Implantable Cardioverter-DefibrillatorePHR-ICD-SJMNCT02989090
Electronic Patient Notification of Remote ICD Data: Impact of Patient Engagement on Outcomes in the Merlin.Net™
A study testing Receive Detailed ICD Information-electronic and Receive Detailed ICD Information-paper in people with Implantable Cardioverter-Defibrillator and Health Information Exchange, run by Parkview Hospital, Indiana at 1 site in United States.
Trial summary
Remote monitoring of implantable cardioverter-defibrillators (ICDs) for patients has led to efficient, safe, and satisfying analysis of their device and cardiac status; resulting in an overall improvement in the quality of care for such patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implantable Cardioverter-Defibrillator, Health Information Exchange, Electronic Health Records
- What is being tested?
- Receive Detailed ICD Information-electronic and Receive Detailed ICD Information-paper
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- Physically and mentally capable of providing an informed consent
- Patient of PPG-Cardiology
- Implanted with a St. Jude Medical ICD
- Undergoing remote monitoring by the Merlin.net™ system
- Ability to read, write and understand English
- Have access to computer and/or Internet (Group A and B only)
- Patient has a scheduled ICD download within the study period at the time of enrollment.
Who cannot join
- Does not meet inclusion criteria
- Unable to physically or cognitively carry out the tasks necessary for activating and/or utilizing an ePHR such as; blindness, loss of function of arms, cognitive impairments (per chart review) that would interfere in learning a new task
- Designated as part of a vulnerable subject population that the investigator or designee identifies to have compromised autonomy related to potential study participation
- Currently participating in another Parkview study that involves other ePHR use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electronic Patient Notification of Remote Implantable Cardioverter-Defibrillator (ICD) Monitoring Data: Impact of Patient Engagement on Outcomes in the Merlin.Net™ System
Remote monitoring of implantable cardioverter-defibrillators (ICDs) for patients has led to efficient, safe, and satisfying analysis of their device and cardiac status; resulting in an overall improvement in the quality of care for such patients. Despite the efficacy of remote monitoring of ICDs and the satisfaction of patients and providers with the process, there is a desire from patients to have access and view ability of the data their ICD is transmitting. However, methods for making ICD device data directly available to the patients are not currently in place. This study aims to elicit the impact of standardized remote monitoring ICD data to patients through an electronic personal health record (ePHR) on patient engagement, healthcare utilization, and patient-provider communication. For this study, patients with an ICD manufactured by St. Jude Medical and that are undergoing remote monitoring through the remote management system, Merlin.net™, will receive a standardized format of their electronic remote monitoring ICD data in MyChart, the ePHR used at Parkview Health. The standard format for the electronic remote monitoring ICD data, as it is delivered to the patient, will be termed the ICD Patient Notification Summary. Additionally, provider attitudes and perceptions regarding the value of the Patient Notification Summary, its impact on clinic workflow, and patient-provider communication will be collected.
Read the detailed description
Currently, patients receive a letter by postal mail from their physician's office with a statement about their ICD status. The St. Jude Medical ICD data is managed by the Merlin.net™ remote monitoring system and maintained in the database with periodic transfer to the healthcare providers EHR system.
This is the first large study that will evaluate the impact of transferring information from the ICD manufacturer's remote monitoring system directly into a patient's ePHR for the purpose of making select information readily available to patients in the form of a report, called the ICD Patient Notification Summary.
The ICD Patient Notification Summary will be transmitted to the healthcare providers' EHR system (Epic) from Merlin.net™ as part of the data flow pathway to the patients' ePHR (MyChart). This will ensure that the Arrhythmia Diagnostic Center (ADC) clinic and other healthcare providers will be able to view the same information that the patients will receive.
Baseline:
Patients from the intervention group and control groups will answer a baseline survey. The baseline survey will assess socio-demographic characteristics, patient engagement, and patient satisfaction with the current standard of care as well as patient perceptions about receiving remote monitoring ICD data in their ePHR. The survey will be administered either paper-based or online, using a secure online survey program, Survey Monkey. Patient engagement will be assessed using the short form Patient Activation Measure (PAM) survey copyrighted by Insignia Health.
The Patient Activation Measure (PAM) is a validated survey tool developed by Judith Hibbard, PhD, MPH of the University of Oregon, which assesses the degree a patient acts as an active agent in their own health care. PAM is associated with improved health outcomes6.
