Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Diabetes Mellitus - Type 2
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Enrolled patients with HbA1c>8% will be randomized to 1 of 3 arms: 1) MTM; 2) MTM + tele- MNT; or 3) usual care in a 1:1:1 ratio using random permuted blocks stratified by HbA1c (>8 to <10 vs. >10) and hospital discharge site (inpatient vs ED). The size of any particular block will be randomly selected and only known by the study biostatistician. This stratification approach was selected as investigators hypothesize that the interventions may have differential effects based on how poorly controlled an individual's DM is at baseline, as well as the degree of acute decompensation of the patient at time of enrollment.Masking: None (Open Label)Masking Description: A computer-generated list of random numbers will be prepared in advance by the study biostatistician and loaded into a REDCap randomization tool to ensure the research staff are blinded to assignment pre-randomization. It is not feasible to blind participants and clinic staff to assignment post enrollment; however, HbA1c is an objective outcome, and as such lack of blinding should not be a significant limitation.Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Despite the availability of evidence-based guidance and treatments, many patients with diabetes mellitus (DM) do not achieve optimal glycemic control. In prior work, patients with DM identified primary needs of improved access to food and nutrition education. Several innovative models for food servi...

Despite the availability of evidence-based guidance and treatments, many patients with diabetes mellitus (DM) do not achieve optimal glycemic control. In prior work, patients with DM identified primary needs of improved access to food and nutrition education. Several innovative models for food services have emerged to address patient needs for improved healthy food access. Currently, select non-profit organizations across the U.S. deliver millions of medically-tailored meals (MTM) to patients with chronic illnesses, based on the premise that food can be as helpful as medicine in improving patient outcomes. While a handful of pilot studies have demonstrated success of MTM in reducing healthcare utilization and hemoglobin A1c (HbA1c) among patients with DM, no randomized trials have assessed the sustained impact of MTM on long-term outcomes for patients with DM. Similarly, individual studies of medical nutrition therapy (MNT), which includes individualized nutrition education and counseling, have shown benefit for improving DM outcomes. However, uptake of MNT across health systems has historically been extremely limited because of patient logistical barriers to attending the in-person visits. MNT delivered by telehealth (tele-MNT) has potential to overcome these barriers. Our goal is to evaluate the effect of MTM, with and without additional tele-MNT, on outcomes for patients with poorly controlled type 2 DM. The investigators will conduct a pragmatic randomized controlled trial with patients who have poorly controlled DM. Outcomes of interest include change in HbA1c, cost effectiveness, weight, diabetes self-efficacy, self-care, diabetes quality of life, and patient satisfaction. Investigators will assess the efficacy of 1) MTM and 2) MTM + tele-MNT compared to usual care in reducing HbA1c at 3, 6 (primary outcome) and 12 months and the cost effectiveness of each intervention compared to usual care up to 12 months. Patient perspectives regarding experiences with MTM and MTM + tele-MNT will also be explored to gain a better understanding of potential factors contributing to treatment failure and success within each group. The proposed research is innovative because it develops and tests a novel tele-MNT intervention tailored to recipients of MTM, provides a comprehensive solution to patient-identified nutrition needs, includes complete utilization data provided by the HealthShare Exchange, and leverages a unique health system and community group partnership to improve sustainability and scalability. Study results will inform 1) provider and payor decisions regarding offering and covering these services; 2) how services should be structured for scalability; and 3) integration of these services into the larger care delivery system to reduce DM disparities.

Tracking Information

NCT #
NCT04264572
Collaborators
  • Rutgers University
  • West Chester University of Pennsylvania
Investigators
Not Provided