Satisfaction, ConsumerNCT03545698
Enhancing and Scaling a High-Touch Home-based Primary Care Program
A study testing Avizia Telehealth Platform in people with Satisfaction, Consumer and Caregiver Stress, run by Northwell Health at 1 site in United States.
Trial summary
The overall goal of the West Health Institute-Northwell PRP is to identify a clinical and economic model that can support scaling the Northwell House Calls program within a four year implementation period, while maintaining the same level of quality, patient/caregiver satisfaction, and "high touch" provider-patient… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Satisfaction, Consumer, Caregiver Stress
- What is being tested?
- Avizia Telehealth Platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2018to 19 Jun 2019
- 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
- Patients from the chronic and complex phone-only acuity level, from House Calls, Advanced Illness Management, Northwell Health Solutions.
- If possible, we will recruit both patient and caregiver dyads.
- The caregiver can be a family member or a paid caregiver.
- If patients are cognitively impaired, then they must have a caregiver who can verbally confirm that they will be present with the patient for the telehealth visit. -Caregiver must be present during Avizia enrollment with the research staff to ensure proper use of the device.
- The eligible patient or the eligible caregiver, must have a mobile phone number or email address listed in Allscripts is the associated chart, in order to participate in an Avizia visit with House Calls.
- Patients will be able to participate in the study regardless of cognitive impairment, if they have a caregiver who is able to consent on their behalf. This caregiver must be their power of attorney or family member, but does not have the be the caregiver present for the Avizia visit.
Who cannot join
- Patients under 18
- Patients that are cognitively impaired and unable to use the device, who also do not have a present and willing caregiver who can use the device.
- If the patient and willing caregiver do not have an email address or phone number listed on the associated chart on Allscripts.
- Patient or caregiver does not have a smart phone, tablet, laptop or desktop computer able to launch Avizia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwell Health Solutions, Advanced Illness Management
Manhasset, New York, 11030
About this study
The overall goal of the West Health Institute-Northwell PRP is to identify a clinical and economic model that can support scaling the Northwell House Calls program within a four year implementation period, while maintaining the same level of quality, patient/caregiver satisfaction, and "high touch" provider-patient communication that the program is known for. The Clinical Trial portion of this study refers to the secondary endpoint listed below.
Read the detailed description
Primary Endpoint: Northwell's House Calls program will be effectively scaled to maintain a patient census of 2000 without compromising patient and caregiver satisfaction.
Secondary Endpoint: The telehealth platform, Avizia, effectively improves communication of patient and caregiver needs to House Calls staff, and overall program satisfaction.
In order to achieve the secondary endpoint, a telehealth platform will be implemented that will allow patients and their caregivers to teleconference with their care manager, who is either a nurse or a social worker, replacing a typical visit which is completed telephonically.
Hypotheses to be tested through a home based telehealth intervention :
- Maintain longitudinal non-inferiority of: in-person acute care home visits from a provider, in-person acute care home visits from a care manager, hospitalizations, ED visits, Community Paramedicine deployments, Community Paramedicine transports to hospital, the patient's acuity level, LACE Score, Charelson Co-Morbidity score and the total number of ADLs group compared to usual care group.
- Telehealth acceptability
- decrease caregiver stress
- Improve program satisfaction
- Improve staff satisfaction and engagement
- Conditions
- Satisfaction, Consumer, Caregiver Stress
- Being tested
- Avizia Telehealth Platform
- Medical subject headings
- Consumer Behavior, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avizia Telehealth PlatformOther
Avizia will be utilized as a communication tool between home-based caregivers (family members, formal caregivers, or informal caregivers) and the House Calls care management team.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth Intervention | Active comparator | Not described Receives: Other: Avizia Telehealth Platform |
| Non-Telehealth Intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telehealth Acceptability Among Geriatric, Homebound patients
The proportion of geriatric patients who agree to use telehealth for a care management visit in lieu of a phone call visit, out of those who are offered the service.
Measured: 12 months
Secondary outcomes (3)
Telehealth Completion Success
The proportion of telehealth visits that are completed successfully, out of those that are scheduled.
Measured: 12 months
Telehealth Satisfaction Among Geriatric Patients
The sum and average of scores across domains on the Telemedicine Satisfaction Questionnaire.
Measured: 12 months
Telehealth Satisfaction Among RNs and Social Workers
The sum and average of scores across domains on the Telemedicine Satisfaction Questionnaire, adapted from original use with providers to use with care management staff (RNS and Social Workers).
