Pressure Ulcers Clinical Trial
Official title:
Chronic Wounds Reference Nurse and Telematic Interconsultation Program for Pressure Ulcers in Primary Care: Evaluation of Effectiveness and Cost Reduction
Verified date | April 2015 |
Source | Basque Health Service |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ethics Committee |
Study type | Interventional |
Introduction: Pressure ulcers (PU) are the most common chronic wounds in all levels of care
in health centers. The chronic wound care by skilled personnel is key to healing and
management of these injuries. An inter-clinical telematic program for PU in Primary Care
(PC) can improve the effectiveness of interventions and cost savings.
Objective: To evaluate the effectiveness and costs reduction after the implementation in PC
setting of a chronic wounds reference nurse and a teleconsultation program aimed to nurses
for the management of PU in patients in home care setting.
Methodology: A prospective pilot clinical trial in which 46 primary care nurses in
Osakidetza will be randomly assigned to two parallel groups: experimental group and control
group. Each nurse will recruit at least 1 new patient in home care with PU in stage II-III.
The intervention will consist of a telematic advice from the reference nurse regarding
chronic wound management in relation to a specific PU. Patients will be monitored for 8
weeks with a minimum of 4 repeated measurements of the Resvech Index 2.0. To evaluate the
effectiveness of the intervention, multilevel models or linear mixed models to take into
account the auto-correlation at the individual level and nurse, will be used
Status | Completed |
Enrollment | 58 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years to 90 Years |
Eligibility |
Inclusion Criteria: - New cases of PU in Stage II-III, treated by the same nurse over time at patient's home. (Stage II: Partial loss of skin thickness that affects the epidermis, dermis, or both. Ulcer surface that looks like abrasion, blister, or shallow crater; Stage III: Full thickness loss of skin involving damage or necrosis of subcutaneous tissue that may extend down to but not through the underlying fascia) Exclusion Criteria: - Patients with chronic wounds that are not PU - PU in patients with plastic surgery - Patients who move periodically - Patients requiring hospitalization during follow-up - Patients in which nurse is expected to be changed during follow-up - Terminal patients |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Basque Health Service |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | healing progression | healing progression as measured by the RESVECH scale by a blinded expert | 8 weeks | No |
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