Introduction Diabetes is one of the most common serious chronic health conditions in the USA. People living with diabetes face multiple barriers to optimal diabetes care, including gaps in access to medical care and self-management education, diabetes distress, and high burden of treatment. Community paramedics (CPs) are uniquely positioned to support multidisciplinary care for patients with diabetes by delivering focused diabetes self-management education and support and bridging the gaps between patients and the clinical and community resources they need to live well with their disease.
Methods and analysis We will conduct a pragmatic single-arm prospective trial of a CP-led Diabetes Rescue, Engagement and Management (D-REM) programme that seeks to reduce diabetes distress. We will enrol 70 adults (≥18 years) with diabetes who have haemoglobin A1c (HbA1c)≥9.0%, experienced an emergency department (ED) visit or hospitalisation for any cause within the prior 6 months, and reside in areas with available CP support in Southeast Minnesota (Olmsted, Freeborn and Mower counties) and Northwest Wisconsin (Barron, Rusk and Dunn counties). Participants will be identified using Mayo Clinic electronic health records, contacted for consent and enrolled into the D-REM programme. Visit frequency will be individualised for each patient, but will be an average of four CP visits over the course of approximately 1 month. Outcomes will be change in diabetes distress (primary outcome), confidence in diabetes self-management, health-related quality of life, self-reported hypoglycaemia and hyperglycaemia, HbA1c, ED visits and hospitalisations. Outcomes will be assessed on enrolment, programme completion and 3 months after programme completion.
Ethics and dissemination The study was approved by Mayo Clinic Institutional Review Board. Findings will be disseminated through peer-reviewed publications and presentations. If demonstrated to be successful, this model of care can be implemented across diverse settings and populations to support patients living with diabetes.
Trial registration number NCT04385758.
- Diabetes & endocrinology
- General diabetes
- Organisation of health services
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Strengths and limitations of this study
This prospective pragmatic clinical trial is the first, to our knowledge, to evaluate the effectiveness of a community paramedic intervention in patients with uncontrolled diabetes.
Strengths of this study include its pragmatic design and evaluation of a scalable, generalisable intervention.
By including patients living in urban, rural and highly rural areas, this study will examine the feasibility and effectiveness of a community-based intervention across settings with a wide range of access to healthcare resources.
Limitations include a relatively small sample size, location in the upper Midwest and limited prevalence of racial/ethnic minorities in the included geography.
More than one in seven American adults, or 37.1 million people, are living with diabetes,1 making it a leading cause of morbidity, disability, impaired quality of life, mortality and high healthcare costs in the USA.1–6 The goals of glucose-lowering therapy are to prevent acute and chronic complications of diabetes by controlling hyperglycaemia, avoiding hypoglycaemia and minimising burdens of treatment and disease.7–12 Despite advances in the science of diabetes management, rates of acute and chronic diabetes complications remain unacceptably high, particularly in racial/ethnic minorities, low income individuals and rural residents13–17 who often have limited access to comprehensive diabetes care. Recent data suggests that control of hyperglycaemia and key cardiovascular disease risk factors, particularly hypertension and hyperlipidaemia, has worsened since 2010.18 Thus, there is great need for innovative care delivery models that can support patient-centred, accessible and affordable diabetes care.
Community paramedicine has emerged across the USA and in other countries around the world as an effective and efficient care delivery model to improve healthcare access for underserved communities and populations.19–26 Community paramedics (CPs) are uniquely positioned to provide multidisciplinary, interprofessional care for patients with both medical and socioeconomic complexities with the goals of improving access to care, health outcomes and reducing costs.27–29 CPs are experienced paramedics with advanced training in the management of low acuity and chronic health conditions, primary/preventive care and social determinant of health. They practice under the supervision of a physician medical director to provide a wide range of services tailored to each patient’s medical, educational and social needs. In contrast to traditional emergency medical services (EMS), which focuses on high acuity medical care, CPs deliver longitudinal low and intermediate acuity care with emphasis on primary care, education, social support and wellness.21 24–28 30–41 In the US fee-for-service healthcare system, financial sustainability is one of the biggest challenges facing CP programmes as a novel care delivery model. Minnesota is currently the only state to legislatively require Medicaid to reimburse for CP services as professional services. Additionally, and not limited to Minnesota, CP services can be billed to Medicare as ‘incident-to’ to other physician services. Finally, CP services can be funded under the umbrella of Accountable Care Organisations, Medicaid Integrated Health Partnerships and other value-based care models.42 For this study, CP services will be supported by institutional grant funding seeking to improve diabetes care in rural and underserved communities, with plans for broader implementation and dissemination using established funding streams once programme effectiveness is established.
