Electronic Medical Record-Assisted Design of a Cluster-Randomized Trial to Improve Diabetes Care and Outcomes

Background Electronic medical records (EMRs) have the potential to facilitate the design of large cluster-randomized trials (CRTs). Objective To describe the design of a CRT of clinical decision support to improve diabetes care and outcomes. Methods In the Diabetes Improvement Group-Intervention Trial (DIG-IT), we identified and balanced preassignment characteristics of 12,675 diabetic patients cared for by 147 physicians in 24 practices of 2 systems using the same vendor’s EMR. EMR-facilitated disease management was system A’s experimental intervention; system B interventions involved patient empowerment, with or without disease management. For our sample, we: (1) identified characteristics associated with response to interventions or outcomes; (2) summarized feasible partitions of 10 system A practices (2 groups) and 14 system B practices (3 groups) using intra-cluster correlation coefficients (ICCs) and standardized differences; (3) selected (blinded) partitions to effectively balance the characteristics; and (4) randomly assigned groups of practices to interventions. Results In System A, 4,306 patients, were assigned to 2 groups of practices; 8,369 patients in system B were assigned to 3 groups of practices. Nearly all baseline outcome variables and covariates were well-balanced, including several not included in the initial design. DIG-IT’s balance was superior to alternative partitions based on volume, geography or demographics alone. Conclusions EMRs facilitated rigorous CRT design by identifying large numbers of patients with diabetes and enabling fair comparisons through preassignment balancing of practice sites. Our methods can be replicated in other settings and for other conditions, enhancing the power of other translational investigations.     

Electronic Risk Alerts to Improve Primary Care Management of Chest Pain: A Randomized,Controlled Trial

BACKGROUND  

The primary care evaluation of chest pain represents a significant diagnostic challenge.     

A Randomized Trial to Improve Patient-Centered Care and Hypertension Control in Underserved Primary Care Patients

BACKGROUND  

African Americans and persons with low socioeconomic status (SES) are disproportionately affected by hypertension and receive less patient-centered care than less vulnerable patient populations. Moreover, continuing medical education (CME) and patient-activation interventions have infrequently been directed to improve the processes of care for these populations.     

A Cluster-Randomized Trial of a Primary Care Informatics-Based System for Breast Cancer Screening

BACKGROUND  

Information technology offers the promise, as yet unfulfilled, of delivering efficient, evidence-based health care.     

Randomized Controlled Trial of a Computer-Based,Tailored Intervention to Increase Smoking Cessation Counseling by Primary Care Physicians

OBJECTIVE: The primary care visit represents an important venue for intervening with a large population of smokers. However, physician adherence to the Smoking Cessation Clinical Guideline (5As) remains low. We evaluated the effectiveness of a computer-tailored intervention designed to increase smoking cessation counseling by primary care physicians. METHODS: Physicians and their patients were randomized to either intervention or control conditions. In addition to brief smoking cessation training, intervention physicians and patients received a one-page report that characterized the patients' smoking habit and history and offered tailored recommendations. Physician performance of the 5As was assessed via patient exit interviews. Quit rates and smoking behaviors were assessed 6 months postintervention via patient phone interviews. Intervention effects were tested in a sample of 70 physicians and 518 of their patients. Results were analyzed via generalized and mixed linear modeling controlling for clustering. MEASUREMENTS AND MAIN RESULTS: Intervention physicians exceeded controls on "Assess" (OR 5.06; 95% CI 3.22, 7.95), "Advise" (OR 2.79; 95% CI 1.70, 4.59), "Assist-set goals" (OR 4.31; 95% CI 2.59, 7.16), "Assist-provide written materials" (OR 5.14; 95% CI 2.60, 10.14), "Assist-provide referral" (OR 6.48; 95% CI 3.11, 13.49), "Assist-discuss medication" (OR 4.72;95% CI 2.90, 7.68), and "Arrange" (OR 8.14; 95% CI 3.98, 16.68), all p values being < 0.0001. Intervention patients were 1.77 (CI 0.94, 3.34,p = 0.078) times more likely than controls to be abstinent (12 versus 8%), a difference that approached, but did not reach statistical significance, and surpassed controls on number of days quit (18.4 versus 12.2, p < .05) but not on number of quit attempts. CONCLUSIONS: The use of a brief computer-tailored report improved physicians' implementation of the 5As and had a modest effect on patients' smoking behaviors 6 months postintervention.     

The Effects of Guided Care on the Perceived Quality of Health Care for Multi-morbid Older Persons: 18-Month Outcomes from a Cluster-Randomized Controlled Trial

BACKGROUND

The quality of health care for older Americans with chronic conditions is suboptimal.

OBJECTIVE

To evaluate the effects of “Guided Care” on patient-reported quality of chronic illness care.

DESIGN

Cluster-randomized controlled trial of Guided Care in 14 primary care teams.

PARTICIPANTS

Older patients of these teams were eligible to participate if, based on analysis of their recent insurance claims, they were at risk for incurring high health-care costs during the coming year. Small teams of physicians and their at-risk older patients were randomized to receive either Guided Care (GC) or usual care (UC).

INTERVENTION

“Guided Care” is designed to enhance the quality of health care by integrating a registered nurse, trained in chronic care, into a primary care practice to work with 2–5 physicians in providing comprehensive chronic care to 50–60 multi-morbid older patients.

MEASUREMENTS

Eighteen months after baseline, interviewers blinded to group assignment administered the Patient Assessment of Chronic Illness Care (PACIC) survey by telephone. Logistic and linear regression was used to evaluate the effect of the intervention on patient-reported quality of chronic illness care.

RESULTS

Of the 13,534 older patients screened, 2,391 (17.7%) were eligible to participate in the study, of which 904 (37.8%) gave informed consent and were cluster-randomized. After 18 months, 95.3% and 92.2% of the GC and UC recipients who remained alive and eligible completed interviews. Compared to UC recipients, GC recipients had twice greater odds of rating their chronic care highly (aOR = 2.13, 95% CI = 1.30–3.50, p = 0.003).

CONCLUSION

Guided Care improves self-reported quality of chronic health care for multi-morbid older persons.KEY WORDS: quality of care, chronic illness, older     

Pain Management in Primary Care: A Randomized Controlled Trial of a Computerized Decision Support Tool

BackgroundPrimary care providers manage most patients with chronic pain. Pain is a complex problem, particularly in underserved populations. A technology-enabled, point-of-care decision support tool may improve pain management outcomes.MethodsWe created an electronic health record (EHR)-based decision support tool, the Pain Management Support System–Primary Care (PMSS-PC), and studied the tool-plus-education in 6 Federally Qualified Health Center practices using a randomized, wait-list controlled design. The PMSS-PC generated “best practice alerts,” gave clinicians access to a pain assessment template, psychological distress and substance use measures, guidelines for drug and non-drug therapies, and facilitated referrals. Practices were randomly assigned to early vs delayed (after 6 months) implementation of the intervention, including technical support and 6 webinars. The primary outcome was change in worst pain intensity scores after 6 months, assessed on the Brief Pain Inventory-Short Form. Changes in outcomes were compared between the practices using linear multilevel modeling. The EHR provided clinician data on PMSS-PC utilization.ResultsThe 256 patients in the early implementation practices had significantly improved worst pain (standardized effect size [ES] = −.32) compared with the 272 patients in the delayed implementation practices (ES = −.11). There was very low clinician uptake of the intervention in both conditions.ConclusionsEarly implementation of the PMSS-PC improved worst pain, but this effect cannot be attributed to clinician use of the tool. Further PMSS-PC development is not indicated, but practice-level interventions can improve pain, and studies are needed to identify the determinants of change.     

