Spinal Cord Injury
Conditions
Keywords
Pressure ulcer, Telemedicine
Brief summary
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
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.
Interventions
BEHAVIORALDaily telephone calls
Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.
BEHAVIORALWeekly telephone calls
Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
\- Veterans admitted to Cleveland VA SCI/D unit or treated in the outpatient clinic
Exclusion criteria
* No phone * Cognitive impairment * Hearing impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days of Data | Enrollment to study end, 8 weeks | Data includes the number of triggered items and types of triggers. |
| Number of Days With Triggers at Certain Timeframe | Enrollment to study end, 8 weeks | 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. |
| Percent of Participant Triggering DMP Items | Enrollment to study end, 8 weeks | Percent of participants who triggered Disease-Management Protocol items by group. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Daily Group Daily telephone calls to remind patients of recommended behaviors
Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers. | 10 |
| Weekly Group Weekly telephone calls to remind patients of recommended behaviors
Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers. | 8 |
| Total | 18 |
Baseline characteristics
| Characteristic | Weekly Group | Daily Group | Total |
|---|---|---|---|
| Age, Continuous | 49.75 years STANDARD_DEVIATION 14.89 | 51.4 years STANDARD_DEVIATION 12.64 | 50.67 years STANDARD_DEVIATION 13.29 |
| American Spinal Injury Association (ASIA) Score A = Complete | 4 participants | 3 participants | 7 participants |
| American Spinal Injury Association (ASIA) Score B = Sensory Incomplete | 2 participants | 2 participants | 4 participants |
| American Spinal Injury Association (ASIA) Score C = Motor Incomplete | 1 participants | 1 participants | 2 participants |
| American Spinal Injury Association (ASIA) Score D = Motor Incomplete | 1 participants | 1 participants | 2 participants |
| American Spinal Injury Association (ASIA) Score Unknown | 0 participants | 3 participants | 3 participants |
| Amputees N/A | 7 participants | 9 participants | 16 participants |
| Amputees Right Lower Extremity | 1 participants | 1 participants | 2 participants |
| Baseline Self-Reported Skin Behaviors Appropriate Cushion | 2 participants | 7 participants | 9 participants |
| Baseline Self-Reported Skin Behaviors Daily Skin Inspection | 4 participants | 8 participants | 12 participants |
| Baseline Self-Reported Skin Behaviors Good Nutrition | 5 participants | 9 participants | 14 participants |
| Baseline Self-Reported Skin Behaviors Hygiene | 5 participants | 8 participants | 13 participants |
| Baseline Self-Reported Skin Behaviors Keep skin clean and dry | 5 participants | 9 participants | 14 participants |
| Baseline Self-Reported Skin Behaviors No tight clothing/shoes | 5 participants | 8 participants | 13 participants |
| Baseline Self-Reported Skin Behaviors Other | 0 participants | 2 participants | 2 participants |
| Baseline Self-Reported Skin Behaviors Pressure releases/Tilts/Weight shifts | 4 participants | 9 participants | 13 participants |
| Baseline Self-Reported Skin Behaviors Safety in transfers | 3 participants | 7 participants | 10 participants |
| Current employment status Not working | 7 participants | 10 participants | 17 participants |
| Current employment status Small business owner | 1 participants | 0 participants | 1 participants |
| Current Pressure Ulcer Location Ischium | 0 participants | 2 participants | 2 participants |
| Current Pressure Ulcer Location N/A | 4 participants | 7 participants | 11 participants |
| Current Pressure Ulcer Location Other | 2 participants | 0 participants | 2 participants |
| Current Pressure Ulcer Location Sacrum | 2 participants | 1 participants | 3 participants |
| Current Pressure Ulcer Stage N/A | 4 participants | 7 participants | 11 participants |
| Current Pressure Ulcer Stage Stage III = Full thickness | 1 participants | 0 participants | 1 participants |
| Current Pressure Ulcer Stage Stage I = Intact skin/non-blanchable redness | 2 participants | 0 participants | 2 participants |
| Current Pressure Ulcer Stage Stage II = Partial thickness | 0 participants | 0 participants | 0 participants |
| Current Pressure Ulcer Stage Stage IV = Full thickness | 1 participants | 2 participants | 3 participants |
| Current Pressure Ulcer Stage Unknown | 0 participants | 1 participants | 1 participants |
| Duration of Injury in years | 18.81 years | 17.94 years | 18.4 years |
| Education College graduate | 0 participants | 1 participants | 1 participants |
| Education Graduate school | 3 participants | 1 participants | 4 participants |
| Education High school graduate | 2 participants | 4 participants | 6 participants |
