- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03545698
Enhancing and Scaling a High-Touch Home-based Primary Care Program
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Manhasset, New York, United States, 11030
- Northwell Health Solutions, Advanced Illness Management
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Telehealth Intervention
|
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.
|
No Intervention: Non-Telehealth Intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Telehealth Completion Success
Time Frame: 12 months
|
The proportion of telehealth visits that are completed successfully, out of those that are scheduled.
|
12 months
|
Telehealth Satisfaction Among Geriatric Patients
Time Frame: 12 months
|
The sum and average of scores across domains on the Telemedicine Satisfaction Questionnaire.
|
12 months
|
Telehealth Satisfaction Among RNs and Social Workers
Time Frame: 12 months
|
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).
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kristopher Smith, MD MPP, Northwell Health Solutions
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 17-0244-NH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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