NCT02318108

Brief Summary

The purpose of this study is to test the effectiveness and cost effectiveness of an assisted work process redesign intervention in achieving improved diabetes care in primary care practices. The strategies that we will test represent a novel method for assisting practices in developing the skills to overcome "clinical inertia" and health care system barriers to improved diabetes care by helping them to implement and use a diabetes registry to identify needed clinical or preventive services an opportunities for treatment intensification where appropriate for their patients with diabetes. This is accomplished by helping practices develop methods for improving the efficiency and effectiveness of clinical care processes through integration of a diabetes registry into regular clinical practice. This integration is accomplished through changes in the work processes in the practice setting to ensure that population health tasks (such as outreach to patients who do not attend scheduled chronic care visits and systematic identification for follow up of patients who may not be taking prescribed medication therapies) become a part of the regular work of clinical support staff and other members of the primary care practice team.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable diabetes-mellitus-type-2

Status
unknown

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

July 1, 2012

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 17, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

October 17, 2017

Status Verified

October 1, 2017

Enrollment Period

6.1 years

First QC Date

December 10, 2014

Last Update Submit

October 15, 2017

Conditions

Keywords

Organizational InnovationPrimary Health Care

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

    Assessment of HbA1c at baseline and two follow up points. Retrospective documentation of most recent value within previous year.

    Change in HbA1c from baseline to follow up (year 1 and year 2)

Study Arms (2)

Intervention

EXPERIMENTAL

Mentored organizational change and feedback.

Other: Mentored organizational change

Education only

OTHER

Education and feedback.

Other: Education only

Interventions

Practices are given basic education related to population-based care and are supported by physician peer mentors and given feedback on performance.

Intervention

Practices are given basic education related to population-based care and are given feedback on performance.

Education only

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Primary care practice organizations with electronic health records.
  • Located in Virginia

You may not qualify if:

  • Not a primary care practice.
  • No electronic health record.
  • Located outside of Virginia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Sabo RT, Etz RS, Gonzalez MM, Johnson NJ, O'Neal JP, Reves SR, Crosson JC. Low-Intensity Intervention Supports Diabetes Registry Implementation: A Cluster-Randomized Trial in the Ambulatory Care Outcomes Research Network (ACORN). J Am Board Fam Med. 2020 Sep-Oct;33(5):728-735. doi: 10.3122/jabfm.2020.05.190455.

  • Keith RE, Crosson JC, O'Malley AS, Cromp D, Taylor EF. Using the Consolidated Framework for Implementation Research (CFIR) to produce actionable findings: a rapid-cycle evaluation approach to improving implementation. Implement Sci. 2017 Feb 10;12(1):15. doi: 10.1186/s13012-017-0550-7.

  • Etz RS, Keith RE, Maternick AM, Stein KL, Sabo RT, Hayes MS, Sevak P, Holland J, Crosson JC. Supporting Practices to Adopt Registry-Based Care (SPARC): protocol for a randomized controlled trial. Implement Sci. 2015 Apr 9;10:46. doi: 10.1186/s13012-015-0232-2.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jay Crosson, Ph.D.

    Mathematica Policy Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

December 10, 2014

First Posted

December 17, 2014

Study Start

July 1, 2012

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

October 17, 2017

Record last verified: 2017-10