Thus far, most CP programmes have primarily focused on specific high-risk patient populations, most often those with history of frequent hospital, emergency department (ED) and/or EMS utilisation, multimorbidity and frailty.21 26 36 38 43–46 While, to our knowledge, there has been no diabetes-specific CP programme, community paramedicine is uniquely suited to meet the multifaceted needs of patients with diabetes living in rural and underserved communities.27 47 48 Our objective in this prospective single-arm pragmatic trial is therefore to evaluate the effectiveness of a CP-led intervention—Diabetes Rescue, Engagement and Management (D-REM)—on reducing diabetes distress and improving diabetes self-efficacy, glycaemic control and quality of life. Our ultimate goal is to bring care to the communities and homes where people live, and thereby improve health outcomes and quality of life for people living with this serious, progressive, chronic disease.
Methods and analysis
Prospective pragmatic single-arm clinical trial that began on 13 July 2020, has an estimated primary completion date 30 June 2022, and a final completion date of 30 June 2023.
Patients residing in six counties of southeast Minnesota (Olmsted, Freeborn and Mower counties) and northwest Wisconsin (Barron, Rusk and Dunn counties) will be eligible for enrolment if they are panelled to a Mayo Clinic Rochester or Mayo Clinic Health System (MCHS) primary care provider (PCP). These specific locations were chosen because they have available CP services and to ensure a diverse patient population in terms race/ethnicity, socioeconomic status, rurality and access to primary and diabetes-specific care.
Mayo Clinic is an integrated healthcare delivery system serving local, regional, national and international patients with a central hub in Rochester, Minnesota (Olmsted County). Mayo Clinic Rochester primary care practices (internal medicine, geriatrics, family medicine and paediatrics specialties) care for Mayo Clinic employees, their dependents, and local area residents. MCHS is a network of community-based clinics, hospitals, and healthcare facilities serving communities in southeast and southwest Minnesota and in northwest and southwest Wisconsin, delivering primary and specialty care to empaneled patient populations.
Mayo Clinic Ambulance carries multiple accreditations including the Commission on Accreditation of Ambulance Services (ground ambulance), Commission on Accreditation of Medical Transport Systems (ground and air ambulance) and Accredited Centre of Excellence (emergency communications centre). It serves as the primary advanced life support provider for 14 locations throughout eastern and central Minnesota and western Wisconsin, covering 6894 square miles of urban, suburban and rural areas. Mayo Clinic Ambulance is staffed by emergency medical technicians, paramedics, and registered nurses, and responds to approximately 100 000 requests for service, including 75 000 911 calls, each year. The Mayo Clinic Ambulance Community Paramedic Service has two hubs: a small hub in Barron county, WI (with 1.0 CP full-time equivalent (FTE) CP staffing, working Monday through Friday, 8:00–17:00 hour) and a larger hub in Olmsted county, MN (3.0 FTE, working 7 days per week, 7:00–19:00 hour). All CPs will be involved in this work.
Eligible participants will be patients with an established diagnosis of type 1 or type 2 diabetes, ≥18 years old, and a most recent haemoglobin A1c (HbA1c)≥9.0% obtained within the last 2 years. Patients will be required to be panelled to a PCP in Mayo Clinic Rochester or MCHS, be able to provide informed consent, have conversational English, live independently in a private residence (ie, not in a skilled nursing facility or another congregate living setting where they receive medication management), and live in Mower, Freeborn or Olmsted counties of Minnesota or Barron, Rusk and Dunn counties of Wisconsin.
Potential participants will be identified by using Mayo Clinic electronic health records (EHR) to identify all patients meeting eligibility criteria. An initial data pull identified 233 potential participants. A report will be run monthly by an analyst within Mayo Clinic Ambulance (MCR) to identify potential participants, with new eligible patients to be identified during each data pull. Their charts will be reviewed by the study coordinator (there will be one study coordinator (AKM) supporting this study at 0.2 FTE) to confirm that inclusion criteria are met and to further exclude individuals if they have (1) cognitive impairment precluding informed consent, (2) lack of conversational English skills, (3) are a resident of a long-term care facility, (4) are enrolled in hospice, (5) are enrolled in a care coordination or disease management programme, or (6) have advanced or terminal illness. Once eligibility is confirmed, the study coordinator will call potential participants to introduce them to the D-REM programme and offer participation in the study. On receipt of oral consent (see online supplemental file), the study coordinator will mail patients (via postal mail or email, per participant preference) a HIPAA release form and (via postal mail only) the baseline study survey.
