Dataset Information

Effect of 2 Clinical Decision Support Strategies on Chronic Kidney Disease Outcomes in Primary Care: A Cluster Randomized Trial.

ABSTRACT:

Importance

Information is needed about optimal strategies to improve evidence-based treatment of chronic kidney disease (CKD) in primary care.

Objective

To determine whether a multimodal intervention delays annualized loss of estimated glomerular filtration rate (eGFR) in stages 3 and 4 CKD.

Design, setting, and participants

This pragmatic cluster randomized clinical trial enrolled 42 primary care practices located in nonhospital settings with electronic health record systems. Practices were recruited through the American Academy of Family Physicians National Research Network. The study was conducted January 2013 through January 2016.

Interventions

Practices were randomized at the organization level to either the clinical decision support (CDS) plus practice facilitation (PF) group (n = 25) or CDS group (n = 17) using covariate constrained randomization. Both groups received point-of-care CDS to prompt screening, diagnosis, and treatment of CKD; the intervention group also received PF based on the 9-point TRANSLATE model (target, use point-of-care reminder systems, get administrative buy-in, network information systems using registries, site coordination, local physician champion, audit and feedback, team approach, and education).

Main outcomes and measures

The primary outcome measure was eGFR over time. Secondary outcome measures were systolic blood pressure over time, change in hemoglobin A1c (HbA1c) over time, avoidance of nonsteroidal anti-inflammatory medications, use of angiotensin converting enzyme inhibitor or angiotensin-renin blocker medication, early recognition and diagnosis of CKD, blood pressure control, and smoking cessation.

Results

In this cluster randomized trial of 30 primary care practices comprising 6699 patients, there were 1685 patients in the control group (10 practices) and 5014 patients in the intervention group (20 practices). The final sample of practices differed from the original set of randomized practices owing to dropout. Patients in the practices were similar at baseline for age (mean [SD], 71.3 [9.6] years), sex (2716 male [40.5%]), and eGFR. There was a significant difference in eGFR slopes for patients in the intervention vs control group practices. The mean (SE) annualized loss of eGFR was 0.95 (0.19) in the control group in propensity-adjusted longitudinal analyses and 0.01 (0.12) in the intervention group (mean [SE] difference in slopes, 0.93 [0.23]; P < .001). Among patients with HbA1c measures, slopes differed significantly for patients in intervention vs control practices, with a mean (SE) annualized increase of 0.14 (0.03) in HbA1c for patients in control practices and a mean (SE) decline of 0.009 (0.02) for patients in intervention practices. There was a significant difference in HbA1c slopes for patients in the intervention compared with control group practices (control vs intervention, -0.14; P < .001), but no difference in the other secondary outcomes.

Conclusions and relevance

A multimodal intervention in primary care, based on the TRANSLATE model, slowed annualized loss of eGFR. This study had several important strengths, weaknesses, and lessons learned regarding the implementation of pragmatic interventions in primary care to improve CKD outcomes.

Trial registration

ClinicalTrials.gov Identifier: NCT01767883.

