Clinical trial NCT06656936: The PharmFIT Study
Official title: Expanding Access to Colorectal Cancer Screening Through Community Pharmacies: The PharmFIT Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Keywords: Cancer Screening
Colorectal Cancer
Implementation Science
Rural Health
Minority Health
Community Pharmacies
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Fred Hutchinson Cancer Center
First posted: 2024-10-24
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.

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)

Primary outcomes:
measure: Service Penetration (Effectiveness)
timeFrame: 6-months post randomization
measure: Appropriateness of the PharmFIT intervention
timeFrame: 6-months post enrollment
measure: Acceptability of the PharmFIT intervention
timeFrame: 6-months post enrollment
measure: Feasibility of the PharmFIT intervention
timeFrame: 6-months post enrollment
measure: Fidelity to the PharmFIT intervention
timeFrame: Baseline, 6-months post enrollment
measure: Cost of the PharmFIT intervention
timeFrame: Through study completion, up to 12 months after PharmFIT intervention implementation
Secondary outcomes:
measure: Reach
timeFrame: 6-months post enrollment
measure: Timely FIT completion
timeFrame: 6-months post enrollment
measure: Timely follow-up colonoscopy
timeFrame: 6-months post enrollment
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Alison T Brenner, PhD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Fred Hutchinson Cancer Center
name: Parth D Shah, PharmD PhD
role: PRINCIPAL_INVESTIGATOR
References: