A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators

NCT03374891 | Completed Results DMC

• 2 other identifiers: 17-16971R01HL136403-01
• Study Type: interventional
• Target: 790
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators goal is to assess real-world effectiveness of patient decision aids (PtDA) for high-risk decisions using the implantable cardioverter-defibrillator (ICD) as a model.

Conditions

Heart Failure, Systolic; Heart Failure

Keywords

Shared Decision Making;; Defibrillator

Outcome Measures

Primary Outcomes (3)

• Knowledge About Defibrillation at Baseline

  Multiple survey responses by participants will indicate knowledge changes over time. The Decision Quality Knowledge Survey measures knowledge about defibrillators. Possible scores range from 0 to 100, with higher scores indicating more knowledge and better outcomes.

  Baseline

• Knowledge About Defibrillation at 1 Month

  Multiple survey responses by participants will indicate knowledge changes over time. The Decision Quality Knowledge Survey measures knowledge about defibrillators. Possible scores range from 0 to 100, with higher scores indicating more knowledge and better outcomes.

  1 month

• Knowledge About Defibrillation at 6 Months

  Multiple survey responses by participants will indicate knowledge changes over time. The Decision Quality Knowledge Survey measures knowledge about defibrillators. Possible scores range from 0 to 100, with higher scores indicating more knowledge and better outcomes.

  6 months

Secondary Outcomes (1)

• Reach of Eligible Patients

  Baseline

Other Outcomes (3)

• Differential Effect by Age

  Baseline, 1 month, 6 months

• Differential Effect by Heart Failure Type

  Baseline, 1 month, 6 months

• Differential Effect by Type of Device

  Baseline, 1 month, 6 months

Study Arms (2)

Participants will fill out surveys

NO INTERVENTION

These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.

Educational video and/or handout

ACTIVE COMPARATOR

These participants will receive an educational video and/or handout about the defibrillator process. Then they will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.

Other: Educational video and/or handout

Interventions

Educational video and/or handout OTHER

The intervention includes a video and/or handout (whichever is easier for the participant) that will give information about defibrillators and about other patients' experiences with their decisions about defibrillators.

Educational video and/or handout

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• English-speaking (videos and surveys have only been validated in English)
• Patients have been offered a primary prevention ICD for initial implant, reimplantation, or CRT with defibrillation

You may not qualify if:

• Prisoners

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Knoepke CE, Wallace BC, Allen LA, Lewis CL, Gupta SK, Peterson PN, Kramer DB, Brancato SC, Varosy PD, Mandrola JM, Tzou WS, Matlock DD. Experiences Implementing a Suite of Decision Aids for Implantable Cardioverter Defibrillators: Qualitative Insights From the DECIDE-ICD Trial. Circ Cardiovasc Qual Outcomes. 2022 Nov;15(11):e009352. doi: 10.1161/CIRCOUTCOMES.122.009352. Epub 2022 Nov 15.

  PMID: 36378770 DERIVED

MeSH Terms

Conditions

Heart Failure, Systolic; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Daniel Matlock, MD
• Organization: University of Colorado Denver | Anschutz

clinicalresearchsupportcenter@ucdenver.edu

303-724-1111

Study Officials

• Daniel D Matlock, MD, MPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Step-wedge design. 6 groups will begin recruiting participants as control participants. Throughout the study, at 5 month intervals, 1 randomly selected site at a time will begin intervention. Due to the impact of COVID-19 on sites and patient visits from March-April 2020, we moved back the implementation of intervention dates for the 5th site (UCH/DH) by 2 months and the 6th site (Beth Israel) by 1 month.

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 15, 2017
• Study Start: May 28, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 8, 2022
• Results First Posted: July 8, 2022

Record last verified: 2022-06

Locations

US (1)