Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656936
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
The PharmFIT Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Expanding Access to Colorectal Cancer Screening Through Community Pharmacies The PharmFIT Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PharmFIT
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 n1200 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 pharmacistsPCPs and 4 Patient navigation and care coordination for follow-up care by both pharmacists and PCPs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None