SUBMITTER: Carroll JK

PROVIDER: S-EPMC6324427 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe diagnosis of chronic kidney disease (CKD) is based on laboratory results easily extracted from electronic health records; therefore, CKD identification and management is an ideal area for targeted electronic decision support efforts. Early CKD management frequently occurs in primary care settings where primary care providers (PCPs) may not implement all the best practices to prevent CKD-related complications. Few previous studies have employed randomized trials to assess a CKD electronic clinical decision support system (eCDSS) that provided recommendations to PCPs tailored to each patient based on laboratory results.ObjectiveThe aim of this study was to report the trial design and implementation experience of a CKD eCDSS in primary care.MethodsThis was a 3-arm pragmatic cluster-randomized trial at an academic general internal medicine practice. Eligible patients had 2 previous estimated-glomerular-filtration-rates by serum creatinine (eGFRCr) <60 mL/min/1.73m2 at least 90 days apart. Randomization occurred at the PCP level. For patients of PCPs in either of the 2 intervention arms, the research team ordered triple-marker testing (serum creatinine, serum cystatin-c, and urine albumin-creatinine-ratio) at the beginning of the study period, to be completed when acquiring labs for regular clinical care. The eCDSS launched for PCPs and patients in the intervention arms during a regular PCP visit subsequent to completing the triple-marker testing. The eCDSS delivered individualized guidance on cardiovascular risk-reduction, potassium and proteinuria management, and patient education. Patients in the eCDSS+ arm also received a pharmacist phone call to reinforce CKD-related education. The primary clinical outcome is blood pressure change from baseline at 6 months after the end of the trial, and the main secondary outcome is provider awareness of CKD diagnosis. We also collected process, patient-centered, and implementation outcomes.ResultsA multidisciplinary team (primary care internist, nephrologists, pharmacist, and informaticist) designed the eCDSS to integrate into the current clinical workflow. All 81 PCPs contacted agreed to participate and were randomized. Of 995 patients initially eligible by eGFRCr, 413 were excluded per protocol and 58 opted out or withdrew, resulting in 524 patient participants (188 usual care; 165 eCDSS; and 171 eCDSS+). During the 12-month intervention period, 53.0% (178/336) of intervention patient participants completed triple-marker labs. Among these, 138/178 (77.5%) had a PCP appointment after the triple-marker labs resulted; the eCDSS was opened for 73.9% (102/138), with orders or education signed for 81.4% (83/102).ConclusionsSuccessful integration of an eCDSS into primary care workflows and high eCDSS utilization rates at eligible visits suggest this tailored electronic approach is feasible and has the potential to improve guideline-concordant CKD care.Trial registrationClinicalTrials.gov NCT02925962; https://clinicaltrials.gov/ct2/show/NCT02925962 (Archived by WebCite at http://www.webcitation.org/78qpx1mjR).International registered report identifier (irrid)DERR1-10.2196/14022.

Project description:Rationale & objectiveThe study aimed to develop, implement, and evaluate a clinical decision support (CDS) system for chronic kidney disease (CKD) in a primary care setting, with the goal of improving CKD care in adults.Study designThis was a cluster randomized trial.Setting & participantsA total of 32 Midwestern primary care clinics were randomly assigned to either receive usual care or CKD-CDS intervention. Between April 2019 and March 2020, we enrolled 6,420 patients aged 18-75 years with laboratory-defined glomerular filtration rate categories of CKD Stage G3 and G4, and 1 or more of 6 CKD care gaps: absence of a CKD diagnosis, suboptimal blood pressure or glycated hemoglobin levels, indication for angiotensin-converting enzyme inhibitor or angiotensin receptor blocker but not prescribed, a nonsteroidal anti-inflammatory agent on the active medication list, or indication for a nephrology referral.InterventionThe CKD-CDS provided personalized suggestions for CKD care improvement opportunities directed to both patients and clinicians at primary care encounters.OutcomesWe assessed the proportion of patients meeting each of 6 CKD-CDS quality metrics representing care gap resolution after 18 months.ResultsThe adjusted proportions of patients meeting quality metrics in CKD-CDS versus usual care were as follows: CKD diagnosis documented (26.6% vs 21.8%; risk ratio [RR], 1.17; 95% CI, 0.91-1.51); angiotensin-converting enzyme inhibitor or angiotensin receptor blocker prescribed (15.9% vs 16.1%; RR, 0.95; 95% CI, 0.76-1.18); blood pressure control (20.4% vs 20.2%; RR, 0.98; 95% CI, 0.84-1.15); glycated hemoglobin level control (21.4% vs 22.1%; RR, 1.00; 95% CI, 0.80-1.24); nonsteroidal anti-inflammatory agent not on the active medication list (51.5% vs 50.4%; RR, 1.03; 95% CI, 0.90-1.17); and referral or visit to a nephrologist (38.7% vs 36.1%; RR, 1.02; 95% CI, 0.79-1.32).LimitationsWe encountered an overall reduction in expected primary care encounters and obstacles to point-of-care CKD-CDS utilization because of the coronavirus disease 2019 pandemic.ConclusionsThe CKD-CDS intervention did not lead to a significant improvement in CKD quality metrics. The challenges to CDS use during the coronavirus disease 2019 pandemic likely influenced these results.FundingNational Institute of Diabetes and Digestive and Kidney Diseases (R18DK118463).Trial registrationclinicaltrials.gov Identifier: NCT03890588.