Trial enrolment will be by invitation only and contingent on CP programme availability. If a clinician was to contact the study team to request enrolment of their patient, that patient will be reviewed for eligibility criteria and offered study enrolment only if all eligibility criteria are met and the CP programme has capacity to accept new patients.
After the signed HIPAA release form is received by the study coordinator, she will notify three CPs (two from Olmsted county and one from Barron county) that the participant is ready to be scheduled for their first visit. Scheduling will be done by the CPs for their respective region. The CP will call the participant and schedule an intake visit for a mutually agreeable time and place (if not at the participant’s home). For southeast Minnesota, the participant will be assigned to be seen by the CP scheduled to work the day the participant selects as most convenient for their first visit. Subsequent visits, whether in person or phone, will be scheduled by the CP caring for them in consultation with the participant. Only one CP is available in northwest Wisconsin and will complete all scheduling and visits herself.
Trial procedures are detailed in figure 1, while the care processes and guidelines for CPs are detailed in figure 2 and the online supplemental appendix During the first (intake) visit, CPs will clarify the roles and responsibilities of the CP as compared with other members of the participant’s healthcare team and answer any questions the participant may have about the intervention. CPs will obtain a full history, review and reconcile medications, obtain vital signs, perform a physical exam and review and validate the information found in the EHR as pertinent to the patient’s diabetes management and overall health. Review of systems and physical exam will pay specific attention to diabetes-related complications, including skin problems (eg, lower extremity ulcers, rashes and/or injection site reactions), nervous system problems (eg, central, autonomic and/or peripheral neuropathy), cardiovascular problems (eg, dyspnoea, angina, claudication), vision and/or hearing impairment, cognitive/memory concerns and mood concerns (eg, depression, anxiety, diabetes distress, burn-out). As part of medication review, CPs will assess medication adherence and how participants store, administer and dispose of their medications. To identify potential barriers to optimal diabetes management and elicit clinical and non-clinical needs, CPs will assess the participant’s socioeconomic challenges, including food insecurity, housing insecurity and cost-related non-adherence to medications and/or care plan.
Following the general assessment portion, diabetes-specific evaluations will include concerns or questions that the participant has related to their diabetes; self-reported hypoglycaemia, hyperglycaemia and impaired hypoglycaemia awareness; and factors potentially contributing to hypoglycaemia and hyperglycaemia. CPs may conduct a variety of assessments and educational interventions including: observe a blood glucose check to make sure it is done correctly and confirm that the participant’s glucose meter is functioning properly; review glucose log with the participant or, if the participant does not keep a log, teach them how to maintain and interpret one; discuss the signs and symptoms of hypoglycaemia and how to manage them; review the negative health consequences associated with hypoglycaemia and hyperglycaemia; discuss the risk factors for and causes of hypoglycaemia and hyperglycaemia; review the participant’s daily routine as it related to diabetes management; ensure an optimal supply of and access to insulin/other medications and testing/administration supplies through local or regional supply chains; and review needle/syringe safe disposal. What items will be covered, and the order in which they are covered, will be guided by the clinical context and participant’s needs.
The CPs will use this information to identify areas in need of intervention and education. They will work with the participant to set ≥3 SMART (Specific, Measurable, Achievable, Relevant and Time-Bound) goals for the 1-month intervention. Depending on the needs identified by the CP and the participant, the CP will recommend referrals to primary care, social services and/or community resources. If the participant agrees, the CP will execute these referrals after each visit is completed. CPs will also introduce the participant to the patient online services portal, a free online resource, as a means of efficient and secure asynchronous communication with the healthcare team, if not already set up.
This information will be charted in the Mayo Clinic EHR. Following completion of the intake visit, the CP will forward a copy of the patient’s care summary, via the EHR, to the CP Medical Director (RGM), who is also the study principal investigator, and the participant’s PCP within 24 hours. If the participant already has established care with an endocrinologist, certified diabetes care and education specialist and/or clinical pharmacist, they will be included in the communication as well. This correspondence will include the participant’s care report; the participant’s set goals, concerns and questions; any needs for the participant identified by the CP; and any referrals to clinical providers or external agencies that the CP deems to be potentially necessary. The PCP will be responsible for ordering any clinical referrals as dictated by their judgement and within the scope of usual practice. Discussion with the PCP related to care planning can occur prior to subsequent visits. Medical issues requiring immediate or urgent attention will be forwarded to the PCP and/or CP Medical Director via the message feature imbedded in the EHR or by telephone, as the acuity of the issue dictates.
