Electronic Frailty Index (eFI)Cacious-Diabetes Care

Diabetes Clinical Trial

Official title:

eFIcacious-Diabetes Care: a Pilot Study of a Pharmacist-Led Optimization Intervention to Achieve Guideline-based Care for Frail Older Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05047237
• Other study ID #: IRB00076190
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 29, 2021
• Est. completion date: April 2025

Study information

• Verified date: October 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to explore whether a pharmacist-led diabetes management program can help optimize diabetes care for older adults. Participation in this study will involve meeting with a pharmacist who works with subjects' doctors, getting some routine bloodwork typical for people with diabetes, and potentially adjusting the subject's diabetes medications to reach American Diabetes Association guidelines. This study aims to bring older adults with diabetes whose measurements and medications are different from the guidelines of the American Diabetes Association into guidelines-based ranges.

Description:

This study is a pragmatic pilot study assessing the feasibility and acceptability, and preliminary impact of a pharmacist-led care pathway to align patient care with guidelines for type 2 diabetes mellitus (T2DM) management in frail older adults, leveraging existing resources and pathways of care led by Clinical Prescribing Pharmacists. Eligible participants will be identified from the Electronic Health Record (EHR). Research staff will then approach the primary care physicians for identified patients to confirm that patients are appropriate for the intervention, as determined by the primary care physician (PCP). Patients will then be contacted both by letter and phone call, and invited to participate in the pharmacist-led pathway. Telephonic informed consent will be obtained. Outcomes for all participants will be accessed passively via the EHR. The study team hypothesizes that patients who go through the pharmacist-led primary care intervention will be more likely to have guideline-concordant medical therapy as compared with an EHR-based control group. Also, the study team believes that the intervention will reach at least 50% of those referred by their physicians to participate, the median number of outpatient visits will be three or less, and that the intervention will require a total of <3 hours for pharmacists and patients across the 3-month intervention period. In addition, the study team expects patients, physicians, and pharmacists will report the intervention is feasible, acceptable, appropriate, and high-value. Lastly, the study team believes that the intervention group will have a lower mortality than the comparison group.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: April 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Attributed to a Atrium Health Wake Forest Baptist-affiliated Accountable Care Organization
• At least 2 consecutive International Classification of Diseases 10th Revision (ICD-10) codes for type two diabetes mellitus in the prior 2 years
• Has a calculable Electronic Frailty Index (eFI) score >0.21
• A glycosylated hemoglobin (HbA1c) value <7.5% in the prior 2 years
• Currently taking a sulfonylurea or insulin for Type 2 Diabetes Mellitus (T2DM)

Exclusion Criteria:

• Moderate to severe hearing loss (due to phone interventions)
• Diagnosed Alzheimer's disease or related dementia (unable to participate)
• Non-English speaking (not all pharmacists speak a second language; subtleties may not be conveyed effectively)
• No phone number available for patient (follow up contacts will be by telehealth or phone

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Type2 Diabetes

Intervention

Behavioral:
• Pharmacist-Led Optimization Intervention
Educational information mailed to participants and up to three pharmacist visits.

Locations

Country	Name	City	State
United States	Atrium Health Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who Achieve Glycosylated Hemoglobin (HbA1c) values	Proportion of subjects who achieve target value of HbA1c >7.5%	Month 6
Primary	Change in HbA1c		From Baseline through Month 6
Primary	Random Glucose Measurements	The study team will track any glucose measurements obtained between initial enrollment and 6-12 months follow up after completion of the intervention, up until a total of 12 months after initial enrollment. This will be reported as a glucose trajectory.	From Baseline through Month 12
Primary	Estimated Change in Out-of-Pocket Costs	Change in diabetes medication cost	From Baseline through Month 6
Primary	Point estimates of Feasibility Measures: Participation/Reach	The proportion of those referred who chose to participate	Month 6
Primary	Point estimates of Feasibility Measures: Number Contacted/Reach	Total number of subjects contacted	Month 6
Primary	Point estimates of Feasibility Measures: Number at Risk/Reach	Total number of patients who meet inclusion/exclusion criteria at each site	Month 6
Primary	Feasibility Measures: Effort Required to Enroll-Number Calls	Number of calls to enroll	Month 6
Primary	Feasibility Measures: Effort Required to Enroll-Average Call Duration	Duration of calls to enroll in minutes.	Month 6
Primary	Point estimates of Feasibility Measure-Number of Visits	Mean and median number of visits with the pharmacist before glucose levels are met.	Month 12
Primary	Point estimates of Feasibility Measures: Time	Time until achieved medication goal per patient will be reported. An achieved medication goal is the following: HbA1c <8 while taking no sulfonylurea or insulin, or HbA1c between 7.5-8 on sulfonylurea or insulin (these would both meet guidelines-based care.	Month 12
Secondary	Rate of Emergency Department Visits and Hospitalizations	Using EHR and Patient Ping, the number of contacts with the Emergency Department (ED) and hospitals (composite)	Baseline through Month 18
Secondary	Number of Hypoglycemic Events Requiring Medical Assistance	Events defined as per action to control cardiovascular risk in diabetes (ACCORD) trial, as hypoglycemic episodes requiring hospitalization or care in an emergency department.	Time Frame: Baseline through Month 18
Secondary	Number of Injurious Falls	Identified by International Classification of Diseases-10th Revision (ICD-10) diagnostic codes; defined as per systolic blood pressure intervention trial (SPRINT) as falls requiring hospitalization or care in an emergency department.	Baseline through Month 18
Secondary	Mortality	Number of people who die as found in EHR and North Carolina (NC) death registry	Baseline through Month 18
Secondary	Implementation Metric--Feasibility	Feasibility (FIM): This is a questionnaire that helps determine feasibility of the intervention. Score ranges from 4-20, with a higher score meaning the participant feels the intervention is more feasible.	Baseline through Month 18
Secondary	Implementation Metric-- Acceptability	This is a questionnaire that helps determine acceptability of the intervention. Score ranges from 4-20, with a higher score meaning the participant feels the intervention is more acceptable.	Baseline through Month 18
Secondary	Implementation Metric-- Appropriateness	This is a questionnaire that helps determine appropriateness of the intervention. Score ranges from 4-20, with a higher score meaning the participant feels the intervention is more appropriate.	Baseline through Month 18
Secondary	Implementation Metric- Value	Three questions will be coded and analyzed through qualitative analysis. The study team will code comments by hand using content analysis and grounded theory.	Baseline through Month 18