Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526988
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Implementation and Interaction of Clinician And Patient-facing Tools Aiming to Intensify Neurohormonal Medicines for Heart Failure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Implementation and Interaction of Clinician And Patient-facing Tools Aiming to Intensify Neurohormonal Medicines for Heart Failure With Reduced Ejection Fraction I-I-CAPTAIN-HF
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
IICAPTAIN-HF
Brief Summary:
An increasing number of guideline-directed medical therapies GDMT have been developed for patients with chronic heart failure with reduced ejection fraction HFrEF When used in combination at recommended doses patients often experience significant improvements in cardiac function quality of life and survival12 However GDMT underuse occurs for the vast majority of patients with HFrEF Two recent trials demonstrated improved GDMT prescribing during a clinic visit each using automated delivery of a patient-centered decision support tool to promote a proactive and holistic approach to prescribing EPIC-HF NCT03334188 tested a brief video and checklist document sent to patients just prior to a clinic visit encouraging them to work with their clinicians to make at least 1 positive change to their GDMT PROMPT-HF NCT05433220 tested tailored electronic health record EHR alerts for GDMT intensification delivered to clinicians during clinic visits The current I-I-CAPTAIN-HF study aims to broadly implement and test the EPIC-HF patient-facing and PROMPT-HF clinician-facing tools for HFrEF medication intensification at 5 health systems around the country through a pragmatic cluster-randomized implementation-effectiveness trial This will occur through an initial phase of adaptation of the 2 tools at each health system Once ready the 2 tools will be tested using a 2x2 randomization at the clinician-level In parallel formal assessment of the implementation of EPIC-HF and PROMPT-HF will work to understand the most effective means of intervention design and delivery as well as adaptations due to contextual factors to optimize use
Detailed Description:
I-I-CAPTAIN-HF is a multi-site type-2 hybrid implementation-effectiveness trial conducted at 5 sites the University of Colorado central site Yale University Northwestern University University of Utah and Sutter Health
Aim 1 Implement the EPIC-HF and PROMPT-HF interventions at 5 health systems through participatory work with a multi-level team using the PRISM framework to guide the delivery of a host of implementation strategies that respect mandatory aspects of the interventions function and explore adaptations form to maximize equitable reach broad adoption fidelity of implementation and long-term maintenance
Hypothesis 1A Standard EHR logic in Epic can be created for HFrEF identification and automated delivery of both interventions followed by tailoring to individual system EHR infrastructure
Hypothesis 1B Challenges around automated intervention delivery can be identified solutions developed and processes shared for optimal integration into the local clinic environment
Hypothesis 1C Issues of equity-digital access language out-of-pocket cost social determinants of health-can be addressed by intervention and delivery adaptations respecting uniqueness of recipients
The initial phase of I-I-CAPTAIN-HF explores a host of implementation strategies that will take the existing EPIC-HF and PROMPT-HF interventions and optimize their ability to be implemented widely while retaining tool fidelity Current versions of EPIC-HF and PROMPT-HF were tested in single sites under research conditions that have led to barriers to wider uptake In Aim 1 the investigators and study team will 1 form an External Advisory Committee 2 apply PRISM domains to define mandatory functions of the interventions 3 engage site partners to define form adaptations using the iPRISM web tool to assess context 4 vet adaptable forms to consider fidelity to function 5 decide final forms for each site and 6 pilot local versions of each interventions using EHR technical testing to ensure feasibility usability and acceptability The tools will be implemented and automated within each EHR and used as standard of care for all eligible patients
Prior to conclusion of Aim 1 all sites will pilot test their site-based implementation approach to assess feasibility usability and user acceptability before widespread implementation in Aim 2 This process will conclude with interviews with team members to assess the fidelity to the intervention as well as gather data on adaptations to the intervention by each site These interviews will be conducted by the central site University of Colorado study team and occur with those involved at each site with implementing the interventions and could include site-principal investigators andor co-investigators IT leadership or analysts
Aim 2 Test the effectiveness as well as the interaction of the EPIC-HF and PROMPT-HF interventions to improve GDMT prescribing from before to after the clinic visit among 2000 patients at 5 health systems using a 2x2 factorial design randomized at the clinician-level
Hypothesis 2A - Effectiveness Both EPIC-HF and PROMPT-HF will improve GDMT intensification
Hypothesis 2B - Interaction Patient- and clinician-facing tools may work better when used in combination
Cluster-randomization will occur at the clinician level where the clinician is randomized to 1 of 4 study arms usual care EPIC-HF only PROMPT-HF only both Randomization will be stratified at the site level Patient assignment follows clinician randomization
Following processes developed in Aim 1 each site will deliver the assigned interventions to patients and clinicians as per randomization Those clinicians randomized to interventions will have the intervention delivered to the clinician themselves PROMPT-HF andor their patient EPIC-HF prior to the patients scheduled routine clinic appointment The interventions will be implemented as standard of care across those in the intervention arms and occur for all eligible patients
Patient-level data will be collected through the patients EHRs
Aim 3 Evaluate ongoing implementation of EPIC-HF and PROMPT-HF using Practical Robust Implementation and Sustainability Model PRISM to understand the most effective means of intervention design and delivery as well as adaptations due to contextual factors
Hypothesis 3 Understanding key mandatory elements and tailored adaptations to the interventions and their delivery will maximize equitable impact across implementation outcomes reach increase uptake by the clinics and their clinicians adoption ease appropriate deployment implementation and adaptations and lead to sustained use after the clinical trial maintenance
Implementation of EPIC-HF and PROMPT-HF will be explored using the Reach Effectiveness Adoption Implementation and Maintenance RE-AIM outcomes from the PRISM framework to understand the most effective means of sustainable delivery
