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临床试验/NCT05761886
NCT05761886已完成不适用

Rural Area Pharmacist Intervention for Diabetes - Management Using eHealth: A Pilot Study (RAPID-ME)

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2023年5月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
87
试验地点
2
主要终点
Patient enrollment rates

研究概览

简要总结

The goal of the project is to inform the system leaders regarding the feasibility and utility of having an embedded telehealth-based clinical pharmacist at rural primary care practices for supportive disease management of patients with Type 2 diabetes (T2D) and whether continuing and expanding the program within the system is worthwhile.

详细描述

Improvement of suboptimal type 2 diabetes (T2D) management and outcomes in rural areas in the United States (US) is an urgent national health policy priority. Novel approaches such as telehealth and supportive clinical management of T2D by non-physician providers have been recommended to fill gaps in care. With specialty in drug therapy, clinical pharmacists are in a position to uniquely contribute to filling gaps in T2D management related to medication therapy, which are common and often the cause of adverse outcomes in patients with T2D. The objective of this pilot study is to determine the feasibility, acceptability, appropriateness, fidelity, barriers and facilitators of implementation, and preliminary effectiveness of a telehealth-based clinical pharmacy intervention to inform the design of a subsequently planned fully powered effectiveness-implementation trial of the intervention. This pilot study will involve randomization based on the days the patients had encounters at participating practices (4 in North Carolina). The 2 study arms will be: 1) Usual care, receiving standard practice of care managed by physicians, nurse practitioners, and physician assistants with access to chronic disease management services and 2) Intervention arm, receiving the intervention consisting of clinical pharmacy services including identification and resolution of medication-related problems and patient needs, optimization of medication regimen and T2D education and self-management support, in addition to usual care. The intervention will last for 3 months and will consist of biweekly video/phone calls between patients and the pharmacist. Based on recommendations from literature on pilot studies, the total planned sample size is 240 patients. Implementation science framework by Proctor and colleagues and scales by Weiner and colleagues (for feasibility, acceptability, appropriateness, and fidelity) and Consolidated Framework for implementation Research (for barriers and facilitators of intervention implementation) will guide collection of data on outcomes. for using complementary medicine and healthcare avoidance. The results of our work will facilitate wide implementation of the intervention and thereby improved outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >= 18 years and <=75 years (since children have different incidence, management, and outcomes of Type 2 diabetes (T2D) compared to adults and older adults aged more than 75 years may have had their hemoglobin A1C (HbA1c) goals adjusted to higher thresholds)
  • HbA1c reading ≥ 8% recorded during 6 months prior to or up to 9 days after the encounter at the participating practices
  • Uncontrolled type 2 diabetes (ICD-10-CM code E11.XX) recorded in the EHR in the year prior to up to 1 week after the uncontrolled HbA1c reading

排除标准

  • Patients with gestational or type 1 diabetes
  • Those enrolled in any other chronic disease management programs delivered by non-physician healthcare professionals
  • Those receiving T2D care from an endocrinologist
  • Those receiving long term, hospice, or palliative care services
  • Those with serious mental illnesses (schizophrenia and other psychotic disorders, major depressive disorders, bipolar disorders, and borderline personality disorder)
  • Those with malignant cancer
  • Those with cognitive impairment

结局指标

主要结局

Patient enrollment rates

时间窗: Month 13

Proportion of eligible patients enrolled

Proportion of patients with complete data

时间窗: Month 17

Proportion of patients with complete data

Proportion of respondents selecting a response - Feasibility

时间窗: Month 17

Proportion of respondents selecting a response of agree/strongly agree (disagree/strongly disagree for negatively worded items) on 70% of the survey items measuring perspectives regarding whether it was possible for the respondents to perform the program activities

Proportion of respondents selecting a response - Acceptability

时间窗: Month 17

Proportion of respondents selecting a response of agree/strongly agree (disagree/strongly disagree for negatively worded items) on 70% of the survey items measuring perspectives regarding whether they approve and like the program

Proportion of respondents selecting a response - Appropriateness

时间窗: Month 17

Proportion of respondents selecting a response of agree/strongly agree (disagree/strongly disagree for negatively worded items) on 70% of the survey items measuring perspectives regarding program fit with the needs of the respondents

Proportion of items self-reported by pharmacist - Fidelity

时间窗: Month 17

Proportion of items self-reported by pharmacist by checking (yes/no/not applicable) in a task-list of program activities

次要结局

  • Change in barriers to medication adherence(Month 17)
  • Change in HbA1c(Month 17)
  • Number of Acute Care Days(Month 17)
  • Change in Blood Pressure(Month 17)
  • Change in patient-reported medication adherence scores(Month 17)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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