Reference Nurse Program for Pressure Ulcers in Primary Care

April 15, 2015 updated by: Cristina Quesada, Basque Health Service

Chronic Wounds Reference Nurse and Telematic Interconsultation Program for Pressure Ulcers in Primary Care: Evaluation of Effectiveness and Cost Reduction

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Assisted Care
Assisted care (Tele=assistance) provided by an expert nurse through a informatic online application
Procedure: 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
Procedure: Active comparator
Usual care as specified in the PU practice guideline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
healing progression
Time Frame: 8 weeks
healing progression as measured by the RESVECH scale by a blinded expert
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Basque Health Service

Investigators

  • Principal Investigator: Cristina Quesada, Nurse, Osakidetza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

June 12, 2013

First Submitted That Met QC Criteria

June 13, 2013

First Posted (Estimate)

June 14, 2013

Study Record Updates

Last Update Posted (Estimate)

April 16, 2015

Last Update Submitted That Met QC Criteria

April 15, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011111099

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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