DiabetesCOACH-DMNCT02065050
Comprehensive Intervention to Evaluate Outcomes AND Cost in Hospitalized Surgical Patients With Diabetes Mellitus (DM)
A study testing team-based care in people with Diabetes, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study is being performed to evaluate whether a comprehensive discharge planning and close follow up for one year can improve clinical outcomes and cut costs of care for patients with poorly controlled diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- team-based care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jun 2016
- 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
- elective surgery
- HbA1c >=8% within 3 months before surgery
- Age > 18 years
Who cannot join
- undergoing same day surgery without post-operative admission
- HbA1c < 8%
- individuals undergoing bariatric surgery
- individuals with metastatic cancer or short life expectancy
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: Comprehensive Intervention to Evaluate Outcomes AND Cost in Hospitalized Surgical Patients With DM: COACH-DM
This study is being performed to evaluate whether a comprehensive discharge planning and close follow up for one year can improve clinical outcomes and cut costs of care for patients with poorly controlled diabetes. The study takes a high risk approach and is focused on patients admitted to hospital for elective surgery with HbA1c >8%. Secondary goals include improving teamwork and communication for clinicians within the team and teaching nurse practitioners and physicians-in-training how to work effectively within interdisciplinary teams. Investigators anticipate that the results of this project may lead to the following benefits: 1) improved health outcomes for surgical patients with diabetes, 2) improved strategies for better communication within interdisciplinary health care teams, and 3) decreased health care costs.
Read the detailed description
All patients who are planned for elective surgery at the hospital are seen in the pre-operative center a few days before admission. The diabetes management team becomes involved in care of patients with HbA1c >8.0% at this time. Once the patients are admitted to the hospital, the diabetes management team continues to follow them until they are ready for discharge. At the point of discharge, patients are randomized to one of two arms- the usual care group and the expanded diabetes management service (eDMS). The eDMS group is followed closely for 1 year after discharge by the investigators to make sure they receive appropriate care for their diabetes.
Aims of this study are:
- To evaluate whether patients that receive the eDMS have lower re-hospitalization rates at 1 month compared to patients who receive the traditional (current) DMS. Investigators hypothesize that the eDMS program will have lower re-hospitalization rates at 1 month.
- To evaluate whether patients that receive the eDMS have lower HbA1c levels at 1 year compared with patients who receive the traditional DMS. Investigators hypothesize that patients in the eDMS program will have lower HbA1c levels and improved diabetes-related health outcomes after 1 year in the program.
- Conditions
- Diabetes
- Being tested
- team-based care
- Keywords
- Diabetes mellitus, Team approach
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
team-based careOther
Patients in the eDMS arm are called at least every month for their diabetes treatment.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Individuals in the usual care arm will not receive frequent contact by the study team. Individuals will be seen by a study team clinician 1 year after discharge to review diabetes management and obtain pertinent study related data. |
| Continued care | Experimental | team-based care: Individuals in the continued care arm will be frequently contacted by the study team (consisting of endocrinologists, nurse practitioners, and health coaches) over the course of one year post-discharge. The team will monitor blood sugars and other health data, altering management as needed. Receives: Other: team-based care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Data on participant HbA1c will be collected at the end of the 1 year.
Measured: 1 year after date of discharge
Secondary outcomes (4)
Blood Pressure
Blood pressure measurements will be obtained at 1 year.
Measured: 1 year after discharge
LDL Cholesterol
LDL cholesterol measured at 1 year after discharge.
Measured: 1 year post-discharge
Urine microalbumin
Urine microalbumin measured at 1 year after discharge.
Measured: 1 year post-discharge
BMI
BMI will be obtained at 1 year
Measured: 1-year post-discahrge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startFeb 2012
- Primary completionJun 2016
- Study completionJun 2016
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajesh K. Garg, Brigham and Women's Hospital
- Investigators
- Rajesh K. Garg, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065050
- Sponsor's protocol ID
- 2012P002461
- Other IDs
- UD7HP25059
- Acronym
- COACH-DM
- Status last verified
- May 2017
- First submitted
- 14 Feb 2014
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: This study will not produce data that can be shared
Publications
Garg R, Hurwitz S, Rein R, Schuman B, Underwood P, Bhandari S. Effect of follow-up by a hospital diabetes care team on diabetes control at one year after discharge from the hospital. Diabetes Res Clin Pract. 2017 Nov;133:78-84. doi: 10.1016/j.diabres.2017.08.014. Epub 2017 Aug 24.
