Community-based Primary Care Practices Research Articles

Community-based interprofessional education in rural primary care

Health disparities and workforce shortages persist in the rural United States. In response, academic health professions programs are providing opportunities for students to participate in rural clinical rotations. We expanded an existing academic-practice partnership with a rural primary care clinic, in which students completed 4-week rotations in their discipline, to add an interprofessional community-based component. The goals were to: 1. Accelerate students’ acquisition of teamwork competence, specifically skills in team effectiveness, team communication, reflective practice, and situational awareness; and 2. Immerse students in community-based rural primary care practice with patients characterized by high rates of chronic illness and adverse social determinants of health. Teams of students participated in home visits with older adult patients that focused on social determinants of health and reducing barriers to health care.We applied a realist evaluation framework to evaluate the program, using data on patient profiles, student profiles, student pre- and post-scores on a teamwork measure; student reflections; preceptor observations of student performance; and perspectives about the program from clinic staff. The ACE-15 was used to measure teamwork. Forty-eight rural patients and 38 students participated. The ACE-15 mean score at T1 was 51.4 (SD 6.6) and at T2 was 56.7 (SD 3.6), a significant improvement (p < .05). Preceptor observations suggested that students’ teamwork skills improved over time. Student self-reflections indicated their appreciation for the opportunity to work in an interprofessional team and the value of visiting rural patients in their homes. Staff observed that patients received better care, and that the program benefited both students and patients.

Effect of a Patient Decision Aid on Preferences for Colorectal Cancer Screening Among Older Adults

Guidelines recommend individualized decision-making for colorectal cancer (CRC) screening among adults aged 76 to 84 years, a process that includes a consideration of health state and patient preference. To determine whether a targeted patient decision aid would align older adults' screening preference with their potential to benefit from CRC screening. This is a prespecified secondary analysis from a randomized clinical trial. Participants aged 70 to 84 years who were not up to date with screening and had an appointment within 6 weeks were purposively sampled by health state (poor, intermediate, or good) at 14 community-based primary care practices and block randomized to receive the intervention or control. Patients were recruited from March 1, 2012, to February 28, 2015, and these secondary analyses were performed from January 15 to March 1, 2022. Patient decision aid targeted to age and sex. The primary outcome of this analysis was patient preference for CRC screening. The a priori hypothesis was that the decision aid (intervention) group would reduce the proportion preferring screening among those in poor and intermediate health compared with the control group. Among the 424 participants, the mean (SD) age was 76.8 (4.2) years; 248 (58.5%) of participants were women; and 333 (78.5%) were White. The proportion preferring screening in the intervention group was less than in the control group for those in the intermediate health state (34 of 76 [44.7%] vs 40 of 73 [54.8%]; absolute difference, -10.1% [95% CI, -26.0% to 5.9%]) and in the poor health state (24 of 62 [38.7%] vs 33 of 61 [54.1%]; absolute difference, -15.4% [95% CI, -32.8% to 2.0%]). These differences were not statistically significant. The proportion of those in good health who preferred screening was similar between the intervention and control groups (44 of 74 [59.5%] for intervention vs 46 of 75 [61.3%] for control; absolute difference, -1.9% [95% CI, -17.6% to 13.8%]). The findings of this secondary analysis of a clinical trial did not demonstrate statistically significant differences in patient preferences between the health groups. Additional studies that are appropriately powered are needed to determine the effect of the decision aid on the preferences of older patients for CRC screening by health state. ClinicalTrials.gov Identifier: NCT01575990.

