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

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).

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Behavioral: Daily telephone calls; Behavioral: Weekly telephone calls

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Hines, Illinois, United States, 60141-5000
      • Edward Hines Jr. VA Hospital, Hines, IL
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Louis Stokes VA Medical Center, Cleveland, OH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Veterans admitted to Cleveland VA SCI/D unit or treated in the outpatient clinic

Exclusion Criteria:

• No phone
• Cognitive impairment
• Hearing impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Investigators: Principal Investigator: Marylou Guihan, PhD MA BA, Edward Hines Jr. VA Hospital, Hines, IL

Publications and helpful links

General Publications

• Woo C, Guihan M, Frick C, Gill CM, Ho CH. What's happening now! Telehealth management of spinal cord injury/disorders. J Spinal Cord Med. 2011;34(3):322-31. doi: 10.1179/2045772311Y.0000000003. Erratum In: J Spinal Cord Med. 2011 Jul;34(4):437.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: February 14, 2008
• First Submitted That Met QC Criteria: February 25, 2008
• First Posted (Estimate): February 27, 2008

Study Record Updates

• Last Update Posted (Estimate): April 28, 2015
• Last Update Submitted That Met QC Criteria: April 6, 2015
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Telemedicine; Pressure ulcer
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Wounds and Injuries; Skin Ulcer; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries; Pressure Ulcer
• Other Study ID Numbers: RRP 07-292