Diabetes MellitusALLNCT02299791
Dissemination of CVD Risk Factor Treatment Among Diabetic Patients in Safety Net Clinics
A study testing ALL in people with Diabetes Mellitus and Cardiovascular Diseases, run by Kaiser Permanente.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Cardiovascular Diseases
- What is being tested?
- ALL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,856 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Convenience sample of 11 community health clinics (CHCs) that are members of OCHIN, Inc.
Who cannot join
- none, for study CHCs
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Cardiovascular Diseases
- Being tested
- ALL
- Keywords
- clinic-level interventions, quality improvement, translational medical research, community health centers
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALLOther
This clinic-level intervention involves a toolkit of decision support tools. These tools are listed below.
- EHR tools to expedite identification
- EHR automated point-of-care alerts (Best Practice Alerts)
- EHR tools to expedite prescribing
- EHR order sets
- EHR text shortcuts for notation
- patient education materials (handout, poster)
- EHR-based outreach support tools a. EHR registries
ALLOther
These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial.
| Study group | Role | What they receive |
|---|---|---|
| Early Intervention | Active comparator | 6 study clinics received the ALL intervention starting 6/1/11 Receives: Other: ALL |
| Late implementation | Active comparator | 5 study clinics received the ALL intervention starting 6/1/12 Receives: Other: ALL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Percent of clinic patients prescribed guideline-concordant cardioprotective medications, as of the 1st day of each month, from up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startSep 2010
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)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 Kaiser PermanenteThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,856 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), OCHIN, Inc., Virginia Garcia Memorial Health Center, Multnomah County Health Department, Oregon Health and Science University
- Responsible party
- Sponsor
- Investigators
- Rachel Gold, PhD, MPH, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299791
- Sponsor's protocol ID
- 1R18HL095481-01A1
- Other IDs
- 1R18HL095481-01A1
- Acronym
- ALL
- Status last verified
- Oct 2017
- First submitted
- 7 Nov 2014
- Last updated
- 4 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 22864500Gold 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.
PubMed 28381249Gold 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.
PubMed 27113199Gold 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.
PubMed 26059264
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissemination of CVD Risk Factor Treatment Among Diabetic Patients in Safety Net Clinics
- ClinicalTrials.gov ID
- NCT02299791
- Acronym / sponsor ID
- ALL / 1R18HL095481-01A1
- Conditions
- Diabetes Mellitus, Cardiovascular Diseases
- Keywords
- clinic-level interventions, quality improvement, translational medical research, community health centers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,856 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), OCHIN, Inc., Virginia Garcia Memorial Health Center, Multnomah County Health Department, Oregon Health and Science University
- Study start
- Sep 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Posted 4 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Intervention | Active comparator | Other: ALL6 study clinics received the ALL intervention starting 6/1/11 |
| Late implementation | Active comparator | Other: ALL5 study clinics received the ALL intervention starting 6/1/12 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Convenience sample of 11 community health clinics (CHCs) that are members of OCHIN, Inc.
Key exclusion criteria (1 listed)
- none, for study CHCs
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 |
|---|---|---|
| ALLThis 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 | Other | Early Intervention |
| ALLThese clinics got the same exact intervention, but one year later, as this was a staggered randomized trial. | Other | Late implementation |
Primary outcome
Patients Indicated for ACE/ARB and Statin Who Had an Active Prescription for Both
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22864500Gold 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.
- Derived from this study: PubMed 28381249Gold 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.
- Derived from this study: PubMed 27113199Gold 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.
- Derived from this study: PubMed 26059264Gold 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.
- PubMedLink provided by the sponsor.
- 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.
Rachel Gold, PhD, MPH principal investigator
Kaiser Permanente
Questions about this trial
What is this clinical trial studying?
A study testing ALL in people with Diabetes Mellitus and Cardiovascular Diseases, run by Kaiser Permanente.
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 1 inclusion and 1 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 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 4 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patients Indicated for ACE/ARB and Statin Who Had an Active Prescription for Both (time frame: Percent of clinic patients prescribed guideline-concordant cardioprotective medications, as of the 1st day of each month, from up to 36 months). 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 NCT02299791, which also lists 4 linked publications.
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 4 Oct 2017.