Reference Nurse Program for Pressure Ulcers in Primary Care

NCT01877681 | Completed Phase 2

• 1 other identifier: 2011111099
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pressure Ulcers

Outcome Measures

Primary Outcomes (1)

• healing progression

  healing progression as measured by the RESVECH scale by a blinded expert

  8 weeks

Study Arms (2)

Assisted Care

EXPERIMENTAL

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

Procedure: Tele-assistance

Active comparator

ACTIVE COMPARATOR

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

Procedure: Active comparator

Interventions

Tele-assistance PROCEDURE

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

Assisted Care

Active comparator PROCEDURE

Usual care as specified in the PU practice guideline

Active comparator

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Basque Health Service: lead

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Cristina Quesada, Nurse

  Osakidetza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: June 14, 2013
• Study Start: October 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 16, 2015

Record last verified: 2015-04