Frequency, timing, and modality (ie, in person or telephone) of follow-up visits will be determined by the participant and the CP during the intake visit and will be reassessed at each subsequent encounter. An average of two in-person visits and two phone visits over the 1-month period is anticipated; however, an alternate schedule will be accommodated depending on clinical need. At each visit, CPs will obtain an interval history and deliver education and other services as dictated by participant’s needs and circumstances.
The primary outcome will be change in diabetes distress, measured by the validated Diabetes Distress Scale (DDS)49 50 and ascertained using mailed survey, from baseline to end of the intervention (1-month survey). Time frame of outcome collection is shown in figure 3. Each participant will receive up to three mailings of each survey with reminder phone calls to complete the survey if not received within a 3-week period.
Multiple secondary outcomes will be examined, measuring the change from baseline to 1 month (approximately at D-REM completion) to assess programme effectiveness and 4 months (approximately 3 months after D-REM completion) to assess programme durability. Outcomes collected via mailed survey will include (1) confidence in diabetes-self management (measured by the Diabetes Self-Management Questionnaire (DSMQ))51; (2) health-related quality of life (measured by the EQ-5D)52 53; (3) frequency of self-reported hypoglycaemia (blood glucose <70 mg/dL and <54 mg/dL) and hyperglycaemia (blood glucose ≥250 mg/dL); (4) open-ended questions regarding concerns/challenges with diabetes management and perceptions of the CP programme. The EHR will be used to assess for (1) HbA1c before and within 3–6 months after enrolment; (2) attainment of the D5 composite measure54 of diabetes care quality (includes indicators of HbA1c, blood pressure and low density lipoprotein cholesterol control, tobacco use and aspirin use) before and 4 months after enrolment and (3) number of ED visits and hospitalisations during the 6 and 12 months before, and 6 and 12 months after, enrolment. EHR-derived outcomes will be collected for all study participants, including those who do not respond to the surveys.
During the final phase of the research, we will conduct interviews with CPs engaged in the programme to examine barriers to implementation, opportunities for improvement and potential gaps in knowledge, training andresources. All CPs delivering the intervention will be invited to participate and share their experiences related to the programme via teleconference technology at a time that is convenient for them. Participation will be voluntary. Interviews will last 45–60 min and be conducted by a qualitative researcher unaffiliated with the CP Service. All interviews will be audiorecorded and transcribed for analysis.
The EHR will be used to ascertain participant age, gender, race/ethnicity, rurality, glucose-lowering medications, comorbidities and prior ED/hospital utilisation for hypoglycaemia and hyperglycaemia. Comorbidities of interest will be ascertained using validated code sets and include retinopathy, neuropathy, coronary artery disease, cerebrovascular disease, peripheral arterial disease, heart failure, chronic kidney disease, chronic obstructive pulmonary disease, asthma, depression, other mental health disorders, hypertension and substance use. Survey will ascertain diabetes type and duration. Survey will also assess baseline diabetes distress (DDS,49 50 DSMQ,51 self-reported hypoglycaemia (glucose <54 mg/dL or need for third party assistance), hyperglycaemia (glucose ≥250 mg/dL) and quality of life (EQ-5D).52 53
There has been no prior study examining impact of CP on diabetes management. However, we anticipate that our programme will be as or more effective than other limited diabetes self-management education/support interventions. Based on a previous study,50 patients with diabetes who were administered an educational intervention showed a decrease in DDS score of 0.24±0.89 over a 4-month period, corresponding to a decline of approximately 0.27 SD. If the change from baseline to end of study has a similar effect size, a sample size of N=64 (one tailed, alpha=0.1) will provide statistical power of 80%. To accommodate sample attrition of up to 10%, a total sample size of 70 is proposed. Participants will be recruited sequentially until target accrual is reached.
The primary outcome of the study will be the change in DDS score from baseline to 1 month. DDS scores from baseline to 4, and 1 month to 4 months will be analysed to see the lasting impact of the intervention. Secondary outcomes of HbA1c, D5 and ED visits/hospitalisations are exploratory due to the short duration of the intervention. Descriptive statistics will be summarised using mean and SD for continuous variables and frequency percentages for categorical variables. Data will be analysed using a one-tailed paired t-test with 90% CIs.
