The PharmFIT Study

N/ANot Yet RecruitingNCT06656936

UNC Lineberger Comprehensive Cancer Center1,500 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Service Penetration (Effectiveness)

Receipt of any USPSTF guideline recommended CRC screening (FIT, FIT-DNA, sigmoidoscopy, colonoscopy, CT colonography, or barium enema), using a yes \["1"\] vs. no \["0"\] dichotomous outcome in the 6 months following randomization.

Time frame: 6-months post randomization

Appropriateness of the PharmFIT intervention

Perceptions that PharmFIT is agreeable, palatable, or satisfactory.

Time frame: 6-months post enrollment

Acceptability of the PharmFIT intervention

Perceptions that PharmFIT is relevant to, fits or is compatible with a given practice site, provider, or patient.

Time frame: 6-months post enrollment

Feasibility of the PharmFIT intervention

Extent to which PharmFIT was successfully implemented and used within the clinics and pharmacies, measured by the Implementation Outcomes Questionnaire (IOQ) Feasibility Subscale.

Time frame: 6-months post enrollment

Fidelity to the PharmFIT intervention

PharmFIT delivered as intended; adherence; integrity; quality of PharmFIT intervention delivery, measured using the study's REDCap tracking database (e.g., patient communications delivered, FIT kits distributed, results reports, etc.).

Time frame: Baseline, 6-months post enrollment

Cost of the PharmFIT intervention

Incremental cost of each additional patient screened in the intervention arm compared to usual care. Comparison of the programmatic costs incurred, and number of subjects screened in Arm 1(trial PharmFIT) compared to Arm 2 (usual care), measured as cost of intervention minus the cost of usual care, divided by the number screened in Arm 1 minus the number screened in Arm 2. Intervention costs will be assessed using periodic episodes of direct observation of PharmFIT outreach activities, time logs maintained by the intervention team, and assembly of administrative data capturing non-personnel/non-labor expenditures, such as costs associated with materials printing, FIT processing, and mailing costs. Usual care costs will be estimated using data collected from collaborative process flow diagramming sessions.

Time frame: Through study completion, up to 12 months after PharmFIT intervention implementation

Secondary Outcomes

Reach

A) The total number of patients who received referrals after being identified for screening, overall and by patient sex, race, ethnicity, age group, insurance category, rurality, previous screening behavior, and clinic/pharmacy cluster. B) The number of patients who received referrals after being identified for screening, overall and by patient sex, race, ethnicity, age group, insurance category, rurality, previous screening behavior, and clinic/pharmacy cluster.

Time frame: 6-months post enrollment

Timely FIT completion

Proportion of patients randomized to PharmFIT who completed the FIT within 60 days.

Time frame: 60 days post FIT receipt

Timely follow-up colonoscopy

Proportion of patients with positive FIT results completing follow-up colonoscopy within 6 months following positive FIT results.

Time frame: 6-months post enrollment

The PharmFIT Study

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts