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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
| Eli Lilly and Company | INDUSTRY |
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COORDINATE-Diabetes is a cluster-randomized clinical trial to test the effectiveness of an innovative, clinic-level educational intervention to improve the management of patients with type 2 diabetes mellitus and cardiovascular disease.
Patients with Type 2 diabetes mellitus and a history of cardiovascular disease will be enrolled in this study. The study will randomize a minimum of 42 US cardiology clinics to an intervention arm vs. control arm. The clinic-level multi-faceted educational intervention will include strategies to develop cardiology and endocrinology partnerships and guideline-recommended care pathways with measurement and feedback to improve the care of patients with type 2 diabetes mellitus and cardiovascular disease.
Patients must be enrolled during a routine visit in a cardiology clinic, and the clinic must have at least 3 physicians and/or APPs on staff with independent patient populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Clinics provided with existing clinical care guidelines. | |
| Intervention | Active Comparator | Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intense Education Intervention | Other | Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Prescribed All 3 Groups of Recommended Evidence-based Medications | Proportion of patients prescribed all three groups of guideline-recommended therapies for management for T2DM and CVD at last follow-up visit. Groups were defined as (1) high-intensity statins (40-80 mg/d atorvastatin or 20-40 mg/d rosuvastatin); (2) ACEIs or ARBs including angiotensin receptor-neprilysin inhibitors (ARNIs); and (3) SGLT2 inhibitors and/or GLP-1RAs with proven cardiovascular benefit (SGLT2 inhibitors: empagliflozin, dapagliflozin, or canagliflozin; GLP-1RAs: liraglutide, semaglutide, or dulaglutide), or metformin monotherapy with hemoglobin A1c < 7%. | Up to 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit. | Number of participants prescribed each of the 3 recommended therapies at the last follow-up visit. | Up to 12 Months |
| Change in Average LDL-C From Baseline to Last Follow-up Visit. |
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Inclusion Criteria:
Age ≥ 18 years old
Diagnosis of Type 2 diabetes mellitus (T2DM)
History of at least one of the following conditions:
Ability to communicate with site staff and understand and provide written informed consent and proof of Health Insurance Portability and Accountability Act (HIPAA) authorization
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Granger, MD | Duke Clinical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grandview Health/Alabama Cardiovascular Group | Birmingham | Alabama | 35243 | United States | ||
| USA Cardiology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26981940 | Background | Zinman B, Lachin JM, Inzucchi SE. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2016 Mar 17;374(11):1094. doi: 10.1056/NEJMc1600827. No abstract available. | |
| 27295427 | Background | Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):311-22. doi: 10.1056/NEJMoa1603827. Epub 2016 Jun 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD. |
| FG001 | Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 25, 2021 | May 1, 2023 |
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|
Average change in LDL-C values between baseline visit and last follow-up visit. |
| Baseline and last follow-up visit (up to 12 months) |
| Number of Participants With LDL-C < 70 mg/dL | Change in number of participants with LDL-C < 70 mg/dL at baseline visit vs. last follow-up visit. | Baseline and last follow-up visit (up to 12 months) |
| Change in Average Blood Pressure From Baseline to Last Follow-up Visit. | Change in systolic and diastolic blood pressure from baseline to last follow-up visit. | Baseline and last follow-up visit (up to 12 months) |
| Number of Participants With sBP < 130 mmHg | Proportion of participants achieving sBP < 130 mmHg at baseline vs. last follow-up visit | Baseline and last follow-up visit (up to 12 months) |
