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Medical assistant health coaching ("MAC") for type 2 diabetes in diverse primary care settings: A pragmatic, cluster-randomized controlled trial protocol.

ABSTRACT: In the US, nearly 11% of adults were living with diagnosed diabetes in 2017, and significant type 2 diabetes (T2D) disparities are experienced by socioeconomically disadvantaged, racial/ethnic minority populations, including Hispanics. The standard 15-min primary care visit does not allow for the ongoing self-management support that is needed to meet the complex needs of individuals with diabetes. "Team-based" chronic care delivery is an alternative approach that supplements physician care with contact from allied health personnel in the primary care setting (e.g., medical assistants; MAs) who are specially trained to provide ongoing self-management support or "health coaching." While rigorous trials have shown MA health coaching to improve diabetes outcomes, less is known about if and how such a model can be integrated within real world, primary care clinic workflows. Medical Assistant Health Coaching for Type 2 Diabetes in Diverse Primary Care Settings - A Pragmatic, Cluster-Randomized Controlled Trial will address this gap. Specifically, this study compares MA health coaching versus usual care in improving diabetes clinical control among N = 600 at-risk adults with T2D, and is being conducted at four primary care clinics that are part of two health systems that serve large, ethnically/racially, and socioeconomically diverse populations in Southern California. Electronic medical records are used to identify eligible patients at both health systems, and to examine change in clinical control over one year in the overall sample. Changes in behavioral and psychosocial outcomes are being evaluated by telephone assessment in a subset (n = 300) of participants, and rigorous process and cost evaluations will assess potential for sustainability and scalability.

SUBMITTER: Fortmann AL

PROVIDER: S-EPMC8093013 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectiveTo assess the fidelity of general practitioners' (GPs) adherence to a long-term pragmatic trial protocol.DesignRetrospective analyses of electronic primary care records of participants in the pragmatic cluster-randomised ADDITION (Anglo-Danish-Dutch Study of Intensive Treatment In People with Screen Detected Diabetes in Primary Care)-Cambridge trial, comparing intensive multifactorial treatment (IT) versus routine care (RC). Data were collected from the date of diagnosis until December 2010.SettingPrimary care surgeries in the East of England.Study sample/participantsA subsample (n=189, RC arm: n=99, IT arm: n=90) of patients from the ADDITION-Cambridge cohort (867 patients), consisting of patients 40-69 years old with screen-detected diabetes mellitus.InterventionsIn the RC arm treatment was delivered according to concurrent treatment guidelines. Surgeries in the IT arm received funding for additional contacts between GPs/nurses and patients, and GPs were advised to follow more intensive treatment algorithms for the management of glucose, lipids and blood pressure and aspirin therapy than in the RC arm.Outcome measuresThe number of annual contacts between patients and GPs/nurses, the proportion of patients receiving prescriptions for cardiometabolic medication in years 1-5 after diabetes diagnosis and the adherence to prescription algorithms.ResultsThe difference in the number of annual GP contacts (?=0.65) and nurse contacts (?=-0.15) between the study arms was small and insignificant. Patients in the IT arm were more likely to receive glucose-lowering (OR=3.27), ACE-inhibiting (OR=2.03) and lipid-lowering drugs (OR=2.42, all p values <0.01) than patients in the RC arm. The prescription adherence varied between medication classes, but improved in both trial arms over the 5-year follow-up.ConclusionsThe adherence of GPs to different aspects of the trial protocol was mixed. Background changes in healthcare policy need to be considered as they have the potential to dilute differences in treatment intensity and hence incremental effects.Trial registration numberISRCTN86769081.

