Reference Nurse Program for Pressure Ulcers in Primary Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-09-30

Brief Summary

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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

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Detailed Description

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Conditions

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Pressure Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Assisted Care

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

Group Type EXPERIMENTAL

Tele-assistance

Intervention Type PROCEDURE

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

Active comparator

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

Group Type ACTIVE_COMPARATOR

Active comparator

Intervention Type PROCEDURE

Usual care as specified in the PU practice guideline

Interventions

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Tele-assistance

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

Intervention Type PROCEDURE

Active comparator

Usual care as specified in the PU practice guideline

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No