Diabetes MellitusNCT02812303
Implementation of a Population Health Chronic Disease Management Program
An observational study of Diabetes Mellitus and Cardiovascular Diseases, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
A pilot program was created by the network's primary care leadership team at Massachusetts General Hospital. A population health management program was implemented for chronic disease management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Cardiovascular Diseases, Hypertension
- What is being tested?
- Centralized support for population health management activities
- How many people
- 108,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult adult (age ≥ 18 years) patients who had at least one visit to a study practice within the prior 3 years at baseline or had a visit during the 6-month study evaluation period and were connected with a specific network physician or practice.
Who may be able to join
- Diabetes mellitus (type 1 or type 2), or cardiovascular disease (including coronary artery disease, peripheral vascular disease, and cerebrovascular disease), or hypertension
- Breast cancer: women 50-74 years of age
- Cervical cancer: women 21-64 years of age
- Colorectal cancer: men or women 52-75 years of age
Who cannot join
- Patients not connected with a specific network physician or practice
- Patients who switched between PHC and non-PHC practices during the follow-up period
- Breast: bilateral mastectomy
- Cervical: total hysterectomy Colorectal: total colectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Implementation of a Population Health Chronic Disease Management Program in a Primary Care Network
A pilot program was created by the network's primary care leadership team at Massachusetts General Hospital. A population health management program was implemented for chronic disease management. The investigators evaluated quality of care process and outcome measures over the first six months of the program and compared practices assigned a central population health coordinator to those not assigned this support.
Read the detailed description
A pilot program was created by the network's primary care leadership team at Massachusetts General Hospital. They hired and allocated 4 population health coordinators (PHCs) as part of a pilot project to centralize population health management efforts to improve quality of care for chronic disease management. The network did not have sufficient resources to implement a PHC in all of the 18 network practices. So the program's team invited practice leaders to participate and the PHCs were allocated by program's leadership team based on a variety of factors including responses from the practice leader, baseline quality scores, size of the practice, nature of the practice (health center vs not), and location of the practice (on campus or community based). These decisions were made in a way that sought to equitably distribute available PHC resources within the practice network as a way to get network buy-in and maximize the impact of the program, both for practices with and without PHCs. In this study, the investigators evaluated quality of care process and outcome measures over the first six months of the chronic disease management program. The investigators hypothesized that practices assigned a central PHC would have greater performance increases in quality measures compared to practices that were not assigned a PHC.
- Conditions
- Diabetes Mellitus, Cardiovascular Diseases, Hypertension
- Being tested
- Centralized support for population health management activities
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centralized support for population health management activitiesOther
| Study group | Role | What they receive |
|---|---|---|
| Population Health Coordinator Support | 8 practices received the support of central population health coordinators (PHCs). PHCs utilized a population health management (PHM) information technology (IT) tool and performed administrative tasks including appointment scheduling, ordering overdue laboratory testing, chart reviews, and obtaining outside tests/labs. In addition, PHCs regularly met with physicians to review those patients who required clinical intervention to develop an action plan.
The network did not have sufficient resources to implement a PHC in all of the 18 network practices. So PHCs were allocated by responses from the practice leader, baseline quality scores, size of the practice, nature of the practice (health center vs not), and location of the practice. These decisions were made in a way that sought to equitably distribute available PHC resources within the practice network as a way to get network buy-in and maximize the impact of the program, both for practices with and without PHCs. Receives: Other: Centralized support for population health management activities | |
| No Population Health Coordinator Support | Ten practices without PHC support were provided training on how to use the PHM IT tool. The staff in these practices remained primarily responsible for managing administrative tasks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in differences in Low density lipoprotein (LDL) goal achievement over the follow-up period comparing PHC to non-PHC practices
Among patients with diabetes and cardiovascular disease
Measured: 6 months
Difference in differences in Hemoglobin A1c (HbA1c) goal achievement over the follow-up period comparing PHC and non-PHC practices
Among patients with diabetes
Measured: 6 months
Difference in differences in Blood pressure (BP) goal achievement over the follow-up period comparing PHC and non-PHC practices
Among patients with diabetes and hypertension
Measured: 6 months
Secondary outcomes (3)
Difference in differences in proportion of patients completing breast cancer screening over the follow-up period comparing PHC and non-PHC practices
Measured: 6 months
Difference in differences in proportion of patients completing cervical cancer screening over the follow-up period comparing PHC and non-PHC practices
Measured: 6 months
Difference in differences in proportion of patients completing colorectal cancer screening over the follow-up period comparing PHC and non-PHC practices
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionDec 2014
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 Massachusetts General 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Atlas, Massachusetts General Hospital
- Investigators
- Steven J Atlas, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812303
- Sponsor's protocol ID
- 2009P002079
- Status last verified
- Jun 2016
- First submitted
- 20 Jun 2016
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
James A, Berkowitz SA, Ashburner JM, Chang Y, Horn DM, O'Keefe SM, Atlas SJ. Impact of a Population Health Management Intervention on Disparities in Cardiovascular Disease Control. J Gen Intern Med. 2018 Apr;33(4):463-470. doi: 10.1007/s11606-017-4227-3. Epub 2018 Jan 8.
