Colorectal Cancer
Conditions
Keywords
Cancer Screening, Colorectal Cancer, Implementation Science, Rural Health, Minority Health, Community Pharmacies
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.
Interventions
BEHAVIORALPharmFIT
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.
Sponsors
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 model description
Participants are assigned to one of two or more groups in parallel for the duration of the study
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Service Penetration (Effectiveness) | 6-months post randomization | 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. |
| Appropriateness of the PharmFIT intervention | 6-months post enrollment | Perceptions that PharmFIT is agreeable, palatable, or satisfactory. |
| Acceptability of the PharmFIT intervention | 6-months post enrollment | Perceptions that PharmFIT is relevant to, fits or is compatible with a given practice site, provider, or patient. |
| Feasibility of the PharmFIT intervention | 6-months post enrollment | Extent to which PharmFIT was successfully implemented and used within the clinics and pharmacies, measured by the Implementation Outcomes Questionnaire (IOQ) Feasibility Subscale. |
| Fidelity to the PharmFIT intervention | Baseline, 6-months post enrollment | 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.). |
| Cost of the PharmFIT intervention | Through study completion, up to 12 months after PharmFIT intervention implementation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reach | 6-months post enrollment | 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. |
| Timely FIT completion | 60 days post FIT receipt | Proportion of patients randomized to PharmFIT who completed the FIT within 60 days. |
| Timely follow-up colonoscopy | 6-months post enrollment | Proportion of patients with positive FIT results completing follow-up colonoscopy within 6 months following positive FIT results. |
Countries
United States
Contacts
CONTACTAlison T Brenner, PhD MPH
CONTACTParth D Shah, PharmD PhD
PRINCIPAL_INVESTIGATORAlison T Brenner, PhD MPH
University of North Carolina, Chapel Hill
PRINCIPAL_INVESTIGATORParth D Shah, PharmD PhD
Fred Hutchinson Cancer Center
Outcome results
None listed