Project description:BackgroundAdherence and completion of programmes in educational and physical exercise sessions is essential in cardiac rehabilitation (CR) to obtain the known benefits on morbidity, mortality, risk factors, lifestyle, and quality of life. The patient education strategy "Learning and Coping" (LC) has been reported to positively impact adherence and completion in a hospital setting. It is unknown if LC has impact on adherence in primary healthcare settings, and whether LC improves self-management. The aim of this pragmatic primary healthcare-based study was to examine whether patients attending CR based on LC had a better adherence to patient education and physical exercise, higher program completion rate, and better self-management compared to patients attending CR based on a consultation program Empowerment, Motivation and Medical Adherence (EMMA).MethodA pragmatic cluster-controlled trial of two types of patient education LC and EMMA including ten primary healthcare settings and 514 patients (LC, n = 266; EMMA, n = 248) diagnosed with ischaemic heart disease discharged from hospital and referred to CR between August 1, 2018 and July 31, 2019. Adherence was defined as participation in ≥ 75% of provided sessions. Completion was defined as patients attended the final interview at the end of the 12-weeks programme. Patient Activation Measure (PAM) was used to obtain information on a person's knowledge, skills and confidence for self-management. PAM questionnaire was completed at baseline and 12-weeks follow-up. Multiple and Linear regression analyses adjusted for potential confounder variables and cluster effect were performed.ResultPatients who followed CR based on LC had a higher adherence rate to educational and physical exercise sessions compared to patients who followed CR based on EMMA (p < 0.01). High-level of completion was found at the end of CR with no statistically significant between clusters (78.9% vs. 78.2%, p > 0.05). At 12-weeks, there was no statistical differences in PAM-score between clusters (p > 0.05).ConclusionThis study indicates that the LC positively impacts adherence in CR compared to EMMA. We found non-significant difference in completing CR and in patient self-management between the two types of patient education. Future studies are needed to investigate if the higher adherence rate achieved by LC in primary healthcare settings translates into better health outcomes.

Project description:BackgroundShared medical appointments (SMAs) have been shown to be an efficient and effective strategy for providing diabetes self-management education and self-management support. SMA features vary and it is not known which features are most effective for different patients and practice settings. The Invested in Diabetes study tests the comparative effectiveness of SMAs with and without multidisciplinary care teams and patient topic choice for improving patient-centered and clinical outcomes related to diabetes.MethodsThis study compares the effectiveness of two SMA approaches using the Targeted Training for Illness Management (TTIM) curriculum. Standardized SMAs are led by a health educator with a set order of TTIM topics. Patient-driven SMAs are delivered collaboratively by a multidisciplinary care team (health educator, medical provider, behavioral health provider, and a peer mentor); patients select the order and emphasis on TTIM topics. Invested in Diabetes is a cluster randomized pragmatic trial involving approximately 1440 adult patients with type 2 diabetes. Twenty primary care practices will be randomly assigned to either standardized or patient-driven SMAs. A mixed-methods evaluation will include quantitative (practice- and patient-level data) and qualitative (practice and patient interviews, observation) components. The primary patient-centered outcome is diabetes distress. Secondary outcomes include autonomy support, self-management behaviors, clinical outcomes, patient reach, and practice-level value and sustainability.DiscussionPractice and patient stakeholder input guided protocol development for this pragmatic trial comparing SMA approaches. Implementation strategies from the enhanced Replicating Effective Programs framework will help ensure practices maintain fidelity to intervention protocols while tailoring workflows to their settings. Invested in Diabetes will contribute to the literature on chronic illness management and implementation science using the RE-AIM model.Trial registrationClinicalTrials.gov, NCT03590041. Registered on 5 July 2018.

Project description:BackgroundChoosing an antipsychotic medication is an important medical decision in the treatment of schizophrenia. This decision requires risk-benefit assessments of antipsychotics, and thus, shared-decision making between physician and patients is strongly encouraged. Although the efficacy and side-effect profiles of antipsychotics are well-established, there is no clear framework for the communication of the evidence between physicians and patients. For this reason, we developed an evidence-based shared-decision making assistant (SDM-assistant) that presents high-quality evidence from network meta-analysis on the efficacy and side-effect profile of antipsychotics and can be used as a basis for shared-decision making between physicians and patients when selecting antipsychotic medications.MethodsThe planned matched-pair cluster-randomised trial will be conducted in acute psychiatric wards (n = 14 wards planned) and will include adult inpatients with schizophrenia or schizophrenia-like disorders (N = 252 participants planned). On the intervention wards, patients and their treating physicians will use the SDM-assistant, whenever a decision on choosing an antipsychotic is warranted. On the control wards, antipsychotics will be chosen according to treatment-as-usual. The primary outcome will be patients' perceived involvement in the decision-making during the inpatient stay as measured with the SDM-Q-9. We will also assess therapeutic alliance, symptom severity, side-effects, treatment satisfaction, adherence, quality of life, functioning and rehospitalizations as secondary outcomes. Outcomes could be analysed at discharge and at follow-up after three months from discharge. The analysis will be conducted per-protocol using mixed-effects linear regression models for continuous outcomes and logistic regression models using generalised estimating equations for dichotomous outcomes. Barriers and facilitators in the implementation of the intervention will also be examined using a qualitative content analysis.DiscussionThis is the first trial to examine a decision assistant specifically designed to facilitate shared-decision making for choosing antipsychotic medications, i.e., SDM-assistant, in acutely ill inpatients with schizophrenia. If the intervention can be successfully implemented, SDM-assistant could advance evidence-based medicine in schizophrenia by putting medical evidence on antipsychotics into the context of patient preferences and values. This could subsequently lead to a higher involvement of the patients in decision-making and better therapy decisions.Trial registrationGerman Clinical Trials Register (ID: DRKS00027316 , registration date 26.01.2022).