Comparison of Sodium-Glucose Cotransporter-2 Inhibitor and Glucagon-Like Peptide-1 Receptor Agonist Prescribing in Patients With Diabetes Mellitus With and Without Cardiovascular Disease

Sodium-glucose cotransporter-2 inhibitors (SGLT2is) and glucagon-like peptide-1 receptor agonists (GLP1-RAs) reduce cardiovascular events and mortality in patients with type 2 diabetes mellitus (T2DM). We sought to describe trends in prescribing for SGLT2is and GLP1-RAs in diverse care settings, including (1) the outpatient clinics of a midwestern integrated health system and (2) small- and medium-sized community-based primary care practices and health centers in 3 midwestern states. We included adults with T2DM and ≥1 outpatient clinic visit. The outcomes of interest were annual active prescription rates for SGLT2is and GLP1-RAs (separately). In the integrated health system, 22,672 patients met the case definition of T2DM. From 2013 to 2019, the overall prescription rate for SGLT2is increased from 1% to 15% (absolute difference [AD] 14%, 95% confidence interval [CI] 13% to 15%, p <0.01). The GLP1-RA prescription rate was stable at 10% (AD 0%, 95% CI -1% to 1%, p=0.9). In community-based primary care practices, 43,340 patients met the case definition of T2DM. From 2013 to 2017, the SGLT2i prescription rate increased from 3% to 7% (AD4%, 95% CI 3% to 6%, p <0.01), whereas the GLP1-RA prescription rate was stable at 2% to 3% (AD1%, 95% CI -1 to 1%, p=0.40). In a fully adjusted regression model, non-Hispanic Black patients had lower odds of SGLT2i or GLP1-RA prescription (odds ratio 0.56, 95% CI 0.34 to 0.89, p=0.016). In conclusion, the increase in prescription rates was greater for SGLT2is than for GLP1-RAs in patients with T2DM in a large integrated medical center and community primary care practices. Overall, prescription rates for eligible patients were low, and racial disparities were observed.

POS0321 CO-MORBIDITY IN POLYMYALGIA RHEUMATICA

BackgroundPolymyalgia rheumatica (PMR) is the most common autoimmune musculoskeletal condition in the developed world, with UK prevalence of 1.7% in those aged older than 55 years. Current guidelines recommend glucocorticoid treatment for one to two years. Since PMR affects older individuals and is associated with prolonged treatment with glucocorticoids, patients are at risk of developing or worsening co-morbidity.ObjectivesThis national study aimed to establish the prevalence of PMR from routinely recorded administrative care records from community-based primary care practices; secondly to calculate the most common comorbidities and their relative risk amongst those diagnosed with PMR.MethodsThe ECLIPSE databased covers over 23m patients across 2400 general practices in England and provides insights for enhanced clinical pathway management and to support patient safety in primary care. Routinely recorded diagnoses from primary care data are updated daily, along with administrative prescribing data. Using standardised nationally agreed disease coding frameworks, all diagnoses of PMR were retrieved from the live patient population of 23.3m individuals registered with general practices across England. Comorbidity was recorded similarly. Diagnoses of PMR were categorised in 12-month bands since their date of diagnoses to examine the rates of prednisolone prescription by time since diagnosis.ResultsAmongst the 23.3 million patient care records there were 146,252 diagnoses of PMR, resulting in a prevalence of 2.2% for those aged older than 55 years. The average age of those with PMR was 77.5 years. There were between 9863 to 11036 diagnoses of PMR made each year over the past five years. The proportion of those receiving prednisolone were highest amongst those most recently diagnosed: 76.4% for those in the last year; 48.4% for those diagnosed between a year and two years ago; 33.0% for those diagnosed between two to three years ago; 28.8% for those diagnosed between three to four years ago, and 24.9% for those diagnosed between four to five years ago. On average each patient with PMR had 3.5 co-morbid conditions and was prescribed 5.4 different medications. The top ten co-morbid conditions were, in rank order: hypertension (53.6%), osteoarthritis (48.6%), anxiety and depression (27.5%), chronic kidney disease (24.3%), type II diabetes (18.9%), ischaemic heart disease (14.9%), atrial fibrillation (13.7%), asthma (12.7%), COPD (7.9%), and heart failure (6.2%).ConclusionRoutinely recorded GP records provide prevalence estimates that are similar to previously published descriptive epidemiological studies, and despite guidelines recommending shorter courses of treatment, show the rates of prednisolone prescription remain high, years after diagnosis. Furthermore, due to the age of onset of PMR, this results in a patient population with high levels of co-morbidity many of whom are at increased risk due to prolonged glucocorticoid use. These data are crucial for developing risk stratification and population health management tools.Disclosure of InterestsNone declared

Patient engagement in an academic community-based primary care practice’s management committee: A case study

Patient engagement in primary care has been the focus of many studies; however, little research has evaluated its added value to organisational management in an academic community-based primary care practice (ACBPCP). In 2017, managers of an ACBPCP in Montreal, Canada, decided to integrate patients into the organization’s management committee to enhance the quality and relevance of decision-making for clinical services, education and research.

