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

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Completed
• CT.gov ID: NCT03374891
• Collaborator: National Institutes of Health (NIH) (NIH), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 790
• Location: 1
• Arms: 2
• Actual Duration (Months): 43.1
• Patients Per Site Per Month: 18.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Systolic; Heart Failure	Other: Educational video and/or handout	N/A

Detailed Description

The investigators propose the DECIDE-ICD trial: a type II effectiveness implementation hybrid trial of the investigators ICD PtDAs. The Investigators will use a 6-site stepped-wedge design, with implementation guided by normalization process theory® and evaluation guided by the RE-AIM framework.

The investigators aim to evaluate reach and effectiveness of the ICD PtDAs using a pragmatic, stepped-wedge design on decision quality (knowledge and value-concordance) and psychosocial outcomes.

• Hypothesis 1a: PtDAs will reach over 50% of eligible patients.

• Hypothesis 1b: ICD PtDAs will be effective in improving decision quality in real-world practice.

• Hypothesis 1c: Better informed patients will have lower anxiety, higher rates of planning for the possibility of deactivation, and increased identification of a surrogate decision maker.

The investigators propose 3 a priori hypotheses:

• The decision aids will have a differential effect on the decisions of participants by age (>= 70 years old vs <70 years old);

• The decision aids will have a differential effect on the decisions of participants by heart failure type (non-ischemic vs ischemic);

• The decision aids will have a differential effect on the decisions of participants by the type of device they are considering (ICD vs ICD replacement vs CRT-D).

Along with these hypotheses, we recognize that other important covariates exist, such as health literacy and education level.

Study Design

• Study Type: Interventional
• Actual Enrollment: 790 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: DECIDE - ICD: A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators
• Actual Study Start Date: May 28, 2018
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Participants will fill out surveys These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.
Active Comparator: Educational video and/or handout 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; 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.

Outcome Measures

Primary Outcome Measures

1. Knowledge About Defibrillation at Baseline [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.

2. Knowledge About Defibrillation at 1 Month [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.

3. Knowledge About Defibrillation at 6 Months [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.

Secondary Outcome Measures

1. Reach of Eligible Patients [Baseline]

   Measuring how many patients of the eligible patient base are able to view or read the educational materials.

Other Outcome Measures

1. Differential Effect by Age [Baseline, 1 month, 6 months]

   The decision aids will have a differential effect on the decisions of participants by age (>= 70 years old vs <70 years old)

2. Differential Effect by Heart Failure Type [Baseline, 1 month, 6 months]

   The decision aids will have a differential effect on the decisions of participants by heart failure type (non-ischemic vs ischemic)

3. Differential Effect by Type of Device [Baseline, 1 month, 6 months]

   The decision aids will have a differential effect on the decisions of participants by the type of device they are considering (ICD vs ICD replacement vs CRT-D).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 18 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

Exclusion Criteria:

• Prisoners

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Denver	Aurora	Colorado	United States	80045

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Daniel D Matlock, MD, MPH, University of Colorado, Denver

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 10, 2018
• Informed Consent Form - Mar 27, 2018

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT03374891
• Other Study ID Numbers: 17-1697; 1R01HL136403-01
• First Posted: Dec 15, 2017
• Last Update Posted: Jul 8, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Colorado, Denver: Shared Decision Making;; Defibrillator
• Additional relevant MeSH terms: Heart Failure; Heart Failure, Systolic

Study Results

Participant Flow

Arm/Group Title	Surveys Only	Educational Video and/or Handout + Surveys
Arm/Group Description	These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.	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. Educational video and/or handout: 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.
Period Title: Overall Study
STARTED	346	444
COMPLETED	323	437
NOT COMPLETED	23	7

