Type 2 diabetes (diabetes) is a serious threat to public health in the United States and disproportionally affects many racial/ethnic minority groups, including African Americans. Limited access to ...treatment and high attrition rates further contribute to health disparities in diabetes-related morbidity and mortality among minorities. Greater opportunities for increasing access and decreasing barriers to treatment are needed. Technology-based interventions have potential for accomplishing this goal but evidence of feasibility and potential effectiveness is lacking, especially for populations that traditionally have limited educational attainment and low computer literacy.
This paper describes the design and methods of a pilot randomized clinical trial that will compare the feasibility and potential efficacy of delivering a diabetes self-management intervention via a virtual world vs. a face-to-face format.
Study participants (n=100) will be African American women with uncontrolled type 2 diabetes recruited from primary care practices and affiliated health centers at a large safety net hospital in Massachusetts. Participants will be randomized into a virtual world-based (VW) intervention condition or a face-to-face control condition. Both conditions provide the same theory-based curriculum and equivalent exposure to the self-management program (eight group sessions), and both will be delivered by a single intervention team (a dietitian and a diabetes educator). Assessments will be conducted at baseline and 4 months. Feasibility will be determined by evaluating the degree to which participants engage in the VW-based intervention compared to face to face (number of sessions completed). Potential efficacy will be determined by comparing change in physiological (glycemic control) and behavioral (self-reported dietary intake, physical activity, blood glucose self-monitoring, and medication adherence) outcomes between the experimental and control groups.
The primary outcomes of interest are feasibility of the VW intervention and its potential efficacy on glucose control and diabetes self-management behaviors, compared to the face-to-face condition. Analysis will use a two-sample Kolmogorov-Smirnov test for changes in variable distribution. P values will be calculated using binomial tests for proportions and t tests for continuous variables.
If the intervention is found to be feasible and promising, it will be tested in a larger RCT.
Objectives(A) To gain insights into the experiences of patients invited to view their doctors’ visit notes, with a focus on those who review multiple notes; (B) to examine the relationships among ...fully transparent electronic medical records and quality of care, the patient-doctor relationship, patient engagement, self-care, self-management skills and clinical outcomes.DesignMixed methods qualitative study: analyses of survey data, including content analysis of free-text answers, and quantitative-descriptive measures combined with semistructured individual interviews, patient activation measures, and member checks.SettingGreater Boston, USA.ParticipantsPatients cared for by primary care physicians (PCPs) at the Beth Israel Deaconess Medical Center who had electronic access to their PCP visit notes. Among those submitting surveys, 576 free-text answers were identified and analysed (414 from female patients, 162 from male patients; 23–88 years). In addition, 13 patients (9 female, 4 male; 58–87 years) were interviewed.ResultsPatient experiences indicate improved understanding (of health information), better relationships (with doctors), better quality (adherence and compliance; keeping track) and improved self-care (patient-centredness, empowerment). Patients want more doctors to offer access to their notes, and some wish to contribute to their generation. Those patients with repeated experience reviewing notes express fewer concerns and more perceived benefits.ConclusionsAs the use of fully transparent medical records spreads, it is important to gain a deeper understanding of possible benefits or harms, and to characterise target populations that may require varying modes of delivery. Patient desires for expansion of this practice extend to specialty care and settings beyond the physician's office. Patients are also interested in becoming involved actively in the generation of their medical records. The OpenNotes movement may increase patient activation and engagement in important ways.
Patient advocates and safety experts encourage adoption of transparent health records, but sceptics worry that shared notes may offend patients, erode trust or promote defensive medicine. As ...electronic health records disseminate, such disparate views fuel policy debates about risks and benefits of sharing visit notes with patients through portals.
Presurveys and postsurveys from 99 volunteer doctors at three US sites who participated in OpenNotes and postsurveys from 4592 patients who read at least one note and submitted a survey.
Patients read notes to be better informed and because they were curious; about a third read them to check accuracy. In total, 7% (331) of patients reported contacting their doctor's office about their note. Of these, 29% perceived an error, and 85% were satisfied with its resolution. Nearly all patients reported feeling better (37%) or the same (62%) about their doctor. Patients who were older (>63), male, non-white, had fair/poor self-reported health or had less formal education were more likely to report feeling better about their doctor. Among doctors, 26% anticipated documentation errors, and 44% thought patients would disagree with notes. After a year, 53% believed patient satisfaction increased, and 51% thought patients trusted them more. None reported ordering more tests or referrals.
Despite concerns about errors, offending language or defensive practice, transparent notes overall did not harm the patient-doctor relationship. Rather, doctors and patients perceived relational benefits. Traditionally more vulnerable populations-non-white, those with poorer self-reported health and those with fewer years of formal education-may be particularly likely to feel better about their doctor after reading their notes. Further informing debate about OpenNotes, the findings suggest transparent records may improve patient satisfaction, trust and safety.
Little information exists about what primary care physicians (PCPs) and patients experience if patients are invited to read their doctors' office notes.
To evaluate the effect on doctors and patients ...of facilitating patient access to visit notes over secure Internet portals.
