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Comprehension of Discharge Instructions for Diabetes Therapy and Hospital Readmission

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ClinicalTrials.gov Identifier: NCT03279627
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Mary Korytkowski, University of Pittsburgh

Brief 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.

Condition or disease Intervention/treatment
Diabetes Mellitus Other: Diabetes Management Questionnaire

Detailed 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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Association of Glycemic Control With Comprehension of Discharge Instructions for Diabetes Therapy and Hospital Readmission
Actual Study Start Date : August 28, 2017
Estimated Primary Completion Date : August 28, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Hypoglycemia
This group will be those who experience a BG < 70 mg/dl in the 24-48 hour time period preceding hospital discharge. Study procedures are identical for each group. All participants in this group will be asked to complete the Diabetes Management Questionnaire.
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.

Hyperglycemia
This group will be those who experience a BG > 250 mg/dl in the 24-48 hour time period preceding hospital discharge. Study procedures are identical for each group. All participants in this group will be asked to complete the Diabetes Management Questionnaire.
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.

Glycemic control
This group will be those who maintain BG of 70 to 250 mg /dl in the 24-48 hour time period preceding hospital discharge. Study procedures are identical for each group, but study outcomes including comprehension of discharge instructions and 1 and 3 month readmissions will be analyzed according to group category.All participants in this group will be asked to complete the Diabetes Management Questionnaire.
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.




Primary Outcome Measures :
  1. 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 [ Time Frame: within 48 hours of hospital discharge ]
    Participants will be asked to complete a questionnaire regarding their home diabetes medications including timing, adjusting, and medication names.


Secondary Outcome Measures :
  1. 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 [ Time Frame: 1 and 3 months following index hospitalization ]
    Questionnaire for ER visits and Hospital Readmission



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Non-critically ill adult patients with diabetes will be recruited during a period of hospitalization for non-critical illness.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279627


Contacts
Contact: Janya Swami, MD 412 586 9714 swamij@upmc.edu
Contact: Mary T Korytkowski, MD 412 586 9706 mtk7@pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Mary T Korytkowski, MD    412-586-9706    mtk7@pitt.edu   
Sub-Investigator: Linda Siminerio, PhD         
Sub-Investigator: Neeti Patel, MD         
Sub-Investigator: Amy Donihi, PharmD         
Sub-Investigator: Janya Swami, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Mary T Korytkowski, MD Univesity of Pittsburgh

Responsible Party: Mary Korytkowski, Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03279627     History of Changes
Other Study ID Numbers: PRO17050222
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share participant data with other researchers

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mary Korytkowski, University of Pittsburgh:
inpatient
hypoglycemia
hyperglycemia
hospital readmission
discharge planning

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases