The Impact of Text Messaging to Promote Patient Reported Outcome Measures (PROMs) Completion in Orthopedic Practice: Findings From a Randomized Controlled Study.

It is difficult to achieve high response rates to Patient Reported Outcome Measures (PROMs) surveys collected as part of clinical care. However, they are operationally and clinically important. To understand the impact of text message reminders on response rates to PROMs collected via email as part of routine care for hip or knee replacement surgery, initial nonresponders were randomized to receive a text reminder or not at 7 and 12 days, if needed. At day 7, the overall survey response rate was 63%. Model-derived estimates for survey return after this point were 51.1% (95% confidence interval [CI], 48.0%-54.2%) in the text arm compared to 34.5% (95% CI, 31.6%-37.6%) in the no text arm. The effect of text messages on response rates did not vary by subpopulations considered nor were there differences in rates of key outcomes between the 2 groups, suggesting that it did not impact any underlying response bias. Given the relative low cost of text messages, they can be an efficient means to increase response rates.

Patient Experiences and Perceptions of Care Coordination in Primary Care.

BACKGROUND: Understanding patient perceptions of care coordination in primary care can help improve responsiveness to patients' needs, outcomes, and quality of care. PURPOSE: The purpose of this study was to explore patient experiences and perceptions of care coordination in primary care. METHOD: Interviews with 13 patients from 10 clinics were conducted and analyzed using directed content analysis. RESULTS: Three primary themes arose: care coordinators provide a gateway to accessing needed care; patients needed and valued the support and trusted advice of their care coordinators; and patients valued care coordinators' help with navigating, engaging, and educating them about their care. CONCLUSIONS: Understanding what patients value in care delivery can help frame a vision for a more responsive approach in delivering primary care, as well as create a pathway to quality improvement, moving toward a truly patient-centered focus in primary care.

Is There Room for Individual Patient-Specified Preferences in the Patient-Reported Outcome Measurement Revolution?

Purpose: The study aim was to test the feasibility of collecting qualitative patient-preferred outcomes or goals and the degree of their attainment as an addition to a standardized process for collecting quantitative composite patient-reported outcome measures (PROMs) from patients undergoing knee joint replacement. Methods: Patients of a large Midwestern medical group scheduled to have total replacement of their knee joint have been asked to complete a PROMs survey preoperatively and at 3 and 12 months after surgery since 2014. In March 2020, an open-ended question about their most important preferred outcome was added to the existing questionnaire. The responses for all 3 time periods from the first 6 months of this addition were summarized quantitatively and analyzed by 2 reviewers. Results: During that 6-month period, 1481 people completed the main survey while 1463 (98.8%) also completed the open-ended question. At baseline, 90.8% of the 590 baseline respondents identified a preferred outcome. If multiple-choice categories had been used, 82.7% of the responses would have lost some or a large amount of their preferred goals' meaning. Of the 144 who completed surveys at both baseline and 3 months, 86.1% reported another outcome in addition to pain relief, while 54.2% reported "Complete or Mostly" achieving their self-identified preferred outcome. Conclusions: Most people who have joint replacement surgery and respond to a quantitative PROMs survey are willing to report on their other preferred outcomes as well. Adding an open-ended question to PROMs surveys may increase clinician focus on addressing outcomes important to each patient.

Care coordination in primary care: mapping the territory.

OBJECTIVE: To document the current approaches to care coordination among different types of care systems in Minnesota. STUDY DESIGN: Observational survey of leaders of most of the care systems in Minnesota that have implemented care coordination. METHODS: Survey questions about organizational structure, size, and approach to care coordination were sent to the leaders of 42 care systems with a total of 327 primary care clinics. RESULTS: Surveys were completed by leaders at every care system participating in this study (100% response rate); 16 small care systems (each with 1-2 clinics) had a total of 26 primary care clinics, 15 medium care systems (3-9 clinics) had 57 clinics, and 11 large care systems (> 9 clinics) had 244 clinics. The large care systems had larger clinics (clinicians per clinic, 8.6 in large vs 4.3 in small and 5.2 in medium; P = .03) and more clinicians per care coordinator (5.7 vs 3.3 and 4.0; P = .04). They also more frequently included a social worker in their care coordination team: 82% vs 25% of small and 40% of medium care systems (P = .01). However, the services provided and complexity tools used were similar. Nearly all reported addressing both medical and social needs for their complex patients with multiple chronic conditions. CONCLUSIONS: Although there are large differences in resources and capabilities between large and small care systems, they were not associated with much difference in the approach taken to care coordination. This map of the care coordination territory in Minnesota has the potential to be valuable to researchers and care system leaders for understanding current implementation trends and directing further evaluations.