PubMed 28898714
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Intervention to Evaluate Outcomes AND Cost in Hospitalized Surgical Patients With DM: COACH-DM
- ClinicalTrials.gov ID
- NCT02065050
- Acronym / sponsor ID
- COACH-DM / 2012P002461
- Conditions
- Diabetes
- Keywords
- Diabetes mellitus, Team approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Feb 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.
This study is being performed to evaluate whether a comprehensive discharge planning and close follow up for one year can improve clinical outcomes and cut costs of care for patients with poorly controlled diabetes. The study takes a high risk approach and is focused on patients admitted to hospital for elective surgery with HbA1c >8%. Secondary goals include improving teamwork and communication for clinicians within the team and teaching nurse practitioners and physicians-in-training how to work effectively within interdisciplinary teams. Investigators anticipate that the results of this project may lead to the following benefits: 1) improved health outcomes for surgical patients with diabetes, 2) improved strategies for better communication within interdisciplinary health care teams, and 3) decreased health care costs.
Detailed description
All patients who are planned for elective surgery at the hospital are seen in the pre-operative center a few days before admission. The diabetes management team becomes involved in care of patients with HbA1c >8.0% at this time. Once the patients are admitted to the hospital, the diabetes management team continues to follow them until they are ready for discharge. At the point of discharge, patients are randomized to one of two arms- the usual care group and the expanded diabetes management service (eDMS). The eDMS group is followed closely for 1 year after discharge by the investigators to make sure they receive appropriate care for their diabetes.
Aims of this study are:
- To evaluate whether patients that receive the eDMS have lower re-hospitalization rates at 1 month compared to patients who receive the traditional (current) DMS. Investigators hypothesize that the eDMS program will have lower re-hospitalization rates at 1 month.
- To evaluate whether patients that receive the eDMS have lower HbA1c levels at 1 year compared with patients who receive the traditional DMS. Investigators hypothesize that patients in the eDMS program will have lower HbA1c levels and improved diabetes-related health outcomes after 1 year in the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Individuals in the usual care arm will not receive frequent contact by the study team. Individuals will be seen by a study team clinician 1 year after discharge to review diabetes management and obtain pertinent study related data. |
| Continued care | Experimental | Other: team-based careteam-based care: Individuals in the continued care arm will be frequently contacted by the study team (consisting of endocrinologists, nurse practitioners, and health coaches) over the course of one year post-discharge. The team will monitor blood sugars and other health data, altering management as needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective surgery
- HbA1c >=8% within 3 months before surgery
- Age > 18 years
Key exclusion criteria (4 listed)
- undergoing same day surgery without post-operative admission
- HbA1c < 8%
- individuals undergoing bariatric surgery
- individuals with metastatic cancer or short life expectancy
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 |
|---|---|---|
| team-based carePatients in the eDMS arm are called at least every month for their diabetes treatment. | Other | Continued care |
Primary outcome
Hemoglobin A1c
Time frame: 1 year after date of discharge
Data on participant HbA1c will be collected at the end of the 1 year.
4 secondary outcomes
Blood Pressure
Time frame: 1 year after discharge
LDL Cholesterol
Time frame: 1 year post-discharge
Urine microalbumin
Time frame: 1 year post-discharge
BMI
Time frame: 1-year post-discahrge
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 10 May 2017.
- Derived from this study: PubMed 28898714Garg R, Hurwitz S, Rein R, Schuman B, Underwood P, Bhandari S. Effect of follow-up by a hospital diabetes care team on diabetes control at one year after discharge from the hospital. Diabetes Res Clin Pract. 2017 Nov;133:78-84. doi: 10.1016/j.diabres.2017.08.014. Epub 2017 Aug 24.
- Individual participant dataSharing planned: No. This study will not produce data that can be shared
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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.
Rajesh K. Garg, MD 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 team-based care in people with Diabetes, 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 3 inclusion and 4 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 10 May 2017. 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?
Hemoglobin A1c (time frame: 1 year after date of 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 NCT02065050, 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 10 May 2017.