Comprehension of Discharge Instructions for Diabetes Therapy and Hospital Readmission

Diabetes Mellitus Clinical Trial

Official title:

Association of Glycemic Control With Comprehension of Discharge Instructions for Diabetes Therapy and Hospital Readmission

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03279627
• Other study ID #: PRO17050222
• Status: Completed
• Start date: August 28, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: August 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to identify and explore the existing components of discharge planning provided to patients with insulin treated diabetes in the inpatient setting and to examine the contribution of glycemic excursions as well as comprehension of discharge instructions among patients with diabetes, in predicting hospital readmissions.

Description:

Background: Diabetes is a major contributor to hospital readmissions and health care expenditures. Previous studies have attempted to identify risk factors for readmission among patients with diabetes. However, no studies have looked at some potentially important factors including duration of diabetes, HbA1c, glycemic excursions preceding hospital discharge, and patient comprehension of discharge instructions provided for home diabetes management. In this study, we propose to examine patient understanding of instructions for insulin therapy provided at the time of hospital discharge as a potential risk factor for readmission during the following 30- and 90-day time periods. In addition, we will examine the contribution of glycemic excursions obtained in the 48-hour period prior to discharge on patient understanding of insulin therapy and risk for readmission.

Purpose: The purpose of this study is to identify and explore the existing components of discharge planning provided to patients with insulin treated diabetes in the inpatient setting and to examine the contribution of glycemic excursions as well as comprehension of discharge instructions among patients with diabetes, in predicting hospital readmissions.

Methods: This will be a prospective non-blinded observational study enrolling non-critically ill, non-pregnant, hospitalized patients aged 18-90 years of age with insulin treated diabetes and no evidence of baseline cognitive. The participants will be recruited from August 2017 to December 2018 from the Inpatient Endocrine and Diabetes Consult Services and from daily reports of patients experiencing BG< 70 mg/dL and >300 mg/dL. Eligible participants will be called within 24-48 hours following hospital discharge at which time they will be asked to complete a Diabetes Management Questionnaire to determine their comprehension of the recommendations provided for home-insulin and other diabetes therapies. This questionnaire will include questions about the types of insulin being used, the doses administered, and times given. Patient interviews will be conducted again via a telephone follow up at approximately 30- and 90-days following discharge with specific questions on home blood glucose control and ER or hospital visits and/or readmissions. The Clinical and Translational Science Institute at the University of Pittsburgh will be consulted for statistical analysis.

Study significance:

This study has the potential to identify modifiable factors that can potentially contribute to the observed frequency of hospital readmissions among patients with insulin treated diabetes. This study could also advocate for discharge protocols and close follow up of patients with insulin-treated diabetes following discharge to ensure appropriate understanding of discharge instructions for insulin therapy and home diabetes management.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: July 31, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Non-pregnant, non-critically ill, hospitalized patients aged 18-90 years with insulin treated diabetes in the hospital

Exclusion Criteria:

• Patients admitted with primary diagnosis of hypoglycemia, DKA; or Hyperglycemic Hyperosmolar Syndrome; patients receiving intravenous narcotic medications; patients discharged to skilled nursing facilities; patients with cognitive impairment defined as dementia or delirium documented in the Electronic Medical Record (EMR); patients with limited life expectancy as determined by "Do Not Resuscitate" Status, or documentation of receiving palliative care or terminal diagnoses with expected survival of less than 1 year

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• Diabetes Management Questionnaire
Patients will be asked questions regarding their understanding of instructions for home diabetes management within 48 hours of hospital discharge. At 1 and 3 months, participants will be contacted to obtain information regarding ER visits or hospital readmissions.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient understanding of discharge instructions for home diabetes therapy according to presence or absence of hypoglycemia (defined as BG < 70 mg/dl), hyperglycemia (defined as BG > 250 mg/dl), or BG 70-250 mg/dl at time of hospital discharge	Participants will be asked to complete a questionnaire regarding their home diabetes medications including timing, adjusting, and medication names.	within 48 hours of hospital discharge
Secondary	Association between patient understanding of home diabetes therapy and frequency of ER visits and hospital readmissions at 30- and 90-day following the index hospitalization	Questionnaire for ER visits and Hospital Readmission	1 and 3 months following index hospitalization