Successful Change Management Strategies for Improving Diabetes Care Delivery Among High-Performing Practices.

PURPOSE: To learn how the highest-performing primary care practices manage change when implementing improvements to diabetes care delivery. METHODS: We ranked a total of 330 primary care practices submitting practice management assessments and diabetes reports to the Understanding Infrastructure Transformation Effects on Diabetes study in 2017 and 2019 by Optimal Diabetes Care performance. We ranked practices from the top quartile by greatest annual improvement to capture dynamic change. Starting with the top performers, we interviewed practice leaders to identify their most effective strategies for managing change. Interview transcripts were qualitatively analyzed to identify change management strategies. Saturation occurred when no new strategies were identified over 2 consecutive interviews. RESULTS: Ten of the top 13 practices agreed to interviews. We identified 199 key comments representing 48 key care management concepts. We also categorized concepts into 6 care management themes and 37 strategic approaches. We categorized strategic approaches into 13 distinct change management strategies. The most common strategies identified were (1) standardizing the care process, (2) performance awareness, (3) enhancing care teams, (4) health care organization participation, (5) improving reporting systems, (6) engaging staff and clinicians, (7) accountability for tasks, (8) engaging leadership, and (9) tracking change. Care management themes identified by most practices included proactive care, improving patient relationships, and previsit planning. CONCLUSIONS: Top-performing primary care practices identify a similar group of strategies as important for managing change during quality improvement activities. Practices involved in diabetes improvement activities, and perhaps other chronic conditions, should consider adopting these change management strategies.

The Impact of COVID-19 on Patients Receiving Care Coordination in Primary Care: A Qualitative Study.

INTRODUCTION: Care coordination addresses the needs of patients with complex chronic illness and psychosocial issues, coordinating their care and social needs. It is not known how such patients receiving these services managed during the COVID-19 pandemic. The objective of this study was to learn how the health, health care, social needs, and finances of patients receiving care coordination were affected by the disruptions caused by the COVID-19 pandemic. METHOD: We conducted semistructured interviews with 19 patients receiving care coordination in primary care across a statewide sample about how the COVID-19 pandemic affected their life in general, including their overall health, social connections, finances and employment, and mental health. A content analysis approach was applied in the data analysis. RESULTS: We identified 4 primary themes in patient interviews including: (1) patients reported few to no impacts on their physical health status or health care services; (2) patients felt disconnected from family, friends, and community in ways that affected their mental health and wellbeing; (3) there were little to no pandemic related impacts for those on fixed incomes or government supports; and (4) care coordinators provided a significant and reliable source of help, support, and comfort. CONCLUSIONS: Care coordination provided a supporting framework for the health and the health care needs of these patients, helping them navigate resources and maintain their physical health during the pandemic. Care coordinators were seen as providing needed communication, connection, and support that was especially needed during a time of social isolation and disconnection.

Care Management Processes Important for High-Quality Diabetes Care.

OBJECTIVE: Identify the improvement in diabetes performance measures and population-based clinical outcomes resulting from changes in care management processes (CMP) in primary care practices over 3 years. RESEARCH DESIGN AND METHODS: This repeated cross-sectional study tracked clinical performance measures for all diabetes patients seen in a cohort of 330 primary care practices in 2017 and 2019. Unit of analysis was patient-year with practice-level CMP exposures. Causal inference is based on dynamic changes in individual CMPs between years by practice. We used the Bayesian method to simultaneously estimate a five-outcome model: A1c, systolic and diastolic blood pressure, guideline-based statin use, and Optimal Diabetes Care (ODC). We control for unobserved time-invariant practice characteristics and secular change. We modeled correlation of errors across outcomes. Statistical significance was identified using 99% Bayesian credible intervals (analogous to P < 0.01). RESULTS: Implementation of 18 of 62 CMPs was associated with statistically significant improvements in patient outcomes. Together, these resulted in 12.1% more patients meeting ODC performance measures. Different CMPs affected different outcomes. Three CMPs accounted for 47% of the total ODC improvement, 68% of A1c decrease, 21% of SBP reduction, and 55% of statin use increase: 1) systems for identifying and reminding patients due for testing, 2) after-visit follow-up by a nonclinician, and 3) guideline-based clinician reminders for preventive services during a clinic visit. CONCLUSIONS: Effective quality improvement in primary care focuses on practice redesign that clearly improves diabetes outcomes. Tailoring CMP adoption in primary care provides effective improvement in ODC performance through focused changes in diabetes outcomes.

