Reference Nurse Program for Pressure Ulcers in Primary Care

Basque Health Service

Status and phase: Completed; Phase 2

Conditions: Pressure Ulcers

Treatments: Procedure: Tele-assistance; Procedure: Active comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT01877681

2011111099

Details and patient eligibility

About

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

Enrollment: 58 patients

Sex: All

Ages: 16 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups

Assisted Care

Experimental group

Description:

Assisted care (Tele=assistance) provided by an expert nurse through a informatic online application

Treatment:

Procedure: Tele-assistance

Active comparator

Active Comparator group

Description:

Usual care as stated by the Clinical Practice Guidelines for Pressure Ulcers treatment

Treatment:

Procedure: Active comparator