Follow-up:
Patients will respond to two follow up surveys in approximately 3 months and 6 months from the baseline survey. The follow up surveys will assess patient engagement, patient satisfaction and perceptions with the ICD Patient Notification Summary or current standard of care as well as technology acceptance, depending on the group randomization. Technology acceptance will be assessed using the Technology Acceptance Model as a framework and will explore patient attitudes regarding ease of use, usefulness and intentions to use the ePHR and ICD Patient Notification Summary.
The Technology Acceptance Model is a commonly used model, originally developed by Fred Davis and Richard Bagozzi, which predicts technology acceptance based on the user's perceived usefulness and perceived ease of use of the technology for a specific purpose 7,8.
Data Collection:
Chart review will be performed to collect past and current data regarding patient's socio-demographic characteristics, comorbidities, laboratory and interventions, and healthcare utilization. These data points will help provide background and descriptive information to supplement the other components of the study. ICD-related data and events as well as measurement and classification of clinic calls will be assessed starting six months prior to the study period and continuing throughout the study period. The amount and type of healthcare utilization in relation to cardiac care will be collected. Data related to the use of MyChart will also be collected.
- Conditions
- Implantable Cardioverter-Defibrillator, Health Information Exchange, Electronic Health Records, Patient Participation
- Being tested
- Receive Detailed ICD Information-electronic, Receive Detailed ICD Information-paper
- Keywords
- Patient Engagement, Defibrillators, Health Records, Personal, Patient Portal
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receive Detailed ICD Information-electronicOther
Receive Detailed ICD Information (Patient Notification Summary Report) via an electronic Patient Portal vs control
Receive Detailed ICD Information-paperOther
Receive Detailed ICD Information (Patient Notification Summary Report) via paper vs control
| Study group | Role | What they receive |
|---|---|---|
| Group A (Intervention Group) | Experimental | Receive Detailed ICD Information-electronic: Receive ICD Patient Notification Summary via MyChart Patient Portal Account - Receive training to familiarize yourself with using the ePHR, MyChart Complete baseline, 3 month and 6 months survey Receives: Other: Receive Detailed ICD Information-electronic |
| Group B (Intervention Group) | Active comparator | Receive Detailed ICD Information-paper: Receive ICD Patient Notification Summary via paper Receive training to familiarize yourself with using the ePHR, MyChart Complete baseline, 3 month and 6 months survey Receives: Other: Receive Detailed ICD Information-paper |
| Group C (Control Group) | No intervention | Receives Standard of Care-No Report Complete baseline, 3 month and 6 months survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Engagement evaluated through Patient Activation Measure (PAM)
This validated survey instrument will be utilized in the patient survey to evaluate patient engagement.
Measured: Baseline, 3 months, and 6 months
Change in health outcomes and healthcare utilization
The number of and reason for ER visits, Hospitalization, Office Visits, and Calls to Clinic will be recorded to evaluate patient health outcomes and healthcare utilization before and during the study.
Measured: 6 months retrospective and 6 months prospective
Secondary outcomes (2)
Change in Technology Acceptance evaluated through Technology Acceptance Model (TAM)
This validated survey instrument will be utilized in the patient survey to evaluate technology acceptance.
Measured: Baseline, 3 months, and 6 months
Providers' attitudes and perceptions evaluated through survey
This survey will be utilized to evaluate providers' attitudes and perceptions of the intervention
Measured: At study conclusion (approximately 1 year post deployment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startOct 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Implantable Cardioverter-DefibrillatorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parkview Hospital, Indiana
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Principal investigator, Michael Mirro, Parkview Hospital, Indiana
- Investigators
- Michael J Mirro, MD, Principal investigator, Parkview Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989090
- Sponsor's protocol ID
- PRC13-0113 ePHR-ICD SJM
- Acronym
- ePHR-ICD-SJM
- Status last verified
- Aug 2019
- First submitted
- 18 Nov 2015
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Guedon-Moreau L, Lacroix D, Sadoul N, Clementy J, Kouakam C, Hermida JS, Aliot E, Boursier M, Bizeau O, Kacet S; ECOST trial Investigators. A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial. Eur Heart J. 2013 Feb;34(8):605-14. doi: 10.1093/eurheartj/ehs425. Epub 2012 Dec 13.
PubMed 23242192Landolina M, Perego GB, Lunati M, Curnis A, Guenzati G, Vicentini A, Parati G, Borghi G, Zanaboni P, Valsecchi S, Marzegalli M. Remote monitoring reduces healthcare use and improves quality of care in heart failure patients with implantable defibrillators: the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study. Circulation. 2012 Jun 19;125(24):2985-92. doi: 10.1161/CIRCULATIONAHA.111.088971. Epub 2012 May 24.