Reach Investigators will attempt to characterize the proportion and representativeness of eligible patients who receive the intervention Representativeness will be assessed by comparing participants who opt in versus those who opt out based on demographicclinical indicators
Effectiveness Assessed in Aim 2 above
Adoption The absolute number proportion and representativeness of settings and intervention agents clinicians who are willing to initiate a program will be assessed Effectively adoption should be 100 at the site level since all programs who were approached have agreed to participate Data will be collected on adoption at the clinician level where each clinician can enroll or decline at study start and then adopt or ignore PROMPT-HF CDS during study conduct Clinicians attitudes towards the new approach will be explored using clinician surveys measured before and after the trial
Implementation The investigators will assess the extent to which the intervention is implemented as intended fidelity and adaptations made With a mixed methods evaluation the experiences of EPIC-HF and PROMPT-HF and their combination will be explored
Maintenance The study team will systematically collect data on local decisions regarding maintenance and will also assess staff recommendations for sustainment
Aim 1 Implement the EPIC-HF and PROMPT-HF interventions at 5 health systems through participatory work with a multi-level team using the PRISM framework to guide the delivery of a host of implementation strategies that respect mandatory aspects of the interventions function and explore adaptations form to maximize equitable reach broad adoption fidelity of implementation and long-term maintenance
Hypothesis 1A Standard EHR logic in Epic can be created for HFrEF identification and automated delivery of both interventions followed by tailoring to individual system EHR infrastructure
Hypothesis 1B Challenges around automated intervention delivery can be identified solutions developed and processes shared for optimal integration into the local clinic environment
Hypothesis 1C Issues of equity-digital access language out-of-pocket cost social determinants of health-can be addressed by intervention and delivery adaptations respecting uniqueness of recipients
The initial phase of I-I-CAPTAIN-HF explores a host of implementation strategies that will take the existing EPIC-HF and PROMPT-HF interventions and optimize their ability to be implemented widely while retaining tool fidelity Current versions of EPIC-HF and PROMPT-HF were tested in single sites under research conditions that have led to barriers to wider uptake In Aim 1 the investigators and study team will 1 form an External Advisory Committee 2 apply PRISM domains to define mandatory functions of the interventions 3 engage site partners to define form adaptations using the iPRISM web tool to assess context 4 vet adaptable forms to consider fidelity to function 5 decide final forms for each site and 6 pilot local versions of each interventions using EHR technical testing to ensure feasibility usability and acceptability The tools will be implemented and automated within each EHR and used as standard of care for all eligible patients
Prior to conclusion of Aim 1 all sites will pilot test their site-based implementation approach to assess feasibility usability and user acceptability before widespread implementation in Aim 2 This process will conclude with interviews with team members to assess the fidelity to the intervention as well as gather data on adaptations to the intervention by each site These interviews will be conducted by the central site University of Colorado study team and occur with those involved at each site with implementing the interventions and could include site-principal investigators andor co-investigators IT leadership or analysts
Aim 2 Test the effectiveness as well as the interaction of the EPIC-HF and PROMPT-HF interventions to improve GDMT prescribing from before to after the clinic visit among 2000 patients at 5 health systems using a 2x2 factorial design randomized at the clinician-level
Hypothesis 2A - Effectiveness Both EPIC-HF and PROMPT-HF will improve GDMT intensification
Hypothesis 2B - Interaction Patient- and clinician-facing tools may work better when used in combination
Cluster-randomization will occur at the clinician level where the clinician is randomized to 1 of 4 study arms usual care EPIC-HF only PROMPT-HF only both Randomization will be stratified at the site level Patient assignment follows clinician randomization
Following processes developed in Aim 1 each site will deliver the assigned interventions to patients and clinicians as per randomization Those clinicians randomized to interventions will have the intervention delivered to the clinician themselves PROMPT-HF andor their patient EPIC-HF prior to the patients scheduled routine clinic appointment The interventions will be implemented as standard of care across those in the intervention arms and occur for all eligible patients
Patient-level data will be collected through the patients EHRs
Aim 3 Evaluate ongoing implementation of EPIC-HF and PROMPT-HF using Practical Robust Implementation and Sustainability Model PRISM to understand the most effective means of intervention design and delivery as well as adaptations due to contextual factors
Hypothesis 3 Understanding key mandatory elements and tailored adaptations to the interventions and their delivery will maximize equitable impact across implementation outcomes reach increase uptake by the clinics and their clinicians adoption ease appropriate deployment implementation and adaptations and lead to sustained use after the clinical trial maintenance
Implementation of EPIC-HF and PROMPT-HF will be explored using the Reach Effectiveness Adoption Implementation and Maintenance RE-AIM outcomes from the PRISM framework to understand the most effective means of sustainable delivery
Reach Investigators will attempt to characterize the proportion and representativeness of eligible patients who receive the intervention Representativeness will be assessed by comparing participants who opt in versus those who opt out based on demographicclinical indicators
Effectiveness Assessed in Aim 2 above
Adoption The absolute number proportion and representativeness of settings and intervention agents clinicians who are willing to initiate a program will be assessed Effectively adoption should be 100 at the site level since all programs who were approached have agreed to participate Data will be collected on adoption at the clinician level where each clinician can enroll or decline at study start and then adopt or ignore PROMPT-HF CDS during study conduct Clinicians attitudes towards the new approach will be explored using clinician surveys measured before and after the trial
Implementation The investigators will assess the extent to which the intervention is implemented as intended fidelity and adaptations made With a mixed methods evaluation the experiences of EPIC-HF and PROMPT-HF and their combination will be explored
Maintenance The study team will systematically collect data on local decisions regarding maintenance and will also assess staff recommendations for sustainment
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