Clinical trial NCT05761886: Rural Area Pharmacist Intervention for Diabetes
Official title: Rural Area Pharmacist Intervention for Diabetes - Management Using eHealth: A Pilot Study (RAPID-ME)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Telehealth
Rural populations
Clinical pharmacy services
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Duke University
First posted: 2023-03-09
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the target sample size in our pilot study is 72 in the intervention group. The target for the control group is 168.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Patient enrollment rates
timeFrame: Month 13
measure: Proportion of patients with complete data
timeFrame: Month 17
measure: Proportion of respondents selecting a response - Feasibility
timeFrame: Month 17
measure: Proportion of respondents selecting a response - Acceptability
timeFrame: Month 17
measure: Proportion of respondents selecting a response - Appropriateness
timeFrame: Month 17
measure: Proportion of items self-reported by pharmacist - Fidelity
timeFrame: Month 17
Secondary outcomes:
measure: Change in HbA1c
timeFrame: Month 17
measure: Change in Blood Pressure
timeFrame: Month 17
measure: Number of Acute Care Days
timeFrame: Month 17
measure: Change in patient-reported medication adherence scores
timeFrame: Month 17
measure: Change in barriers to medication adherence
timeFrame: Month 17
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Atrium Health Wake Forest University Health Sciences
name: Rohan Mahabaleshwarkar, PhD
role: PRINCIPAL_INVESTIGATOR
References: