Clinical trial NCT04107935: Telemedicine for Reach, Education, Access and Treatment-ongoing
Official title: Telemedicine for Reach, Education, Access and Treatment-ongoing
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Self management education and support
Telemedicine
Rural
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-09-27
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Diabetes (DM) management requires health care providers to provide patients with the appropriate amount of time, education and support that are necessary for quality care. Unfortunately, this is often impeded by limited access to resources, particularly in rural communities where DM rates are high and providers are scarce. Therefore, study investigators propose addressing these issues by implementing a model of care that includes diabetes educator (DE)-led planned visits with a real-time videoconferencing telemedicine program for ongoing patient support to improve DM outcomes.

Detailed description: Health care systems need to seek ways through quality improvement, care coordination, and workforce capacity to support quality care. It has been proposed that new models of care coupled with technology are needed. DM provides an ideal model for testing new approaches as the number of people with DM continues to rise, with an inverse shortage of health providers available to meet their needs. Most patients with Type 2 DM (T2DM) are seen in primary care (PC) where providers report barriers to comprehensive care that include limited time, educational resources, added workload and feeling ill-equipped to counsel patients on behavior change. Efforts to restructure PC are underway, like DE-led planned management visits, reported to improve healthy behaviors and outcomes in patients at high risk. DEs are well suited to support the skills, decision making, self-care behaviors, problem solving and active collaboration with the care team that serve as the foundation for diabetes self-management education and key to an effective planned visit. DEs supporting care and self-management education in PC have been shown to improve access and outcomes. For patients to sustain a lifetime of behavior to effectively self-manage, continued support to sustain the ongoing skills, knowledge, and behaviors required to manage their condition is needed. Given the need for enduring support and scarcity of providers, particularly in underserved rural areas, efforts to understand how best to re-design practice to involve DEs in PC and utilize technology to enable and scale engagement in self-management and ongoing support must be considered. The purpose of this application is to evaluate the deployment of Telemedicine for Reach, Education, Access, Treatment and Ongoing Support (TREAT-ON), a DE-driven, PC-based telemedicine model that relies on PC practice redesign to afford access to real-time ongoing support. Investigators hypothesize that the TREAT-ON model will help individuals identified as being high risk in an underserved rural community to achieve and sustain improvements in clinical, psychosocial and behavioral outcomes, and aim to demonstrate the model's viability in terms of feasibility and acceptability to inform future testing of TREAT-ON.

Eligibility criteria: Inclusion Criteria:

* Intervention group: UPMC Health Plan patient-members who are 18-75y, have diagnosis of type 2 diabetes, are considered "high risk" (HbA1c \>9%), receiving care at participating Federally Qualified Health Centers, and willing and able to participate in a technology-supported intervention.
* Control group: The control group will be selected from individuals who have already participated in the UPMC Health Plan's Diabetes High Risk Initiative.

Exclusion Criteria:

* Non UPMC Health Plan patients
* Not enrolled in the UPMC Health Plan Diabetes High Risk Initiative
* Less than 18 or greater than 75 years of age
* Unwilling/unable to participate in the telemedicine diabetes education program

Primary outcomes:
measure: Change From Baseline in Glycemic Control
timeFrame: Change every 3 months for 12 months.
Secondary outcomes:
measure: Change From Baseline in Diabetes Self-care Behavior [Diet] Across 3 Month Intervals for 12 Months.
timeFrame: Change every 3 months for 12 months total.
measure: Change From Baseline in Diabetes Distress Across 3 Month Intervals for 12 Months
timeFrame: Change every three months for 12 months total
measure: Change From Baseline in Diabetes Empowerment Across 3 Month Intervals for 12 Months
timeFrame: Change every 3 months for 12 months total
measure: Intervention Acceptability
timeFrame: 12 months
measure: Change From Baseline in Medication Adherence Across 3 Month Intervals for 12 Months
timeFrame: Change every 3 months for 12 months total
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Linda Siminerio, RN, PhD, CDE
role: PRINCIPAL_INVESTIGATOR
References: