Type II DiabetesIDIDNCT02122926
Intensive Discharge Intervention in Diabetes
A study testing Intensive discharge intervention in people with Type II Diabetes and Cardiovascular Disease, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The goal of this study is to design and implement an intensive discharge intervention for inpatients with type 2 diabetes and cardiovascular disease, and determine the effects of the intervention on post-discharge insulin adherence, glycemic control, cardiac medication adherence, hypoglycemic events, and emergency… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type II Diabetes, Cardiovascular Disease
- What is being tested?
- Intensive discharge intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jul 2013
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult inpatients at BWH on the medicine or cardiology services with a primary care physician who belongs to a participating practice or has not explicitly opted out of the study
- Type 2 diabetes
- Active cardiovascular disease
- Likely to be discharged home, and one of the following:
- prescribed insulin prior to admission
- prescribed two oral agents and with an A1c > 8.0 within 30 days of admission. - Practices that have already agreed to participate in this study for all their eligible patients.
Who cannot join
- Discharge to a location other than home or rehabilitation (or to a caregiver's home)
- Patient does not administer own medications and absence of a caregiver who lives with patient and administers all medications
- Police custody, no telephone or homeless
- Previous enrolment in the study within 90 days of discharge
- Patient unable to communicate in either English or Spanish
- Participation in the Integrated Care Management Program (iCMP)
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Effects of an Intensive Discharge Intervention on Medication Adherence, Glycemic Control, and Readmission Rates in Patients With Type 2 Diabetes
The goal of this study is to design and implement an intensive discharge intervention for inpatients with type 2 diabetes and cardiovascular disease, and determine the effects of the intervention on post-discharge insulin adherence, glycemic control, cardiac medication adherence, hypoglycemic events, and emergency department visits and hospital readmissions.
- Conditions
- Type II Diabetes, Cardiovascular Disease
- Being tested
- Intensive discharge intervention
- Keywords
- Transitions in care, discharge intervention, RCT, readmission rates, medication adherence, glycemic control, ED visits, medication reconciliation, Coleman Transitions Coach, telemonitoring; hypoglycemic events
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive discharge interventionOther
The intervention is a multi-modal program consisting of the following:
- Inpatient protocol for adjusting the discharge diabetes regimen;
- Nurse practitioner "discharge advocate" to schedule follow-up appointments, prepare an after-hospital care plan, and patient education and counseling;
- Inpatient pharmacist counseling (identifying and addressing previous barriers to medication adherence, performing enhanced medication reconciliation, and patient education);
- Visiting nurse intervention after discharge;
- Follow-up in a post-discharge clinic with the NP discharge advocate and pharmacist /certified diabetes educator within 3 days of discharge;
- Telemonitoring of POC glucose levels to the study CDE, patient's PCP, or endocrinologist as appropriate; and
- Follow-up with PCP or endocrinologist within 1 week of discharge.
| Study group | Role | What they receive |
|---|---|---|
| Intensive discharge intervention | Experimental | The intervention is a multi-modal program consisting of the following:
1. Inpatient protocol for adjusting the discharge diabetes regimen;
2. Nurse practitioner "discharge advocate" to schedule follow-up appointments, prepare an after-hospital care plan, and patient education and counseling;
3. Inpatient pharmacist counseling (identifying and addressing previous barriers to medication adherence, performing enhanced medication reconciliation, and patient education);
4. Visiting nurse intervention after discharge;
5. Follow-up in a post-discharge clinic with the NP discharge advocate and pharmacist /certified diabetes educator within 3 days of discharge;
6. Telemonitoring of POC glucose levels to the study CDE, patient's PCP, or endocrinologist as appropriate; and
7. Follow-up with PCP or endocrinologist within 1 week of discharge. Receives: Other: Intensive discharge intervention |
| Usual Care | No intervention | Patients in the control arm of this study receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac medication adherence
Cardiac medication adherence as determined by patient self report 30 days after discharge
Measured: 30 days after discharge
Secondary outcomes (6)
Glycemic control
Glycemic control as determined by change in A1c 90 days after discharge.
Measured: 90 days after discharge
Emergency department visits
Emergency department visits within 30 days of discharge.
Measured: Within 30 days after discharge
Number of self-reported hypoglycemic events
Number of self-reported hypoglycemic events within 30 days of discharge.
Measured: Within 30 days of discharge
Number of patient-days with hypoglycemia
Number of patient-days with hypoglycemia (point-of-care glucose less than 70 mg/dL) or with severe hypoglycemia (less than 40 mg/dL) within 30 days of discharge
Measured: Within 30 days of discharge
Cardiac medication adherence
Cardiac medication adherence as determined by pharmacy refill rates for 90 days after discharge.
Measured: 90 days after discharge
Hospital Readmissions
Hospital readmissions within 30 days of discharge.
Measured: Within 30 days of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startDec 2011
- Primary completionMay 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II DiabetesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Jeffrey L. Schnipper, MD.,MPH., Brigham and Women's Hospital
- Investigators
- Jeffrey L Schnipper, MD, MPH, FHM, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122926
- Sponsor's protocol ID
- 2010A056508
- Other IDs
- 2011-P-000217
- Acronym
- IDID
- Status last verified
- Apr 2014
- First submitted
- 25 Jan 2013
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Intensive Discharge Intervention on Medication Adherence, Glycemic Control, and Readmission Rates in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02122926
- Acronym / sponsor ID
- IDID / 2010A056508
- Conditions
- Type II Diabetes, Cardiovascular Disease
- Keywords
- Transitions in care, discharge intervention, RCT, readmission rates, medication adherence, glycemic control, ED visits, medication reconciliation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Dec 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 25 Apr 2014 (estimated)
- 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 goal of this study is to design and implement an intensive discharge intervention for inpatients with type 2 diabetes and cardiovascular disease, and determine the effects of the intervention on post-discharge insulin adherence, glycemic control, cardiac medication adherence, hypoglycemic events, and emergency department visits and hospital readmissions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive discharge intervention | Experimental | Other: Intensive discharge interventionThe intervention is a multi-modal program consisting of the following: 1. Inpatient protocol for adjusting the discharge diabetes regimen; 2. Nurse practitioner "discharge advocate" to schedule follow-up appointments, prepare an after-hospital care plan, and patient education and counseling; 3. Inpatient pharmacist counseling (identifying and addressing previous barriers to medication adherence, performing enhanced medication reconciliation, and patient education); 4. Visiting nurse intervention after discharge; 5. Follow-up in a post-discharge clinic with the NP discharge advocate and pharmacist /certified diabetes educator within 3 days of discharge; 6. Telemonitoring of POC glucose levels to the study CDE, patient's PCP, or endocrinologist as appropriate; and 7. Follow-up with PCP or endocrinologist within 1 week of discharge. |
| Usual Care | No intervention | –Patients in the control arm of this study receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult inpatients at BWH on the medicine or cardiology services with a primary care physician who belongs to a participating practice or has not explicitly opted out of the study
- Type 2 diabetes
- Active cardiovascular disease
- Likely to be discharged home, and one of the following:
Key exclusion criteria (6 listed)
- Discharge to a location other than home or rehabilitation (or to a caregiver's home)
- Patient does not administer own medications and absence of a caregiver who lives with patient and administers all medications
- Police custody, no telephone or homeless
- Previous enrolment in the study within 90 days of discharge
- Patient unable to communicate in either English or Spanish
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 |
|---|---|---|
| Intensive discharge interventionThe intervention is a multi-modal program consisting of the following: 1. Inpatient protocol for adjusting the discharge diabetes regimen; 2. Nurse practitioner "discharge advocate" to schedule follow-up appointments, prepare an after-hospital care plan, and patient education and counseling; 3. Inpatient pharmacist counseling (identifying and addressing previous barriers to medication adherence, performing enhanced medication reconciliation, and patient education); 4. Visiting nurse intervention after discharge; 5. Follow-up in a post-discharge clinic with the NP discharge advocate and pharmacist /certified diabetes educator within 3 days of discharge; 6. Telemonitoring of POC glucose levels to the study CDE, patient's PCP, or endocrinologist as appropriate; and 7. Follow-up with PCP or endocrinologist within 1 week of discharge. | Other | Intensive discharge intervention |
Primary outcome
Cardiac medication adherence
Time frame: 30 days after discharge
Cardiac medication adherence as determined by patient self report 30 days after discharge
6 secondary outcomes
Glycemic control
Time frame: 90 days after discharge
Emergency department visits
Time frame: Within 30 days after discharge
Number of self-reported hypoglycemic events
Time frame: Within 30 days of discharge
Number of patient-days with hypoglycemia
Time frame: Within 30 days of discharge
Cardiac medication adherence
Time frame: 90 days after discharge
Hospital Readmissions
Time frame: Within 30 days of discharge
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 25 Apr 2014.
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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.
Jeffrey L Schnipper, MD, MPH, FHM principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive discharge intervention in people with Type II Diabetes and Cardiovascular Disease, run by Brigham and Women's Hospital 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 6 inclusion and 6 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 25 Apr 2014. 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?
Cardiac medication adherence (time frame: 30 days after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2014.