Project description:BackgroundThe EBMeDS system is the computerized clinical decision support (CCDS) system of EBPNet, a national computerized point-of-care information service in Belgium. There is no clear evidence of more complex CCDS systems to manage chronic diseases in primary care practices (PCPs). The objective of this study was to assess the effectiveness of EBMeDS use in improving diabetes care.MethodsA cluster-randomized trial with before-and-after measurements was performed in Belgian PCPs over 1 year, from May 2017 to May 2018. We randomly assigned 51 practices to either the intervention group (IG), to receive the EBMeDS system, or to the control group (CG), to receive usual care. Primary and secondary outcomes were the 1-year pre- to post-implementation change in HbA1c, LDL cholesterol, and systolic and diastolic blood pressure. Composite patient and process scores were calculated. A process evaluation was added to the analysis. Results were analyzed at 6 and 12 months. Linear mixed models and logistic regression models based on generalized estimating equations were used where appropriate.ResultsOf the 51 PCPs that were enrolled and randomly assigned (26 PCPs in the CG and 25 in the IG), 29 practices (3815 patients) were analyzed in the study: 2464 patients in the CG and 1351 patients in the IG. No change differences existed between groups in primary or secondary outcomes. Change difference between CG and IG after 1-year follow-up was - 0.09 (95% CI - 0.18; 0.01, p-value = 0.06) for HbA1c; 1.76 (95% CI - 0.46; 3.98, p-value = 0.12) for LDL cholesterol; and 0.13 (95% CI - 0.91; 1.16, p-value = 0.81) and 0.12 (95% CI - 1.25;1.49, p-value = 0.86) for systolic and diastolic blood pressure respectively. The odds ratio of the IG versus the CG for the probability of no worsening and improvement was 1.09 (95% CI 0.73; 1.63, p-value = 0.67) for the process composite score and 0.74 (95% CI 0.49; 1.12, p-value = 0.16) for the composite patient score. All but one physician was satisfied with the EBMeDS system.ConclusionsThe CCDS system EBMeDS did not improve diabetes care in Belgian primary care. The lack of improvement was mainly caused by imperfections in the organizational context of Belgian primary care for chronic disease management and shortcomings in the system requirements for the correct use of the EBMeDS system (e.g., complete structured records). These shortcomings probably caused low-use rates of the system.Trial registrationClinicalTrials.gov, NCT01830569, Registered 12 April 2013.

Project description:BACKGROUND:Advanced primary care models emphasize patient-centered care, including self-management support (SMS), but the effective use of SMS for patients with type 2 diabetes (T2DM) remains a challenge. Interactive behavior-change technology (IBCT) can facilitate the adoption of SMS interventions. To meet the need for effective SMS intervention, we have developed Connection to Health (CTH), a comprehensive, evidence-based SMS program that enhances interactions between primary care clinicians and patients to resolve self-management problems and improve outcomes. Uptake and maintenance of programs such as CTH in primary care have been limited by the inability of practices to adapt and implement program components into their culture, patient flow, and work processes. Practice facilitation has been shown to be effective in helping practices make the changes required for optimal program implementation. The proposed research is designed to promote the translation of SMS into primary care practices for patients with T2DM by combining two promising lines of research, specifically, (a) testing the effectiveness of CTH in diverse primary-care practices, and (b) evaluating the impact of practice facilitation to enhance implementation of the intervention. METHODS:A three-arm, cluster-randomized trial will evaluate three discrete strategies for implementing SMS for patients with T2DM in diverse primary care practices. Practices will be randomly assigned to receive and implement the CTH program, the CTH program plus practice facilitation, or a SMS academic detailing educational intervention. Through this design, we will compare the effectiveness, adoption and implementation of these three SMS practice implementation strategies. Primary effectiveness outcomes including lab values and evidence of SMS will be abstracted from medical records covering baseline through 18 months post-baseline. Data from CTH assessments and action plans completed by patients enrolled in CTH will be used to evaluate practice implementation of CTH and the impact of CTH participation. Qualitative data including field notes from encounters with the practices and interviews of practice personnel will be analyzed to assess practice implementation of SMS. DISCUSSION:This study will provide important information on the implementation of SMS in primary care, the effectiveness of an IBCT tool such as CTH, and the use of practice facilitation to assist implementation. TRIAL REGISTRATION:Registered with ClinicalTrials.gov - ClinicalTrials.gov ID: NCT01945918 , date 08/27/2013. Modifications have been updated.

