NCT02299791

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,856

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable diabetes-mellitus

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

October 4, 2017

Completed
Last Updated

October 4, 2017

Status Verified

October 1, 2017

Enrollment Period

3.7 years

First QC Date

November 7, 2014

Results QC Date

March 30, 2017

Last Update Submit

October 2, 2017

Conditions

Diabetes MellitusCardiovascular Diseases

Keywords

clinic-level interventionsquality improvementtranslational medical researchcommunity health centers

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Early Intervention

ACTIVE COMPARATOR

6 study clinics received the ALL intervention starting 6/1/11

Other: ALL

Late implementation

ACTIVE COMPARATOR

5 study clinics received the ALL intervention starting 6/1/12

Other: ALL

Interventions

ALLOTHER

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

Early Intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Convenience sample of 11 community health clinics (CHCs) that are members of OCHIN, Inc.

You may not qualify if:

  • none, for study CHCs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 22864500RESULT

  • 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.

    PMID: 28381249DERIVED

  • 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.

    PMID: 27113199DERIVED

  • 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.

    PMID: 26059264DERIVED

Related Links

MeSH Terms

Conditions

Diabetes MellitusCardiovascular Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Rachel Gold
Organization
KaiserPermanente Center for Health Research
rachel.gold@kpchr.org
503-528-3902

Study Officials

  • Rachel Gold, PhD, MPH

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2014

First Posted

November 24, 2014

Study Start

September 1, 2010

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

October 4, 2017

Results First Posted

October 4, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share