Clinical trial NCT03520413: Practical Telemedicine to Improve Control and Engagement for Veterans With Clinic-Refractory Diabetes Mellitus
Official title: Practical Telemedicine to Improve Control and Engagement for Veterans With Clinic-Refractory Diabetes Mellitus (PRACTICE-DM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemedicine
Keywords: Complex Care
Outcomes
Telemedicine
Rural Health
Diabetes
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-05-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: VA Home Telehealth (HT) nurses will deliver the 5 intervention components during telephone encounters. The standard encounter frequency will be every two weeks, but may be extended to every 4 weeks for participants achieving their HbA1c goal. Should Veterans relapse while receiving the lower encounter frequency, HT will return to every-two-week encounters until the next HbA1c assessment. The 5 intervention components are: Telemonitoring, Self-management support, Diet/activity support, Medication management, \& Depression support
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Diabetes generates significant morbidity, mortality, and costs within the Veterans Health Administration (VHA). Veterans with persistently poor diabetes control despite clinic-based care are among the highest-risk diabetes patients in VHA, and contribute disproportionately to VHA's massive burden of diabetes complications and costs. VHA critically needs effective, practical management alternatives for Veterans whose diabetes does not respond to clinic-based management. The proposed study will address this need by leveraging VHA's unique Home Telehealth capacity to deliver comprehensive telemedicine-based management for Veterans with persistently poor diabetes control despite clinic-based care. Because this intensive intervention is delivered using only existing Home Telehealth workforce, infrastructure, and technical resources - which are ubiquitous at VHA centers nationwide - it could represent an effective, practical approach to improving outcomes in Veterans with PPDM, potentially translating to a substantial reduction in VHA's diabetes burden.

Detailed description: This study will evaluate a comprehensive telemedicine intervention for Veterans with persistently poor diabetes control despite clinic-based Veterans Health Administration (VHA) care. Because this approach is designed for delivery via existing Home Telehealth (HT) services, which are ubiquitous throughout VHA, it may represent an effective, practical alternative for Veterans whose diabetes is refractory to clinic-based care.

Although efforts by clinicians and researchers have improved diabetes control across VHA, Veterans with persistent poorly-controlled diabetes mellitus (PPDM) have not benefitted from these advances. The investigators define PPDM as maintenance of a hemoglobin A1c (HbA1c) 8.5% for \>1 year, despite receiving clinic-based diabetes care during this period. Veterans meeting this definition - approximately 12% of all Veterans with type 2 diabetes - contribute disproportionately to VHA's burden of diabetes complications and costs.

While clinic-based care is insufficiently effective in PPDM, telemedicine-based management that comprehensively addresses factors underlying poor diabetes control could improve outcomes for these high-risk Veterans. Unfortunately, healthcare systems have rarely integrated comprehensive telemedicine-based care into real-world practice, even for clinic-refractory conditions like PPDM. This gap stems from the fact that comprehensive telemedicine-based diabetes care has not previously been designed for practical delivery under real-world conditions. In order for telemedicine to fulfill its potential as a means to reduce the burden of PPDM, interventions must be developed with an emphasis on feasible delivery through existing workforce, infrastructure, and technical resources, such that effective implementation is eventually achievable. Until then, Veterans with PPDM will be left without alternatives when clinic-based care proves inadequate.

The proposed trial will evaluate Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM), a novel, comprehensive telemedicine intervention for PPDM that is designed for practical delivery within VHA. The Specific Aims of this study are to: 1) determine PRACTICE-DM's effectiveness; 2) evaluate PRACTICE-DM's acceptability and mechanisms of effect using a mixed method process evaluation; and 3) understand costs associated with PRACTICE-DM.

Two hundred Veterans with PPDM from two sites (Durham, North Carolina (NC) and Richmond, Virginia (VA)) will be randomized to receive one of two HT-delivered interventions: 1) PRACTICE-DM, a comprehensive intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression support; or 2) an active control, standard HT care coordination and telemonitoring. Both interventions will be delivered over a 12-month period and all participants will continue to receive usual VHA care.