Baseline Characteristics

Arm/Group Title	Surveys Only	Educational Video and/or Handout + Surveys	Total
Arm/Group Description	These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.	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. Educational video and/or handout: 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.	Total of all reporting groups
Overall Participants	323	437	760
Age (years) [Mean (Inter-Quartile Range) ]
Mean (Inter-Quartile Range) [years]	66	67	66.5
Sex: Female, Male (Count of Participants)
Female	89 27.6%	120 27.5%	209 27.5%
Male	234 72.4%	317 72.5%	551 72.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	24 7.4%	18 4.1%	42 5.5%
Not Hispanic or Latino	299 92.6%	419 95.9%	718 94.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	8 2.5%	5 1.1%	13 1.7%
Asian	2 0.6%	2 0.5%	4 0.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	37 11.5%	47 10.8%	84 11.1%
White	250 77.4%	339 77.6%	589 77.5%
More than one race	10 3.1%	16 3.7%	26 3.4%
Unknown or Not Reported	16 5%	28 6.4%	44 5.8%
Region of Enrollment (participants) [Number]
United States	323 100%	437 100%	760 100%

Outcome Measures

1. Primary Outcome

Title	Knowledge About Defibrillation at Baseline
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Data was not able to be collected for all participants.

Arm/Group Title	Surveys Only	Educational Video and/or Handout + Surveys
Arm/Group Description	These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.	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. Educational video and/or handout: 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.
Measure Participants	312	412
Mean (Standard Deviation) [score on a scale]	53.4 (17.6)	55.4 (17.0)

2. Primary Outcome

Title	Knowledge About Defibrillation at 1 Month
Description	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.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Data was not able to be collected for all participants.

Arm/Group Title	Surveys Only	Educational Video and/or Handout + Surveys
Arm/Group Description	These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.	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. Educational video and/or handout: 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.
Measure Participants	253	370
Mean (Standard Deviation) [score on a scale]	57.1 (18.2)	58.0 (15.4)

3. Primary Outcome

Title	Knowledge About Defibrillation at 6 Months
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Data was not able to be collected for all participants.

Arm/Group Title	Surveys Only	Educational Video and/or Handout + Surveys
Arm/Group Description	These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.	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. Educational video and/or handout: 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.
Measure Participants	245	343
Mean (Standard Deviation) [score on a scale]	56.6 (17.4)	58.6 (14.5)

4. Secondary Outcome

Title	Reach of Eligible Patients
Description	Measuring how many patients of the eligible patient base are able to view or read the educational materials.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

The control group did not receive the intervention, and was not analyzed for this outcome measure.

Arm/Group Title	Surveys Only	Educational Video and/or Handout + Surveys
Arm/Group Description	These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.	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. Educational video and/or handout: 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.
Measure Participants	0	437
Were administered intervention by hospital	349 108%
Were not administered intervention by hospital	88 27.2%

5. Other Pre-specified Outcome

Title	Differential Effect by Age
Description	The decision aids will have a differential effect on the decisions of participants by age (>= 70 years old vs <70 years old)
Time Frame	Baseline, 1 month, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Other Pre-specified Outcome

Title	Differential Effect by Heart Failure Type
Description	The decision aids will have a differential effect on the decisions of participants by heart failure type (non-ischemic vs ischemic)
Time Frame	Baseline, 1 month, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Other Pre-specified Outcome

Title	Differential Effect by Type of Device
Description	The decision aids will have a differential effect on the decisions of participants by the type of device they are considering (ICD vs ICD replacement vs CRT-D).
Time Frame	Baseline, 1 month, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	6 Months
Adverse Event Reporting Description	Serious Adverse Events and All cause Mortality were not collected for this study for any participant, due to the design of this implementation study. The only participants that were at risk for the incomplete consent process adverse event were the participants enrolled at the one site which required a separate written HIPAA authorization.
Arm/Group Title	Surveys Only		Educational Video and/or Handout + Surveys
Arm/Group Description	These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.		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. Educational video and/or handout: 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.
All Cause Mortality
	Surveys Only		Educational Video and/or Handout + Surveys
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Surveys Only		Educational Video and/or Handout + Surveys
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Surveys Only		Educational Video and/or Handout + Surveys
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/346 (0.9%)		0/444 (0%)
Investigations
Incomplete consent process	3/9 (33.3%)	3	0/51 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.