The Diabetes Telephone Study: Design and challenges of a pragmatic cluster randomized trial to improve diabetic peripheral neuropathy treatment.

BACKGROUND: Challenges to effective pharmacologic management of symptomatic diabetic peripheral neuropathy include the limited effectiveness of available medicines, frequent side effects, and the need for ongoing symptom assessment and treatment titration for maximal effectiveness. We present here the rationale and implementation challenges of the Diabetes Telephone Study, a randomized trial designed to improve medication treatment, titration, and quality of life among patients with symptomatic diabetic peripheral neuropathy. METHODS: We implemented a pragmatic cluster randomized controlled trial to test the effectiveness of an automated interactive voice response tool designed to provide physicians with real-time patient-reported data about responses to newly prescribed diabetic peripheral neuropathy medicines. A total of 1834 primary care physicians treating patients in the diabetes registry at Kaiser Permanente Northern California were randomized into the intervention or control arm. In September 2014, we began identification and recruitment of patients assigned to physicians in the intervention group who receive three brief interactive calls every 2 months after a medication is prescribed to alleviate diabetic peripheral neuropathy symptoms. These calls provide patients with the opportunity to report on symptoms, side effects, self-titration of medication dose and overall satisfaction with treatment. We plan to compare changes in self-reported quality of life between the intervention group and patients in the control group who receive three non-interactive automated educational phone calls. RESULTS: Successful implementation of this clinical trial required robust stakeholder engagement to help tailor the intervention and to address pragmatic concerns such as provider time constraints. As of 27 October 2015, we had screened 2078 patients, 1447 of whom were eligible for participation. We consented and enrolled 1206 or 83% of those eligible. Among those enrolled, 53% are women and the mean age is 67 (standard deviation = 12) years. The racial ethnic make-up is 56% White, 8% Asian, 13% Black or African American, and 19% Hispanic or Latino. CONCLUSION: Innovative strategies are needed to guide improvements in healthcare delivery for patients with symptomatic diabetic peripheral neuropathy. This trial aims to assess whether real-time collection and clinical feedback of patient treatment experiences can reduce patient symptom burden. Implementation of a clinical trial closely involving clinical care required researchers to partner with clinicians. If successful, this intervention provides a critical information feedback loop that would optimize diabetic peripheral neuropathy medication titration through widely available interactive voice response technology.

Improved blood pressure control associated with a large-scale hypertension program.

IMPORTANCE: Hypertension control for large populations remains a major challenge. OBJECTIVE: To describe a large-scale hypertension program in Northern California and to compare rates of hypertension control in that program with statewide and national estimates. DESIGN, SETTING, AND PATIENTS: The Kaiser Permanente Northern California (KPNC) hypertension program included a multifaceted approach to blood pressure control. Patients identified as having hypertension within an integrated health care delivery system in Northern California from 2001-2009 were included. The comparison group comprised insured patients in California between 2006-2009 who were included in the Healthcare Effectiveness Data and Information Set (HEDIS) commercial measurement by California health insurance plans participating in the National Committee for Quality Assurance (NCQA) quality measure reporting process. A secondary comparison group was included to obtain the reported national mean NCQA HEDIS commercial rates of hypertension control between 2001-2009 from health plans that participated in the NCQA HEDIS quality measure reporting process. MAIN OUTCOMES AND MEASURES: Hypertension control as defined by NCQA HEDIS. RESULTS: The KPNC hypertension registry included 349,937 patients when established in 2001 and increased to 652,763 by 2009. The NCQA HEDIS commercial measurement for hypertension control within KPNC increased from 43.6% (95% CI, 39.4%-48.6%) to 80.4% (95% CI, 75.6%-84.4%) during the study period (P < .001 for trend). In contrast, the national mean NCQA HEDIS commercial measurement increased from 55.4% to 64.1%. California mean NCQA HEDIS commercial rates of hypertension were similar to those reported nationally from 2006-2009 (63.4% to 69.4%). CONCLUSIONS AND RELEVANCE: Among adults diagnosed with hypertension, implementation of a large-scale hypertension program was associated with a significant increase in hypertension control compared with state and national control rates. Key elements of the program included a comprehensive hypertension registry, development and sharing of performance metrics, evidence-based guidelines, medical assistant visits for blood pressure measurement, and single-pill combination pharmacotherapy.

