Diabetes Mellitus, Type 2
Conditions
Brief summary
This pragmatic randomized controlled trial will assess the efficacy of medically tailored meals and medical nutrition therapy via telehealth on clinical outcomes for patients with poorly controlled type 2 diabetes. The goal of these interventions is to improve outcomes for patients with diabetes by impacting self-care behaviors and diet self-efficacy in the short and long term. This study leverages a unique health system and community group partnership to inform the utility of reimbursement for medically tailored meal programs and medical nutrition therapy, which would ultimately facilitate their scalability and sustainability within the healthcare system.
Detailed 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 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.
Interventions
MTM are meals designed by a Registered Dietitian Nutritionist to reflect appropriate dietary therapy according to evidence-based nutrition practice guidelines. They address medical diagnoses, symptoms, allergies, inability to chew or swallow, medication management, and side effects to ensure the best possible nutrition-related health outcomes.
BEHAVIORALTele-Medical Nutrition Therapy (tele-MNT)
Medical nutrition therapy (MNT) is offered as a component of usual care in many health systems, and consists of individuals receiving nutrition education tailored to their unique medical needs. Tele-MNT is the use of video technology to deliver MNT.
Sponsors
Rutgers University
West Chester University of Pennsylvania
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have type 2 diabetes mellitus (DM) 2. Are 18 years or older of age 3. English speaking 4. Are a patient in the ED or inpatient at TJUH or Methodist Hospital 5. Have a HbA1c \>8% as assessed during enrollment screening 6. Have a PCP or Endocrine provider 7. Have access to a device (e.g., smartphone, tablet, computer with WiFi) that can support video visits 8. Have access to an email account (either own or family member) 9. Are able to keep food fresh for a week after delivery (e.g., not homeless) and reheat food using a microwave or oven 10. Live in the MANNA service area
Exclusion criteria
1. Have type 1 DM (to reduce confounding related to underlying differences in pathophysiology and primary treatment approaches (lifestyle change vs medication regimens) between type 1 and type 2 DM) 2. Pregnant, planning to be pregnant, or currently breastfeeding, as these patients have unique nutritional requirements outside the MNT curriculum 3. Does not eat by mouth (i.e. receives tube feeds or total parenteral nutrition \[TPN\]) 4. History of severe gastroparesis 5. Has a life expectancy of less than one year, per clinician 6. Inability to provide informed consent 7. Psychiatric co-morbidity that would preclude study participation 8. Major communication barriers such as visual or hearing impairment that would compromise the ability to participate in a video visit 9. Lives in or is being discharged to a facility (incarcerated, IP rehab, nursing home) 10. Currently receiving MTM from MANNA or another provider 11. Have life threatening food allergies 12. Currently participating in DM-I or PREVENT study 13. Has 3 or more ED visits for alcohol or other substance use in past month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hemoglobin A1C for patients with poorly controlled type 2 diabetes mellitus | 6 months | Change in hemoglobin A1C for patients with poorly controlled type 2 diabetes mellitus who receive 1) medically tailored meals and 2) medically tailored meals + telehealth-delivered medical nutrition therapy compared to usual care |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention costs of 1) medically tailored meals, 2) medically tailored meals + telehealth-delivered medical nutrition therapy, and 3) usual care | 6 months | Cost of delivering usual care and MTM will be obtained from administrative billing data. Cost of delivering tele-MNT will be obtained from data logs which capture time preparing and delivering sessions. |
| Healthcare costs | 6 months | Total participant health care cost will be obtained from the Healthshare Exchange of Southeast Pennsylvania (HSX), the regional health information exchange, or Jefferson billing and claims data. HSX captures administrative billing information (i.e., claims) for outpatient care, emergency department care, inpatient care, and post-acute care and prescription drugs. |
| Health care quality of life as measured by the EQ-5D-5L | 6 months | Health utility will be measured using the EQ-5D-5L, which measures health-related quality of life by assessing 5 dimensions on a scale from 1-5. A summary index score is derived by applying an appropriate value set to the responses. The value sets provide weights to each health dimensions according to the preferences of the general population of a country or region. These values sets have been developed and verified by the EuroQol Research Foundation. |
| Incremental Cost-Effectiveness Ratio (ICER) | 6 months | The ICER is the measure of cost-effectiveness. It is calculated as the difference in cost (health care costs + intervention costs) between two strategies divided by the difference in health care related quality of life between two strategies. |
| Change in hemoglobin A1C for patients with poorly controlled type 2 diabetes mellitus | 3 months | Change in hemoglobin A1C for patients with poorly controlled type 2 diabetes mellitus who receive 1) medically tailored meals and 2) medically tailored meals + telehealth-delivered medical nutrition therapy compared to usual care |
| Change in diabetes self-efficacy for patients with poorly controlled type 2 diabetes mellitus as measured by The Diabetes Self Efficacy Scale | 6 months | Change in diabetes self-efficacy for patients with poorly controlled type 2 diabetes mellitus who receive 1) medically tailored meals and 2) medically tailored meals + telehealth-delivered medical nutrition therapy compared to usual care. The Diabetes Self Efficacy Scale is made up of 8 questions, all scored on a 10-point Likert scale. Each questions asks about the respondent's confidence in performing an activity relative to diabetes. A response of 10 indicates total confidence, while a response of 1 indicates no confidence. The score for the scale is the mean of the eight items. Higher numbers are indicative of higher self-efficacy. |
| Change in self-care for patients with poorly controlled type 2 diabetes mellitus as measured by the Summary of Diabetes Self-Care Activities (SDSCA) | 6 months | Change in self-care for patients with poorly controlled type 2 diabetes mellitus who receive 1) medically tailored meals and 2) medically tailored meals + telehealth-delivered medical nutrition therapy compared to usual care. The Summary of Diabetes Self-Care Activities (SDSCA) is a survey made up of 11 questions, all scored on a 7-point scale. Each question asks how many days in the last 7 days a diabetes related task was performed. The scale represents the number of days per week this task was performed and the respondent indicates the frequency with which they performed these tasks. The SDSCA assess five regimen areas: General Diet, Specific Diet, Exercise, Blood-Glucose Testing, Foot Care, and Smoking Status. Scores are calculated for each of the five regimen areas by finding the mean number of days each task was performed within each regimen. Higher scores indicate better management of diabetes self-care activities. |
| Change in diabetes quality of life for patients with poorly controlled type 2 diabetes mellitus as measured by Diabetes Quality of Life (DQoL) instrument | 6 months | Change in diabetes quality of life for patients with poorly controlled type 2 diabetes mellitus who receive 1) medically tailored meals and 2) medically tailored meals + telehealth-delivered medical nutrition therapy compared to usual care. The Diabetes Quality of Life (DQoL) instrument is made up of 15 questions, all scored on a 5-point Likert scale assessing either frequency (never - all the time) or satisfaction (very satisfied - very dissatisfied). Higher scores on DQOL items indicate higher frequency of negative impact of diabetes or higher dissatisfaction with diabetes care and quality of life. |
| Change in weight for patients with poorly controlled type 2 diabetes mellitus | 3 months | Change in weight for patients with poorly controlled type 2 diabetes mellitus who receive 1)medically tailored meals and 2) medically tailored meals + telehealth-delivered medical nutrition therapy compared to usual care |
Countries
United States
Outcome results
None listed