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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SUBMITTER: Fortmann AL
PROVIDER: S-EPMC8093013 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectivesTo describe multilevel recruitment strategies for an ongoing clinical trial in pediatric primary care settings, and assess adoption and reach of these strategies via the RE-AIM framework.MethodsThis study is part of a larger pragmatic cluster randomized clinical trial focused on the effectiveness of interventions on the practice, provider, and caregiver levels on dental utilization for Medicaid-enrolled 3-6 year old children. Pediatric practices were recruited according to the proportion of Medicaid-eligible children, geographic region, and County. In accordance with the RE-AIM framework, providers reached were those approached directly and consented, and those who participated in the intervention training adopted to deliver the intervention. Caregivers reached were those approached and consented at their child's well-child visit to participate in the trial.ResultsRecruitment goals were met over a 21 month period, with an overall enrollment of 18 practices, 62 providers, and 1024 caregivers-child dyads. The majority of practices enrolled were small, suburban, and located in an urban county. The participation rates among approached providers and caregivers was 93% and 84% respectively. Enablers for recruitment was the one-on-one interaction with the provider and caregivers. Barriers to recruitment for caregivers included no-shows and cancellations at well-child visits. Adoption of intervention among providers was high, and caregiver reached were representative of the eligible target population.ConclusionsActive approaches to recruitment, such as utilizing opinion leaders, in-person recruitment, and building relationships with practice staff, can result in successful enrollment and imp lementation of a multi-level intervention in pediatric primary care settings.
| S-EPMC7905074 | biostudies-literature
Project description:Health coaching is potentially a practical method to assist patients in achieving and maintaining healthy lifestyles. In health coaching, the coach partners with the patient, helping patients discover their own strengths, challenges, and solutions.Two medical assistants were provided with brief training. The 12-week program consisted of telephone coaching with in-person visits at the beginning and end of the program. Coaching targeted improvements in diet, physical activity, and/or sleep habits using a self-care planning form.A total of 82 subjects enrolled in the program, 72% completed 8 weeks and 49% completed 12 weeks. Subjects who completed assessments at 12 weeks had significant weight loss despite the fact that weight loss was not a study goal. There also were improvements in diet and physical activity. Subject who completed the study were highly satisfied with the program and felt that health coaching should be available in all family medicine clinics. The main barrier providers voiced was remembering to refer patients. The medical providers indicated high satisfaction with the study and valued having coaching available for their patients.Medical assistants can be trained to assist patients with lifestyle changes that are associated with improved health and weight control.
| S-EPMC5634140 | biostudies-literature
Project description:Most primary care patients have at least 1 major behavioral risk: smoking, risky drinking, low physical activity, or unhealthy diet. We studied the effectiveness of a medical assistant-based program to identify and refer patients with risk behaviors to appropriate interventions.We undertook a randomized control trial in a practice-based research network. The trial included 864 adult patients from 6 primary care practices. Medical assistants screened patients for 4 risk behaviors and applied behavior-specific algorithms to link patients with interventions. Primary outcomes were improved risk behaviors on standardized assessments. Secondary outcomes included participation in a behavioral intervention and the program's effect on the medical assistants' workflow and job satisfaction.Follow-up data were available for 55% of participants at a mean of 12 months. The medical assistant referral arm referred a greater proportion of patients than did usual care (67.4 vs 21.8%; P <.001) but did not achieve a higher success rate for improved behavioral outcomes (21.7 vs 16.9%; P=0.19). Qualitative interviews found both individual medical assistant and organizational effects on program adoption.Engaging more primary care team members to address risk behaviors improved referral rates. More extensive medical assistant training, changes in practice culture, and sustained behavioral interventions will be necessary to improve risk behavior outcomes.
| S-EPMC2775613 | biostudies-literature
Project description:Targeting the medical monitoring applications of wireless body area networks (WBANs), a hybrid medium access control protocol using an interrupt mechanism (I-MAC) is proposed to improve the energy and time slot utilization efficiency and to meet the data delivery delay requirement at the same time. Unlike existing hybrid MAC protocols, a superframe structure with a longer length is adopted to avoid unnecessary beacons. The time slots are mostly allocated to nodes with periodic data sources. Short interruption slots are inserted into the superframe to convey the urgent data and to guarantee the real-time requirements of these data. During these interruption slots, the coordinator can break the running superframe and start a new superframe. A contention access period (CAP) is only activated when there are more data that need to be delivered. Experimental results show the effectiveness of the proposed MAC protocol in WBANs with low urgent traffic.
| S-EPMC4507673 | biostudies-literature
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.
| S-EPMC6009504 | biostudies-literature
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.
| S-EPMC6954498 | biostudies-literature
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).
| S-EPMC6304713 | biostudies-literature
Project description:The 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.We 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.Stroke 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.ClinicalTrials.gov ( NCT01927445 ). Registered August 14, 2014 at https://clinicaltrials.gov/ .
| S-EPMC5135743 | biostudies-literature
Project description:BackgroundMost people with opioid use disorder (OUD) never receive treatment. Medication treatment of OUD in primary care is recommended as an approach to increase access to care. The PRimary Care Opioid Use Disorders treatment (PROUD) trial tests whether implementation of a collaborative care model (Massachusetts Model) using a nurse care manager (NCM) to support medication treatment of OUD in primary care increases OUD treatment and improves outcomes. Specifically, it tests whether implementation of collaborative care, compared to usual primary care, increases the number of days of medication for OUD (implementation objective) and reduces acute health care utilization (effectiveness objective). The protocol for the PROUD trial is presented here.MethodsPROUD is a hybrid type III cluster-randomized implementation trial in six health care systems. The intervention consists of three implementation strategies: salary for a full-time NCM, training and technical assistance for the NCM, and requiring that three primary care providers have DEA waivers to prescribe buprenorphine. Within each health system, two primary care clinics are randomized: one to the intervention and one to Usual Primary Care. The sample includes all patients age 16-90 who visited the randomized primary care clinics from 3 years before to 2 years after randomization (anticipated to be?>?170,000). Quantitative data are derived from existing health system administrative data, electronic medical records, and/or health insurance claims ("electronic health records," [EHRs]). Anonymous staff surveys, stakeholder debriefs, and observations from site visits, trainings and technical assistance provide qualitative data to assess barriers and facilitators to implementation. The outcome for the implementation objective (primary outcome) is a clinic-level measure of the number of patient days of medication treatment of OUD over the 2 years post-randomization. The patient-level outcome for the effectiveness objective (secondary outcome) is days of acute care utilization [e.g. urgent care, emergency department (ED) and/or hospitalizations] over 2 years post-randomization among patients with documented OUD prior to randomization.DiscussionThe PROUD trial provides information for clinical leaders and policy makers regarding potential benefits for patients and health systems of a collaborative care model for management of OUD in primary care, tested in real-world diverse primary care settings. Trial registration # NCT03407638 (February 28, 2018); CTN-0074 https://clinicaltrials.gov/ct2/show/NCT03407638?term=CTN-0074&draw=2&rank=1.
| S-EPMC7849121 | biostudies-literature
Project description:BACKGROUND:Falls are common among older people, and General Practitioners (GPs) could play an important role in implementing strategies to manage fall risk. Despite this, fall prevention is not a routine activity in general practice settings. The iSOLVE cluster randomised controlled trial aimed to evaluate implementation of a fall prevention decision tool in general practice. This paper sought to describe the strategies used and reflect on the enablers and barriers relevant to successful recruitment of general practices, GPs and their patients. METHODS:Recruitment was conducted within the geographical area of a Primary Health Network in Northern Sydney, Australia. General practices and GPs were engaged via online surveys, mailed invitations to participate, educational workshops, practitioner networks and promotional practice visits. Patients 65?years or older were recruited via mailed invitations, incorporating the practice letterhead and the name(s) of participating GP(s). Observations of recruitment strategies, results and enabling factors were recorded in field notes as descriptive and narrative data, and analysed using mixed-methods. RESULTS:It took 19?months to complete recruitment of 27 general practices, 75 GPs and 560 patients. The multiple strategies used to engage general practices and GPs were collectively useful in reaching the targeted sample size. Practice visits were valuable in engaging GPs and staff, establishing interest in fall prevention and commitment to the trial. A mix of small, medium and large practices were recruited. While some were recruited as a whole-practice, other practices had few or half of the number of GPs recruited. The importance of preventing falls in older patients, simplicity of research design, provision of resources and logistic facilitation of patient recruitment appealed to GPs. Recruitment of older patients was successfully achieved by mailed invitations which was a strategy that was familiar to practice staff and patients. Patient response rates were above the expected 10% for most practices. Many practices (n =?17) achieved the targeted number of 20 or more patients. CONCLUSIONS:Recruitment in general practice settings can be successfully achieved through multiple recruitment strategies, effective communication and rapport building, ensuring research topic and design suit general practice needs, and using familiar communication strategies to engage patients. TRIAL REGISTRATION:The trial was prospectively registered on 29 April 2015 with the Australian New Zealand Clinical Trial Registry www.anzctr.org.au (trial ID: ACTRN12615000401550).
| S-EPMC6907149 | biostudies-literature