Friday, April 26, 2024 4/26/2024

A Multicenter Trial of a Shared DECision Support Intervention for Patients offered implantable Cardioverter-DEfibrillators: DECIDE - ICD Trial

Award Number: R01HL136403
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

Group Awards By Issue Date FY or Funding FY:

View Award Abstract

Project Summary/Abstract Shared decision making (SDM) is growing in clinical and political importance. Based on a large Cochrane review, the science supporting the assertion that patient decision aids (PtDAs) result in SDM and improve decision outcomes is strong. However, the benefits of real-world use of PtDAs remains unrealized as PtDAs are largely unused in routine health care. Previous attempts at real-world implementation of PtDAs have been characterized by a focus on low-risk decisions in primary care. The problem with this approach is that, since the stakes are so low, busy clinicians perceive PtDAs to be of little value, undermining their implementation. This team's overall goal is to assess real-world effectiveness (Aim 1) and implementation (Aim 2) of patient decision aids (PtDA) for high-risk decisions using the implantable cardioverter-defibrillator (ICD) as a model. ICDs are ideal to study because they are common and involve complex trade-offs. While they can prolong lives, they do not improve quality of life (QOL) and come with a host of risks including device failure, inappropriate shocks, shocks (and subsequent suffering) at the end of life, anxiety, depression, and post- traumatic stress disorder. While most patients see prevention of sudden death as desirable, they also prefer to die peacefully in their sleep (which the ICD would try to prevent). In recognition of the personal nature of ICDs, professional guidelines now recommend SDM for eligible patients. This proposal addresses two big problems: 1) a lack of effectiveness data for PtDAs in real world settings, as efficacy trials comprise virtually all of the data supporting PtDAs; and 2) the optimal implementation strategy for PtDAs is unknown. This team has developed a reproducible, sustainable, low-cost strategy to facilitate implementation across diverse clinical settings. This application proposes the DECIDE-ICD trial: a type II effectiveness implementation hybrid trial of three ICD PtDAs. The DECIDE-ICD trial is a 6-site stepped-wedge randomized trial, with implementation guided by normalization process theory and a mixed methods evaluation guided by the RE-AIM framework. The study team has the relationships, infrastructure, and transdisciplinary expertise to execute this project. By simultaneously exploring effectiveness and implementation, this project will provide pragmatic information that will inform a growing national agenda to better involve patients in their health care via SDM.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = -$305 )
2024	2021	THE REGENTS OF THE UNIVERSITY OF COLORADO	13001 E 17TH PL STE F428	AURORA	CO	80045	ADAMS	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	5	12/6/2023	NON-COMPETING CONTINUATION	-$305
														Subtotal = -$305

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	5	3/16/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $725,572 )
2021	2021	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	001	5	2/24/2021	NON-COMPETING CONTINUATION	$725,572
2021	2020	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	4	2/12/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $725,572

Issue Date FY: 2020 ( Subtotal = $736,542 )
2020	2020	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	001	4	1/17/2020	NON-COMPETING CONTINUATION	$736,542
2020	2019	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	002	3	1/22/2020	NON-COMPETING CONTINUATION	$0
2020	2019	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	3	11/14/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $736,542

Issue Date FY: 2019 ( Subtotal = $747,960 )
2019	2019	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	3	3/9/2019	NON-COMPETING CONTINUATION	$747,960
														Subtotal = $747,960

Issue Date FY: 2018 ( Subtotal = $756,907 )
2018	2018	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	001	2	6/23/2018	NON-COMPETING CONTINUATION	$15,138
2018	2018	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	2	2/21/2018	NON-COMPETING CONTINUATION	$741,769
														Subtotal = $756,907

Issue Date FY: 2017 ( Subtotal = $821,921 )
2017	2017	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	001	1	5/18/2017	NEW	$0
2017	2017	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	1	5/13/2017	NEW	$821,921
														Subtotal = $821,921

Grand Total All Awards = $3,788,597

Top

All Categories

About

Search

Reports

Data Submission

Award Information

A Multicenter Trial of a Shared DECision Support Intervention for Patients offered implantable Cardioverter-DEfibrillators: DECIDE - ICD Trial

Award Number: R01HL136403

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer