Developing a Home Telehealth Program to Manage Pressure Ulcers in SCI/D

Study Overview
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Brief Summary
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The Veteran's Health Administration (VHA) is a national leader in using distance technology to monitor patients' self-care via an in-home messaging device with disease management protocols (DMPs). No such DMPs exist for the community dwelling spinal cord injury/disorders (SCI/D) population. Our objective is to develop the tools necessary for implementing a new home telehealth program to manage community-dwelling veterans with SCI/D at high risk of developing pressure ulcers (PrUs).

Detailed Description
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Background: VHA is a national leader in using distance technology to monitor patients' self-care via an in-home messaging device with disease management protocols (DMPs). No such DMPs exist for the community dwelling spinal cord injury/disorders (SCI/D) population. Our objective is to develop the tools necessary for implementing a new home telehealth program to manage community-dwelling veterans with SCI/D at high risk of developing pressure ulcers (PrUs). Objectives: The goal of the study was to complete activities necessary in preparation for implementing a Home Telehealth program to manage veterans with SCI/D at risk of developing PrUs. Specifically this Rapid Response Project (RRP) included: 1) Convening an expert panel to validate Pressure Ulcer (PrU) PrU DMP items; 2) Developing a standardized protocol that specified how the nurse Care Coordinator who would manage patients who develop open skin wounds across the Hub and Spoke system of care; 3) Assessing individual telehealth DMP items by calling a sample of patients on a daily or weekly basis for up to 2 months to determine their validity and 4) Developing an instrument to assess staff satisfaction with this method of patient management. Methods: A convenience sample of veterans about to be discharged home from the Cleveland SCI/D inpatient unit were asked to participate in the study. This included patients living close to the Hub and those referred from spoke sites. Subjects were randomly assigned to receive either daily calls (5 days/week) for 40 total calls, or weekly calls (8 total calls) over the course of the 8 week/2month study intervention period. Status: The project team is conducting ongoing analysis of the data to develop publications.

Official Title
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Developing a Home Telehealth Program to Manage Pressure Ulcers in SCI/D

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Behavioral: Daily telephone calls
* Behavioral: Weekly telephone calls


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Veterans admitted to Cleveland VA SCI/D unit or treated in the outpatient clinic Exclusion Criteria: No phone Cognitive impairment Hearing impairment
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daily telephone calls<br>Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers | Behavioral: Daily telephone calls<br>* Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.<br>|
| Active Comparator: Weekly telephone calls<br>Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers. | Behavioral: Weekly telephone calls<br>* Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of Data | Data includes the number of triggered items and types of triggers. | Enrollment to study end, 8 weeks | 
| Number of Days With Triggers at Certain Timeframe | Measured the number of days with triggers that occurred on the Baseline day, during the 8-week intervention, and on the End of Study day. | Enrollment to study end, 8 weeks | 
| Percent of Participant Triggering DMP Items | Percent of participants who triggered Disease-Management Protocol items by group. | Enrollment to study end, 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pressure ulcer, Telemedicine