Postoperative Rheumatic Heart Disease Follow-Up: Creating a National Registry and First Results from Rwanda.

Background: In many developing countries, rheumatic heart disease (RHD) is diagnosed at an advanced stage and requires surgery for patient survival. However, access to cardiac surgery in this context is limited and often provided through partnerships, requiring centralized patient data systems for monitoring and follow-up. Objectives: This study used data from a national postoperative RHD registry to analyze clinical outcomes of Rwandan patients who received surgery between 2006 and 2017. Methods: The RHD registry was created in 2017 using data compiled from Rwanda Ministry of Health and RHD surgery partners. We extracted pre- and post-operative data on patients who were alive and in care. We excluded patients who died or were lost to follow-up, as their data was not collected in the registry. We evaluated the association between demographic, surgical, and follow-up characteristics and most recent patient symptoms, categorized by New York Heart Association (NYHA) class. Findings: Among the 191 patients eligible for inclusion in this study, 107(56.0%) were female, 110(57.6%) were adults at the time of surgery (>15 years), and 128(67.4%) had surgery in Rwanda. Most patients (n = 166, 86.9%) were on penicillin prophylaxis. Of the patients with mechanical valves, 47(29.9%) had therapeutic International Normalized Ratio values. 90% of patients were asymptomatic (NYHA I) at the time of most recent visit. NYHA class was not significantly associated with any of the considered variables. The median length of follow-up for patients was four years (IQR: 2, 5 years). Conclusion: This study shows both the feasibility and challenges of creating a RHD registry 11 years after the national initiation of RHD surgeries. Most patients captured in the registry are asymptomatic; however, collecting details on patients who had died or were lost to follow-up has proven difficult. Implementing strategies to maintain a complete and up-to-date registry will facilitate follow-up for pre- and postoperative patients.

Genome-wide association of implantable cardioverter-defibrillator activation with life-threatening arrhythmias.

OBJECTIVES: To identify genetic factors that would be predictive of individuals who require an implantable cardioverter-defibrillator (ICD), we conducted a genome-wide association study among individuals with an ICD who experienced a life-threatening arrhythmia (LTA; cases) vs. those who did not over at least a 3-year period (controls). BACKGROUND: Most individuals that receive implantable cardioverter-defibrillators never experience a life-threatening arrhythmia. Genetic factors may help identify who is most at risk. METHODS: Patients with an ICD and extended follow-up were recruited from 34 clinical sites with the goal of oversampling those who had experienced LTA, with a cumulative 607 cases and 297 controls included in the analysis. A total of 1,006 Caucasian patients were enrolled during a time period of 13 months. Arrhythmia status of 904 patients could be confirmed and their genomic data were included in the analysis. In this cohort, there were 704 males, 200 females, and the average age was 73.3 years. We genotyped DNA samples using the Illumina Human660 W Genotyping BeadChip and tested for association between genotype at common variants and the phenotype of having an LTA. RESULTS AND CONCLUSIONS: We did not find any associations reaching genome-wide significance, with the strongest association at chromosome 13, rs11856574 at P = 5×10⁻6. Loci previously implicated in phenotypes such as QT interval (measure of the time between the start of the Q wave and the end of the T wave as measured by electrocardiogram) were not found to be significantly associated with having an LTA. Although powered to detect such associations, we did not find common genetic variants of large effect associated with having a LTA in those of European descent. This indicates that common gene variants cannot be used at this time to guide ICD risk-stratification. TRIAL REGISTRATION: ClinicalTrials.gov NCT00664807.

Qualitative evaluation of a mobile phone and web-based collaborative care intervention for patients with type 2 diabetes.

BACKGROUND: Drawing on previous web-based diabetes management programs based on the Chronic Care Model, we expanded an intervention to include care management through mobile phones and a game console web browser. METHODS: The pilot intervention enrolled eight diabetes patients from the University of Washington in Seattle into a collaborative care program: connecting them to a care provider specializing in diabetes, providing access to their full electronic medical record, allowing wireless glucose uploads and e-mail with providers, and connecting them to the program's web services through a game system. To evaluate the study, we conducted qualitative thematic analysis of semistructured interviews. RESULTS: Participants expressed frustrations with using the cell phones and the game system in their everyday lives, but liked the wireless system for collaborating with a provider on uploaded glucoses and receiving automatic feedback on their blood sugar trends. A majority of participants also expressed that their participation in the trial increased their health awareness. DISCUSSION: Mobile communication technologies showed promise within a web-based collaborative care program for type 2 diabetes. Future intervention design should focus on integrating easy-to-use applications within mobile technologies already familiar to patients and ensure the system allows for sufficient collaboration with a care provider.