Effect of Lifestyle Coaching or Enhanced Pharmacotherapy on Blood Pressure Control Among Black Adults With Persistent Uncontrolled Hypertension: A Cluster Randomized Clinical Trial.

Importance: Greater difficulty in controlling blood pressure (BP) and adverse lifestyle practices such as higher salt intake or less physical activity may account for some of the differences between BP control rates in Black vs White adults, thereby exposing Black adults to a higher risk of vascular events. Objective: To determine whether a lifestyle coaching intervention or an enhanced pharmacotherapy protocol is more effective than usual care in improving BP control rates in Black adults treated within an integrated health care delivery system. Design, Setting, and Participants: Shake, Rattle & Roll, a cluster randomized clinical trial, was conducted from June 5, 2013, to June 11, 2018, in a large integrated health care delivery system. Enrollment was completed during a 12-month period and interventions were implemented for 12 months. Follow-up lasted 48 months after enrollment. Panels of Black adult members of the health care delivery system with BP of at least 140/90 mm Hg from 98 adult primary care physicians were randomly assigned at the primary care physician level to usual care (UC group [n = 1129]), enhanced pharmacotherapy monitoring (EP group [n = 346]) of current BP management protocol, or diet and lifestyle coaching consisting of photographs, stories, and recipes, for example, that are appropriate for Black adults (LC group [n = 286]) focused on the Dietary Approaches to Stop Hypertension (DASH) diet. Data were analyzed from June 1, 2016, to March 25, 2022. Interventions: The UC group received care per customary protocol. The EP group was contacted by a research nurse and/or a clinical pharmacist to discuss barriers to hypertension control, and drug therapy emphasized the use of thiazide diuretic intensification and addition of spironolactone as needed. The LC group received as many as 16 telephone sessions with a lifestyle coach and an emphasis on implementing reduction of sodium intake and the DASH diet. Main Outcomes and Measures: Intention-to-treat analysis of BP control rates at end of the 12-month intervention. Results: Among the 1761 participants, the mean (SD) age was 61 (13) years, and 1214 (68.9%) were women. At the end of the 12-month intervention period, there was no significant difference in BP control rate among study groups (UC, 61.8% [95% CI, 58.8%-64.9%]; EP, 64.5% [95% CI, 59.0%-69.4%]; LC, 67.8% [95% CI, 62.1%-73.2%]; LC vs EP, P = .07). However, greater BP control was present in the LC group vs UC at 24 months (UC, 61.2% [95% CI, 57.3%-64.7%]; EP, 67.6% [95% CI, 61.9%-72.8%]; LC, 72.4% [95% CI, 66.9%-78.1%]; LC vs UC, P = .001), and 48 months (UC, 64.5% [95% CI, 61.6%-67.2%]; EP, 66.5% [95% CI, 61.3%-71.3%]; LC, 73.1% [95% CI, 67.6%-77.9%]; LC vs UC, P = .006) after enrollment. The contribution of BP medication adherence to explain group differences was inconclusive. Conclusions and Relevance: In this cluster randomized clinical trial including Black adults with persistent uncontrolled hypertension, a 12-month LC intervention was more effective at controlling BP than UC at 24 and 48 months after enrollment. Further research is needed to explore the potential implementation of this intervention into clinical practice. Trial Registration: ClinicalTrials.gov Identifier: NCT01892592.

Clinical Decision Support to Address Racial Disparities in Hypertension Control in an Integrated Delivery System: Evaluation of a Natural Experiment.