| Education Some college | 2 participants | 3 participants | 5 participants |
| Education Some high school | 1 participants | 1 participants | 2 participants |
| Level of Injury Cervical | 6 participants | 6 participants | 12 participants |
| Level of Injury Lumbar | 0 participants | 1 participants | 1 participants |
| Level of Injury N/A | 0 participants | 2 participants | 2 participants |
| Level of Injury Thoracic | 2 participants | 1 participants | 3 participants |
| Marital status Divorced | 3 participants | 4 participants | 7 participants |
| Marital status Married | 3 participants | 2 participants | 5 participants |
| Marital status Never married | 2 participants | 3 participants | 5 participants |
| Marital status Widowed | 0 participants | 1 participants | 1 participants |
| Number of Current Pressure Ulcers | 0.5 pressure ulcers | 1.2 pressure ulcers | 0.89 pressure ulcers |
| Number of prior pressure ulcers (PrU) | 1.7 pressure ulcers | 2.43 pressure ulcers | 2 pressure ulcers |
| Number of Prior Pressure Ulcer Surgeries | 0.63 surgeries | 0.6 surgeries | 0.61 surgeries |
| Past Work History Administrator, professional, manager | 1 participants | 2 participants | 3 participants |
| Past Work History Clerical, sales worker | 0 participants | 2 participants | 2 participants |
| Past Work History Never worked | 1 participants | 0 participants | 1 participants |
| Past Work History Other | 3 participants | 1 participants | 4 participants |
| Past Work History Semi-skilled worker | 2 participants | 2 participants | 4 participants |
| Past Work History Skilled manual worker, crafstman | 1 participants | 1 participants | 2 participants |
| Past Work History Unskilled worker | 0 participants | 2 participants | 2 participants |
| Prior Ulcer Locations Coccyx | 2 pressure ulcers | 1 pressure ulcers | 3 pressure ulcers |
| Prior Ulcer Locations Heel | 1 pressure ulcers | 1 pressure ulcers | 2 pressure ulcers |
| Prior Ulcer Locations Ischium | 2 pressure ulcers | 4 pressure ulcers | 6 pressure ulcers |
| Prior Ulcer Locations Lateral Malleolus | 1 pressure ulcers | 0 pressure ulcers | 1 pressure ulcers |
| Prior Ulcer Locations Medial Malleolus | 1 pressure ulcers | 0 pressure ulcers | 1 pressure ulcers |
| Prior Ulcer Locations Sacrum | 3 pressure ulcers | 1 pressure ulcers | 4 pressure ulcers |
| Prior Ulcer Locations Trochanter | 1 pressure ulcers | 3 pressure ulcers | 4 pressure ulcers |
| Prior Ulcer Surgery Locations Coccyx | 0 participants | 1 participants | 1 participants |
| Prior Ulcer Surgery Locations Ischium | 1 participants | 3 participants | 4 participants |
| Prior Ulcer Surgery Locations Lateral Malleolus | 1 participants | 0 participants | 1 participants |
| Prior Ulcer Surgery Locations N/A | 2 participants | 5 participants | 7 participants |
| Prior Ulcer Surgery Locations Sacrum | 4 participants | 0 participants | 4 participants |
| Prior Ulcer Surgery Locations Trochanter | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Black | 2 participants | 4 participants | 6 participants |
| Race/Ethnicity, Customized White | 6 participants | 6 participants | 12 participants |
| Receive regular assistance from: Other Relatives | 1 participants | 2 participants | 3 participants |
| Receive regular assistance from: Paid Attendant | 3 participants | 5 participants | 8 participants |
| Receive regular assistance from: Partner/Significant Other | 1 participants | 1 participants | 2 participants |
| Receive regular assistance from: Spouse | 3 participants | 2 participants | 5 participants |
| Residence type Apartment | 2 participants | 2 participants | 4 participants |
| Residence type House | 6 participants | 8 participants | 14 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 10 Participants | 18 Participants |
| Spinal Cord Injury (SCI) Etiology Diving | 1 participants | 0 participants | 1 participants |
| Spinal Cord Injury (SCI) Etiology Fall | 2 participants | 1 participants | 3 participants |
| Spinal Cord Injury (SCI) Etiology Gunshot wound | 2 participants | 1 participants | 3 participants |
| Spinal Cord Injury (SCI) Etiology Other etiology | 1 participants | 3 participants | 4 participants |
| Spinal Cord Injury (SCI) Etiology Vehicular accident | 2 participants | 5 participants | 7 participants |
| Urinary Management Condom Catheter | 0 participants | 2 participants | 2 participants |
| Urinary Management Intermittent Catheter | 6 participants | 2 participants | 8 participants |
| Urinary Management Other | 1 participants | 5 participants | 6 participants |
| Urinary Management Unknown | 1 participants | 1 participants | 2 participants |
| Years Since Employment | 14.64 years | 10.43 years | 12.12 years |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 8 |
| serious Total, serious adverse events | 0 / 10 | 0 / 8 |
Outcome results
Primary
Days of Data
Data includes the number of triggered items and types of triggers.