Qualitative data gathered through free-text responses to the participant surveys and CP interview transcripts will be analysed separately using a content analysis approach.55 Data will be uploaded into NVivo qualitative management software for coding and analysis. A code structure will be developed for each using an integrated deductive and inductive approach informed by survey/interview questions and content that emerges from the data. An iterative process involving multiple members of the research team will be used to develop and refine the analysis and interpretation. An analysis audit trail will document decisions made during the analyses. Cross-cutting themes will be identified among the participant groups and compared within and across key subgroups, and presented through aggregate description.
Patient and public involvement
This work was motivated by the need for accessible patient-centred care delivery models for patients with diabetes, though not explicitly informed by individual patients’ experience and preference. Patients were not directly involved in the design or conduct of this study.
Ethics and dissemination
The study protocol, consent form, survey instruments and all communication materials have been reviewed and approved by the Mayo Clinic Institutional Review Board (IRB). Any protocol modifications that will occur during the course of the study will be reported to the IRB. Participants will be consented using verbal consent but will need to sign a HIPAA release form (either mailed or electronic) prior to enrolment in the study. At the time potential participants provide verbal consent, they will be asked, for follow-up purposes, to provide their name, address, phone number and email address. They will be informed that study records will be kept as confidential as possible. No individual identities will be used on any reports or publications resulting from the study. Study information will be coded and stored in secured files. Only authorised study personnel will have access to the files. Individuals with cognitive impairment, which precludes them from providing informed consent, will not be included in the study per inclusion/exclusion criteria.
The potential risks associated with participation in this study are low, and the involved activities are considered minimal risk to subjects. Participants may be uncomfortable being identified as having uncontrolled diabetes, revealing personal information to the CPs, revealing their home living situation or providing responses to certain questions included in the questionnaires. They will have the option to refuse to provide any information they are not comfortable providing and to schedule appointments outside of their home in a convenient, mutually agreed on location. Safety and COVID-19 infection control precautions will be implemented and followed according to contemporaneous Mayo Clinic and Mayo Clinic Ambulance standard protocols.
CP participation in the interviews will be voluntary. Members of the CP leadership team, including the Medical Director, will not know if a CP declined participation and will not have access to identifiable interview transcripts. CPs will be advised that their decision whether to participate, and any information they provide during the interview, will have no impact on their employment or standing in Mayo Clinic Ambulance.
Dissemination of research findings will be a collaborative, multimodal effort by the study investigators and Mayo Clinic Ambulance as a critical partner. Dissemination will occur at academic conferences, peer-reviewed publications and institutional meetings. We further anticipate that results of this study will inform clinical practice and allow for D-REM to be a standard offering to patients with uncontrolled diabetes.
Patient consent for publication
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Contributors MBJ oversees the community paramedic intervention and reviewed/revised the manuscript. CPL cocreated the diabetes clinical practice guidelines and reviewed/revised the manuscript. PNC codesigned the community paramedic intervention and reviewed/revised the manuscript. LAM participated in study design and reviewed/revised the manuscript. ZRS supported the study coordinator and reviewed/revised the manuscript. JARS supported the study coordinator and reviewed/revised the manuscript. AKM is the lead study coordinator on the study and reviewed/revised the manuscript. EB supported the study coordinator, participated in study design and reviewed/revised the manuscript. MAL participated in study design, will oversee qualitative analyses and reviewed/revised the manuscript. MCR conducted analyses and reviewed/revised the manuscript. KMF participated in study design, will be conducting analyses and reviewed/revised the manuscript. RGM secured funding, designed the study, prepared the protocol and drafted the manuscript. All authors approved the final version of the manuscript. All authors will have access to study data.
Funding This effort was funded by the National Institute of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) grant number K23DK114497 (McCoy) and the Mayo Clinic Center for Health Equity and Community Engagement Research.
Disclaimer The study sponsors have had no role, and will not have a role, in the study design; collection, management, analysis, or interpretation of data; writing of the report; or the decision to submit the report for publication. Study contents are the sole responsibility of the authors and do not necessarily represent the official views of NIH.
Competing interests In the last 36 months, RGM received support from NIDDK, PCORI and AARP. She also serves as a consultant to Emmi (Wolters Kluwer) on developing patient education materials related to diabetes.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.