COVID-19 Impacts on Primary Care Clinic Care Management Processes.

PURPOSE: To learn whether the COVID-19 pandemic's disruptions and associated reduced health outcomes for people with chronic conditions might have been caused by a decrease in care management processes (CMPs) in primary care clinics METHODS: Longitudinal cohort design with repeated survey-based measures of CMPs from 2017, 2019, and 2021 in 269 primary care clinics in Minnesota. RESULTS: There were only small differences in organizational characteristics and no differences in overall CMPs between the 269 clinics analyzed and the 287 that only completed surveys in 1 or 2 years. Overall CMP scores rose by similar amounts (1.6% and 2.1%) from 2017 to 2019 and from 2019 to 2021. In 2021, CMP scores were lower in small medical groups than in large medical groups in 2017 (66.1% vs 78.5%, P <.001), a similar difference to that in 2017. Care management process scores were also lower in clinics in urban areas compared with rural areas (73.9% vs 79.0%, P <.001), but overall scores in all subgroups were higher in 2021 than in 2017. This improvement occurred despite reports from 55% of clinic leaders that the pandemic had been very or extremely disruptive. CONCLUSIONS: Although quite disrupted by the pandemic, care management processes for chronic disease care in these resilient primary care clinics actually increased from 2019 to 2021, at least in clinics that were part of large organizations. However, that was not true for clinics from smaller groups and perhaps for other areas of care.

Design of a pragmatic clinical trial to improve screening and treatment for opioid use disorder in primary care.

BACKGROUND: Opioid-related deaths continue to rise in the U.S. A shared decision-making (SDM) system to help primary care clinicians (PCCs) identify and treat patients with opioid use disorder (OUD) could help address this crisis. METHODS: In this cluster-randomized trial, primary care clinics in three healthcare systems were randomized to receive or not receive access to an OUD-SDM system. The OUD-SDM system alerts PCCs and patients to elevated risk of OUD and supports OUD screening and treatment. It includes guidance on OUD screening and diagnosis, treatment selection, starting and maintaining patients on buprenorphine for waivered clinicians, and screening for common comorbid conditions. The primary study outcome is, of patients at high risk for OUD, the percentage receiving an OUD diagnosis within 30 days of index visit. Additional outcomes are, of patients at high risk for or with a diagnosis of OUD, (a) the percentage receiving a naloxone prescription, or (b) the percentage receiving a medication for OUD (MOUD) prescription or referral to specialty care within 30 days of an index visit, and (c) total days covered by a MOUD prescription within 90 days of an index visit. RESULTS: The intervention started in April 2021 and continues through December 2023. PCCs and patients in 90 clinics are included; study results are expected in 2024. CONCLUSION: This protocol paper describes the design of a multi-site trial to help PCCs recognize and treat OUD. If effective, this OUD-SDM intervention could improve screening of at-risk patients and rates of OUD treatment for people with OUD.

Clinician Experiences With Telepsychiatry Collaborative Care for Posttraumatic Stress Disorder and Bipolar Disorder.