Practice Context Affects Efforts to Improve Diabetes Care for Primary Care Patients: A Pragmatic Cluster Randomized Trial

BackgroundEfforts to improve primary care diabetes management have assessed strategies across heterogeneous groups of patients and practices. However, there is substantial variability in how well practices implement interventions and achieve desired outcomes.ObjectiveTo examine practice contextual features that moderate intervention effectiveness.DesignSecondary analysis of data from a cluster randomized trial of three approaches for implementing the Chronic Care Model to improve diabetes care.ParticipantsForty small to mid-sized primary care practices participated, with 522 clinician and staff member surveys. Outcomes were assessed for 822 established patients with a diagnosis of type 2 diabetes who had at least one visit to the practice in the 18 months following enrollment.ConclusionsThis study supports the need for broader use of methodological approaches to better examine contextual effects on implementation and effectiveness of quality improvement interventions in primary care settings.KEY WORDS: Diabetes, Contextual effects, Multilevel modeling     

Resistant Hypertension Optimal Treatment Trial: A Randomized Controlled Trial

The prevalence of resistant hypertension (ReHy) is not well established. Furthermore, diuretics, angiotensin‐converting enzyme inhibitors or angiotensin‐receptor blockers, and calcium channel blockers are largely used as the first 3‐drug combinations for treating ReHy. However, the fourth drug to be added to the triple regimen is still controversial and guided by empirical choices. We sought (1) to determine the prevalence of ReHy in patients with stage II hypertension; (2) to compare the effects of spironolactone vs clonidine, when added to the triple regimen; and (3) to evaluate the role of measuring sympathetic and renin‐angiotensin‐aldosterone activities in predicting blood pressure response to spironolactone or clonidine. The Resistant Hypertension Optimal Treatment (ReHOT) study ( ClinicalTrials.gov NCT01643434) is a prospective, multicenter, randomized trial comprising 26 sites in Brazil. In step 1, 2000 patients will be treated according to hypertension guidelines for 12 weeks, to detect the prevalence of ReHy. Medical therapy adherence will be checked by pill count monitoring. In step 2, patients with confirmed ReHy will be randomized to an open label 3‐month treatment with spironolactone (titrating dose, 12.5–50 mg once daily) or clonidine (titrating dose, 0.1–0.3 mg twice daily). The primary endpoint is the effective control of blood pressure after a 12‐week randomized period of treatment. The ReHOT study will disseminate results about the prevalence of ReHy in stage II hypertension and the comparison of spironolactone vs clonidine for blood pressure control in patients with ReHy under 3‐drug standard regimen.     

Optimizing Huddle Engagement Through Leadership and Problem Solving Within Primary Care: Results from a Cluster-Randomized Trial

BackgroundLeaders play a crucial role in implementing and sustaining changes in clinical practice, yet there is limited evidence on the strategies to engage them in team problem solving and communication.ObjectiveExamine the impact of an intervention focused on facilitating leadership during daily huddles on optimizing team-based care and improving outcomes.DesignCluster-randomized trial using intention-to-treat analysis to measure the effects of the intervention (n = 13 teams) compared with routine practice (n = 16 teams).ParticipantsTwenty-nine primary care clinics affiliated with a large integrated health system in the upper Midwest; representing differing practice types and geographic settings.InterventionFull-day leadership training retreat for team leaders to facilitate of care team huddles. Biweekly coaching calls and two site visits with an assigned coach.Main MeasuresPrimary outcomes of team development and function were collected, pre- and post-intervention using surveys. Patient satisfaction and quality outcomes were compared pre- and post-intervention as secondary outcomes. Leadership engagement and adherence to the intervention were also assessed.Key ResultsA total of 279 pre-intervention and 272 post-intervention surveys were completed. We found no impact on team development (− 0.98, 95% CI (− 3.18, 1.22)), improved team credibility (0.18, 95% CI (0.00, 0.35)), but worse psychological safety (− 0.19, 95% CI (− 0.38, 0.00)). No differences were observed in patient satisfaction; however, results were mixed among quality outcomes. Post hoc analysis within the intervention group showed higher adherence to the intervention was associated with improvement in team coordination (0.47, 95% CI (0.18, 0.76)), credibility (0.28, 95% CI (0.02, 0.53)), team learning (0.42, 95% CI (0.10, 0.74)), and knowledge creation (0.74, 95% CI (0.35, 1.13)) compared to teams that were less engaged.ConclusionsResults of this evaluation showed that leadership training and facilitation were not associated with better team functioning. Additional components to the intervention tested may be necessary to enhance team functioning.Trial RegistrationClinicaltrials.gov Identifier {"type":"clinical-trial","attrs":{"text":"NCT03062670","term_id":"NCT03062670"}}NCT03062670. Registration Date: February 23, 2017. URL: https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT03062670","term_id":"NCT03062670"}}NCT03062670Supplementary InformationThe online version contains supplementary material available at 10.1007/s11606-020-06487-6.KEY WORDS: teamwork, huddle, training, practice transformation     