Quasi-experimental trial of PCPs and patient volunteers in a year-long program that provided patients with electronic links to their doctors' notes.
Primary care practices at Beth Israel Deaconess Medical Center (BIDMC) in Massachusetts, Geisinger Health System (GHS) in Pennsylvania, and Harborview Medical Center (HMC) in Washington.
105 PCPs and 13,564 of their patients who had at least 1 completed note available during the intervention period.
Portal use and electronic messaging by patients and surveys focusing on participants' perceptions of behaviors, benefits, and negative consequences.
11,155 corrected of 13,564 patients with visit notes available opened at least 1 note (84% at BIDMC, 82% corrected at GHS, and 47% at HMC). Of 5219 corrected patients who opened at least 1 note and completed a postintervention survey, 77% to 59% corrected across the 3 sites reported that open notes helped them feel more in control of their care; 60% to 78% of those taking medications reported increased medication adherence; 26% to 36% had privacy concerns; 1% to 8% reported that the notes caused confusion, worry, or offense; and 20% to 42% reported sharing notes with others. The volume of electronic messages from patients did not change. After the intervention, few doctors reported longer visits (0% to 5%) or more time addressing patients' questions outside of visits (0% to 8%), with practice size having little effect; 3% to 36% of doctors reported changing documentation content; and 0% to 21% reported taking more time writing notes. Looking ahead, 59% to 62% of patients believed that they should be able to add comments to a doctor's note. One out of 3 patients believed that they should be able to approve the notes' contents, but 85% to 96% of doctors did not agree. At the end of the experimental period, 99% of patients wanted open notes to continue and no doctor elected to stop.
Only 3 geographic areas were represented, and most participants were experienced in using portals. Doctors volunteering to participate and patients using portals and completing surveys may tend to offer favorable feedback, and the response rate of the patient surveys (41%) may further limit generalizability.
Patients accessed visit notes frequently, a large majority reported clinically relevant benefits and minimal concerns, and virtually all patients wanted the practice to continue. With doctors experiencing no more than a modest effect on their work lives, open notes seem worthy of widespread adoption.
The Robert Wood Johnson Foundation, the Drane Family Fund, the Richard and Florence Koplow Charitable Foundation, and the National Cancer Institute.
Objective To examine whether patients invited to review their clinicians’ notes continue to access them and to assess the impact of reminders on whether patients continued to view notes.
Materials ...and methods We followed OpenNotes trial participants for 2 years at Beth Israel Deaconess Medical Center (BIDMC) and Geisinger Health System (GHS). Electronic invitations alerting patients to signed notes stopped at GHS after year 1, creating a natural experiment to assess the impact of reminders. We used generalized linear models to measure whether notes were viewed within 30 days of availability.
Results We identified 14 360 patients (49 271 visits); mean age 52.2; 57.8% female. In year 1, patients viewed 57.5% of their notes, and their interest in viewing notes persisted over time. In year 2, BIDMC patients viewed notes with similar frequency. In contrast, GHS patients viewed notes far less frequently, a change starting when invitations ceased (RR 0.29 0.26–0.32) and persisting to the end of the study (RR 0.20 0.17–0.23). A subanalysis of BIDMC patients revealed that black and other/multiracial patients also continued to view notes, although they were overall less likely to view notes compared with whites (RR 0.75 0.67–0.83 and 0.93 0.89–0.98, respectively).
Discussion As millions of patients nationwide increasingly gain access to clinicians’ notes, explicit email invitations to review notes may be important for fostering patient engagement and patient-doctor communication.
Conclusion Note viewing persists when accompanied by email alerts, but may decline substantially in their absence. Non-white patients at BIDMC viewed notes less frequently than whites, although their interest also persisted.
Offering patients online access to medical records, including doctors' visit notes, holds considerable potential to improve care. However, patients may worry about loss of privacy when accessing ...personal health information through Internet-based patient portals. The OpenNotes study provided patients at three US health care institutions with online access to their primary care doctors' notes and then collected survey data about their experiences, including their concerns about privacy before and after participation in the intervention.
To identify patients' attitudes toward privacy when given electronic access to their medical records, including visit notes.
The design used a nested cohort study of patients surveyed at baseline and after a 1-year period during which they were invited to read their visit notes through secure patient portals. Participants consisted of 3874 primary care patients from Beth Israel Deaconess Medical Center (Boston, MA), Geisinger Health System (Danville, PA), and Harborview Medical Center (Seattle, WA) who completed surveys before and after the OpenNotes intervention. The measures were patient-reported levels of concern regarding privacy associated with online access to visit notes.
32.91% of patients (1275/3874 respondents) reported concerns about privacy at baseline versus 36.63% (1419/3874 respondents) post-intervention. Baseline concerns were associated with non-white race/ethnicity and lower confidence in communicating with doctors, but were not associated with choosing to read notes or desire for continued online access post-intervention (nearly all patients with notes available chose to read them and wanted continued access). While the level of concern among most participants did not change during the intervention, 15.54% (602/3874 respondents, excluding participants who responded "don't know") reported more concern post-intervention, and 12.73% (493/3874 respondents, excluding participants who responded "don't know") reported less concern.