| Number of Participants With dBP < 180 mmHg | Change in number of participants with dBP < 180 mmHg from baseline to last follow-up visit | Baseline and last follow-up visit (up to 12 months) |
| Change in Average HbA1c From Baseline to Last Follow-up Visit. | Change in hemoglobin A1c (HbA1c) between baseline and last follow-up visit. | Baseline and last follow-up visit (up to 12 months) |
| Number of Participants With HbA1c < 7% | Change in number of participants with HbA1c < 7% from baseline to last follow-up visit. | Baseline and last follow-up visit (up to 12 months) |
| Number of Participants Experiencing an Event Within 1 Year | Number of participants experiencing an event within 12 months of enrollment. Also known as cumulative incidence of events. | Up to 12 Months |
| Mobile |
| Alabama |
| 36617 |
| United States |
| Alaska Heart and Vascular Institute | Anchorage | Alaska | 99508 | United States |
| Dignity Health/DHMG Specialty Medicine | Phoenix | Arizona | 85013 | United States |
| Stanford University | Stanford | California | 94305 | United States |
| Blue Coast Cardiology | Vista | California | 92083 | United States |
| Aurora Denver Cardiology | Denver | Colorado | 80012 | United States |
| Bridgeport Hospital | Bridgeport | Connecticut | 06610 | United States |
| Orlando Heart and Vascular Institute | Altamonte Springs | Florida | 32714 | United States |
| Riverside Medical Center/Synergy Healthcare | Bradenton | Florida | 34208 | United States |
| Lennar Foundation/Univ. of Miami | Coral Gables | Florida | 33146 | United States |
| Citrus Cardiology | Inverness | Florida | 34452 | United States |
| Baptist Health Research Institute | Jacksonville | Florida | 32258 | United States |
| Advanced Research for Health Improvement, LLC | Naples | Florida | 34102 | United States |
| Cardiovascular Inst. of Northwest Florida | Panama City | Florida | 32401 | United States |
| Bayfront Cardiovascular Associates | St. Petersburg | Florida | 33701 | United States |
| Interventional Cardiac Consultants | Trinity | Florida | 34655 | United States |
| Emory/Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States |
| Advocate Heart Institute | Chicago | Illinois | 60657 | United States |
| Advanced Heart Care Group/Medicoricium LLC | Fairview Heights | Illinois | 62208 | United States |
| Specialty Physicians of Illinois | Olympia Fields | Illinois | 60461 | United States |
| UnityPoint Health Cardiovascular Services | Peoria | Illinois | 61606 | United States |
| Prairie Cardiovascular Consultants | Springfield | Illinois | 62701 | United States |
| Iowa Heart Center | Des Moines | Iowa | 50266 | United States |
| Heart Clinic of Louisiana | Marrero | Louisiana | 70072 | United States |
| The Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Endeavor Medical Research | Alpena | Michigan | 49707 | United States |
| Cardiology Institute of Michigan | Flint | Michigan | 48507 | United States |
| Hannibal Regional Medical Group | Hannibal | Missouri | 63401 | United States |
| Advanced Heartcare LLC | Bridgewater | New Jersey | 08807 | United States |
| New Jersey Heart | Linden | New Jersey | 07036 | United States |
| Garden State Heart Care | Manalapan | New Jersey | 07726 | United States |
| Cardiovascular Associates of the Delaware Valley | Sewell | New Jersey | 08080 | United States |
| Northwell Health/Lenox Hill Hospital | Manhasset | New York | 11030 | United States |
| Kernodle Clinic | Burlington | North Carolina | 27215 | United States |
| Cone Health/LeBauer Brodie Ctr for Cardiovascular Rsch | Greensboro | North Carolina | 27401 | United States |
| Cape Fear Heart Associates | Wilmington | North Carolina | 28401 | United States |
| Cardiovascular Health Clinic | Oklahoma City | Oklahoma | 73134 | United States |
| Guthrie Medical Group | Sayre | Pennsylvania | 18840 | United States |
| Advanced Cardiology Associates | Greenwood | South Carolina | 29646 | United States |
| Black Hills Cardiovascular Research | Rapid City | South Dakota | 57701 | United States |
| Univ. of Texas Southwestern | Dallas | Texas | 75390 | United States |
| Lonestar Heart and Vascular | Tomball | Texas | 77375 | United States |
| ProHealth Care Heart and Vascular | Waukesha | Wisconsin | 53188 | United States |
| 28545639 | Background | Sattar N, Petrie MC, Zinman B, Januzzi JL Jr. Novel Diabetes Drugs and the Cardiovascular Specialist. J Am Coll Cardiol. 2017 May 30;69(21):2646-2656. doi: 10.1016/j.jacc.2017.04.014. |
| 28859942 | Background | Vinereanu D, Lopes RD, Bahit MC, Xavier D, Jiang J, Al-Khalidi HR, He W, Xian Y, Ciobanu AO, Kamath DY, Fox KA, Rao MP, Pokorney SD, Berwanger O, Tajer C, de Barros E Silva PGM, Roettig ML, Huo Y, Granger CB; IMPACT-AF investigators. A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial. Lancet. 2017 Oct 14;390(10104):1737-1746. doi: 10.1016/S0140-6736(17)32165-7. Epub 2017 Aug 28. |
| 30559235 | Background | American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S90-S102. doi: 10.2337/dc19-S009. |
| 30559236 | Background | American Diabetes Association. 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S103-S123. doi: 10.2337/dc19-S010. |
| 38934111 | Derived | Tannu M, Kaltenbach L, Pagidipati NJ, McGuire DK, Aroda VR, Pop-Busui R, Kondamudi N, Al-Khalidi HR, Lopes RD, Cavender MA, Nelson AJ, Kirk J, Lingvay I, Magwire M, Richardson CR, Webb L, Leyva M, Pandey A, Washington A, Pak J, Gaynor T, Khan W, Weston P, Granger CB, Green J. Effects of an Intervention to Improve Evidence-Based Care for People With Diabetes and Cardiovascular Disease Across Sex, Race, and Ethnicity Subgroups: Insights From the COORDINATE-Diabetes Trial. Circulation. 2024 Jul 16;150(3):180-189. doi: 10.1161/CIRCULATIONAHA.124.068962. Epub 2024 Jun 27. |
| 36877177 | Derived | Pagidipati NJ, Nelson AJ, Kaltenbach LA, Leyva M, McGuire DK, Pop-Busui R, Cavender MA, Aroda VR, Magwire ML, Richardson CR, Lingvay I, Kirk JK, Al-Khalidi HR, Webb L, Gaynor T, Pak J, Senyucel C, Lopes RD, Green JB, Granger CB; COORDINATE-Diabetes Site Investigators. Coordinated Care to Optimize Cardiovascular Preventive Therapies in Type 2 Diabetes: A Randomized Clinical Trial. JAMA. 2023 Apr 18;329(15):1261-1270. doi: 10.1001/jama.2023.2854. |
Provided with existing clinical care guidelines. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD. |
| BG001 | Control | Clinics provided with existing clinical care guidelines. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Health Insurance | Count of Participants | Participants |
| ||||||||||||||||
| Baseline Composite Medication Score | Number of recommended medications being taken by the participant at baseline. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Prescribed All 3 Groups of Recommended Evidence-based Medications | Proportion of patients prescribed all three groups of guideline-recommended therapies for management for T2DM and CVD at last follow-up visit. Groups were defined as (1) high-intensity statins (40-80 mg/d atorvastatin or 20-40 mg/d rosuvastatin); (2) ACEIs or ARBs including angiotensin receptor-neprilysin inhibitors (ARNIs); and (3) SGLT2 inhibitors and/or GLP-1RAs with proven cardiovascular benefit (SGLT2 inhibitors: empagliflozin, dapagliflozin, or canagliflozin; GLP-1RAs: liraglutide, semaglutide, or dulaglutide), or metformin monotherapy with hemoglobin A1c < 7%. | All participants for whom medication data was available at 6 or 12 months. | Posted | Count of Participants | Participants | Up to 12 Months |
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| Secondary | Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit. | Number of participants prescribed each of the 3 recommended therapies at the last follow-up visit. | All participants for whom medication data was available at 6 or 12 months. | Posted | Count of Participants | Participants | Up to 12 Months |
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| Secondary | Change in Average LDL-C From Baseline to Last Follow-up Visit. | Average change in LDL-C values between baseline visit and last follow-up visit. | All participants for whom medication data was available at 6 or 12 months, and who had cholesterol data available at baseline and last follow-up. | Posted | Mean | Standard Error | mg/dL | Baseline and last follow-up visit (up to 12 months) |
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| Secondary | Number of Participants With LDL-C < 70 mg/dL | Change in number of participants with LDL-C < 70 mg/dL at baseline visit vs. last follow-up visit. | Participants with outcome data available at both baseline and last follow-up visit. | Posted | Number | participants | Baseline and last follow-up visit (up to 12 months) |