Using Community Health Workers to Improve Clinical Outcomes Among People Living with HIV: A Randomized Controlled Trial

AIDS-related mortality remains a leading cause of preventable death among African-Americans. We sought to determine if community health workers could improve clinical outcomes among vulnerable African-Americans living with HIV in Miami, Florida. We recruited 91 medically indigent persons with HIV viral loads ≥1,000 and/or a CD4 cell count ≤350. Patients were randomized to a community health worker (CHW) intervention or control group. Viral load and CD4 cell count data were abstracted from electronic medical records. At 12 months, the mean VL in the intervention group was log 0.9 copies/μL lower than the control group. The CD4 counts were not significantly different among the groups. Compared to the control group, patients randomized to CHWs experienced statistically significant improvements in HIV viral load. Larger multi-site studies of longer duration are needed to determine whether CHWs should be incorporated into standard treatment models for vulnerable populations living with HIV.     

A Randomized Controlled Trial of Team-Based Care: Impact of Physician-Pharmacist Collaboration on Uncontrolled Hypertension

OBJECTIVE  Evaluate the effectiveness of collaborative management of hypertension by primary care-pharmacist teams in community-based clinics. STUDY DESIGN  A 12-month prospective, single-blind, randomized, controlled trial in the Providence Primary Care Research Network of patients with hypertension and uncontrolled blood pressure. METHODS  As compared to usual primary care, intervention consisted of pharmacy practitioners participating in the active management of hypertension in the primary care office according to established collaborative treatment protocols. At baseline, there was no significant difference in blood pressure between groups. Primary outcome measures were the differences in mean systolic and diastolic blood pressures between arms at study end. Secondary measures included blood pressure goal attainment (<140/90 mmHg), hypertension-related knowledge, medication adherence, home blood pressure monitoring, resource utilization, quality of life, and satisfaction. RESULTS  A total of 463 subjects were enrolled (n = 233 control, n = 230 intervention). Subjects receiving the intervention achieved significantly lower systolic (p = 0.007) and diastolic (p = 0.002) blood pressures compared to control (137/75 mmHg vs. 143/78 mmHg). In addition, 62% of intervention subjects achieved target blood pressure compared to 44% of control subjects (p = 0.003). The intervention group received more total office visits (7.2 vs. 4.9, p < 0.0001), however had fewer physician visits (3.2 vs. 4.7, p < 0.0001) compared to control. Intervention subjects were prescribed more antihypertensive medications (2.7 vs. 2.4, p = 0.02), but did not take more antihypertensive pills per day (2.4 vs. 2.5, p = 0.87). There were minimal differences between groups in hypertension-related knowledge, medication adherence, quality of life, or satisfaction. CONCLUSIONS  Patients randomized to collaborative primary care-pharmacist hypertension management achieved significantly better blood pressure control compared to usual care with no difference in quality of life or satisfaction. The primary author had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.     

Randomized, Controlled Trial of a Multimodal Intervention to Improve Cancer Screening Rates in a Safety-Net Primary Care Practice

Background

Cancer screening rates are suboptimal for low-income patients.

Objective

To assess an intervention to increase cancer screening among patients in a safety-net primary care practice.

Design

Patients at an inner-city family practice who were overdue for cancer screening were randomized to intervention or usual care. Screening rates at 1 year were compared using the chi-square test, and multivariable analysis was performed to adjust for patient factors.

Subjects

All average-risk patients at an inner-city family practice overdue for mammography or colorectal cancer (CRC) screening. Patients’ ages were 40 to 74 years (mean 53.9, SD 8.7) including 40.8 % African Americans, 4.2 % Latinos, 23.2 % with Medicaid and 10.9 % without any form of insurance.

