The PharmFIT Study

Trial Title: The PharmFIT Study

NCT ID: NCT06656936

Condition: Colorectal Cancer

Conditions: Official terms:
Colorectal Neoplasms

Conditions: Keywords:
Cancer Screening
Colorectal Cancer
Implementation Science
Rural Health
Minority Health
Community Pharmacies

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Participants are assigned to one of two or more groups in parallel for the duration of the study

Primary purpose: Health Services Research

Masking: Single (Outcomes Assessor)

Masking description: This is a pragmatic trial, so study participants and the investigator team will be unblinded to study procedures, however, the outcomes assessors (biostatistical team) will be blinded to arm assignments.

Intervention:

Intervention type: Behavioral
Intervention name: PharmFIT
Description: The PharmFIT intervention involves the following components: referral notice to patient, FIT ready notification, FIT ready reminders, FIT distribution, FIT completion reminders, negative and positive results notification, patient navigation support.
Arm group label: Intervention: PharmFIT

Summary: This study will conduct a randomized controlled trial to assess the impact of a pharmacy-based FIT intervention, Pharmacy-based FIT (PharmFIT), on colorectal cancer screening (CRC) screening rates in primary care patients who are not up to date on CRC screening. Through collaboration with community partners in North Carolina and the Pacific Northwest region, 1) the impact will be evaluated, 2) the implementation will be assessed, and 3) the costs of the PharmFIT intervention cost will be estimated. Patients (n=1,200) will be individually randomized to a usual care arm or a PharmFIT arm and we will determine whether there are statistically significant differences in CRC screening rates. Concurrently, a mixed methods approach will be used to assess a range of preliminary implementation outcomes, identify outcome barriers and facilitators, and identify implementation strategies to support future research. Also, the cost of PharmFIT will be calculated, using collaborative process flow diagramming (PFD) to inform micro-costing and budget impact analysis. Supported by preliminary work from the investigators, demonstrating widespread acceptability, feasibility, and preliminary effectiveness of PharmFIT, the rationale to conduct this hybrid 1 effectiveness-implementation trial1 is to generate new knowledge about pharmacy-based interventions to effectively increase CRC screening uptake and implementation. The central hypothesis is that the PharmFIT intervention will increase screening uptake by improving access to, and opportunities for, this preventive service through the involvement of a multidisciplinary, multisite, team-based care approach to CRC screening.

Detailed description: The long-term goal of this study is to reduce CRC mortality by increasing access to CRC screening. The overall objective is to evaluate the effectiveness and implementation of a pharmacy-based FIT (PharmFIT) intervention. PharmFIT is a collaborative patient care service intervention that involves primary care clinics identifying active patients who are due for screening and referring them, outside of a medical visit, to community pharmacies to receive their CRC screening via FITs. The program consists of 1) Patient eligibility assessments and endorsement by the Primary Care Provider (PCP); 2) Counseling on FIT use and return by the pharmacists; 3) Reminders to complete screening by the pharmacy staff; 3) Test result communication by the pharmacists/PCPs; and 4) Patient navigation and care coordination for follow-up care by both pharmacists and PCPs.

Criteria for eligibility:
Criteria:
Inclusion Criteria: Clinic and pharmacy staff (n up to 100) - Age ≥18 years - Employed at a participating primary care clinic or pharmacy - Fluent in English - Has access to a computer with internet Exclusion Criteria: Clinic and pharmacy staff - Floaters/per diem employees - Those who would object to having their interview audio recorded - Those who would object to participation in evaluation surveys Inclusion Criteria: Patients (n=1400) - Age 45-75 years - Patient at a participating primary care facility (medical visit within last 18 months) - Current resident of NC or WA state - Not up to date with recommended screening (e.g., no colonoscopy within 10 years, no FIT-DNA test within 3 years; no FIT/FOBT within 12 months) - English and Spanish speakers - Has access to a computer or smartphone with internet Exclusion Criteria: Patients - Previous USPST CRC screening within recommended screening period: 1) Colonoscopy within the past 10 years, 2) FIT/FOBT/FIT-DNA test within the past 12 months, 3) Previous sigmoidoscopy within the past 5 years, 4) Previous CT colonography within the past 10 years, 5) Other CRC screening tests - CRC screening is contraindicated - Previous positive FIT/FOBT/FIT-DNA - Colorectal neoplasm or colorectal polyp - Adenoma by biopsy - Family history of colorectal cancer - Diagnosed with inflammatory bowel disease - Total or partial colectomy - Diagnosis of Alzheimer's/other forms of severe dementia - Resides in an assisted living facility - Currently receiving hospice care - Diagnosed with end stage renal disease - Current diagnosis of certain cancers (e.g., CRC, mesothelioma, glioblastoma, lung, pancreatic, and liver/bile duct)

Gender: All

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: Accepts Healthy Volunteers

Start date: January 1, 2025

Completion date: January 31, 2029

Lead sponsor:
Agency: UNC Lineberger Comprehensive Cancer Center
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Collaborator:
Agency: Fred Hutchinson Cancer Center
Agency class: Other

Source: UNC Lineberger Comprehensive Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06656936