eFIcacious-Diabetes Care: a Pilot Study of a Pharmacist-Led Optimization Intervention to Achieve Guideline-based Care for Frail Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Control
Subjects in this arm will receive standard of care treatment with no intervention. They will receive month 6 follow up.
Active Decliners
Subjects who decline intervention. Standard of care treatment with month 6 follow up.
Active 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.
干预措施: Pharmacist-Led Optimization Intervention (Behavioral)
结局指标
主要结局
Change in HbA1c
时间窗: From Baseline through Month 6
Random Glucose Measurements
时间窗: 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
时间窗: Month 6
Duration of calls to enroll in minutes.
Estimated Change in Out-of-Pocket Costs
时间窗: From Baseline through Month 6
Change in diabetes medication cost
Point estimates of Feasibility Measures: Participation/Reach
时间窗: Month 6
The proportion of those referred who chose to participate
Point estimates of Feasibility Measure-Number of Visits
时间窗: 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
时间窗: Month 6
Proportion of subjects who achieve target value of HbA1c \>7.5%
Point estimates of Feasibility Measures: Number Contacted/Reach
时间窗: Month 6
Total number of subjects contacted
Point estimates of Feasibility Measures: Number at Risk/Reach
时间窗: Month 6
Total number of patients who meet inclusion/exclusion criteria at each site
Feasibility Measures: Effort Required to Enroll-Number Calls
时间窗: Month 6
Number of calls to enroll
Point estimates of Feasibility Measures: Time
时间窗: 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.
次要结局
- Rate of Emergency Department Visits and Hospitalizations(Baseline through Month 18)
- Number of Hypoglycemic Events Requiring Medical Assistance(Time Frame: Baseline through Month 18)
- Implementation Metric- Value(Baseline through Month 18)
- Mortality(Baseline through Month 18)
- Implementation Metric-- Acceptability(Baseline through Month 18)
- Number of Injurious Falls(Baseline through Month 18)
- Implementation Metric--Feasibility(Baseline through Month 18)
- Implementation Metric-- Appropriateness(Baseline through Month 18)