Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438640
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-23
Brief Title:
Evaluating a Strategy to Improve Pre-Anesthesia Care Discussions My Anesthesia Choice-Hip Fracture
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Implementation and Evaluation of a Strategy to Improve Pre-Anesthesia Care Discussions My Anesthesia Choice-Hip Fracture
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to assess the implementation process for and the effectiveness of a quality improvement QI strategy to increase shared decision-making around anesthesia options for hip fracture surgery at 6 US hospitals The QI strategy is to be facilitated by a clinician-administered 1-page bedside conversation aid designed to improve the quality of physician-patient communication paired with brief clinician training The evaluation will occur via a stepped wedge cluster randomized trial to be carried out over a period of 27 months
Detailed Description:
The objective of this study is to assess the implementation process for and the effectiveness of a quality improvement QI strategy to increase shared decision-making around anesthesia options for hip fracture surgery at 6 US hospitals The QI strategy is to be facilitated by a clinician-administered 1-page bedside conversation aid designed to improve the quality of physician-patient communication paired with brief clinician training The evaluation will occur via a stepped wedge cluster randomized trial to be carried out over a period of 27 months
Activities at each site will be divided into three phases Pre-Implementation Active Implementation and Sustainment Data collection will occur across all study phases at each site although specific data elements collected will vary across phases To facilitate evaluation sites will be randomly assigned to one of three possible timing sequences A B C for project implementation 2 sitessequence The duration of the active implementation phase will be the same for each sequence 12 months however the duration of pre-implementation and sustainment phases will vary across sequences
During the pre-implementation phase data collection on selected outcome variables will occur but no interventions will be delivered During the implementation phase site clinicians will undergo training in use of the My Anesthesia Choice-HF tool and the tool will be made available for use in clinical areas with eligible patients Data collection on key outcomes will continue over this period and clinicians will receive reminders to encourage tool use During Sustainment the tool will remain available for use and outcomes will continue to be measured to assess sustainment of the intervention over time
Activities at each site will be divided into three phases Pre-Implementation Active Implementation and Sustainment Data collection will occur across all study phases at each site although specific data elements collected will vary across phases To facilitate evaluation sites will be randomly assigned to one of three possible timing sequences A B C for project implementation 2 sitessequence The duration of the active implementation phase will be the same for each sequence 12 months however the duration of pre-implementation and sustainment phases will vary across sequences
During the pre-implementation phase data collection on selected outcome variables will occur but no interventions will be delivered During the implementation phase site clinicians will undergo training in use of the My Anesthesia Choice-HF tool and the tool will be made available for use in clinical areas with eligible patients Data collection on key outcomes will continue over this period and clinicians will receive reminders to encourage tool use During Sustainment the tool will remain available for use and outcomes will continue to be measured to assess sustainment of the intervention over time
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None