Reference Nurse Program for Pressure Ulcers in Primary Care

Pressure Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877681
• Other study ID #: 2011111099
• Status: Completed
• Phase: Phase 2
• First received: June 12, 2013
• Last updated: April 15, 2015
• Start date: October 2012
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers
• Ulcer

Intervention

Procedure:
• Tele-assistance
Assisted care (Tele-assistance) provided by an expert nurse through a informatic online application
• Active comparator
Usual care as specified in the PU practice guideline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	healing progression	healing progression as measured by the RESVECH scale by a blinded expert	8 weeks	No