Reference Nurse Program for Pressure Ulcers in Primary Care

Phase 2

Completed

• Conditions: Pressure Ulcers
• Interventions: Procedure: Tele-assistance; Procedure: Active comparator

• Registration Number: NCT01877681
• Lead Sponsor: Basque Health Service

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-06-12
• Study First Submitted QC: 2013-06-13
• Study First Posted: 2013-06-14
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Assisted Care	Tele-assistance	Assisted care (Tele=assistance) provided by an expert nurse through a informatic online application
Active comparator	Active comparator	Usual care as stated by the Clinical Practice Guidelines for Pressure Ulcers treatment

Primary Outcome Measures

Name	Time	Method
healing progression	8 weeks	healing progression as measured by the RESVECH scale by a blinded expert