Time frame: Enrollment to study end, 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1 | Days of Data | 9 days |
| Arm 2 | Days of Data | 7 days |
Primary
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.
Time frame: Enrollment to study end, 8 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 | Number of Days With Triggers at Certain Timeframe | Baseline Day Triggers | 5 days |
| Arm 1 | Number of Days With Triggers at Certain Timeframe | Days with Triggers during Intervention | 24 days |
| Arm 1 | Number of Days With Triggers at Certain Timeframe | End of Study Day Triggers | 1 days |
| Arm 2 | Number of Days With Triggers at Certain Timeframe | Baseline Day Triggers | 6 days |
| Arm 2 | Number of Days With Triggers at Certain Timeframe | Days with Triggers during Intervention | 24 days |
| Arm 2 | Number of Days With Triggers at Certain Timeframe | End of Study Day Triggers | 4 days |
Primary
Percent of Participant Triggering DMP Items
Percent of participants who triggered Disease-Management Protocol items by group.
Time frame: Enrollment to study end, 8 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 | Percent of Participant Triggering DMP Items | Positioning/Pressure Reliefs/Weight Shifts | 46.7 % of participants triggering an item |
| Arm 1 | Percent of Participant Triggering DMP Items | Quality of CG Care | 3.3 % of participants triggering an item |
| Arm 1 | Percent of Participant Triggering DMP Items | Equipment Issues | 40 % of participants triggering an item |
| Arm 1 | Percent of Participant Triggering DMP Items | Feelings of Depression | 0 % of participants triggering an item |
| Arm 1 | Percent of Participant Triggering DMP Items | Skin Moisture Issues | 0 % of participants triggering an item |
| Arm 1 | Percent of Participant Triggering DMP Items | Ongoing Problems Affecting Self-Mgmt | 6.7 % of participants triggering an item |
| Arm 1 | Percent of Participant Triggering DMP Items | Daily Skin Inspection | 23.3 % of participants triggering an item |
| Arm 1 | Percent of Participant Triggering DMP Items | Dragging Across Surfaces | 3.3 % of participants triggering an item |
| Arm 1 | Percent of Participant Triggering DMP Items | Existing Pressure Ulcer Care | 0 % of participants triggering an item |
| Arm 1 | Percent of Participant Triggering DMP Items | Diabetic Comorbidities | 6.7 % of participants triggering an item |
| Arm 2 | Percent of Participant Triggering DMP Items | Diabetic Comorbidities | 2.9 % of participants triggering an item |
| Arm 2 | Percent of Participant Triggering DMP Items | Daily Skin Inspection | 23.5 % of participants triggering an item |
| Arm 2 | Percent of Participant Triggering DMP Items | Equipment Issues | 55.9 % of participants triggering an item |
| Arm 2 | Percent of Participant Triggering DMP Items | Positioning/Pressure Reliefs/Weight Shifts | 50 % of participants triggering an item |
| Arm 2 | Percent of Participant Triggering DMP Items | Skin Moisture Issues | 11.8 % of participants triggering an item |
| Arm 2 | Percent of Participant Triggering DMP Items | Existing Pressure Ulcer Care | 17.6 % of participants triggering an item |
| Arm 2 | Percent of Participant Triggering DMP Items | Quality of CG Care | 8.8 % of participants triggering an item |
| Arm 2 | Percent of Participant Triggering DMP Items | Feelings of Depression | 11.8 % of participants triggering an item |
| Arm 2 | Percent of Participant Triggering DMP Items | Ongoing Problems Affecting Self-Mgmt | 14.7 % of participants triggering an item |
| Arm 2 | Percent of Participant Triggering DMP Items | Dragging Across Surfaces | 8.8 % of participants triggering an item |