Project description:BackgroundNational quality indicators show little change in the overuse of antibiotics for uncomplicated acute bronchitis. We compared the effect of 2 decision support strategies on antibiotic treatment of uncomplicated acute bronchitis.MethodsWe conducted a 3-arm cluster randomized trial among 33 primary care practices belonging to an integrated health care system in central Pennsylvania. The printed decision support intervention sites (11 practices) received decision support for acute cough illness through a print-based strategy, the computer-assisted decision support intervention sites (11 practices) received decision support through an electronic medical record-based strategy, and the control sites (11 practices) served as a control arm. Both intervention sites also received clinician education and feedback on prescribing practices, as well as patient education brochures at check-in. Antibiotic prescription rates for uncomplicated acute bronchitis in the winter period (October 1, 2009, through March 31, 2010) following introduction of the intervention were compared with the previous 3 winter periods in an intent-to-treat analysis.ResultsCompared with the baseline period, the percentage of adolescents and adults prescribed antibiotics during the intervention period decreased at the printed decision support intervention sites (from 80.0% to 68.3%) and at the computer-assisted decision support intervention sites (from 74.0% to 60.7%) but increased slightly at the control sites (from 72.5% to 74.3%). After controlling for patient and clinician characteristics, as well as clustering of observations by clinician and practice site, the differences for the intervention sites were statistically significant from the control sites (P = .003 for control sites vs printed decision support intervention sites and P = .01 for control sites vs computer-assisted decision support intervention sites) but not between themselves (P = .67 for printed decision support intervention sites vs computer-assisted decision support intervention sites). Changes in total visits, 30-day return visit rates, and proportion diagnosed as having uncomplicated acute bronchitis were similar among the study sites.ConclusionsImplementation of a decision support strategy for acute bronchitis can help reduce the overuse of antibiotics in primary care settings. The effect of printed vs computer-assisted decision support strategies for providing decision support was equivalent.Trial registrationclinicaltrials.gov Identifier: NCT00981994.

Project description:IMPORTANCE:For antidepressants, the translation of evidence of comparative effectiveness into practice is suboptimal. This deficit directly affects outcomes and quality of care for patients with depression. To overcome this problem, we developed the Depression Medication Choice (DMC) encounter decision aid, designed to help patients and clinicians consider the available antidepressants and the extent to which they improved depression and other issues important to patients. OBJECTIVE:Estimate the effect of DMC on quality of the decision-making process and depression outcomes. DESIGN, SETTING, AND PARTICIPANTS:We conducted a cluster randomized trial of adults with moderate to severe depression considering treatment with an antidepressant. Primary care practices in 10 rural, suburban, and urban primary care practices across Minnesota and Wisconsin were randomly allocated to treatment of depression with or without use of the DMC decision aid. INTERVENTION:Depression Medication Choice, a series of cards, each highlighting the effect of the available options on an issue of importance to patients for use during face-to-face consultations. MAIN OUTCOMES AND MEASURES:Decision-making quality as judged by patient knowledge and involvement in decision making, patient and clinician decisional comfort (Decisional Conflict Scale) and satisfaction, encounter duration, medication adherence, depression symptoms, and the Patient Health Questionnaire for depression (PHQ-9). RESULTS:We enrolled 117 clinicians and 301 patients (67% women; mean [SD] age, 44 [15] years; mean [SD] PHQ-9 score, 15 [4]) into the trial. Compared with usual care (UC), use of DMC significantly improved patients' decisional comfort (DMC, 80% vs UC, 75%; P = .02), knowledge (DMC, 65% vs UC, 56%; P =?.03), satisfaction (risk ratio [RR], from 1.25 [P =?.81] to RR, 2.4 [P =?.002] depending on satisfaction domain), and involvement (DMC, 47% vs UC, 33%; P<.001). It also improved clinicians' decisional comfort (DMC, 80% vs UC, 68%; P <?.001) and satisfaction (RR, 1.64; P =?.02). There were no differences in encounter duration, medication adherence, or improvement of depression control between arms. CONCLUSIONS AND RELEVANCE:The DMC decision aid helped primary care clinicians and patients with moderate to severe depression select antidepressants together, improving the decision-making process without extending the visit. On the other hand, DMC had no discernible effect on medication adherence or depression outcomes. By translating comparative effectiveness into patient-centered care, use of DMC improved the quality of primary care for patients with depression. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT01502891.

