Enhancing and Scaling a High-Touch Home-based Primary Care Program

July 25, 2019 updated by: Karen Abrashkin, Northwell Health
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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Manhasset, New York, United States, 11030
        • Northwell Health Solutions, Advanced Illness Management

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kristopher Smith, MD MPP, Northwell Health Solutions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2018

Primary Completion (Actual)

February 15, 2019

Study Completion (Actual)

June 19, 2019

Study Registration Dates

First Submitted

May 9, 2018

First Submitted That Met QC Criteria

May 22, 2018

First Posted (Actual)

June 4, 2018

Study Record Updates

Last Update Posted (Actual)

July 29, 2019

Last Update Submitted That Met QC Criteria

July 25, 2019

Last Verified

July 1, 2019

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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