Designing mobile support for glycemic control in patients with diabetes.

We assessed the feasibility and acceptability of using mobile phones as part of an existing Web-based system for collaboration between patients with diabetes and a primary care team. In design sessions, we tested mobile wireless glucose meter uploads and two approaches to mobile phone-based feedback on glycemic control. Mobile glucose meter uploads combined with graphical and tabular data feedback were the most desirable system features tested. Participants had a mixture of positive and negative reactions to an automated and tailored messaging feedback system for self-management support. Participants saw value in the mobile system as an adjunct to the Web-based program and traditional office-based care. Mobile diabetes management systems may represent one strategy to improve the quality of diabetes care.

Web-based collaborative care for type 1 diabetes: a pilot randomized trial.

BACKGROUND: To determine whether a Web-based diabetes case management program based in an electronic medical record can improve glycemic control (primary outcome) and diabetes-specific self-efficacy (secondary outcome) in adults with type 1 diabetes, a pilot randomized controlled trial was conducted. METHODS: A 12-month randomized trial tested a Web-based case management program in a diabetes specialty clinic. Patients 21-49 years old with type 1 diabetes receiving multiple daily injections with insulin glargine and rapid-acting analogs who had a recent A1C >7.0% were eligible for inclusion. Participants were randomized to receive either (1) usual care plus the nurse-practitioner-aided Web-based case management program (intervention) or (2) usual clinic care alone (control). We compared patients in the two study arms for changes in A1C and self-efficacy measured with the Diabetes Empowerment Scale. RESULTS: A total of 77 patients were recruited from the diabetes clinic and enrolled in the trial. The mean baseline A1C among study participants was 8.0%. We observed a nonsignificant decrease in average A1C (-0.48; 95% confidence interval -1.22 to 0.27; P = 0.160) in the intervention group compared to the usual care group. The intervention group had a significant increase in diabetes-related self-efficacy compared to usual care (group difference of 0.30; 95% confidence interval 0.01 to 0.59; P = 0.04). CONCLUSIONS: Use of a Web-based case management program was associated with a beneficial treatment effect on self-efficacy, but change in glycemic control did not reach statistical significance in this trial of patients with moderately poorly controlled type 1 diabetes. Larger studies may be necessary to further clarify the intervention's impact on health outcomes.

Web-based collaborative care for type 2 diabetes: a pilot randomized trial.

OBJECTIVE: To test Web-based care management of glycemic control using a shared electronic medical record with patients who have type 2 diabetes. RESEARCH DESIGN AND METHODS: We conducted a trial of 83 adults with type 2 diabetes randomized to receive usual care plus Web-based care management or usual care alone between August 2002 and May 2004. All patients had GHb > or =7.0%, had Web access from home, and could use a computer with English language-based programs. Intervention patients received 12 months of Web-based care management. The Web-based program included patient access to electronic medical records, secure e-mail with providers, feedback on blood glucose readings, an educational Web site, and an interactive online diary for entering information about exercise, diet, and medication. The primary outcome was change in GHb. RESULTS: GHb levels declined by 0.7% (95% CI 0.2-1.3) on average among intervention patients compared with usual-care patients. Systolic blood pressure, diastolic blood pressure, total cholesterol levels, and use of in-person health care services did not differ between the two groups. CONCLUSIONS: Care management delivered through secure patient Web communications improved glycemic control in type 2 diabetes.

Self-management support in a web-based medical record: a pilot randomized controlled trial.

Physicians were much less likely than other primary care team members to use a Web-based application to counsel patients with diabetes about behavior change.

Patients' experience with a diabetes support programme based on an interactive electronic medical record: qualitative study.

OBJECTIVE: To describe the experiences of patients with type 2 diabetes in a web based disease management programme based on an interactive electronic medical record. DESIGN: Qualitative analysis of semistructured interviews with patients enrolled in a diabetes care module that included access to their electronic medical record, secure email, ability to upload blood glucose readings, an education site with endorsed content, and an interactive online diary for entering exercise, diet, and medication. SETTING: Patients' homes in Washington state, United States. PARTICIPANTS: Nine participants aged 45-65 completed interviews before and after they used the programme. RESULTS: Six themes emerged: feeling that non-acute concerns are uniquely valued; enhanced sense of security about health and health care; frustration with unmet expectations; feeling more able to manage; valuing feedback; and difficulty fitting the programme into activities of daily life. Three themes--valuing non-acute concerns, feeling secure, and unmet expectations--have particular relevance to the design and use of web based tools for care of patients with diabetes and chronic medical conditions. CONCLUSION: Participants' experiences support further study of open access to the electronic medical record and online communication between patients and their care providers. The development of web based disease management programmes should take into account the specific needs and expectations of patients, and patients and providers should have candid discussions about what web based care can and cannot provide.