Project description:BackgroundInnovative interventions are needed to address gaps in preventive cancer care, especially in rural areas. This study evaluated the impact of clinical decision support (CDS) with and without shared decision making (SDM) on cancer-screening completion.MethodsIn this 3-arm, parallel-group, cluster-randomized trial conducted at a predominantly rural medical group, 34 primary care clinics were randomized to clinical decision support (CDS), CDS plus shared decision making (CDS+SDM), or usual care (UC). The CDS applied web-based clinical algorithms identifying patients overdue for United States Preventive Services Task Force-recommended preventive cancer care and presented evidence-based recommendations to patients and providers on printouts and on the electronic health record interface. Patients in the CDS+SDM clinic also received shared decision-making tools (SDMTs). The primary outcome was a composite indicator of the proportion of patients overdue for breast, cervical, or colorectal cancer screening at index who were up to date on these 1 y later.ResultsFrom August 1, 2018, to March 15, 2019, 69,405 patients aged 21 to 74 y had visits at study clinics and 25,198 were overdue for 1 or more cancer screening tests at an index visit. At 12-mo follow-up, 9,543 of these (37.9%) were up to date on the composite endpoint. The adjusted, model-derived percentage of patients up to date was 36.5% (95% confidence interval [CI]: 34.0-39.1) in the UC group, 38.1% (95% CI: 35.5-40.9) in the CDS group, and 34.4% (95% CI: 31.8-37.2) in the CDS+SDM group. For all comparisons, the screening rates were higher than UC in the CDS group and lower than UC in the CDS+SDM group, although these differences did not reach statistical significance.ConclusionThe CDS did not significantly increase cancer-screening rates. Exploratory analyses suggest a deeper understanding of how SDM and CDS interact to affect cancer prevention decisions is needed. Trial registration: ClinicalTrials.gov ID: NCT02986230, December 6, 2016.

Project description:ImportanceChronic kidney disease (CKD) affects 37 million adults in the United States, and for patients with CKD, hypertension is a key risk factor for adverse outcomes, such as kidney failure, cardiovascular events, and death.ObjectiveTo evaluate a computerized clinical decision support (CDS) system for the management of uncontrolled hypertension in patients with CKD.Design, setting, and participantsThis multiclinic, randomized clinical trial randomized primary care practitioners (PCPs) at a primary care network, including 15 hospital-based, ambulatory, and community health center-based clinics, through a stratified, matched-pair randomization approach February 2021 to February 2022. All adult patients with a visit to a PCP in the last 2 years were eligible and those with evidence of CKD and hypertension were included.InterventionThe intervention consisted of a CDS system based on behavioral economic principles and human-centered design methods that delivered tailored, evidence-based recommendations, including initiation or titration of renin-angiotensin-aldosterone system inhibitors. The patients in the control group received usual care from PCPs with the CDS system operating in silent mode.Main outcomes and measuresThe primary outcome was the change in mean systolic blood pressure (SBP) between baseline and 180 days compared between groups. The primary analysis was a repeated measures linear mixed model, using SBP at baseline, 90 days, and 180 days in an intention-to-treat repeated measures model to account for missing data. Secondary outcomes included blood pressure (BP) control and outcomes such as percentage of patients who received an action that aligned with the CDS recommendations.ResultsThe study included 174 PCPs and 2026 patients (mean [SD] age, 75.3 [0.3] years; 1223 [60.4%] female; mean [SD] SBP at baseline, 154.0 [14.3] mm Hg), with 87 PCPs and 1029 patients randomized to the intervention and 87 PCPs and 997 patients randomized to usual care. Overall, 1714 patients (84.6%) were treated for hypertension at baseline. There were 1623 patients (80.1%) with an SBP measurement at 180 days. From the linear mixed model, there was a statistically significant difference in mean SBP change in the intervention group compared with the usual care group (change, -14.6 [95% CI, -13.1 to -16.0] mm Hg vs -11.7 [-10.2 to -13.1] mm Hg; P = .005). There was no difference in the percentage of patients who achieved BP control in the intervention group compared with the control group (50.4% [95% CI, 46.5% to 54.3%] vs 47.1% [95% CI, 43.3% to 51.0%]). More patients received an action aligned with the CDS recommendations in the intervention group than in the usual care group (49.9% [95% CI, 45.1% to 54.8%] vs 34.6% [95% CI, 29.8% to 39.4%]; P < .001).Conclusions and relevanceThese findings suggest that implementing this computerized CDS system could lead to improved management of uncontrolled hypertension and potentially improved clinical outcomes at the population level for patients with CKD.Trial registrationClinicalTrials.gov Identifier: NCT03679247.