Aspects of Medication and Patient participation\u2014an Easy guideLine (AMPEL). A conversation guide increases patients\u2019 and physicians\u2019 satisfaction with prescription talks

Patients want more information and active participation in medical decisions. Information and active participation correlate with increased adherence. A conversation guide, combining patient-relevant drug information with steps of shared decision-making, was developed to support physicians in effective and efficient prescription talks. Six GP trainees in community-based primary care practices participated in a controlled pilot study in sequential pre-post design. Initially, they conducted 41 prescription talks as usual, i.e., without knowing the guide. Then, they conducted 23 talks considering the guide (post-intervention phase). Immediately after the respective talk, patients filled in a questionnaire on satisfaction with the information on medication and physician–patient interaction, and physicians about their satisfaction with the talk and the application of the guide. Patients felt better informed after guide-based prescription talks (e.g., SIMS-D in median 10 vs. 17, p < 0.05), more actively involved (KPF-A for patient activation 2.9 ± 0.8 vs. 3.6 ± 0.8, p < 0.05), and more satisfied with the physician–patient interaction. Physicians rated the guide helpful and feasible. Their satisfaction with the conversation was significantly enhanced during the post-intervention phase. The evaluation of the duration of the talk was not influenced. Enhanced patients’ and physicians’ satisfaction with prescription talks encourages further examinations of the conversation guide. We invite physicians to try our guide in everyday medical practice.

Food Insecurity Among Older Adults: A Transprofessional, Community-Based Collaboration

To address inequities related to food insecurity among older adults, a better understanding of the phenomenon was needed. An innovative screening tool to distinguish among high, medium and low risk and that considers cultural preferences related to food acquisition and related behaviors was developed and piloted. Screenings and healthy eating education were offered at health fairs and other community events. Information about food insecurity and healthy eating as well as resources, such as food maps, guidelines, and food preparation materials were disseminated. Preliminary findings suggest that over half of those screened have high levels of food insecurity. Approximately 37% have five or more comorbidities that combined with food insecurity, represent a significant threat to health and well-being. Elected officials and community leaders soon learned about this initiative and sought education and screening for their constituencies. The research and project evaluation will be used in collaboration with these leaders to identify polices at the local, state and federal level to promote health equity and reduce food insecurity disparities. Efforts are under development to integrate the new screening and referral mechanisms in community-based primary care practices.

2020 PBRN CONFERENCE HIGHLIGHTS: Living Laboratories for Innovation and Dissemination/Implementation in Our Communities.

Most of the care for most of the patients most of the time is provided in community-based primary care practices. Generating new knowledge by conducting research in these practices and communities, and implementing research findings, is widely recognized as necessary to achieve better health for

\u201cThey heard our voice!\u201d patient engagement councils in community-based primary care practices: a participatory action research pilot study