INTRODUCTION: Effective, equity-promoting interventions implemented by health care systems are needed to address health care disparities and population-level health disparities. We evaluated the impact of a clinical decision support tool to improve evidence-based thiazide diuretic prescribing among Black patients to address racial disparities in hypertension control. METHODS: We employed an interrupted time series design and qualitative interviews to evaluate the implementation of the tool. Our primary outcome measure was the monthly rate of thiazide use among eligible patients before and after implementation of the tool (January 2013-December 2016). We modeled month-to-month changes in thiazide use for Black and White patients, overall, and by sex and medical center racial composition. We conducted key informant interviews to identify modifiable facilitators and barriers to implementation of the tool across medical centers. RESULTS: Of the 318,720 patients, 15.5% were Black. We observed no change in thiazide use or blood pressure control following the implementation of the tool in either racial subgroup. There was a slight but statistically significant reduction (2.32 percentage points, p < 0.01) in thiazide use among Black patients following the removal the tool that was not observed among White patients. Factors affecting the tool's implementation included physician and pharmacist resistance to thiazide use and a lack of ongoing promotion of the tool. DISCUSSION: The clinical decision support tool was insufficient to change prescribing practices and improve blood pressure control among Black patients. CONCLUSIONS: Future interventions should consider physician attitudes about thiazide prescribing and the importance of multilevel approaches to address hypertension disparities.

Shake Rattle & Roll - Design and rationale for a pragmatic trial to improve blood pressure control among blacks with persistent hypertension.

BACKGROUND: In Kaiser Permanente Northern California (KPNC), members had similar access to care and a very high overall rate of hypertension control. However, blacks had poorer blood pressure (BP) control than whites. The Shake Rattle & Roll (SRR) trial aimed to improve BP control rates in blacks and to reduce disparities in hypertension control. METHODS: SRR was a cluster randomized controlled trial conducted at an urban medical center. All 98 adult primary care physicians (PCP) and their panels of hypertensive black patients were randomized, stratified by panel size, to one of three arms: 1) Usual Care (n = 33 PCPs, N = 1129 patients); 2) Enhanced Monitoring arm with an emphasis on improving pharmacotherapy protocol adherence (n = 34 PCPs, N = 349 patients); or 3) Lifestyle arm with a culturally tailored diet and lifestyle coaching intervention focusing on the Dietary Approaches to Stop Hypertension eating plan (n = 31 PCPs, N = 286 patients). The intervention period was for 12-months post-enrollment. Follow-up was planned for one and three years post-intervention completion. Primary outcome measure was the proportion of participants with controlled BP, defined as <140/90 mmHg, at 12-months post-enrollment. Secondary outcome included adverse cardiovascular events. An intention-to-treat analysis was carried out as the primary analysis. CONCLUSION: SRR was a uniquely designed trial that included components from both pragmatic and explanatory methods. The pragmatic aspects allow for a more cost-effective way to conduct a clinical trial and easier implementation of successful interventions into clinical practice. However, there were also challenges of having mixed methodology with regards to trial conduction and analysis.

The Delivery Science Rapid Analysis Program: A Research and Operational Partnership at Kaiser Permanente Northern California.

INTRODUCTION: Health care researchers and delivery system leaders share a common mission to improve health care quality and outcomes. However, differing timelines, incentives, and priorities are often a barrier to research and operational partnerships. In addition, few funding mechanisms exist to generate and solicit analytic questions that are of interest to both research and to operations within health care settings, and provide rapid results that can be used to improve practice and outcomes. METHODS: The Delivery Science Rapid Analysis Program (RAP) was formed in 2013 within the Kaiser Permanente Northern California Division of Research, sponsored by The Permanente Medical Group. A Steering Committee consisting of both researchers and clinical leaders solicits and reviews proposals for rapid analytic projects that will use existing data and are feasible within 6 months and with up to $30,000 (approximately 25-50% full-time equivalent) of programmer/analyst effort. Review criteria include the importance of the analytic question for both research and operations, and the potential for the project to have a significant impact on care delivery within 12 months of completion. RESULTS: The RAP funded 5 research and operational analytic projects between 2013 and 2017. These projects spanned a wide range of clinical areas, including lupus, pediatric obesity, diabetes, e-cigarette use, and hypertension. The hypertension RAP project, which focused on optimizing thiazide prescribing in Black/African-American patients with hypertension, led to new insights that inform an equitable care quality metric designed to reduce blood pressure control disparities throughout the KPNC region. CONCLUSIONS: Programs that actively encourage research and operational analytic partnerships have significant potential to improve care, enhance research collaborations, and contribute to the building and sustaining of learning health care systems.