Monitoring and responding to signals of suicidal ideation in pragmatic clinical trials: Lessons from the GRACE trial for Chronic Sickle Cell Disease Pain.

Sickle cell disease (SCD) is a hemoglobin disorder and the most common genetic disorder that affects 100,000 Americans and millions worldwide. Adults living with SCD have pain so severe that it often requires opioids to keep it in control. Depression is a major global public health concern associated with an increased risk in chronic medical disorders, including in adults living with sickle cell disease (SCD). A strong relationship exists between suicidal ideation, suicide attempts, and depression. Researchers enrolling adults living with SCD in pragmatic clinical trials are obligated to design their methods to deliberately monitor and respond to symptoms related to depression and suicidal ideation. This will offer increased protection for their participants and help clinical investigators meet their fiduciary duties. This article presents a review of this sociotechnical milieu that highlights, analyzes, and offers recommendations to address ethical considerations in the development of protocols, procedures, and monitoring activities related to suicidality in depressed patients in a pragmatic clinical trial.

Potential bias and lack of generalizability in electronic health record data: reflections on health equity from the National Institutes of Health Pragmatic Trials Collaboratory.

Embedded pragmatic clinical trials (ePCTs) play a vital role in addressing current population health problems, and their use of electronic health record (EHR) systems promises efficiencies that will increase the speed and volume of relevant and generalizable research. However, as the number of ePCTs using EHR-derived data grows, so does the risk that research will become more vulnerable to biases due to differences in data capture and access to care for different subsets of the population, thereby propagating inequities in health and the healthcare system. We identify 3 challenges-incomplete and variable capture of data on social determinants of health, lack of representation of vulnerable populations that do not access or receive treatment, and data loss due to variable use of technology-that exacerbate bias when working with EHR data and offer recommendations and examples of ways to actively mitigate bias.

Equity and bias in electronic health records data.

Embedded pragmatic clinical trials (ePCTs) are conducted during routine clinical care and have the potential to increase knowledge about the effectiveness of interventions under real world conditions. However, many pragmatic trials rely on data from the electronic health record (EHR) data, which are subject to bias from incomplete data, poor data quality, lack of representation from people who are medically underserved, and implicit bias in EHR design. This commentary examines how the use of EHR data might exacerbate bias and potentially increase health inequities. We offer recommendations for how to increase generalizability of ePCT results and begin to mitigate bias to promote health equity.

Hybrid effectiveness-implementation trial of guided relaxation and acupuncture for chronic sickle cell disease pain (GRACE): A protocol.

Background: People with sickle cell disease frequently use complementary and integrative therapies to cope with their pain, yet few studies have evaluated their effectiveness. The 3-arm, 3-site pragmatic Hybrid Effectiveness-implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain (GRACE) has 3 priorities: (1) evaluate guided relaxation and acupuncture to improve pain control; (2) determine the most appropriate and effective treatment sequence for any given patient based on their unique characteristics; and (3) describe the processes and structures required to implement guided relaxation and acupuncture within health care systems. Methods: Participants (N = 366) are being recruited and randomized 1:1:1 to one of 2 intervention groups or usual care. The acupuncture intervention group receives 10 sessions over approximately 5 weeks. The guided relaxation intervention group receives access to video sessions ranging from 2 to 20 min each viewed daily over 5 weeks. The usual care group receives the standard of clinical care for sickle cell disease. Participants are re-randomized at 6 weeks depending on their pain impact score. Assessments occur at 6 weeks, 12 weeks, and 24 weeks. The primary outcome is the change in pain impact score and secondary measures include opioid use, anxiety, depression, sleep, pain catastrophizing, substance use, global impression of change, constipation, and hospitalizations. The GRACE study uses the Consolidated Framework for Implementation Research to plan, execute, and evaluate the associated implementation processes. Conclusion: The results from GRACE will represent a critical step toward improving management of pain affecting patients with sickle cell disease.ClinicalTrials.gov Identifier: NCT04906447.

Smartphone Ownership and Interest in Mobile Health Technologies for Self-care Among Patients With Chronic Heart Failure: Cross-sectional Survey Study.

BACKGROUND: Heart failure (HF) is a highly prevalent chronic condition that places a substantial burden on patients, families, and health care systems worldwide. Recent advances in mobile health (mHealth) technologies offer great opportunities for supporting many aspects of HF self-care. There is a need to better understand patients' adoption of and interest in using mHealth for self-monitoring and management of HF symptoms. OBJECTIVE: The purpose of this study is to assess smartphone ownership and patient attitudes toward using mHealth technologies for HF self-care in a predominantly minority population in an urban clinical setting. METHODS: We conducted a cross-sectional survey of adult outpatients (aged ≥18 years) at an academic outpatient HF clinic in the Midwest. The survey comprised 34 questions assessing patient demographics, ownership of smartphones and other mHealth devices, frequently used smartphone features, use of mHealth apps, and interest in using mHealth technologies for vital sign and HF symptom self-monitoring and management. RESULTS: A total of 144 patients were approached, of which 100 (69.4%) participated in the study (63/100, 63% women). The participants had a mean age of 61.3 (SD 12.25) years and were predominantly Black or African American (61/100, 61%) and Hispanic or Latino (18/100, 18%). Almost all participants (93/100, 93%) owned a cell phone. The share of patients who owned a smartphone was 68% (68/100). Racial and ethnic minorities that identified as Black or African American or Hispanic or Latino reported higher smartphone ownership rates compared with White patients with HF (45/61, 74% Black or African American and 11/18, 61% Hispanic or Latino vs 9/17, 53% White). There was a moderate and statistically significant association between smartphone ownership and age (Cramér V [ΦC]=0.35; P<.001), education (ΦC=0.29; P=.001), and employment status (ΦC=0.3; P=.01). The most common smartphone features used by the participants were SMS text messaging (51/68, 75%), internet browsing (43/68, 63%), and mobile apps (41/68, 60%). The use of mHealth apps and wearable activity trackers (eg, Fitbits) for self-monitoring of HF-related parameters was low (15/68, 22% and 15/100, 15%, respectively). The most popular HF-related self-care measures participants would like to monitor using mHealth technologies were physical activity (46/68, 68%), blood pressure (44/68, 65%), and medication use (40/68, 59%). CONCLUSIONS: Most patients with HF have smartphones and are interested in using commercial mHealth apps and connected health devices to self-monitor their condition. Thus, there is a great opportunity to capitalize on the high smartphone ownership among racial and ethnic minority patients to increase reach and enhance HF self-management through mHealth interventions.