Design and Methods for a Comparative Effectiveness Pilot Study: Virtual World vs. Face-to-Face Diabetes Self-Management

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: If the intervention is found to be feasible and promising, it will be tested in a larger RCT

A Virtual World Versus Face-to-Face Intervention Format to Promote Diabetes Self-Management Among African American Women: A Pilot Randomized Clinical Trial

BACKGROUND: Virtual world environments have the potential to increase access to diabetes self-management interventions and may lower cost. OBJECTIVE: We tested the feasibility and comparative effectiveness of a virtual world versus a face-to-face diabetes self-management group intervention. METHODS: 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). RESULTS: Participants (N = 89) were an average of 52 years old (SD 10), 60% had \u3c /=high school, 82% had household incomes \u3c 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$1117 versus US $931 for face-to-face. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT01340079; http://clinicaltrials.gov/show/NCT01340079 (Archived by WebCite at http://www.webcitation.org/6T2aSvmka)

Patients learning to read their doctors' notes: the importance of reminders.

ObjectiveTo 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 methodsWe 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.ResultsWe 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).DiscussionAs 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.ConclusionNote 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

Inviting patients to read their doctors’ notes: a quasi-experimental study and a look ahead

Background: Little information exists about what primary care physicians (PCPs) and patients experience if patients are invited to read their doctors’ office notes. Objective: To evaluate the effect on doctors and patients of facilitating patient access to visit notes over secure Internet portals. Design: Quasi-experimental trial of PCPs and patient volunteers in a year-long program that provided patients with electronic links to their doctors’ notes. Setting: 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. Participants: 105 PCPs and 13 564 of their patients who had at least 1 completed note available during the intervention period. Measurements: Portal use and electronic messaging by patients and surveys focusing on participants’ perceptions of behaviors, benefits, and negative consequences. Results: 11 797 of 13 564 patients with visit notes available opened at least 1 note (84% at BIDMC, 92% at GHS, and 47% at HMC). Of 5391 patients who opened at least 1 note and completed a postintervention survey, 77% to 87% 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. Limitations: 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. Conclusion: 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

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