BackgroundPatient engagement could improve the quality of primary care practices. However, we know little about effective patient engagement strategies. We aimed to assess the acceptability and feasibility of embedding advisory councils of clinicians, managers, patients and caregivers to conduct patient-oriented quality improvement projects in primary care practices.MethodsUsing a participatory action research approach, we conducted our study in two non-academic primary care practices in Quebec City (Canada). Patient-experts (patients trained in research) were involved in study design, council recruitment and meeting facilitation. Advisory councils were each to include patients and/or caregivers, clinicians and managers. Over six meetings, councils would identify quality improvement priorities and plan projects accordingly. We assessed acceptability and feasibility of the councils using non-participant observations, audio-recordings and self-administered questionnaires. We used descriptive analyses, triangulated qualitative data and performed inductive thematic analysis.ResultsBetween December 2017 and June 2018, two advisory councils were formed, each with 11 patients (36% male, mean age 53.8 years), a nurse and a manager practising as a family physician (25% male, mean age 45 years). The six meetings per practice occurred within the study period with a mean of eight patients per meeting. Councils worked on two projects each: the first council on a new information leaflet about clinic organization and operation, and on communications about local public health programs; the second on methods to further engage patients in the practice, and on improving the appointment scheduling system. Median patient satisfaction was 8/10, and 66.7% perceived councils had an impact on practice operations. They considered involvement of a manager, facilitation by patient-experts, and the fostering of mutual respect as key to this impact. Clinicians and managers liked having patients as facilitators and the respect among members. Limiting factors were difficulty focusing on a single feasible project and time constraints. Managers in both practices were committed to pursuing the councils post-study.ConclusionOur results indicated that embedding advisory councils of clinicians, managers, patients and caregivers to conduct patient-oriented quality improvement projects in primary care practices is both acceptable and feasible. Future research should assess its transferability to other clinical contexts.

Penn State College of Medicine.

Penn State College of Medicine.

Effect of a Digital Health Intervention on Decreasing Barriers and Increasing Facilitators for Colorectal Cancer Screening in Vulnerable Patients.

Colorectal cancer is the second leading cause of cancer-related death in the United States, in part, because one third of Americans fail to get screened. In a prior randomized controlled trial, we found that an iPad patient decision aid called Mobile Patient Technology for Health-CRC (mPATH-CRC) doubled the proportion of patients who completed colorectal cancer screening. All data for the current analysis were collected as part of a randomized controlled trial to determine the impact of mPATH-CRC on receipt of colorectal cancer screening within 24 weeks. Participants were enrolled from six community-based primary care practices between June 2014 and May 2016 and randomized to either usual care or mPATH-CRC. Six potential mediators of the intervention effect on screening were considered. The Iacobucci method was used to assess the significance of the mediation. A total of 408 patients had complete data for all potential mediators. Overall, the potential mediators accounted for approximately three fourths (76.3%) of the effect of the program on screening completion. Perceived benefits, self-efficacy, ability to state a screening decision, and patient-provider discussion were statistically significant mediators. Patient-provider discussion accounted for the largest proportion of the effect of mPATH-CRC (70.7%). mPATH-CRC increased completion of colorectal cancer screening by affecting patient-level and system-level mediators. However, the most powerful mediator was the occurrence of a patient-provider discussion about screening. Digital interventions like mPATH-CRC are an important adjunct to the patient-provider encounter. Understanding the factors that mediated mPATH-CRC's success is paramount to developing other effective interventions.

A survey of outpatient Internal Medicine clinician perceptions of diagnostic error.

Background Little is known about how practicing Internal Medicine (IM) clinicians perceive diagnostic error, and whether perceptions are in agreement with the published literature. Methods A 16-question survey was administered across two IM practices: one a referral practice providing care for patients traveling for a second opinion and the other a traditional community-based primary care practice. Our aim was to identify individual- and system-level factors contributing to diagnostic error (primary outcome) and conditions at greatest risk of diagnostic error (secondary outcome). Results Sixty-five of 125 clinicians surveyed (51%) responded. The most commonly perceived individual factors contributing to diagnostic error included atypical patient presentations (83%), failure to consider other diagnoses (63%) and inadequate follow-up of test results (53%). The most commonly cited system-level factors included cognitive burden created by the volume of data in the electronic health record (EHR) (68%), lack of time to think (64%) and systems that do not support collaboration (40%). Conditions felt to be at greatest risk of diagnostic error included cancer (46%), pulmonary embolism (43%) and infection (37%). Conclusions Inadequate clinician time and sub-optimal patient and test follow-up are perceived by IM clinicians to be persistent contributors to diagnostic error. Clinician perceptions of conditions at greatest risk of diagnostic error may differ from the published literature.