Intervention

The 6-month intervention to promote cancer screening included letters, automated phone calls, prompts and a mailed Fecal Immunochemical Testing (FIT) Kit.

Main Measures

Rates of cancer screening at 1 year.

Key Results

Three hundred sixty-six patients overdue for screening were randomly assigned to intervention (n?=?185) or usual care (n?=?181). Primary analysis revealed significantly higher rates of cancer screening in intervention subjects: 29.7 % vs. 16.7 % for mammography (p?=?0.034) and 37.7 % vs. 16.7 % for CRC screening (p?=?0.0002). In the intervention group, 20 % of mammography screenings and 9.3 % of CRC screenings occurred at the early assessment, while the remainder occurred after repeated interventions. Within the CRC intervention group 44 % of screened patients used the mailed FIT kit. On multivariable analysis the CRC screening rates remained significantly higher in the intervention group, while the breast cancer screening rates were not statistically different.

Conclusions

A multimodal intervention significantly increased CRC screening rates among patients in a safety-net primary care practice. These results suggest that relatively inexpensive letters and automated calls can be combined for a larger effect. Results also suggest that mailed screening kits may be a promising way to increase average-risk CRC screening.     

Teaching Medical Students to Help Patients Quit Smoking: Outcomes of a 10-School Randomized Controlled Trial

Background

Early in medical education, physicians must develop competencies needed for tobacco dependence treatment.

Objective

To assess the effect of a multi-modal tobacco dependence treatment curriculum on medical students’ counseling skills.

Design

A group-randomized controlled trial (2010–2014) included ten U.S. medical schools that were randomized to receive either multi-modal tobacco treatment education (MME) or traditional tobacco treatment education (TE).

Setting/Participants

Students from the classes of 2012 and 2014 at ten medical schools participated. Students from the class of 2012 (N?=?1345) completed objective structured clinical examinations (OSCEs), and 50 % (N?=?660) were randomly selected for pre-intervention evaluation. A total of 72.9 % of eligible students (N?=?1096) from the class of 2014 completed an OSCE and 69.7 % (N?=?1047) completed pre and post surveys.

Interventions

The MME included a Web-based course, a role-play classroom demonstration, and a clerkship booster session. Clerkship preceptors in MME schools participated in an academic detailing module and were encouraged to be role models for third-year students.

Measurements

The primary outcome was student tobacco treatment skills using the 5As measured by an objective structured clinical examination (OSCE) scored on a 33-item behavior checklist. Secondary outcomes were student self-reported skills for performing 5As and pharmacotherapy counseling.

Results

Although the difference was not statistically significant, MME students completed more tobacco counseling behaviors on the OSCE checklist (mean 8.7 [SE 0.6] vs. mean?8.0 [SE 0.6], p?=?0.52) than TE students. Several of the individual Assist and Arrange items were significantly more likely to have been completed by MME students, including suggesting behavioral strategies (11.8 % vs. 4.5 %, p?<?0.001) and providing information regarding quitline (21.0 % vs. 3.8 %, p?<?0.001). MME students reported higher self-efficacy for Assist, Arrange, and Pharmacotherapy counseling items (ps?≤0.05).

Limitations

Inclusion of only ten schools limits generalizability.

Conclusions

Subsequent interventions should incorporate lessons learned from this first randomized controlled trial of a multi-modal longitudinal tobacco treatment curriculum in multiple U.S. medical schools.NIH Trial Registry Number: NCT01905618

     

Diabetes Group Visits: Integrated Medical Care and Behavioral Support to Improve Diabetes Care and Outcomes from a Primary Care Perspective

Of the many innovations in health care delivery proposed in the context of health reform for those with chronic diseases such as diabetes, the group visit model is relatively easy to implement and is effective for improving health outcomes and patient and provider satisfaction, with a neutral to positive effect on health care costs. This article describes the evolution of group visits for those with diabetes, the theory underlying group visits for patients with chronic medical conditions, and the existing evidence for the effectiveness of this model. It also addresses implementation of groups in practice, with an emphasis on the practical aspects of program implementation, integration of behavioral expertise into medical groups, individualization in various practice settings, and reimbursement issues.