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| ID | Type | Description | Link |
|---|---|---|---|
| 1R18HL095481-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| OCHIN, Inc. | OTHER |
| Virginia Garcia Memorial Health Center | UNKNOWN |
| Multnomah County Health Department |
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The purpose of the ALL Study is to determine the effectiveness of the dissemination of the ALL intervention from an integrated care setting into Community Health Centers (CHCs) by measuring changes in diabetes mellitus (DM) population prescription rates for the medications, using a pre-post comparison within clinics and a staggered, randomized implementation across clinics.
The ALL Initiative ('ALL') is a population-level management program developed at Kaiser Permanente (KP). It seeks to decrease cardiovascular disease (CVD) morbidity and mortality in patients with diabetes by improving rates of prescribing for guideline-concordant cardioprotective medications. Multiple mechanisms supported this intervention at KP. The investigators implemented ALL in 11 Community Health Centers (CHC) in the Portland, Oregon metropolitan area. To our knowledge, this was the first clinical trial testing the translation and implementation of a successful quality improvement (QI) initiative from a private, integrated care setting into CHCs.
The investigators adapted the ALL intervention for CHCs through an iterative, stakeholder-driven process. The investigators then conducted a cluster-randomized pragmatic trial in 11 CHCs in a staggered process with six 'early' CHCs implementing the intervention one year before five 'late' CHCs. The investigators measured monthly rates of cardioprotective prescribing rates. Through segmented regression analysis, the investigators evaluated the intervention's effects in June 2011-May 2013. Participants included 11 CHCs serving ~6,500 adult patients with diabetes mellitus (DM) who were indicated for cardioprotective medications per national guidelines. The investigators also conducted a process evaluation to identify factors important to implementation success.
Our overarching goals were to identify and resolve issues in disseminating a successful program from a large, well-organized health system into CHCs. The investigators hypothesized that cross-setting translation was feasible, and that adapting and implementing proven QI approaches could improve the care CHCs provide without requiring them to develop native initiatives. The investigators anticipated that this implementation would involve substantially adapting potentially 'translatable' practices and interventions, due to the differences between private, integrated care settings and CHCs in terms of patient needs and vulnerability, and system resources.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Intervention | Active Comparator | 6 study clinics received the ALL intervention starting 6/1/11 |
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| Late implementation | Active Comparator | 5 study clinics received the ALL intervention starting 6/1/12 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALL | Other | This clinic-level intervention involves a toolkit of decision support tools. These tools are listed below.
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients Indicated for ACE/ARB and Statin Who Had an Active Prescription for Both | Number of patients indicated for ACE/ARB and statin who had an active prescription for both, as a proportion of patients indicated for ACE/ARB and statin. | Percent of clinic patients prescribed guideline-concordant cardioprotective medications, as of the 1st day of each month, from up to 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Gold, PhD, MPH | Kaiser Permanente | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22864500 | Result | Gold R, Muench J, Hill C, Turner A, Mital M, Milano C, Shah A, Nelson C, DeVoe JE, Nichols GA. Collaborative development of a randomized study to adapt a diabetes quality improvement initiative for federally qualified health centers. J Health Care Poor Underserved. 2012 Aug;23(3 Suppl):236-46. doi: 10.1353/hpu.2012.0132. | |
| 28381249 | Derived | Gold R, Bunce A, Cowburn S, Davis JV, Hollombe C, Nelson CA, Puro J, Muench J, Hill C, Jaworski V, Mercer M, Howard C, Perrin N, DeVoe J. Cardiovascular care guideline implementation in community health centers in Oregon: a mixed-methods analysis of real-world barriers and challenges. BMC Health Serv Res. 2017 Apr 5;17(1):253. doi: 10.1186/s12913-017-2194-3. |
| Label | URL |
|---|---|
| PubMed | View source |
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Recruitment was done at the clinic level. All patients seen in the clinics were potentially eligible for the intervention based on clinic visit and clinical criteria.
| ID | Title | Description |
|---|---|---|
| FG000 | Early Intervention Number of Patients | Patients in 6 study clinics received the ALL intervention starting 6/1/11 ALL: This clinic-level intervention involves a toolkit of decision support tools. These tools are listed below.
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| FG001 | Late Interventions Number of Patients | 5 study clinics received the ALL intervention starting 6/1/12 ALL: These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Early Intervention | 6 study clinics received the ALL intervention starting 6/1/11 ALL: This clinic-level intervention involves a toolkit of decision support tools. These tools are listed below.
|
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Patients Indicated for ACE/ARB and Statin Who Had an Active Prescription for Both | Number of patients indicated for ACE/ARB and statin who had an active prescription for both, as a proportion of patients indicated for ACE/ARB and statin. | clinic patients with diabetes who had a clinic encounter (in person or by telephone) within the previous year and were indicated for ACE/ARB and statin per current national care guidelines | Posted | Count of Participants | Participants | Percent of clinic patients prescribed guideline-concordant cardioprotective medications, as of the 1st day of each month, from up to 36 months |
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Adverse events were not monitored for this cluster randomized trial.
Adverse events were not monitored for this cluster randomized trial.
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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 | Early Intervention | 6 study clinics received the ALL intervention starting 6/1/11 ALL: This clinic-level intervention involves a toolkit of decision support tools. These tools are listed below.
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Gold | KaiserPermanente Center for Health Research | 503-528-3902 | rachel.gold@kpchr.org |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| OTHER_GOV |
| Oregon Health and Science University | OTHER |
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| ALL | Other | These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial. |
|
| 27113199 | Derived | Gold R, Bunce AE, Cohen DJ, Hollombe C, Nelson CA, Proctor EK, Pope JA, DeVoe JE. Reporting on the Strategies Needed to Implement Proven Interventions: An Example From a "Real-World" Cross-Setting Implementation Study. Mayo Clin Proc. 2016 Aug;91(8):1074-83. doi: 10.1016/j.mayocp.2016.03.014. Epub 2016 Apr 23. |
| 26059264 | Derived | Gold R, Nelson C, Cowburn S, Bunce A, Hollombe C, Davis J, Muench J, Hill C, Mital M, Puro J, Perrin N, Nichols G, Turner A, Mercer M, Jaworski V, Howard C, Abiles E, Shah A, Dudl J, Chan W, DeVoe J. Feasibility and impact of implementing a private care system's diabetes quality improvement intervention in the safety net: a cluster-randomized trial. Implement Sci. 2015 Jun 10;10:83. doi: 10.1186/s13012-015-0259-4. |
| BG001 | Late Implementation | 5 study clinics received the ALL intervention starting 6/1/12 ALL: These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | Years |
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| 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 |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Late Implementation | 5 study clinics received the ALL intervention starting 6/1/12 ALL: These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial. |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Late Implementation | 5 study clinics received the ALL intervention starting 6/1/12 ALL: These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial. | 0 | 0 | 0 | 0 | 0 | 0 |
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