The primary study outcome will be change in HbA1c from study baseline to 12 months. The secondary outcomes are guided by a theoretical framework, and will include diabetes self-care, diabetes burden, self-efficacy, and depressive symptoms. Qualitative interviews will be conducted with 20 intervention-group Veterans, the HT nurses delivering the intervention, and administrators at each site. Intervention costs will be comprehensively assessed and compared to standard HT care coordination and telemonitoring.

Although VHA is a leader in telemedicine, its telemedicine capabilities are currently underutilized for Veterans with PPDM. These Veterans are refractory to clinic-based care, so contribute disproportionately to diabetes complications and costs. This study will leverage VHA's unique telemedicine infrastructure to deliver comprehensive management designed for PPDM, with the goal of improving outcomes in this high-risk, high cost population. Because the proposed intervention is designed for delivery using existing HT services, it may represent an effective, practical approach to reducing the burden of poor diabetes control across VHA.

Eligibility criteria: Inclusion Criteria:

* Veterans with persistently poorly-controlled type 2 diabetes mellitus defined as the presence of 2 HbA1c values 8.5% during the prior year (none \<8.5%) despite 1 or more appointments with a VHA Primary Care Provider (PCP) or Endocrinology during this period.

Exclusion Criteria:

* age \>70
* life expectancy \<5 years, or other comorbidities that would offset the benefits of HbA1c \<8.5%
* inability to communicate by telephone
* dementia or psychosis
* active alcohol/substance disorder
* pregnancy
* prior hypoglycemic seizure/coma
* refusal to perform self-monitored blood glucose (SMBG)
* use of insulin infusion pumps
* hospitalized for stroke, heart attack or had surgery for blocked arteries in the past 12m
* receiving kidney dialysis
* metastatic cancer diagnosis
* use of a continuous blood glucose monitor (due to HT equipment constraints)
* primary provider requests patient not participate

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 12 months
Secondary outcomes:
measure: Diabetes Distress Scale
timeFrame: 12 months
measure: Diabetes Self-Management Questionnaire
timeFrame: 12 months
measure: Perceived Competence Scale
timeFrame: 12 months
measure: Body Mass Index
timeFrame: 6 months
measure: Patient Health Questionnaire-8
timeFrame: 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center, Richmond, VA
state: Virginia
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Matthew Crowley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kobe EA, Edelman D, Tarkington PE, Bosworth HB, Maciejewski ML, Steinhauser K, Jeffreys AS, Coffman CJ, Smith VA, Strawbridge EM, Szabo ST, Desai S, Garrett MP, Wilmot TC, Marcano TJ, Overby DL, Tisdale GA, Durkee M, Bullard S, Dar MS, Mundy AC, Hiner J, Fredrickson SK, Majette Elliott NT, Howard T, Jeter DH, Danus S, Crowley MJ. Practical telehealth to improve control and engagement for patients with clinic-refractory diabetes mellitus (PRACTICE-DM): Protocol and baseline data for a randomized trial. Contemp Clin Trials. 2020 Nov;98:106157. doi: 10.1016/j.cct.2020.106157. Epub 2020 Sep 21.
citation: Lewinski AA, Crowley MJ, Miller C, Bosworth HB, Jackson GL, Steinhauser K, White-Clark C, McCant F, Zullig LL. Applied Rapid Qualitative Analysis to Develop a Contextually Appropriate Intervention and Increase the Likelihood of Uptake. Med Care. 2021 Jun 1;59(Suppl 3):S242-S251. doi: 10.1097/MLR.0000000000001553.
citation: Crowley MJ, Tarkington PE, Bosworth HB, Jeffreys AS, Coffman CJ, Maciejewski ML, Steinhauser K, Smith VA, Dar MS, Fredrickson SK, Mundy AC, Strawbridge EM, Marcano TJ, Overby DL, Majette Elliott NT, Danus S, Edelman D. Effect of a Comprehensive Telehealth Intervention vs Telemonitoring and Care Coordination in Patients With Persistently Poor Type 2 Diabetes Control: A Randomized Clinical Trial. JAMA Intern Med. 2022 Sep 1;182(9):943-952. doi: 10.1001/jamainternmed.2022.2947.