OBJECTIVE: Posttraumatic stress disorder (PTSD) and bipolar disorder are common in primary care. Evidence supports collaborative care in primary care settings to treat depression and anxiety, and recent studies have evaluated its effectiveness in treating complex conditions such as PTSD and bipolar disorder. This study aimed to examine how primary care clinicians experience collaborative care for patients with these more complex psychiatric disorders. METHODS: The authors conducted semistructured interviews with 22 primary care clinicians participating in a pragmatic trial that included telepsychiatry collaborative care (TCC) to treat patients with PTSD or bipolar disorder in rural or underserved areas. Analysis utilized a constant comparative method to identify recurring themes. RESULTS: Clinicians reported that TCC improved their confidence in managing medications for patients with PTSD or bipolar disorder and supported their ongoing learning and skill development. Clinicians also reported improvements in patient engagement in care. Care managers were crucial to realizing these benefits by fostering communication within the clinical team while engaging patients through regular outreach. Clinicians valued TCC because it included and supported them in improving the care of patients' mental health conditions, which opened opportunities for clinicians to enhance care and address co-occurring general medical conditions. Overall, benefits of the TCC model outweighed its minimal burdens. CONCLUSIONS: Clinicians found that TCC supported their care of patients with PTSD or bipolar disorder. This approach has the potential to extend the reach of specialty mental health care and to support primary care clinicians treating patients with these more complex psychiatric disorders.

The potential impact of clinical decision support on nonwaivered primary care clinicians' prescribing of buprenorphine.

Elimination of the X-waiver increased potential buprenorphine prescribers 13-fold, but growth in prescribing will likely be much lower. We explored self-assessments of nonwaivered primary care clinicians (PCCs) for factors affecting their likelihood to prescribe buprenorphine were the X-waiver eliminated (since realized January 2023) and the potential impacts of a clinical decision-support (CDS) tool for opioid use disorder (OUD). Cross-sectional survey data were obtained between January 2021 and March 2022 from 305 nonwaivered PCCs at 3 health systems. Factors explored were patient requests for buprenorphine, PCC access to an OUD-CDS, and PCC confidence and abilities for 5 OUD-care activities. Relationships were described using descriptive statistics and odds ratios. Only 26% of PCCs were more likely to prescribe buprenorphine upon patient request, whereas 63% were more likely to prescribe with the OUD-CDS. PCC confidence and abilities for some OUD-care activities were associated with increased prescribing likelihood from patient requests, but none were associated with the OUD-CDS. The OUD-CDS may increase buprenorphine prescribing for PCCs less likely to prescribe upon patient request. Future research is needed to develop interventions that increase PCC buprenorphine prescribing. Clinical trial registration: ClinicalTrials.gov. Identifier: NCT04198428. Clinical trial name: Clinical Decision Support for Opioid Use Disorders in Medical Settings (Compute 2.0).

How Does Prior Experience Pay Off in Large-Scale Quality Improvement Initiatives?

INTRODUCTION: To examine the association of prior investment on the effectiveness of organizations delivering large-scale external support to improve primary care. METHODS: Mixed-methods study of 7 EvidenceNOW grantees (henceforth, Cooperatives) and their recruited practices (n = 1720). Independent Variable: Cooperatives's experience level prior to EvidenceNOW, defined as a sustained track record in delivering large-scale quality improvement (QI) to primary care practices (high, medium, or low). Dependent Variables: Implementation of external support, measured as facilitation dose; effectiveness at improving (1) clinical quality, measured as practices' performance on Aspirin, Blood Pressure, Cholesterol, and Smoking (ABCS); and (2) practice capacity, measured using the Adaptive Reserve (AR) score and Change Process Capacity Questionnaire (CPCQ). Data were analyzed using multivariable linear regressions and a qualitative inductive approach. RESULTS: Cooperatives with High (vs low) levels of prior experience with and investment in large-scale QI before EvidenceNOW recruited more geographically dispersed and diverse practices, with lower baseline ABCS performance (differences ranging from 2.8% for blood pressure to 41.5% for smoking), delivered more facilitation (mean=+20.3 hours, P = .04), and made greater improvements in practices' QI capacity (CPCQ: +2.04, P < .001) and smoking performance (+6.43%, P = .003). These Cooperatives had established networks of facilitators at the start of EvidenceNOW and leadership experienced in supporting this workforce, which explained their better recruitment, delivery of facilitation, and improvement in outcomes. DISCUSSION: Long-term investment that establishes regionwide organizations with infrastructure and experience to support primary care practices in QI is associated with more consistent delivery of facilitation support, and greater improvement in practice capacity and some clinical outcomes.

Quality and team care response to the pandemic stresses in high performing primary care practices: A qualitative study.

OBJECTIVE: To learn how high performing primary care practices organized care for patients with diabetes during the initial months of the COVID-19 pandemic. PARTICIPANTS AND METHODS: Semi-structured interviews were conducted between August 10 and December 10, 2020 with 16 leaders from 11 practices that had top quartile performance measures for diabetes outcomes pre-COVID. Each clinic had completed a similar interview and a survey about the existence of care management systems associated with quality outcomes before the pandemic. Transcript analysis utilized a theoretical thematic analysis at the semantic level. RESULTS: The pandemic disrupted the primary care practices' operations and processes considered important for quality prior to the pandemic, particularly clinic reliance on proactive patient care. Safety concerns resulted from the shift to virtual visits, which produced documentation gaps and led practices to reorder their use of proactive patient care processes. Informal interactions with patients also declined. These practices' challenges were mitigated by technical, informational and operational help from the larger organizations of which they were a part. Care management processes had to accommodate both in-person and virtual visits. CONCLUSION: These high performing practices demonstrated an ability to adapt their use of proactive patient care processes in pursuing quality outcomes for patients with diabetes during the pandemic. Continued clinic transformation and improvements in quality within primary care depend on the ability to restructure the responsibilities of care team members and their interactions with patients.

Patient Perspectives on Opioid Risk Discussions in Primary Care.

Purpose: Both patients and clinicians have described discussions of potential opioid risks as challenging. This study's goal was to understand patient perspectives on discussing opioid risks with primary care clinicians (PCCs). Methods: Patients identified to be at elevated risk for problems with opioids (ie, opioid use disorder [OUD] diagnosis, taking a medication for OUD, or having ≥3 opioid prescriptions in the last year) were recruited from an integrated, Upper Midwest health system to participate in semi-structured qualitative interviews. Interview questions aimed to better understand patient views on conversations about opioid risks with PCCs and perceptions of OUD screening and treatment in primary care. Interviews were analyzed using an inductive thematic analysis approach. Results: A total of 20 patients participated (mean age: 53.5 years; 65% male). Six themes emerged: 1) archetypes of patient relationships with opioids (long-term opioid use, acute opioid use, OUD in treatment, OUD no treatment) require different approaches in discussing opioid risks; 2) patients may develop their own archetypes about PCCs and opioids; 3) these archetypes may help guide how conversations about opioids are conducted (eg, PCC demeanor, terminology); 4) most patients believe that primary care is an appropriate setting for opioid risk discussions; 5) patients may have limited awareness of the availability and value of overdose rescue medications; and 6) handouts are more acceptable if perceived to come from the PCC's assessment instead of a computer. Conclusions: Results suggest that patients generally perceive discussing opioid risks with PCCs acceptable. PCCs should tailor opioid risk conversations to patients' specific situations and needs.

Comparing Pharmacist-Led Telehealth Care and Clinic-Based Care for Uncontrolled High Blood Pressure: The Hyperlink 3 Pragmatic Cluster-Randomized Trial.

BACKGROUND: A team approach is one of the most effective ways to lower blood pressure (BP) in uncontrolled hypertension, but different models for organizing team-based care have not been compared directly. METHODS: A pragmatic, cluster-randomized trial compared 2 interventions in adult patients with moderately severe hypertension (BP≥150/95 mm Hg): (1) clinic-based care using best practices and face-to-face visits with physicians and medical assistants; and (2) telehealth care using best practices and adding home BP telemonitoring with home-based care coordinated by a clinical pharmacist or nurse practitioner. The primary outcome was change in systolic BP over 12 months. Secondary outcomes were change in patient-reported outcomes over 6 months. RESULTS: Participants (N=3071 in 21 primary care clinics) were on average 60 years old, 47% male, and 19% Black. Protocol-specified follow-up within 6 weeks was 32% in clinic-based care and 27% in telehealth care. BP decreased significantly during 12 months of follow-up in both groups, from 157/92 to 139/82 mm Hg in clinic-based care patients (adjusted mean difference -18/-10 mm Hg) and 157/91 to 139/81 mm Hg in telehealth care patients (adjusted mean difference -19/-10 mm Hg), with no significant difference in systolic BP change between groups (-0.8 mm Hg [95% CI, -2.84 to 1.32]). Telehealth care patients were significantly more likely than clinic-based care patients to report frequent home BP measurement, rate their BP care highly, and report that BP care visits were convenient. CONCLUSIONS: Telehealth care that includes extended team care is an effective and safe alternative to clinic-based care for improving patient-centered care for hypertension. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02996565.