PubMed 22626743Buntin MB, Jain SH, Blumenthal D. Health information technology: laying the infrastructure for national health reform. Health Aff (Millwood). 2010 Jun;29(6):1214-9. doi: 10.1377/hlthaff.2010.0503.
PubMed 20530358Carman KL, Dardess P, Maurer M, Sofaer S, Adams K, Bechtel C, Sweeney J. Patient and family engagement: a framework for understanding the elements and developing interventions and policies. Health Aff (Millwood). 2013 Feb;32(2):223-31. doi: 10.1377/hlthaff.2012.1133.
PubMed 23381514Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.
PubMed 15230939
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Patient Notification of Remote Implantable Cardioverter-Defibrillator (ICD) Monitoring Data: Impact of Patient Engagement on Outcomes in the Merlin.Net™ System
- ClinicalTrials.gov ID
- NCT02989090
- Acronym / sponsor ID
- ePHR-ICD-SJM / PRC13-0113 ePHR-ICD SJM
- Conditions
- Implantable Cardioverter-Defibrillator, Health Information Exchange, Electronic Health Records, Patient Participation
- Keywords
- Patient Engagement, Defibrillators, Health Records, Personal, Patient Portal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Parkview Hospital, IndianaUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- Oct 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 12 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Remote monitoring of implantable cardioverter-defibrillators (ICDs) for patients has led to efficient, safe, and satisfying analysis of their device and cardiac status; resulting in an overall improvement in the quality of care for such patients. Despite the efficacy of remote monitoring of ICDs and the satisfaction of patients and providers with the process, there is a desire from patients to have access and view ability of the data their ICD is transmitting. However, methods for making ICD device data directly available to the patients are not currently in place. This study aims to elicit the impact of standardized remote monitoring ICD data to patients through an electronic personal health record (ePHR) on patient engagement, healthcare utilization, and patient-provider communication. For this study, patients with an ICD manufactured by St. Jude Medical and that are undergoing remote monitoring through the remote management system, Merlin.net™, will receive a standardized format of their electronic remote monitoring ICD data in MyChart, the ePHR used at Parkview Health. The standard format for the electronic remote monitoring ICD data, as it is delivered to the patient, will be termed the ICD Patient Notification Summary. Additionally, provider attitudes and perceptions regarding the value of the Patient Notification Summary, its impact on clinic workflow, and patient-provider communication will be collected.
Detailed description
Currently, patients receive a letter by postal mail from their physician's office with a statement about their ICD status. The St. Jude Medical ICD data is managed by the Merlin.net™ remote monitoring system and maintained in the database with periodic transfer to the healthcare providers EHR system.
This is the first large study that will evaluate the impact of transferring information from the ICD manufacturer's remote monitoring system directly into a patient's ePHR for the purpose of making select information readily available to patients in the form of a report, called the ICD Patient Notification Summary.
The ICD Patient Notification Summary will be transmitted to the healthcare providers' EHR system (Epic) from Merlin.net™ as part of the data flow pathway to the patients' ePHR (MyChart). This will ensure that the Arrhythmia Diagnostic Center (ADC) clinic and other healthcare providers will be able to view the same information that the patients will receive.
Baseline:
Patients from the intervention group and control groups will answer a baseline survey. The baseline survey will assess socio-demographic characteristics, patient engagement, and patient satisfaction with the current standard of care as well as patient perceptions about receiving remote monitoring ICD data in their ePHR. The survey will be administered either paper-based or online, using a secure online survey program, Survey Monkey. Patient engagement will be assessed using the short form Patient Activation Measure (PAM) survey copyrighted by Insignia Health.
The Patient Activation Measure (PAM) is a validated survey tool developed by Judith Hibbard, PhD, MPH of the University of Oregon, which assesses the degree a patient acts as an active agent in their own health care. PAM is associated with improved health outcomes6.
Follow-up:
Patients will respond to two follow up surveys in approximately 3 months and 6 months from the baseline survey. The follow up surveys will assess patient engagement, patient satisfaction and perceptions with the ICD Patient Notification Summary or current standard of care as well as technology acceptance, depending on the group randomization. Technology acceptance will be assessed using the Technology Acceptance Model as a framework and will explore patient attitudes regarding ease of use, usefulness and intentions to use the ePHR and ICD Patient Notification Summary.
The Technology Acceptance Model is a commonly used model, originally developed by Fred Davis and Richard Bagozzi, which predicts technology acceptance based on the user's perceived usefulness and perceived ease of use of the technology for a specific purpose 7,8.
