activities electronically (95.5% versus 48.4%; P < .001), access the patient portal (89.2% versus 30.3%; P < .001), and use patient portal functionality such as secure messaging (39.6% versus 13.9%; P < .001). Care partners used their own credentials (89.1%) and patient credentials (23.3%) to access the patient portal. DISCUSSION AND CONCLUSION: Shared access is an underused strategy that may bridge patients' health literacy deficits and lack of technology experience and that helps but does not fully resolve concerns regarding patient and care partner identity credentials.

Opening Residents' Notes to Patients: A Qualitative Study of Resident and Faculty Physician Attitudes on Open Notes Implementation in Graduate Medical Education.

PURPOSE: OpenNotes is a growing national initiative inviting patients to read clinician progress notes (open notes) through a secure electronic portal. The goals of this study were to (1) identify resident and faculty preceptor attitudes about sharing notes with patients, and (2) assess specific educational needs, policy recommendations, and approaches to facilitate open notes implementation. METHOD: This was a qualitative study using focus groups with residents and faculty physicians who supervise residents, representing primary care, general surgery, surgical and procedural specialties, and nonprocedural specialties, from Beth Israel Deaconess Medical Center and Geisinger Health System in spring 2013. Data were audio recorded and transcribed verbatim, then coded and organized into themes. RESULTS: Thirty-six clinicians (24 [66.7%] residents and 12 [33.3%] faculty physicians) participated. Four main themes emerged: (1) implications of full transparency, (2) note audiences and ideology, (3) trust between patients and doctors, and (4) time pressures. Residents and faculty discussed how open notes might yield more engaged patients and better notes but were concerned about the time needed to edit notes and respond to patient inquiries. Residents were uncertain how much detail they should share with patients and were concerned about the potential to harm the patient-doctor relationship. Residents and faculty offered several recommendations for open notes implementation. CONCLUSIONS: Overall, participants were ambivalent about resident participation in open notes. Residents and faculty identified clinical and educational benefits to open notes but were concerned about potential effects on the patient-doctor relationship, requirements for oversight, and increased workload and burnout.

Assessing the Quality of Death and Dying in an Integrated Health Care System in Rural Pennsylvania.

CONTEXT: With growing emphasis on improving the value of health care, there is increased scrutiny of quality outcomes and high health expenditures during the final months of life. OBJECTIVES: The purpose of this project is to answer 1) how do next of kin (NOK) perceive the quality of their loved ones' dying and death; 2) are there patient and NOK characteristics that predict lower quality; and 3) are there structural aspects of care associated with lower quality? METHODS: A mailed survey was administered to a stratified random sample of NOK of Geisinger Health System patients who had died in the past year. The Quality of Death and Dying, the General Anxiety Disorder seven-item scale, the Patient Health Questionnaire eight-item depression scale, and selected questions from the Toolkit of Instruments to Measure End of Life Care were used. RESULTS: There were 672 respondents. Significant predictors of Quality of Death and Dying score were number of doctors involved in care (P = 0.0415), location of death (P < 0.0001), frequency of receiving confusing or contradictory information (P < 0.0001), illness progression (P = 0.0343), Patient Health Questionnaire-2 score (P = 0.0148), and General Anxiety Disorder seven-item scale score (P < 0.0070). CONCLUSION: Several findings suggest that factors such as NOK depression and anxiety, prolonged illness, dying in the hospital, receipt of conflicting information, and confusion around the doctor in charge are associated with lower quality of the dying and death experience for NOK. Further investigation is warranted to facilitate high-quality measurement and the use of measurement results to improve care.

Operationalizing the learning health care system in an integrated delivery system.

INTRODUCTION: The Learning Health Care System (LHCS) model seeks to utilize sophisticated technologies and competencies to integrate clinical operations, research and patient participation in order to continuously generate knowledge, improve care, and deliver value. Transitioning from concept to practical application of an LHCS presents many challenges but can yield opportunities for continuous improvement. There is limited literature and practical experience available in operationalizing the LHCS in the context of an integrated health system. At Geisinger Health System (GHS) a multi-stakeholder group is undertaking to enhance organizational learning and develop a plan for operationalizing the LHCS system-wide. We present a framework for operationalizing continuous learning across an integrated delivery system and lessons learned through the ongoing planning process. FRAMEWORK: The framework focuses attention on nine key LHCS operational components: Data and Analytics; People and Partnerships; Patient and Family Engagement; Ethics and Oversight; Evaluation and Methodology; Funding; Organization; Prioritization; and Deliverables. Definitions, key elements and examples for each are presented. The framework is purposefully broad for application across different organizational contexts. CONCLUSION: A realistic assessment of the culture, resources and capabilities of the organization related to learning is critical to defining the scope of operationalization. Engaging patients in clinical care and discovery, including quality improvement and comparative effectiveness research, requires a defensible ethical framework that undergirds a system of strong but flexible oversight. Leadership support is imperative for advancement of the LHCS model. Findings from our ongoing work within the proposed framework may inform other organizations considering a transition to an LHCS.

Implementing family communication pathway in neurosurgical patients in an intensive care unit.

OBJECTIVE: Family-centered care provides family members with basic needs, which includes information, reassurance, and support. Though national guidelines exist, clinical adoption often lags behind in this area. The Geisinger Health System developed and implemented a program for reliable delivery of best practices related to family communication to patients and families admitted to the intensive care unit (ICU). METHOD: Using a quasiexperimental study design and the 24-item Family Satisfaction in the Intensive Care Unit questionnaire (FSICU-24©) to determine family satisfaction, we measured the impact of a "family communication pathway" facilitated by tools built into the electronic health record on the family satisfaction of neurosurgical patients admitted to the ICU. RESULTS: There was no statistically significant difference noted in family satisfaction as determined by FSICU-24 scores, including the Care and Decision Making constructs between the pre- and post-intervention pilot population. The percentage of families reporting the occurrence of a family conference showed only minimal improvement, from 46.5% before to 52.5% following the intervention (p = 0.565). This was mirrored by low numbers of documented family conferences by providers, suggesting poor uptake despite buy-in, use of electronic checklists, and repeated attempts at education. SIGNIFICANCE OF RESULTS: This paper reviews the challenges to and implications for implementing national guidelines in the area of family communication in an ICU coupled with the principles of clinical reengineering.

Family experience with intensive care unit care: association of self-reported family conferences and family satisfaction.

PURPOSE: A family conference is recommended as a best practice to improve communication in the intensive care unit (ICU), but this can be challenging given the setting. This study examined whether family members who reported that a family conference occurred had higher satisfaction than those who did not report that a conference was held. MATERIALS AND METHODS: The study used a retrospective data analysis of family satisfaction based on family member's responses to a questionnaire. Families of all the patients admitted to ICUs of 2 quaternary hospitals in an integrated health system were surveyed. RESULTS: The families of 457 patients who matched the inclusion and exclusion criteria were surveyed with a 55.6% response rate. Family satisfaction with decision making was significantly higher (83.6 vs 78.2, P=.0211) for families who reported that family conferences occurred. No significant difference in the satisfaction with care and overall satisfaction scores was found (84.2 vs 80.0, P=.10). Patients whose families reported a family conference were older and had higher mortality. CONCLUSION: This study confirms that families who report attending family conferences are more satisfied with decision making in the ICU. This study highlights the need to increase communication in ICUs.