Diabetes MellitusNCT03279627
Comprehension of Discharge Instructions for Diabetes Therapy and Hospital Readmission
An observational study of Diabetes Mellitus, run by University of Pittsburgh at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Diabetes Management Questionnaire
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2017to 31 Jul 2019
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-critically ill adult patients with diabetes will be recruited during a period of hospitalization for non-critical illness.
Who may be able to join
- Non-pregnant, non-critically ill, hospitalized patients aged 18-90 years with insulin treated diabetes in the hospital
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Association of Glycemic Control With Comprehension of Discharge Instructions for Diabetes Therapy and Hospital Readmission
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Diabetes Management Questionnaire
- Keywords
- inpatient, hypoglycemia, hyperglycemia, hospital readmission, discharge planning
- Medical subject headings
- Diabetes Mellitus, Hypoglycemia, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Management QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Diabetes Management Questionnaire | |
| 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. Receives: Other: Diabetes Management Questionnaire | |
| 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. Receives: Other: Diabetes Management Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 48 hours of hospital discharge
Secondary outcomes (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
Questionnaire for ER visits and Hospital Readmission
Measured: 1 and 3 months following index hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start28 Aug 2017
- Primary completion1 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Korytkowski, University of Pittsburgh
- Investigators
- Mary T Korytkowski, MD, Principal investigator, Univesity of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279627
- Sponsor's protocol ID
- PRO17050222
- Status last verified
- Aug 2019
- First submitted
- 18 Aug 2017
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share participant data with other researchers
Publications
Patel N, Swami J, Pinkhasova D, Karslioglu French E, Hlasnik D, Delisi K, Donihi A, Siminerio L, Rubin DJ, Wang L, Korytkowski MT. Sex differences in glycemic measures, complications, discharge disposition, and postdischarge emergency room visits and readmission among non-critically ill, hospitalized patients with diabetes. BMJ Open Diabetes Res Care. 2022 Mar;10(2):e002722. doi: 10.1136/bmjdrc-2021-002722.
PubMed 35246452
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Glycemic Control With Comprehension of Discharge Instructions for Diabetes Therapy and Hospital Readmission
- ClinicalTrials.gov ID
- NCT03279627
- Acronym / sponsor ID
- PRO17050222
- Conditions
- Diabetes Mellitus
- Keywords
- inpatient, hypoglycemia, hyperglycemia, hospital readmission, discharge planning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypoglycemia | – | Other: Diabetes Management QuestionnaireThis 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. |
| Hyperglycemia | – | Other: Diabetes Management QuestionnaireThis 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. |
| Glycemic control | – | Other: Diabetes Management QuestionnaireThis 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-critically ill adult patients with diabetes will be recruited during a period of hospitalization for non-critical illness.
Key inclusion criteria (1 listed)
- Non-pregnant, non-critically ill, hospitalized patients aged 18-90 years with insulin treated diabetes in the hospital
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes Management QuestionnairePatients 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. | Other | Glycemic control, Hyperglycemia, Hypoglycemia |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Derived from this study: PubMed 35246452Patel N, Swami J, Pinkhasova D, Karslioglu French E, Hlasnik D, Delisi K, Donihi A, Siminerio L, Rubin DJ, Wang L, Korytkowski MT. Sex differences in glycemic measures, complications, discharge disposition, and postdischarge emergency room visits and readmission among non-critically ill, hospitalized patients with diabetes. BMJ Open Diabetes Res Care. 2022 Mar;10(2):e002722. doi: 10.1136/bmjdrc-2021-002722.
- Individual participant dataSharing planned: No. There is no plan to share participant data with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary T Korytkowski, MD principal investigator
Univesity of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03279627, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.