PubMed 29313223
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Population Health Chronic Disease Management Program in a Primary Care Network
- ClinicalTrials.gov ID
- NCT02812303
- Acronym / sponsor ID
- 2009P002079
- Conditions
- Diabetes Mellitus, Cardiovascular Diseases, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108,000 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Jun 2016 (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.
A pilot program was created by the network's primary care leadership team at Massachusetts General Hospital. A population health management program was implemented for chronic disease management. The investigators evaluated quality of care process and outcome measures over the first six months of the program and compared practices assigned a central population health coordinator to those not assigned this support.
Detailed description
A pilot program was created by the network's primary care leadership team at Massachusetts General Hospital. They hired and allocated 4 population health coordinators (PHCs) as part of a pilot project to centralize population health management efforts to improve quality of care for chronic disease management. The network did not have sufficient resources to implement a PHC in all of the 18 network practices. So the program's team invited practice leaders to participate and the PHCs were allocated by program's leadership team based on a variety of factors including responses from the practice leader, baseline quality scores, size of the practice, nature of the practice (health center vs not), and location of the practice (on campus or community based). These decisions were made in a way that sought to equitably distribute available PHC resources within the practice network as a way to get network buy-in and maximize the impact of the program, both for practices with and without PHCs. In this study, the investigators evaluated quality of care process and outcome measures over the first six months of the chronic disease management program. The investigators hypothesized that practices assigned a central PHC would have greater performance increases in quality measures compared to practices that were not assigned a PHC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Population Health Coordinator Support | – | Other: Centralized support for population health management activities8 practices received the support of central population health coordinators (PHCs). PHCs utilized a population health management (PHM) information technology (IT) tool and performed administrative tasks including appointment scheduling, ordering overdue laboratory testing, chart reviews, and obtaining outside tests/labs. In addition, PHCs regularly met with physicians to review those patients who required clinical intervention to develop an action plan. The network did not have sufficient resources to implement a PHC in all of the 18 network practices. So PHCs were allocated by responses from the practice leader, baseline quality scores, size of the practice, nature of the practice (health center vs not), and location of the practice. These decisions were made in a way that sought to equitably distribute available PHC resources within the practice network as a way to get network buy-in and maximize the impact of the program, both for practices with and without PHCs. |
| No Population Health Coordinator Support | – | –Ten practices without PHC support were provided training on how to use the PHM IT tool. The staff in these practices remained primarily responsible for managing administrative tasks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult adult (age ≥ 18 years) patients who had at least one visit to a study practice within the prior 3 years at baseline or had a visit during the 6-month study evaluation period and were connected with a specific network physician or practice.
Key inclusion criteria (4 listed)
- Diabetes mellitus (type 1 or type 2), or cardiovascular disease (including coronary artery disease, peripheral vascular disease, and cerebrovascular disease), or hypertension
- Breast cancer: women 50-74 years of age
- Cervical cancer: women 21-64 years of age
- Colorectal cancer: men or women 52-75 years of age
Key exclusion criteria (4 listed)
- Patients not connected with a specific network physician or practice
- Patients who switched between PHC and non-PHC practices during the follow-up period
- Breast: bilateral mastectomy
- Cervical: total hysterectomy Colorectal: total colectomy
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 |
|---|---|---|
| Centralized support for population health management activities | Other | Population Health Coordinator Support |
Primary outcome
Difference in differences in Low density lipoprotein (LDL) goal achievement over the follow-up period comparing PHC to non-PHC practices
Time frame: 6 months
Among patients with diabetes and cardiovascular disease
Difference in differences in Hemoglobin A1c (HbA1c) goal achievement over the follow-up period comparing PHC and non-PHC practices
Time frame: 6 months
Among patients with diabetes
Difference in differences in Blood pressure (BP) goal achievement over the follow-up period comparing PHC and non-PHC practices
Time frame: 6 months
Among patients with diabetes and hypertension
3 secondary outcomes
Difference in differences in proportion of patients completing breast cancer screening over the follow-up period comparing PHC and non-PHC practices
Time frame: 6 months
Difference in differences in proportion of patients completing cervical cancer screening over the follow-up period comparing PHC and non-PHC practices
Time frame: 6 months
Difference in differences in proportion of patients completing colorectal cancer screening over the follow-up period comparing PHC and non-PHC practices
Time frame: 6 months
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 24 Jun 2016.
- Derived from this study: PubMed 29313223James A, Berkowitz SA, Ashburner JM, Chang Y, Horn DM, O'Keefe SM, Atlas SJ. Impact of a Population Health Management Intervention on Disparities in Cardiovascular Disease Control. J Gen Intern Med. 2018 Apr;33(4):463-470. doi: 10.1007/s11606-017-4227-3. Epub 2018 Jan 8.
- Individual participant dataSharing planned: No
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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.
Steven J Atlas, MD, MPH principal investigator
Massachusetts General Hospital
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 and Cardiovascular Diseases, run by Massachusetts General 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 4 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 24 Jun 2016. 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?
Difference in differences in Low density lipoprotein (LDL) goal achievement over the follow-up period comparing PHC to non-PHC practices (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT02812303, 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 24 Jun 2016.