Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522568
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Testing a Mammography Decision Intervention in a Rural Setting
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Toward Optimization of a Mammography Decision Aid and Clinician Communication Intervention Trial for Rural Settings
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
The overall objective of this COBRE pilot project is to enhance the design of a 3-arm cluster randomized trial that will test the efficacy and mechanism of effect of the MyMammogram DA with or without a provider communication intervention This will be accomplished through two aims 1 Refine with community partner input a clinical trial protocol to optimize engagement among patients and primary care providers PCPs practicing in rural settings In consultation with patients PCPs and informatics experts the study team will refine site selection randomization patient and PCP recruitment and data collection protocols to meet the needs of the rural health care delivery system and participants The result of this aim will be a modified protocol and intervention strategy that is acceptable to partners 2 Adapt and test trial and intervention implementation features to achieve protocol acceptance and adherence The investigators will pilot the adapted three-arm randomized trial protocol in rural primary care settings that compares the MyMammogram DA with or without a risk summary provided to the PCP pre-visit relative to usual care Implementing the trial in two phases n15 each will systematically identify barriers and facilitators to trial participation to refine protocols Participants will receive acceptability surveys and investigators will conduct qualitative interviews with patients and PCPs to understand experiences with trial implementation from multiple perspectives
Detailed Description:
None
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