Improving care for elderly patients living with polypharmacy: protocol for a pragmatic cluster randomized trial in community-based primary care practices in Canada

BackgroundElders living with polypharmacy may be taking medications that do not benefit them. Polypharmacy can be associated with elevated risks of poor health, reduced quality of life, high care costs, and persistently complex care needs. While many medications could be problematic, this project targets medications that should be deprescribed for most elders and for which guidelines and evidence-based deprescribing tools are available. These are termed potentially inappropriate prescriptions (PIPs) and are as follows: proton pump inhibitors, benzodiazepines, antipsychotics, and sulfonylureas. Implementation strategies for deprescribing PIPs in complex older patient populations are needed.MethodsThis will be a pragmatic cluster randomized controlled trial in community-based primary care practices across Canada. Eligible practices provide comprehensive primary care and have at least one physician that consents to participate. Community-dwelling patients aged 65 years and older with ten or more unique medication prescriptions in the past year will be included. The objective is to assess whether the intervention reduces targeted PIPs for these patients compared with usual care. The intervention, Structured Process Informed by Data, Evidence and Research (SPIDER), is a collaboration between quality improvement (QI) and research programs. Primary care teams will form interprofessional Learning Collaboratives and work with QI coaches to review electronic medical record data provided by their regional Practice Based Research Networks (PBRNs), identify areas of improvement, and develop and implement changes. The study will be tested for feasibility in three PBRNs (Toronto, Montreal, and Edmonton) using prospective single-arm mixed methods. Findings will then guide a pragmatic cluster randomized controlled trial in five PBRNs (Calgary, Winnipeg, Ottawa, Montreal, and Halifax). Seven practices per PBRN will be recruited for each arm. The analysis will be by intention to treat. Ten percent of patients who have at least one PIP at baseline will be randomly selected to participate in the assessment of patient experience and self-reported outcomes. Qualitative methods will be used to explore patient and physician experience and evaluate SPIDER’s processes.ConclusionWe are testing SPIDER in a primary care population with complex care needs. This could provide a widely applicable model for care improvement.Trial registrationClinicaltrials.gov NCT03689049; registered September 28, 2018

How to engage patients in research and quality improvement in community-based primary care settings: protocol for a participatory action research pilot study

Plain English summaryMaking primary care clinics more patient-centered is key to improving patients’ experience of care. If patients themselves were engaged in helping define priorities and suggesting quality improvements in the clinic, care would respond better to their needs. However, patient engagement is a new phenomenon, particularly in community based primary care clinics. How to engage patients in quality improvement in these clinics, or what effect this might have, is not well known. The involvement of patients needs to be adapted to the way these clinics function. The aim of this study is to create and evaluate a new model of patient engagement for quality improvement in community based primary care clinics. Patients, primary care professionals and researchers will create advisory councils in two primary care clinics in Quebec City (Canada). In each clinic, the advisory council will include 12 patients or caregivers registered at the clinic, a clinician and a clinic manager. The advisory council will meet every 6 weeks for a total of six meetings. Two patient-experts will facilitate meetings. During meetings, members of the council will list their needs in order of importance. Then they will suggest improvements in line with these needs. We will study if our advisory council model is well adapted to community based primary care settings and meets participants’ expectations. At the end of the study we will be able to offer guidance about engaging patients with health professionals in quality improvement in primary care clinics.BackgroundInvolvement of end-users, including patients, managers and clinicians, in identifying quality improvement and research priorities might improve the relevance of projects and increase their impact. Few patient engagement initiatives have taken place in community based primary care practices (CBPCPs) and best practices for engaging patients in such settings are not well defined. The aim of this pilot study is to develop and assess the feasibility of a new collaborative model of advisory council involving clinicians, managers, patients and caregivers in CBPCP to strengthen their capacity to conduct quality improvement and patient-oriented research projects.MethodsWe will conduct a participatory action research project in two non-academic CBPCPs in Quebec City (Canada). In each CBPCP, the advisory council will include 12 patients or caregivers, a clinician and a clinic manager. Patients or their caregivers will be identified by clinicians and contacted by patient-experts. They will be eligible if they are registered at the practice, motivated, and available to attend meetings. The council will meet every 6 weeks for a total of six meetings. Two patient-experts will guide council members to identify quality improvement priorities and patient-oriented research questions based on their experience in the clinic. They will then be supported to plan actions to target these priorities. Analysis of meetings will be based on feasibility criteria, notes by non-participant observers in log books, audio-recording of the meetings and questionnaires to evaluate council members’ perceptions and the likelihood they would engage in such councils.DiscussionThe results of this study will be a model of patient engagement and a discussion of factors to improve the model to fit the needs of primary care patients and professionals. This will lay the foundation for a sustainable structure for long-term patient engagement and contribute to the development of a patient-centered and quality-improvement culture in CBPCPs.