Using an Internet comanagement module to improve the quality of chronic disease care.

BACKGROUND: Web-based applications have the potential to support the ongoing care needs of patients with chronic disease. At the University of Washington, a diabetes care module was developed, and the feasibility of allowing patients with type 2 diabetes to comanage their disease from home was pilot tested. METHODS: The disease management module consisted of five Web sites that enabled patients to access their electronic medical records; upload blood glucose readings; enter medication, nutrition, and exercise data into an online diary; communicate with providers by using clinical e-mail; and browse an education site with endorsed content. All data could be viewed by patients and providers in online trended displays that a nurse practitioner case manager used to review cases weekly. RESULTS: "Proof-of-concept" was demonstrated by the three pilot participants who were the module's most active users. For example, one newly diagnosed patient was started on an oral hypoglycemic, underwent two upward dose adjustments, and achieved control (glycohemoglobin [HbA1c] from 8.0% to 6.1%). His treatment was conducted by exchanging 14 e-mails based on the 231 glucose-meter readings sent from home without requiring in-person follow-up visits. CONCLUSIONS: The Internet offers the opportunity to involve patients and providers in collaborative management of chronic diseases between office visits.

Managed care, access to specialists, and outcomes among primary care patients with pain.

OBJECTIVE: To determine whether managed care controls were associated with reduced access to specialists and worse outcomes among primary care patients with pain. DATA SOURCES/STUDY SETTING: Patient, physician, and office manager questionnaires collected in the Seattle area in 1996-1997, plus data abstracted from patient records and health plans. STUDY DESIGN: A prospective cohort study of 2,275 adult patients with common pain problems recruited in the offices of 261 primary care physicians in Seattle. DATA COLLECTION: Patients completed a waiting room questionnaire and follow-up surveys at the end of the first and sixth months to measure access to specialists and outcomes. Intensity of managed care controls measured by plan managed care index and benefit/cost-sharing indexes, office managed care index, physician compensation, financial incentives, and use of clinical guidelines. PRINCIPAL FINDINGS: A financial withhold for referral was associated with a lower likelihood of referral to a physician specialist, a greater likelihood of seeing a specialist without referral, and a lower patient rating of care from the primary physician. Otherwise, patients in more managed offices and with greater out-of-network plan benefits had greater access to specialists. Patients with more versus less managed care had similar health outcomes, but patients in more managed offices had lower ratings of care provided by their primary physicians. CONCLUSIONS: Increased managed care controls were generally not associated with reduced access to specialists and worse health outcomes for primary care patients with pain, but patients in more managed offices had lower ratings of care provided by their primary physicians.

A multifaceted intervention in support of diabetes treatment guidelines: a cont trial.

OBJECTIVE: in an academic family practice clinic, we performed a controlled trial of a multifaceted intervention versus usual care for managing diabetes. Providers received didactic training and computerized compliance feedback to support staged diabetes management, an evidenced-based approach to diabetes care. RESEARCH DESIGN AND METHODS: one firm of the clinic practice received the intervention, the other served as the control group during a 14-month baseline period and a 14-month study period. HbA1(c) was the principal outcome measure. RESULTS: there was a significant 0.71% difference in change in HbA1(c) values between the intervention and control firms (P=0.02). The subgroup with the greatest improvement in HbA1(c) was those subjects who started the intervention with a HbA1(c) above 8%. The overall improvement in glycemic control could not be explained by differences in visit frequency or the aggressiveness of drug therapy. There were no changes in healthcare utilization or costs between the two firms. CONCLUSION: in an academic family practice clinic, a multifaceted intervention in support of diabetes treatment guidelines modestly improved glycemic control without incurring additional costs. The improvement was mostly due to mitigation of the natural deterioration in control usually seen. Further efforts are required to involve all patients in co-managing their diabetes.

The Midpeninsula Health Service: action research using small primary care groups to provide evidence-based medicine that empowers patients while continuously improving quality and lowering costs.

