The PharmFIT Study

UNC Lineberger Comprehensive Cancer Center

Status: Begins enrollment in 4 months

Conditions: Colorectal Cancer

Treatments: Behavioral: PharmFIT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06656936

1R01CA279010-01A1 (U.S. NIH Grant/Contract)

LCCC2430

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,500 participants in 2 patient groups

Intervention: PharmFIT

Experimental group

Description:

Subjects enrolled in the PharmFIT intervention will receive a referral notice from their primary care facility to pick up a FIT and receive support for screening from their pharmacist. After receiving the FIT and completing the FIT subject will receive their FIT results. Those with positive results will also be provided patient navigation support. This support will be provided by the pharmacist, in collaboration with the subject's PCP, and will include a) Discussing barriers to colonoscopy (e.g., fear, lack of transportation, inability to pay); b) Support for and confirmation of colonoscopy appointment scheduling; c) Review and support prep procedures; e) Post-procedure, discuss results and answer questions.

Treatment:

Behavioral: PharmFIT

Control: Usual Care

No Intervention group

Description:

Subjects randomized to this arm receive usual care.