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| Secondary | Change in Average Blood Pressure From Baseline to Last Follow-up Visit. | Change in systolic and diastolic blood pressure from baseline to last follow-up visit. | All participants for whom medication data was available at 6 or 12 months, who had systolic and diastolic blood pressure data at baseline and last follow-up visit. | Posted | Mean | Standard Error | mmHg | Baseline and last follow-up visit (up to 12 months) |
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| Secondary | Number of Participants With sBP < 130 mmHg | Proportion of participants achieving sBP < 130 mmHg at baseline vs. last follow-up visit | Participants with outcome data available at both baseline and last follow-up visits | Posted | Number | participants | Baseline and last follow-up visit (up to 12 months) |
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| Secondary | Number of Participants With dBP < 180 mmHg | Change in number of participants with dBP < 180 mmHg from baseline to last follow-up visit | Participants with outcome data available at both baseline and last follow-up visit | Posted | Number | participants | Baseline and last follow-up visit (up to 12 months) |
|
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| Secondary | Change in Average HbA1c From Baseline to Last Follow-up Visit. | Change in hemoglobin A1c (HbA1c) between baseline and last follow-up visit. | All participants for whom medication data was available at 6 or 12 months, and who had HbA1c values available at baseline and last follow-up visit. | Posted | Mean | Standard Error | HbA1c % | Baseline and last follow-up visit (up to 12 months) |
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| Secondary | Number of Participants With HbA1c < 7% | Change in number of participants with HbA1c < 7% from baseline to last follow-up visit. | Participants with outcome data available at both baseline and last follow-up visit | Posted | Number | participants | Baseline and last follow-up visit (up to 12 months) |
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| Secondary | Number of Participants Experiencing an Event Within 1 Year | Number of participants experiencing an event within 12 months of enrollment. Also known as cumulative incidence of events. | All participants for whom medication data was available at 6 or 12 months. | Posted | Number | participants | Up to 12 Months |
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Up to 12 months.
Per protocol, each site reported adverse events to Boehringer-Ingelheim (BI)'s pharmacovigilance team. Not all end point data were reported as adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD. | 6 | 459 | 3 | 459 | 4 | 459 |
| EG001 | Control | Clinics provided with existing clinical care guidelines. | 16 | 590 | 0 | 590 | 1 | 590 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Hyperglycaemic hyperosmolar nonketotic syndrome | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Acute kidney injury | Infections and infestations | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Inflammation | General disorders | Non-systematic Assessment |
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| Mental status changes | Infections and infestations | Non-systematic Assessment |
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| Hypoglycemia | Infections and infestations | Non-systematic Assessment |
| ||
| Fungal infection | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chris Granger, MD | Duke Clinical Research Institute | 9196688700 | christopher.granger@duke.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 16, 2022 | May 1, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Private only |
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| Medicaid only |
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| Other insurance only |
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| No insurance |
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| 1 point (taking one recommended medication) |
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| 2 points (taking two recommended medications) |
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