OBJECTIVES: A Joint Planning Committee Report was issued in 1974 exploring how Stanford University might itself provide primary care to students, faculty, employees and their dependents at low cost. The report called for the creation of a health maintenance organization owned by its subscribers in affiliation with Stanford Medical Center. However, because the report was dismissed by the dean of the School of Medicine as being unworkable, the Midpeninsula Health Service (MHS) began operating as an unaffiliated, nonprofit health plan in downtown Palo Alto in January 1976. The MHS's planning, early operation, move to the Stanford campus, financial viability and ultimate fate are examined as an example of action research in health care. METHODS: Source documents were examined by the authors, a founding MHS board member and its two inaugural medical directors, in compiling a 30-year organizational history. RESULTS: The MHS was remarkably prescient in its early use of small primary care groups that included midlevel practitioners, the principles of evidence-based medicine, the participation of patients in self-care activities, and a commitment to the continuous monitoring and improvement of quality. Imputed annualized costs of care were 30% lower than contemporary fee-for-service care and 20% lower than that of Kaiser, with no discernible difference in health outcomes. CONCLUSION: Action research methods can be useful in identifying and testing potential solutions to vexing problems in health care delivery.

Managed care, access to mental health specialists, and outcomes among primary care patients with depressive symptoms.

OBJECTIVE: To determine whether managed care is associated with reduced access to mental health specialists and worse outcomes among primary care patients with depressive symptoms. DESIGN: Prospective cohort study. SETTING: Offices of 261 primary physicians in private practice in Seattle. PATIENTS: Patients (N = 17,187) were screened in waiting rooms, enrolling 1,336 adults with depressive symptoms. Patients (n = 942) completed follow-up surveys at 1, 3, and 6 months. MEASUREMENTS AND RESULTS: For each patient, the intensity of managed care was measured by the managedness of the patient's health plan, plan benefit indexes, presence or absence of a mental health carve-out, intensity of managed care in the patient's primary care office, physician financial incentives, and whether the physician read or used depression guidelines. Access measures were referral and actually seeing a mental health specialist. Outcomes were the Symptom Checklist for Depression, restricted activity days, and patient rating of care from primary physician. Approximately 23% of patients were referred to mental health specialists, and 38% saw a mental health specialist with or without referral. Managed care generally was not associated with a reduced likelihood of referral or seeing a mental health specialist. Patients in more-managed plans were less likely to be referred to a psychiatrist. Among low-income patients, a physician financial withhold for referral was associated with fewer mental health referrals. A physician productivity bonus was associated with greater access to mental health specialists. Depressive symptom and restricted activity day outcomes in more-managed health plans and offices were similar to or better than less-managed settings. Patients in more-managed offices had lower ratings of care from their primary physicians. CONCLUSIONS: The intensity of managed care was generally not associated with access to mental health specialists. The small number of managed care strategies associated with reduced access were offset by other strategies associated with increased access. Consequently, no adverse health outcomes were detected, but lower patient ratings of care provided by their primary physicians were found.

Evidence-based management: using serial firm trials to improve diabetes care quality.

BACKGROUND: The design of delivery systems that can truly conduct continuous quality improvement (CQI) as a routine part of clinical care provision remains a vexing problem. The effectiveness of the "computerized firm system" approach to chronic disease CQI was examined, with diabetes as the focus of a 5-year case study. METHODS: A large family medical center had been divided into two parallel group practices for reasons of efficiency. These frontline structures (also known as primary care "firms") were supported to serially adapt and evaluate selected CQI interventions by first introducing process changes on one firm but not the other and comparing the groups. Because all the required longitudinal data were contained in a computerized repository, it was possible to conduct these controlled "firm trials" in a matter of months at low cost. RESULTS: During a 3-year period, implementation of point-of-service reminders and a pharmacist out-reach program increased recommended glycohemoglobin (HbA1c) testing by 50% (p = 0.02) and reduced the number of diabetic patients inadequately controlled by 43% (p < 0.01). Following this outcome improvement, patients exhibited a 16% reduction in ambulatory visit rates (p = 0.04). The observed outcome improvement, however, was reversed during the subsequent 2 years, when staffing austerities forced by unrelated declines in clinic revenue caused the withdrawal of trial interventions. CONCLUSIONS: The processes and outcomes of diabetes care were improved, demonstrating that CQI and controlled trials are not mutually exclusive in moving toward the practice of evidence-based management. Health care systems can, by conducting serial firm trials, become learning organizations. CQI programs of all kinds will likely never flourish, however, until quality improvement and reimbursement mechanisms have become better aligned.