Is the Promise of PROMs Being Realized? Implementation Experience in a Large Orthopedic Practice.

Patient-reported outcome measures (PROMs), increasingly used for research and quality measurement, are lauded for their potential to improve patient-centered care, both through aggregate reporting and when integrated into clinical practice. However, there are few published studies of the resultant use of PROMs in clinical practice. This case study describes the implementation and use of PROMS in a Midwestern multispecialty medical group orthopedic practice among patients undergoing total knee and hip surgery. Specifically, rates of PROMs use by care teams are tracked over time once made available in the electronic health record. During this time, the orthopedics department achieved a patient PROMS survey response rate of 68% at baseline, 58% 3 months post-surgery, and 55% 12 months post-surgery. However, these data were only accessed by the care teams for fewer than 1% of associated clinical encounters. This suggests that making PROMs available for care team review in the electronic health record, even when coupled with relatively high response rates from patients and departmental leadership support is not enough to encourage integration of PROMs into clinical care for patients. Additional effort is required to identify barriers to PROMs use in clinical care and to test methods to enhance use.

How Does Prior Experience Pay Off in Large-Scale Quality Improvement Initiatives?

INTRODUCTION: To examine the association of prior investment on the effectiveness of organizations delivering large-scale external support to improve primary care. METHODS: Mixed-methods study of 7 EvidenceNOW grantees (henceforth, Cooperatives) and their recruited practices (n = 1720). Independent Variable: Cooperatives's experience level prior to EvidenceNOW, defined as a sustained track record in delivering large-scale quality improvement (QI) to primary care practices (high, medium, or low). Dependent Variables: Implementation of external support, measured as facilitation dose; effectiveness at improving (1) clinical quality, measured as practices' performance on Aspirin, Blood Pressure, Cholesterol, and Smoking (ABCS); and (2) practice capacity, measured using the Adaptive Reserve (AR) score and Change Process Capacity Questionnaire (CPCQ). Data were analyzed using multivariable linear regressions and a qualitative inductive approach. RESULTS: Cooperatives with High (vs low) levels of prior experience with and investment in large-scale QI before EvidenceNOW recruited more geographically dispersed and diverse practices, with lower baseline ABCS performance (differences ranging from 2.8% for blood pressure to 41.5% for smoking), delivered more facilitation (mean=+20.3 hours, P = .04), and made greater improvements in practices' QI capacity (CPCQ: +2.04, P < .001) and smoking performance (+6.43%, P = .003). These Cooperatives had established networks of facilitators at the start of EvidenceNOW and leadership experienced in supporting this workforce, which explained their better recruitment, delivery of facilitation, and improvement in outcomes. DISCUSSION: Long-term investment that establishes regionwide organizations with infrastructure and experience to support primary care practices in QI is associated with more consistent delivery of facilitation support, and greater improvement in practice capacity and some clinical outcomes.

Reach in a pragmatic hypertension trial: A critical RE-AIM component.

BACKGROUND: Hypertension control is falling in the US yet efficacious interventions exist. Poor patient reach has limited the ability of pragmatic trials to demonstrate effectiveness. This paper uses quantitative and qualitative data to understand factors influencing reach in Hyperlink 3, a pragmatic hypertension trial testing an efficacious pharmacist-led Telehealth Care intervention in comparison to a physician-led Clinic-based Care intervention. Referrals to both interventions were ordered by physicians. METHODS: A sequential-explanatory mixed methods approach was used to understand barriers and facilitators to reach. Reach was assessed quantitatively using EHR data, defined as the proportion of eligible patients attending intended follow-up hypertension care and qualitatively, via semi-structured interviews with patients who were and were not reached. Quantitative data were analyzed using descriptive and inferential statistics. Qualitative data were analyzed via combined deductive and inductive content analysis. RESULTS: Of those eligible, 27% of Clinic-based (n = 532/1945) and 21% of Telehealth patients (n = 385/1849) were reached. In both arms, the largest drop was between physician-signed orders and patients attending initial intended follow-up care. Qualitative analyses uncovered patient barriers related to motivation, capability, and opportunity to attend follow-up care. CONCLUSIONS: Although the proportion of eligible patients with signed orders was high in both arms, the proportion ultimately reached was lower. Patients described barriers related to the influence of one's own personal beliefs or priorities, decision making processes, logistics, and patient perceptions on physician involvement on reach. Addressing these barriers in the design of pragmatic interventions is critical for future effectiveness. TRIAL REGISTRATION: NCT02996565.

