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Reference Nurse Program for Pressure Ulcers in Primary Care

Primary Purpose

Pressure Ulcers

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tele-assistance
Active comparator
Sponsored by
Basque Health Service
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pressure Ulcers

Eligibility Criteria

16 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Assisted Care

    Active comparator

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    June 12, 2013
    Last Updated
    April 15, 2015
    Sponsor
    Basque Health Service
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01877681
    Brief Title
    Reference Nurse Program for Pressure Ulcers in Primary Care
    Official Title
    Chronic Wounds Reference Nurse and Telematic Interconsultation Program for Pressure Ulcers in Primary Care: Evaluation of Effectiveness and Cost Reduction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2012 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    September 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Basque Health Service

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pressure Ulcers

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    58 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Assisted Care
    Arm Type
    Experimental
    Arm Description
    Assisted care (Tele=assistance) provided by an expert nurse through a informatic online application
    Arm Title
    Active comparator
    Arm Type
    Active Comparator
    Arm Description
    Usual care as stated by the Clinical Practice Guidelines for Pressure Ulcers treatment
    Intervention Type
    Procedure
    Intervention Name(s)
    Tele-assistance
    Intervention Description
    Assisted care (Tele-assistance) provided by an expert nurse through a informatic online application
    Intervention Type
    Procedure
    Intervention Name(s)
    Active comparator
    Intervention Description
    Usual care as specified in the PU practice guideline
    Primary Outcome Measure Information:
    Title
    healing progression
    Description
    healing progression as measured by the RESVECH scale by a blinded expert
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cristina Quesada, Nurse
    Organizational Affiliation
    Osakidetza
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Reference Nurse Program for Pressure Ulcers in Primary Care

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