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 posted4 Jun 2018
- Study start26 Jun 2018
- Primary completion15 Feb 2019
- Study completion19 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Satisfaction, ConsumerStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Gary and Mary West Health Institute
- Responsible party
- Principal investigator, Karen Abrashkin, Northwell Health
- Investigators
- Kristopher Smith, MD MPP, Principal investigator, Northwell Health Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545698
- Sponsor's protocol ID
- 17-0244-NH
- Status last verified
- Jul 2019
- First submitted
- 9 May 2018
- Last updated
- 29 Jul 2019
- Results posted
- 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 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing and Scaling a High-Touch Home-based Primary Care Program
- ClinicalTrials.gov ID
- NCT03545698
- Acronym / sponsor ID
- 17-0244-NH
- Conditions
- Satisfaction, Consumer, Caregiver Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Gary and Mary West Health Institute
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 4 Jun 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.
The overall goal of the West Health Institute-Northwell PRP is to identify a clinical and economic model that can support scaling the Northwell House Calls program within a four year implementation period, while maintaining the same level of quality, patient/caregiver satisfaction, and "high touch" provider-patient communication that the program is known for. The Clinical Trial portion of this study refers to the secondary endpoint listed below.
Detailed description
Primary Endpoint: Northwell's House Calls program will be effectively scaled to maintain a patient census of 2000 without compromising patient and caregiver satisfaction.
Secondary Endpoint: The telehealth platform, Avizia, effectively improves communication of patient and caregiver needs to House Calls staff, and overall program satisfaction.
In order to achieve the secondary endpoint, a telehealth platform will be implemented that will allow patients and their caregivers to teleconference with their care manager, who is either a nurse or a social worker, replacing a typical visit which is completed telephonically.
Hypotheses to be tested through a home based telehealth intervention :
- Maintain longitudinal non-inferiority of: in-person acute care home visits from a provider, in-person acute care home visits from a care manager, hospitalizations, ED visits, Community Paramedicine deployments, Community Paramedicine transports to hospital, the patient's acuity level, LACE Score, Charelson Co-Morbidity score and the total number of ADLs group compared to usual care group.
- Telehealth acceptability
- decrease caregiver stress
- Improve program satisfaction
- Improve staff satisfaction and engagement
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telehealth Intervention | Active comparator | Other: Avizia Telehealth Platform |
| Non-Telehealth Intervention | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients from the chronic and complex phone-only acuity level, from House Calls, Advanced Illness Management, Northwell Health Solutions.
- If possible, we will recruit both patient and caregiver dyads.
- The caregiver can be a family member or a paid caregiver.
- If patients are cognitively impaired, then they must have a caregiver who can verbally confirm that they will be present with the patient for the telehealth visit. -Caregiver must be present during Avizia enrollment with the research staff to ensure proper use of the device.
- The eligible patient or the eligible caregiver, must have a mobile phone number or email address listed in Allscripts is the associated chart, in order to participate in an Avizia visit with House Calls.
Key exclusion criteria (4 listed)
- Patients under 18
- Patients that are cognitively impaired and unable to use the device, who also do not have a present and willing caregiver who can use the device.
- If the patient and willing caregiver do not have an email address or phone number listed on the associated chart on Allscripts.
- Patient or caregiver does not have a smart phone, tablet, laptop or desktop computer able to launch Avizia.
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 |
|---|---|---|
| Avizia Telehealth PlatformAvizia will be utilized as a communication tool between home-based caregivers (family members, formal caregivers, or informal caregivers) and the House Calls care management team. | Other | Telehealth Intervention |
Primary outcome
Telehealth Acceptability Among Geriatric, Homebound patients
Time frame: 12 months
The proportion of geriatric patients who agree to use telehealth for a care management visit in lieu of a phone call visit, out of those who are offered the service.
3 secondary outcomes
Telehealth Completion Success
Time frame: 12 months
Telehealth Satisfaction Among Geriatric Patients
Time frame: 12 months
Telehealth Satisfaction Among RNs and Social Workers
Time frame: 12 months
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 29 Jul 2019.
- 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.
Kristopher Smith, MD MPP principal investigator
Northwell Health Solutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avizia Telehealth Platform in people with Satisfaction, Consumer and Caregiver Stress, run by Northwell Health 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 6 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 29 Jul 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?
Telehealth Acceptability Among Geriatric, Homebound patients (time frame: 12 months). 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 29 Jul 2019.