Comparison of explanatory and pragmatic design choices in a cluster-randomized hypertension trial: effects on enrollment, participant characteristics, and adherence.

BACKGROUND: Explanatory trials are designed to assess intervention efficacy under ideal conditions, while pragmatic trials are designed to assess whether research-proven interventions are effective in "real-world" settings without substantial research support. METHODS: We compared two trials (Hyperlink 1 and 3) that tested a pharmacist-led telehealth intervention in adults with uncontrolled hypertension. We applied PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) scores to describe differences in the way these studies were designed and enrolled study-eligible participants, and the effect of these differences on participant characteristics and adherence to study interventions. RESULTS: PRECIS-2 scores demonstrated that Hyperlink 1 was more explanatory and Hyperlink 3 more pragmatic. Recruitment for Hyperlink 1 was conducted by study staff, and 2.9% of potentially eligible patients enrolled. Enrollees were older, and more likely to be male and White than non-enrollees. Study staff scheduled the initial pharmacist visit and adherence to attending this visit was 98%. Conversely for Hyperlink 3, recruitment was conducted by clinic staff at routine encounters and 81% of eligible patients enrolled. Enrollees were younger, and less likely to be male and White than non-enrollees. Study staff did not assist with scheduling the initial pharmacist visit and adherence to attending this visit was only 27%. Compared to Hyperlink 1, patients in Hyperlink 3 were more likely to be female, and Asian or Black, had lower socioeconomic indicators, and were more likely to have comorbidities. Owing to a lower BP for eligibility in Hyperlink 1 (>140/90 mm Hg) than in Hyperlink 3 (>150/95 mm Hg), mean baseline BP was 148/85 mm Hg in Hyperlink 1 and 158/92 mm Hg in Hyperlink 3. CONCLUSION: The pragmatic design features of Hyperlink 3 substantially increased enrollment of study-eligible patients and of those traditionally under-represented in clinical trials (women, minorities, and patients with less education and lower income), and demonstrated that identification and enrollment of a high proportion of study-eligible subjects could be done by usual primary care clinic staff. However, the trade-off was much lower adherence to the telehealth intervention than in Hyperlink 1, which is likely to reflect uptake under real-word conditions and substantially dilute intervention effect on BP. TRIAL REGISTRATION: The Hyperlink 1 study (NCT00781365) and the Hyperlink 3 study (NCT02996565) are registered at ClinicalTrials.gov.

Patient and Clinician Perspectives on Two Telemedicine Approaches for Treating Patients with Mental Health Disorders in Underserved Areas.

BACKGROUND: Primary care practices in underserved and/or rural areas have limited access to mental health specialty resources for their patients. Telemedicine can help address this issue, but little is known about how patients and clinicians experience telemental health care. METHODS: This pragmatic randomized effectiveness trial compared telepsychiatry collaborative care, where telepsychiatrists provided consultation to primary care teams, to a referral approach, where telepsychiatrists and telepsychologists assumed responsibility for treatment. Twelve Federally Qualified Health Centers in rural and/or underserved areas in 3 states participated. RESULTS: Patients and clinicians reported that both interventions alleviated barriers to accessing mental health care, provided quality treatment, and offered improvements over usual care. Telepsychiatry collaborative care was identified as better for patients with difficulty developing trust with new providers. This approach also required more primary care involvement than referral care, creating more opportunities for clinician learning related to mental health diagnosis and treatment. The referral approach was identified as better suited for patients with higher complexity or desiring specific psychotherapies. CONCLUSIONS: Both approaches addressed patient needs and provided access to specialty mental health care. Each approach better aligned with different patients' needs, suggesting that having both approaches available to practices is optimal for supporting patient-centered care.