When considering online access to visit notes, approximately one-third of patients had concerns about privacy at baseline and post-intervention. These perceptions did not deter participants from accessing their notes, suggesting that the benefits of online access to medical records may outweigh patients' perceived risks to privacy.
As health care costs alarm the nation and the debate increases about the impact of health information technologies, patients are reviewing their medical records increasingly through secure Internet ...portals. Important questions remain about the impact of portal use on office visits.
To evaluate whether use of patient Internet portals to access records is associated with increased primary care utilization.
A prospective cohort study.
Primary care patients registered on patient Internet portals, within an integrated health system serving rural Pennsylvania and an academic medical center in Boston.
Frequency of "clinical portal use" (days/2 mo intervals over 2 y) included secure messaging about clinical issues and viewing laboratory and radiology findings. In year 2, a subset of patients also gained access to their primary care doctor's visit notes. The main outcome was number of primary care office visits.
In the first 2 months of the 2-year period, 14% of 44,951 primary care patients engaged in clinical portal use 2 or more days per month, 31% did so 1 day per month, and the remainder had no clinical portal use. Overall, adjusted for age, sex, and chronic conditions, clinical portal use was not associated with subsequent office visits. Fewer than 0.1% of patients engaged in high levels of clinical portal use (31 or more login days in 2 mo) that were associated with 1 or more additional visits in the subsequent 2 months (months 3 and 4). However, the reverse was true: office visits led to subsequent clinical portal use. Similar trends were observed among patients with or without access to visit notes.
Patients turn to their portals following visits, but clinical portal use does not contribute to an increase in primary care visits.
Virtual world environments have the potential to increase access to diabetes self-management interventions and may lower cost.
We tested the feasibility and comparative effectiveness of a virtual ...world versus a face-to-face diabetes self-management group intervention.
We recruited African American women with type 2 diabetes to participate in an 8-week diabetes self-management program adapted from Power to Prevent, a behavior-change in-person group program for African Americans with diabetes or pre-diabetes. The program is social cognitive theory-guided, evidence-based, and culturally tailored. Participants were randomized to participate in the program via virtual world (Second Life) or face-to-face, both delivered by a single intervention team. Blinded assessors conducted in-person clinical (HbA1c), behavioral, and psychosocial measurements at baseline and 4-month follow-up. Pre-post differences within and between intervention groups were assessed using t tests and chi-square tests (two-sided and intention-to-treat analyses for all comparisons).
Participants (N=89) were an average of 52 years old (SD 10), 60% had ≤high school, 82% had household incomes <US $30,000, and computer experience was variable. Overall session attendance was similar across the groups (6.8/8 sessions, P=.90). Compared to face-to-face, virtual world was slightly superior for total activity, light activity, and inactivity (P=.05, P=.07, and P=.025, respectively). HbA1c reduction was significant within face-to-face (-0.46, P=02) but not within virtual world (-0.31, P=.19), although there were no significant between group differences in HbA1c (P=.52). In both groups, 14% fewer patients had post-intervention HbA1c ≥9% (virtual world P=.014; face-to-face P=.002), with no significant between group difference (P=.493). Compared to virtual world, face-to-face was marginally superior for reducing depression symptoms (P=.051). The virtual world intervention costs were US $1117 versus US $931 for face-to-face.
It is feasible to deliver diabetes self-management interventions to inner city African American women via virtual worlds, and outcomes may be comparable to those of face-to-face interventions. Further effectiveness research is warranted.
ClinicalTrials.gov NCT01340079; http://clinicaltrials.gov/show/NCT01340079 (Archived by WebCite at http://www.webcitation.org/6T2aSvmka).
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.
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.
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.
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.
Inviting patients to read their primary care visit notes may improve communication and help them engage more actively in their health care. Little is known about how patients will use the opportunity ...to share their visit notes with family members or caregivers, or what the benefits might be.
Our goal was to evaluate the characteristics of patients who reported sharing their visit notes during the course of the study, including their views on associated benefits and risks.
The OpenNotes study invited patients to access their primary care providers' visit notes in Massachusetts, Pennsylvania, and Washington. Pre- and post-intervention surveys assessed patient demographics, standardized measures of patient-doctor communication, sharing of visit notes with others during the study, and specific health behaviors reflecting the potential benefits and risks of offering patients easy access to their visit notes.
More than half (55.43%, 2503/4516) of the participants who reported viewing at least one visit note would like the option of letting family members or friends have their own Web access to their visit notes, and 21.70% (980/4516) reported sharing their visit notes with someone during the study year. Men, and those retired or unable to work, were significantly more likely to share visit notes, and those sharing were neither more nor less concerned about their privacy than were non-sharers. Compared to participants who did not share clinic notes, those who shared were more likely to report taking better care of themselves and taking their medications as prescribed, after adjustment for age, gender, employment status, and study site.
One in five OpenNotes patients shared a visit note with someone, and those sharing Web access to their visit notes reported better adherence to self-care and medications. As health information technology systems increase patients' ability to access their medical records, facilitating access to caregivers may improve perceived health behaviors and outcomes.
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