Reference Nurse Program for Pressure Ulcers in Primary Care
Primary Purpose
Pressure Ulcers
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tele-assistance
Active comparator
Sponsored by
About this trial
This is an interventional treatment trial for Pressure Ulcers
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Assisted Care
Active comparator
Arm Description
Assisted care (Tele=assistance) provided by an expert nurse through a informatic online application
Usual care as stated by the Clinical Practice Guidelines for Pressure Ulcers treatment
Outcomes
Primary Outcome Measures
healing progression
healing progression as measured by the RESVECH scale by a blinded expert
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01877681
Brief Title
Reference Nurse Program for Pressure Ulcers in Primary Care
Official Title
Chronic Wounds Reference Nurse and Telematic Interconsultation Program for Pressure Ulcers in Primary Care: Evaluation of Effectiveness and Cost Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Basque Health Service
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Assisted Care
Arm Type
Experimental
Arm Description
Assisted care (Tele=assistance) provided by an expert nurse through a informatic online application
Arm Title
Active comparator
Arm Type
Active Comparator
Arm Description
Usual care as stated by the Clinical Practice Guidelines for Pressure Ulcers treatment
Intervention Type
Procedure
Intervention Name(s)
Tele-assistance
Intervention Description
Assisted care (Tele-assistance) provided by an expert nurse through a informatic online application
Intervention Type
Procedure
Intervention Name(s)
Active comparator
Intervention Description
Usual care as specified in the PU practice guideline
Primary Outcome Measure Information:
Title
healing progression
Description
healing progression as measured by the RESVECH scale by a blinded expert
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina Quesada, Nurse
Organizational Affiliation
Osakidetza
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Reference Nurse Program for Pressure Ulcers in Primary Care
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