Cardiovascular Diseases, Diabetes Mellitus
Conditions
Keywords
clinic-level interventions, quality improvement, translational medical research, community health centers
Brief summary
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.
Detailed description
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.
Interventions
OTHERALL
This clinic-level intervention involves a toolkit of decision support tools. These tools are listed below. 1. EHR tools to expedite identification a. EHR automated point-of-care alerts (Best Practice Alerts) 2. EHR tools to expedite prescribing 1. EHR order sets 2. EHR text shortcuts for notation 3. patient education materials (handout, poster) 3. EHR-based outreach support tools a. EHR registries
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
OCHIN, Inc.
Virginia Garcia Memorial Health Center
Multnomah County Health Department
Oregon Health and Science University
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Convenience sample of 11 community health clinics (CHCs) that are members of OCHIN, Inc.
Exclusion criteria
* none, for study CHCs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients Indicated for ACE/ARB and Statin Who Had an Active Prescription for Both | Percent of clinic patients prescribed guideline-concordant cardioprotective medications, as of the 1st day of each month, from up to 36 months | 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. |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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.
1. EHR tools to expedite identification
a. EHR automated point-of-care alerts (Best Practice Alerts)
2. EHR tools to expedite prescribing
1. EHR order sets
2. EHR text shortcuts for notation
3. patient education materials (handout, poster)
3. EHR-based outreach support tools a. EHR registries | 2,053 |
| 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. | 2,803 |
| Total | 4,856 |
Baseline characteristics
| Characteristic | Early Intervention | Late Implementation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 535 Participants | 559 Participants | 1094 Participants |
| Age, Categorical Between 18 and 65 years | 1518 Participants | 2244 Participants | 3762 Participants |
| Age, Continuous | 62 Years | 63 Years | 63 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 659 Participants | 900 Participants | 1559 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1374 Participants | 1877 Participants | 3251 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 20 Participants | 26 Participants | 46 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 16 Participants | 22 Participants | 38 Participants |
| Race (NIH/OMB) Asian | 101 Participants | 138 Participants | 239 Participants |
| Race (NIH/OMB) Black or African American | 179 Participants | 244 Participants | 423 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 14 Participants | 19 Participants | 33 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 485 Participants | 663 Participants | 1148 Participants |
| Race (NIH/OMB) White | 1258 Participants | 1717 Participants | 2975 Participants |
| Region of Enrollment United States | 2053 Participants | 2803 Participants | 4856 Participants |
| Sex: Female, Male Female | 1240 Participants | 1634 Participants | 2874 Participants |
| Sex: Female, Male Male | 813 Participants | 1169 Participants | 1982 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Percent of clinic patients prescribed guideline-concordant cardioprotective medications, as of the 1st day of each month, from up to 36 months
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Early Intervention | Patients Indicated for ACE/ARB and Statin Who Had an Active Prescription for Both | 1279 Participants |
| Late Implementation | Patients Indicated for ACE/ARB and Statin Who Had an Active Prescription for Both | 1318 Participants |