Cardiovascular DiseasesNCT03659565
Increasing Caregiver and Patient Engagement Through PHR Use
A study testing Enhanced Pre-Visit Consultation in people with Cardiovascular Diseases, run by University of Nebraska at 1 site in United States.
Trial summary
Informal caregivers play an integral role in managing complex, chronic disease patients providing services equivalent to an estimated economic value of $470 billion. The inclusion of informal caregivers in the healthcare team can improve care coordination and make health care safer by reducing potential medical errors… Read more about this study
- Who is it for?
- Ages 19 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Enhanced Pre-Visit Consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2019to 17 Jun 2022
- 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 19 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible patients will be patients with heart disease, able read, write, and speak English, and at least 65 years of age.
- Eligible caregivers will be a primary caregiver of an eligible patient, able to read, write, and speak English, and at least 18 years of age.
Who cannot join
- Individuals under the age of 19 will not be considered for participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Increasing Caregiver and Patient Engagement Through an Optimized Personal Health Record
Informal caregivers play an integral role in managing complex, chronic disease patients providing services equivalent to an estimated economic value of $470 billion. The inclusion of informal caregivers in the healthcare team can improve care coordination and make health care safer by reducing potential medical errors caused by miscommunication. the investigators reason that a properly designed PHR with a simplified user interface and easy access to relevant content can improve the management of chronic diseases and better integrate caregivers and patients into the healthcare team.
Read the detailed description
Informal caregivers (caregivers, often family or friends) play an integral role in managing patients with complex, chronic diseases. It is estimated that caregivers provide $470 billion of uncompensated care. Despite their impact, healthcare systems largely neglect caregivers. Long distance caregivers of older adults (who make up 15% of caregivers in America) are at a particular disadvantage. In the current healthcare system, health information technology (HIT) has not been optimized to support the needs of caregivers and patients. Providing HIT that supports enhanced communication between patients, caregivers, and clinicians can improve patient safety by increasing the accuracy of patient data and by reducing miscommunication(1).
There is limited knowledge concerning best practices to promote caregivers' and patients' activation and engagement, especially with HIT. Access to personal health information through the personal health record (PHR) has the potential to improve chronic health care management, and encourage patient engagement. Although caregivers and patients express a willingness to adopt PHRs, in practice, multiple barriers hinder PHR adoption. A properly designed PHR can help caregivers and patients manage their health and become partners in the healthcare team.
This study's overall objective is to identify caregivers and cardiovascular patients' communication and technology needs and to build and test an optimized PHR design that promotes active participation of patients and their caregivers in their health. The overall hypothesis is that an optimized PHR will expand the role of caregivers to improve the patient's health and improve the satisfaction of both patients and caregivers with their care. The investigators will employ an agile, user-centered design process involving caregivers and older cardiovascular patients.
- Conditions
- Cardiovascular Diseases
- Being tested
- Enhanced Pre-Visit Consultation, Usual Care Control
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Pre-Visit ConsultationBehavioural
The Intervention Group will be given access to the optimized personal health record and will use Zoom as part of the pre-visit consultation.
Usual Care ControlBehavioural
Caregivers and patients will participate in usual pre-visit process.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Pre-Visit Consultation | Experimental | Patients and caregivers will participate in an enhanced pre-visit consultation using Zoom for remote video and audio conferencing with screen sharing capabilities. Receives: Behavioral: Enhanced Pre-Visit Consultation |
| Usual Care Control | Active comparator | Patients continue to receive usual care from their cardiologist. Receives: Behavioral: Usual Care Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient activation
Patient activation will be measured using Altarum Consumer Engagement (ACE) Measure™. The ACE survey is a 21-item survey that measures patient engagement and health consumerism.
Measured: 12 months
Caregiver activation
Caregiver activation will be measured using the Family Caregiver Activation in Transitions (FCAT) Tool. FCAT is a 10-item tool used to measure caregivers' activation and self-efficacy.
Measured: 12 months
Secondary outcomes (3)
Medication adherence
Medication adherence will be measured using the Medication Adherence Survey (MAS)
Measured: 12 months
Caregiver Satisfaction
Child Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) will be used to measure caregiver satisfaction. HCAHPS is a 62-item survey used to measure that will be modified to measure caregiver satisfaction.
