Clinical trial NCT01495975: Impact of a Diabetes Transitions Tool Kit on Post-Hospitalization Glycemic Control
Official title: Impact of a Web-based Diabetes Transitions Tool Kit on Post-Hospitalization Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus
Diabetes Mellitus, Type 2
Hospitalization
Patient Discharge
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-12-20
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this research is to evaluate the impact and feasibility of using web-based patient-provider communication and a remote glucose monitoring tool to improve post-hospitalization glycemic control and patient self-care. The investigators hypothesize that providing patients this web-based tool over a 4-week period after discharge to home will result in more effective glycemic control compared to usual care, and that patients with access to the "tool kit" will have a trend towards improved diabetes self-management and less diabetes-related distress.

Detailed description: Diabetes affects 12-25% of all hospitalized adult patients, and 30% of hospitalized diabetes patients have one or more readmissions within one year. While glycemic control is rarely the primary reason for admission, poor glycemic control has been associated with increased rates of hospitalization and worse clinical outcomes, including infections, poor wound healing, and death. Hospitalization has been proposed as a "teachable moment" for patients with diabetes, as they have intensive contact with a full range of expert clinicians, but the effects of changes implemented during hospitalization after discharge are poorly studied.

The objective of this study is to conduct a randomized controlled trial to test a novel approach to diabetes management in the transition from inpatient to outpatient care. We will assign 40 hospitalized adult patients with type 2 diabetes to usual care or access to a web-based patient-provider communication and remote glucose monitoring tool ("Diabetes Transitions Tool Kit"). Our aims are to evaluate feasibility of implementation of the tool as well as impact on post-discharge glycemic control, diabetes-related self-care and distress. We hypothesize that providing patients this web-based tool over a 4-week period after discharge to home will result in more effective glycemic control compared to usual care, and that patients with access to the "tool kit" will have a trend towards improved diabetes self-management and less diabetes-related distress. Feasibility and preliminary data from this pilot study will be the foundation for larger-scale interventions that may ultimately improve the delivery of diabetes care in the transition from hospital to home.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* English speaking and able to read English
* Diagnosis of type 2 diabetes (new and pre-existing)
* Hospital admission with endocrinology or inpatient diabetes management consult
* On insulin during hospitalization with plan for continuation upon discharge.
* Discharge planned for home.
* Access to the internet and an active email account throughout the 6-week study period.

Exclusion Criteria:

* Inability to connect to, navigate, and utilize the web-based system, or designate someone who is capable of using the system.
* No identifiable outpatient healthcare provider.
* Pregnancy, ruled out by urine hCG test after consent is obtained in all women who continue to have menstrual cycles.
* End-stage liver disease with prothrombin time \>15 seconds and albumin \<3 mg/dL.
* Hypoglycemia unawareness: patient lacks sensation of common signs of blood glucose \<60 mg/dL (tachycardia, diaphoresis, hunger, confusion, fatigue).
* Projected survival \<1 year.

Primary outcomes:
measure: Glycemic Control
timeFrame: 1 month from discharge
Secondary outcomes:
measure: Diabetes Distress
timeFrame: 1 month from discharge
measure: Diabetes Self-Management
timeFrame: 1 month from discharge
measure: Unplanned Readmission or ED Visit
timeFrame: 1 month after discharge
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Nancy J Wei, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Deborah J Wexler, MD
role: PRINCIPAL_INVESTIGATOR
References: