Electronic Decision Support for Intervention in Poorly Controlled Type 2 Diabetes

NCT02924207 | Completed DMC

• 1 other identifier: 6/2016-018
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the impact of an electronic decision support tool on physician decision making and patient outcomes for the treatment of poorly controlled diabetes mellitus. Primary endpoint will measure change in hemoglobin A1c. Secondary endpoints will examine cost of therapy and patient satisfaction with therapy. Study hypothesis is that use of the PATH decision tool will produce greater reduction overall in measurements of hemoglobin A1c in patients who participate and follow the PATH decision tool than patients who elect not to follow the PATH decision tool. PATH decision tool will provide more cost effective solutions for management of diabetic medication than current methods.

Conditions

Diabetes Mellitus

Keywords

diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• change in hemoglobin A1c from baseline

  change in hemoglobin A1c from baseline

  1 year

Secondary Outcomes (2)

• change in patient's perception of cost of diabetes medicine and side effects

  1 year

• actual cost and change in frequency of drug side effects

  1 year

Study Arms (1)

Intervention

EXPERIMENTAL

Path Electronic decision support arm

Other: PATH electronic decision support tool

Interventions

PATH electronic decision support tool OTHER

PATH, a clinical decision support tool for Type 2 Diabetes, was developed based on patient impact of efficacy, cost, implementation difficulty, comorbidities, side effects, and evidence based pleiotropic benefit. Drug efficacy was estimated using published clinical data for agents, both in terms of placebo controlled trials and head-to-head studies. Additional information regarding interventions was added with regard to FDA package inserts as well as large post marketing studies. Cost impact of intervention was described in terms of patient's estimated copay drawn from insurance plan as well as average retail price.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient under the care of a primary care physician within St. Elizabeth Physicians
• \>=18 years of age
• Diagnosis of Type 2 Diabetes for at least 6 months
• Hemoglobin A1c values of \>= 7.0 (drawn within the last year).

You may not qualify if:

• Type 1 Diabetes, Secondary Diabetes, Gestational Diabetes or LADA (presence of anti-GAD, IA-2, C-Peptide \<0.5)
• Participant is currently or intended to start hemodialysis or peritoneal dialysis during the course of the study.
• Chronic or planned systemic glucocorticoid use
• Scheduled prandial insulin therapy (premix and basal okay)
• Other health threatening disease state at investigator's discretion
• Potential participant is unable to fully comprehend the risks of study participation or comply with study procedures.
• New diabetes intervention in the last 3 months (change in diabetes medication or dosage)

Sponsors & Collaborators

• St Elizabeth Healthcare: lead
• PATH Decision Support Software, LLC: collaborator

Study Sites (1)

St. Elizabeth Healthcare

Covington, Kentucky, 41011, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: October 5, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 9, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)