Project description:Expanded partnership with the medical community is a promising strategy for reducing disparities in dental caries among young children. However, no validated caries risk instrument exists for use in primary health care settings. To help resolve this gap, a 52-item caries risk questionnaire was developed and targeted to primary caregivers (PCGs) to test in a 3-y prospective study. To begin to understand the validity of the questionnaire items, the purpose of this study was to compare responses to the questionnaire based on key demographic characteristics known to be associated with disparities in caries experience (e.g., race/ethnicity and insurance status). A total of 1,323 one-year-old children were recruited primarily through 3 medical research networks. Baseline questionnaire responses were analyzed via logistic regression. The sample was 49% female. Its racial/ethnic makeup was as follows: 13% Hispanic, 37% White, 37% Black, and 13% other or multiracial. Sixty-one percent were enrolled in Medicaid, and 95% resided in urban communities. Mothers represented 94% of PCGs. There were significant differences ( P < 0.05) in baseline responses based on Medicaid status and race/ethnicity. As compared with those not enrolled in Medicaid, children in the Medicaid group were significantly more likely (after adjusting for race/ethnicity) to 1) go to sleep while nursing or drinking something other than water, 2) eat sugary snacks between meals, 3) consume sugary drinks between meals, 4) receive topical fluoride from a health professional, 5) visit the dentist, and 6) not have an employed adult in the household. PCGs of children enrolled in Medicaid were significantly more likely to be the mother, have bleeding gums, eat sugary snacks between meals, consume sugary drinks between meals, eat or drink something other than water before going to bed, and not get regular dental checkups. In conclusion, there are significant differences in caries risk questionnaire responses based on Medicaid status and race/ethnicity that provide construct and criterion validity to the developed caries risk tool (ClinicalTrials.gov NCT01707797).

Project description:BackgroundThe prevalence of atrial fibrillation (AF) is growing as the population ages, and at least 15% of ischemic strokes are attributed to AF. However, many high-risk AF patients are not offered guideline-recommended stroke prevention therapy due to a variety of system, provider, and patient-level barriers.MethodsWe will conduct a pragmatic, cluster-randomized controlled trial randomizing primary care clinics to test a "toolkit" of quality improvement interventions in primary care. In keeping with the recommendations of the chronic care model to simultaneously activate patients and facilitate proactive care by providers, the toolkit includes provider-focused strategies (education, audit and feedback, electronic decision support, and reminders) plus patient-directed strategies (educational letters and reminders). The trial will include two feedback cycles at baseline and approximately 6 months and a final data collection at approximately 12 months. The study will be powered to show a difference of 10% in the primary outcome of proportion of patients receiving guideline-recommended stroke prevention therapy. Analysis will follow the intention-to-treat principle and will be blind to treatment allocation. Unit of analysis will be the patient; models will use generalized estimating equations to account for clustering at the clinical level.DiscussionStroke prevention therapy using anticoagulation in patients with AF is known to reduce strokes by two thirds or more in clinical trials, but most studies indicate under-use of this treatment in real-world practice. If the toolkit successfully improves care for patients with AF, stakeholders will be engaged to facilitate broader application to maximize the potential to improve patient outcomes. The intervention toolkit tested in this project could also provide a model to improve quality of care for other chronic cardiovascular conditions managed in primary care.Trial registrationClinicalTrials.gov ( NCT01927445 ). Registered August 14, 2014 at https://clinicaltrials.gov/ .

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Medical assistant health coaching ("MAC") for type 2 diabetes in diverse primary care settings: A pragmatic, cluster-randomized controlled trial protocol.

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