Lost in Translation: Anthropological Reflections on Cancer Survivorship in Primary Care

Abstract In 2006, the Institute of Medicine released a report detailing how cancer survivors in the United States were “lost in transition” from specialty to primary care. Here, I address a different problem: that of being “lost in translation.” Interviews with cancer survivors in community-based primary care practices across the United States revealed a fundamental disconnect between survivorship rhetoric and patients' perspectives on what was clinically, emotionally, and physically relevant to them. In reflecting on this disconnect, I ask how anthropologists can negotiate top-down stakeholder interests with ground-level understandings in biomedical research settings, where clinicians and biomedical scientists often dictate the terms of research. I argue that anthropology has a valuable role to play in teasing out the complexities of clinical and identity categories in biomedical research.

Effect of a Digital Health Intervention on Receipt of Colorectal Cancer Screening in Vulnerable Patients: A Randomized Controlled Trial.

Screening for colorectal cancer (CRC) reduces mortality, yet more than one third of age-eligible Americans are unscreened. To examine the effect of a digital health intervention, Mobile Patient Technology for Health-CRC (mPATH-CRC), on rates of CRC screening. Randomized clinical trial. (ClinicalTrials.gov: NCT02088333). 6 community-based primary care practices. 450 patients (223 in the mPATH-CRC group and 227 in usual care) scheduled for a primary care visit and due for routine CRC screening. An iPad application that displays a CRC screening decision aid, lets patients order their own screening tests, and sends automated follow-up electronic messages to support patients. The primary outcome was chart-verified completion of CRC screening within 24 weeks. Secondary outcomes were ability to state a screening preference, intention to receive screening, screening discussions, and orders for screening tests. All outcome assessors were blinded to randomization. Baseline characteristics were similar between groups; 37% of participants had limited health literacy, and 53% had annual incomes less than $20000. Screening was completed by 30% of mPATH-CRC participants and 15% of those receiving usual care (logistic regression odds ratio, 2.5 [95% CI, 1.6 to 4.0]). Compared with usual care, more mPATH-CRC participants could state a screening preference, planned to be screened within 6 months, discussed screening with their provider, and had a screening test ordered. Half of mPATH-CRC participants (53%; 118 of 223) "self-ordered" a test via the program. Participants were English speakers in a single health care system. A digital health intervention that allows patients to self-order tests can increase CRC screening. Future research should identify methods for implementing similar interventions in clinical care. National Cancer Institute.

Defining the Scope of Prognosis: Primary Care Clinicians' Perspectives on Predicting the Future Health of Older Adults

ContextStudies examining the attitudes of clinicians toward prognostication for older adults have focused on life expectancy prediction. Little is known about whether clinicians approach prognostication in other ways. ObjectivesTo describe how clinicians approach prognostication for older adults, defined broadly as making projections about patients' future health. MethodsIn five focus groups, 30 primary care clinicians from community-based, academic-affiliated, and Veterans Affairs primary care practices were given open-ended questions about how they make projections about their patients' future health and how this informs the approach to care. Content analysis was used to organize responses into themes. ResultsClinicians spoke about future health in terms of a variety of health outcomes in addition to life expectancy, including independence in activities and decision making, quality of life, avoiding hospitalization, and symptom burden. They described approaches in predicting these health outcomes, including making observations about the overall trajectory of patients to predict health outcomes and recognizing increased risk for adverse health outcomes. Clinicians expressed reservations about using estimates of mortality risk and life expectancy to think about and communicate patients' future health. They discussed ways in which future research might help them in thinking about and discussing patients' future health to guide care decisions, including identifying when and whether interventions might impact future health. ConclusionThe perspectives of primary care clinicians in this study confirm that prognostic considerations can go beyond precise estimates of mortality risk and life expectancy to include a number of outcomes and approaches to predicting those outcomes.