Data Collection:
Chart review will be performed to collect past and current data regarding patient's socio-demographic characteristics, comorbidities, laboratory and interventions, and healthcare utilization. These data points will help provide background and descriptive information to supplement the other components of the study. ICD-related data and events as well as measurement and classification of clinic calls will be assessed starting six months prior to the study period and continuing throughout the study period. The amount and type of healthcare utilization in relation to cardiac care will be collected. Data related to the use of MyChart will also be collected.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (Intervention Group) | Experimental | Other: Receive Detailed ICD Information-electronicReceive Detailed ICD Information-electronic: Receive ICD Patient Notification Summary via MyChart Patient Portal Account - Receive training to familiarize yourself with using the ePHR, MyChart Complete baseline, 3 month and 6 months survey |
| Group B (Intervention Group) | Active comparator | Other: Receive Detailed ICD Information-paperReceive Detailed ICD Information-paper: Receive ICD Patient Notification Summary via paper Receive training to familiarize yourself with using the ePHR, MyChart Complete baseline, 3 month and 6 months survey |
| Group C (Control Group) | No intervention | –Receives Standard of Care-No Report Complete baseline, 3 month and 6 months survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age and older
- Physically and mentally capable of providing an informed consent
- Patient of PPG-Cardiology
- Implanted with a St. Jude Medical ICD
- Undergoing remote monitoring by the Merlin.net™ system
Key exclusion criteria (4 listed)
- Does not meet inclusion criteria
- Unable to physically or cognitively carry out the tasks necessary for activating and/or utilizing an ePHR such as; blindness, loss of function of arms, cognitive impairments (per chart review) that would interfere in learning a new task
- Designated as part of a vulnerable subject population that the investigator or designee identifies to have compromised autonomy related to potential study participation
- Currently participating in another Parkview study that involves other ePHR use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Receive Detailed ICD Information-electronicReceive Detailed ICD Information (Patient Notification Summary Report) via an electronic Patient Portal vs control | Other | Group A (Intervention Group) |
| Receive Detailed ICD Information-paperReceive Detailed ICD Information (Patient Notification Summary Report) via paper vs control | Other | Group B (Intervention Group) |
Primary outcome
Change in Patient Engagement evaluated through Patient Activation Measure (PAM)
Time frame: Baseline, 3 months, and 6 months
This validated survey instrument will be utilized in the patient survey to evaluate patient engagement.
Change in health outcomes and healthcare utilization
Time frame: 6 months retrospective and 6 months prospective
The number of and reason for ER visits, Hospitalization, Office Visits, and Calls to Clinic will be recorded to evaluate patient health outcomes and healthcare utilization before and during the study.
2 secondary outcomes
Change in Technology Acceptance evaluated through Technology Acceptance Model (TAM)
Time frame: Baseline, 3 months, and 6 months
Providers' attitudes and perceptions evaluated through survey
Time frame: At study conclusion (approximately 1 year post deployment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- Background: PubMed 23242192Guedon-Moreau L, Lacroix D, Sadoul N, Clementy J, Kouakam C, Hermida JS, Aliot E, Boursier M, Bizeau O, Kacet S; ECOST trial Investigators. A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial. Eur Heart J. 2013 Feb;34(8):605-14. doi: 10.1093/eurheartj/ehs425. Epub 2012 Dec 13.
- Background: PubMed 22626743Landolina M, Perego GB, Lunati M, Curnis A, Guenzati G, Vicentini A, Parati G, Borghi G, Zanaboni P, Valsecchi S, Marzegalli M. Remote monitoring reduces healthcare use and improves quality of care in heart failure patients with implantable defibrillators: the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study. Circulation. 2012 Jun 19;125(24):2985-92. doi: 10.1161/CIRCULATIONAHA.111.088971. Epub 2012 May 24.
- Background: PubMed 20530358Buntin MB, Jain SH, Blumenthal D. Health information technology: laying the infrastructure for national health reform. Health Aff (Millwood). 2010 Jun;29(6):1214-9. doi: 10.1377/hlthaff.2010.0503.
- Background: PubMed 23381514Carman KL, Dardess P, Maurer M, Sofaer S, Adams K, Bechtel C, Sweeney J. Patient and family engagement: a framework for understanding the elements and developing interventions and policies. Health Aff (Millwood). 2013 Feb;32(2):223-31. doi: 10.1377/hlthaff.2012.1133.
- Background: PubMed 15230939Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Mirro, MD principal investigator
Parkview Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Receive Detailed ICD Information-electronic and Receive Detailed ICD Information-paper in people with Implantable Cardioverter-Defibrillator and Health Information Exchange, run by Parkview Hospital, Indiana at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Engagement evaluated through Patient Activation Measure (PAM) (time frame: Baseline, 3 months, and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02989090, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019.