Electronic Frailty Index (eFI)Cacious-Diabetes Care
- Conditions
- Type2 DiabetesDiabetes
- Interventions
- Behavioral: Pharmacist-Led Optimization Intervention
- Registration Number
- NCT05047237
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief 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.
- Detailed 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 & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Intervention Pharmacist-Led Optimization Intervention Subjects are mailed Information about Type 2 Diabetes Mellitus (T2DM) Guidelines and Appointment Information (Face to face \[F2F\] or Telehealth). They attend up to 3 pharmacist visits, depending on if they reach target glucose levels. And they attend interviews. They also have month 6 follow up.
- Primary Outcome Measures
Name Time Method Random Glucose Measurements From Baseline through Month 12 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.
Feasibility Measures: Effort Required to Enroll-Average Call Duration Month 6 Duration of calls to enroll in minutes.
Estimated Change in Out-of-Pocket Costs From Baseline through Month 6 Change in diabetes medication cost
Point estimates of Feasibility Measures: Participation/Reach Month 6 The proportion of those referred who chose to participate
Point estimates of Feasibility Measure-Number of Visits Month 12 Mean and median number of visits with the pharmacist before glucose levels are met.
Proportion of subjects who Achieve Glycosylated Hemoglobin (HbA1c) values Month 6 Proportion of subjects who achieve target value of HbA1c \>7.5%
Point estimates of Feasibility Measures: Number Contacted/Reach Month 6 Total number of subjects contacted
Point estimates of Feasibility Measures: Number at Risk/Reach Month 6 Total number of patients who meet inclusion/exclusion criteria at each site
Feasibility Measures: Effort Required to Enroll-Number Calls Month 6 Number of calls to enroll
Point estimates of Feasibility Measures: Time Month 12 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.
Change in HbA1c From Baseline through Month 6
- Secondary Outcome Measures
Name Time Method Rate of Emergency Department Visits and Hospitalizations Baseline through Month 18 Using EHR and Patient Ping, the number of contacts with the Emergency Department (ED) and hospitals (composite)
Number of Hypoglycemic Events Requiring Medical Assistance Time Frame: Baseline through Month 18 Events defined as per action to control cardiovascular risk in diabetes (ACCORD) trial, as hypoglycemic episodes requiring hospitalization or care in an emergency department.
Implementation Metric- Value Baseline through Month 18 Three questions will be coded and analyzed through qualitative analysis. The study team will code comments by hand using content analysis and grounded theory.
Mortality Baseline through Month 18 Number of people who die as found in EHR and North Carolina (NC) death registry
Implementation Metric-- Acceptability Baseline through Month 18 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.
Number of Injurious Falls Baseline through Month 18 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.
Implementation Metric--Feasibility Baseline through Month 18 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.
Implementation Metric-- Appropriateness Baseline through Month 18 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.
Trial Locations
- Locations (1)
Atrium Health Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States