Practice Variation in Management of Childhood Asthma Is Associated With Outcome Differences

JM Garbutt, Y Yan, RC Strunk. J Allergy Clin Immunol Pract. 2016;4(3):474–480 To determine how variation in preventive and acute care approaches to asthma in pediatric primary care practices affects patient outcomes. The study included 948 children from 22 community-based primary care practices with a physician diagnosis of asthma and evidence of bothersome asthma within the past year. The data for this study were obtained over the year prior to participant entry into a trial. Inclusion criteria included 1 of the following indicators of bothersome asthma: (1) prescription for daily controller medicine; (2) ≥1 acute asthma exacerbation requiring an …

Effectiveness of certified diabetes educators following pre-approved protocols to redesign diabetes care delivery in primary care: Results of the REMEDIES 4D trial

ObjectiveTo evaluate changes in HbA1c, blood pressure, and LDLc levels in participants from practices where certified diabetes educators (CDEs) implemented standardized protocols to intensify treatment compared with those receiving usual care. Research design and methodsThis clustered, randomized, clinical trial was implemented in community-based primary care practices. Fifteen primary care practices and 240 patients with type 2 diabetes were randomized to the intervention (n=175) or usual care (n=65). Participants had uncontrolled HbA1c, blood pressure, or LDLc. The one-year intervention included CDEs implementing pre-approved protocols to intensify treatment. Diabetes self-management education was also provided in both study groups. ResultsThe population was 50.8% male with a mean age of 61years. The HbA1c in the intervention group decreased from 8.8% to 7.8%, (p=0.001) while the HbA1c in the usual care group increased slightly from 8.2% to 8.3%. There was also a significant difference in HbA1c between the two groups (p=0.004). There was not a significant difference between groups for systolic blood pressure (SBP) or LDLc at the end of the intervention. Those in the intervention group were more likely to have glucose-lowering medications intensified and were more likely to have their HbA1c (35% vs 15%), SBP (80% vs 77%) and HbA1c, SBP, and LDLc at goal (11% vs 1.5%) compared with the usual care group. There was no significant difference in intensification of blood pressure or cholesterol medication. ConclusionsFindings suggest that CDEs following standardized protocols in primary care is feasible and can effectively intensify treatment and improve glycemic control.

Three approaches to glucose monitoring in non-insulin treated diabetes: a pragmatic randomized clinical trial protocol

BackgroundFor the nearly 75% of patients living with type 2 diabetes (T2DM) that do not use insulin, decisions regarding self-monitoring of blood glucose (SMBG) can be especially problematic. While in theory SMBG holds great promise for sparking favorable behavior change, it is a resource intensive activity without firmly established patient benefits. This study describes our study protocol to assess the impact of three different SMBG testing approaches on patient-centered outcomes in patients with non-insulin treated T2DM within a community-based, clinic setting.Methods/DesignUsing stakeholder engagement approach, we developed and implemented a pragmatic trial of patient with non-insulin treated T2DM patients from five primary care practices randomized to one of three SMBG regimens: 1) no testing; 2) once daily testing with standard feedback consisting of glucose values being immediately reported to the patient through the glucose meter; and 3) once daily testing with enhanced patient feedback consisting of glucose values being immediately reported to the patient PLUS automated, tailored feedback messaging delivered to the patient through the glucose meter following each testing. Main outcomes assessed at 52 weeks include quality of life and glycemic control.DiscussionThis pragmatic trial seeks to better understand the value of SMBG in non-insulin treated patients with T2DM. This paper outlines the protocol used to implement this study in fifteen community-based primary care practices and highlights the impact of stakeholder involvement from the earliest stages of project conception and implementation. Plans for stakeholder involvement for result dissemination are also discussed.Trial registrationClinicalTrials.gov NCT02033499, January 9, 2014.