Measured: 12 months
Patient Satisfaction
Consumer Assessment for Healthcare Providers and Systems Survey (CAHPS) will be used to measure patient satisfaction. CAHPS is a 77-item survey used to assess patients' experiences with care.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start23 Apr 2019
- Primary completion17 Jun 2022
- Study completion17 Jun 2022
Why it stopped: Poor accrual due to Covid-19 restrictions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martina Clarke, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659565
- Sponsor's protocol ID
- 0491-18-EP
- Status last verified
- Oct 2024
- First submitted
- 1 Aug 2018
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Caregiver and Patient Engagement Through an Optimized Personal Health Record
- ClinicalTrials.gov ID
- NCT03659565
- Acronym / sponsor ID
- 0491-18-EP
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual due to Covid-19 restrictions
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 17 Jun 2022 (actual)
- First posted
- 6 Sep 2018 (actual)
- 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.
Informal caregivers play an integral role in managing complex, chronic disease patients providing services equivalent to an estimated economic value of $470 billion. The inclusion of informal caregivers in the healthcare team can improve care coordination and make health care safer by reducing potential medical errors caused by miscommunication. the investigators reason that a properly designed PHR with a simplified user interface and easy access to relevant content can improve the management of chronic diseases and better integrate caregivers and patients into the healthcare team.
Detailed description
Informal caregivers (caregivers, often family or friends) play an integral role in managing patients with complex, chronic diseases. It is estimated that caregivers provide $470 billion of uncompensated care. Despite their impact, healthcare systems largely neglect caregivers. Long distance caregivers of older adults (who make up 15% of caregivers in America) are at a particular disadvantage. In the current healthcare system, health information technology (HIT) has not been optimized to support the needs of caregivers and patients. Providing HIT that supports enhanced communication between patients, caregivers, and clinicians can improve patient safety by increasing the accuracy of patient data and by reducing miscommunication(1).
There is limited knowledge concerning best practices to promote caregivers' and patients' activation and engagement, especially with HIT. Access to personal health information through the personal health record (PHR) has the potential to improve chronic health care management, and encourage patient engagement. Although caregivers and patients express a willingness to adopt PHRs, in practice, multiple barriers hinder PHR adoption. A properly designed PHR can help caregivers and patients manage their health and become partners in the healthcare team.
This study's overall objective is to identify caregivers and cardiovascular patients' communication and technology needs and to build and test an optimized PHR design that promotes active participation of patients and their caregivers in their health. The overall hypothesis is that an optimized PHR will expand the role of caregivers to improve the patient's health and improve the satisfaction of both patients and caregivers with their care. The investigators will employ an agile, user-centered design process involving caregivers and older cardiovascular patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Pre-Visit Consultation | Experimental | Behavioral: Enhanced Pre-Visit ConsultationPatients and caregivers will participate in an enhanced pre-visit consultation using Zoom for remote video and audio conferencing with screen sharing capabilities. |
| Usual Care Control | Active comparator | Behavioral: Usual Care ControlPatients continue to receive usual care from their cardiologist. |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eligible patients will be patients with heart disease, able read, write, and speak English, and at least 65 years of age.
- Eligible caregivers will be a primary caregiver of an eligible patient, able to read, write, and speak English, and at least 18 years of age.
Key exclusion criteria (1 listed)
- Individuals under the age of 19 will not be considered for participation.
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 |
|---|---|---|
| Enhanced Pre-Visit ConsultationThe Intervention Group will be given access to the optimized personal health record and will use Zoom as part of the pre-visit consultation. | Behavioural | Enhanced Pre-Visit Consultation |
| Usual Care ControlCaregivers and patients will participate in usual pre-visit process. | Behavioural | Usual Care Control |
Primary outcome
Patient activation
Time frame: 12 months
Patient activation will be measured using Altarum Consumer Engagement (ACE) Measure™. The ACE survey is a 21-item survey that measures patient engagement and health consumerism.
Caregiver activation
Time frame: 12 months
Caregiver activation will be measured using the Family Caregiver Activation in Transitions (FCAT) Tool. FCAT is a 10-item tool used to measure caregivers' activation and self-efficacy.
3 secondary outcomes
Medication adherence
Time frame: 12 months
Caregiver Satisfaction
Time frame: 12 months
Patient Satisfaction
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Poor accrual due to Covid-19 restrictions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- 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.
Martina Clarke, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Pre-Visit Consultation in people with Cardiovascular Diseases, run by University of Nebraska 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 3 Oct 2024. 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 was stopped early (reason given: Poor accrual due to Covid-19 restrictions). Results are not available in the source record.
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?
Patient activation (time frame: 12 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?
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 3 Oct 2024.