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Pressure Ulcer Multi-disciplinary Teams Via Telemedicine (PUMTT): A Trial in Long Term Care

This study has been completed.
Sponsor:
Collaborators:
Ontario Ministry of Health and Long Term Care
Canadian Patient Safety Institute
Central Community Care Access Center
Information provided by (Responsible Party):
Anita Stern, University of Toronto
ClinicalTrials.gov Identifier:
NCT01232764
First received: October 29, 2010
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the effectiveness of 'enhanced' multi-disciplinary wound care teams (MDTs) vs. 'usual' care teams in Long Term Care (LTC) facilities in Ontario for the treatment of pressure ulcers. LTC facilities with more than 100 beds that are within a 100 km distance from St. Mikes and have a problem with pressure ulcers will be asked to participate. A total of 10 LTC facilities will be randomly selected (i.e. selected by chance) from those that agree to participate.

The 'enhanced' MDT will be an Advance Practice Nurse(APN) with expertise in wound care who has direct access to the wound care team at St. Mikes. This APN will develop treatment plans in consultation with facility staff, providing targeted pressure ulcer treatment education on an ongoing, case by case basis. Care is supported by telemedicine with the use of digital photography and online communication between members of the care team.

This study is a stepped wedge randomized trial, meaning LTC facilities are assigned to a start date for this study totally by chance. Changes in healing rates, wound related pain, cost, number of new pressure ulcers, and number of wounds healed will be measured before, and after the APN is introduced to facilities. In order to gain more insight into how people felt about this model of care, interviews will be held with individuals and groups of staff at 5 randomly selected facilities before, during, and after the study has been completed.


Condition Intervention Phase
Pressure Ulcers
Multi-disciplinary Wound Care Teams
Remote Support
Digital Wound Photography
 Other: Exposure to multi-disciplinary wound care team
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Pressure Ulcer Multi-disciplinary Teams Via Telemedicine (PUMTT): A Cluster Pragmatic Randomised Controlled Trial in Long Term Care

Resource links provided by NLM:

MedlinePlus related topics: Pressure Sores
U.S. FDA Resources

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Rate of reduction in wound surface area (cm2/days) [ Time Frame: 6 mths ]

Secondary Outcome Measures:
  • Percentage of wounds healed [ Time Frame: 6 mths ]

Enrollment: 137
Study Start Date: October 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multi-disciplinary wound care team
Stepped wedge study design i.e. start date of exposure is randomized.
 Other: Exposure to multi-disciplinary wound care team

Phase 1: In Person Support (3 mths)

Advance Practice Nurses (APNs) affiliated with Enhanced Multi-Disciplinary visit LTC facilities on a weekly basis. The APN may communicate with other members of an EMDT via telephone or online.EMDTs will collectively teach and mentor LTC facility wound care teams throughout the study.

Phase 2: Remote Support (2-11 mths) In the second phase, EMDTs will support LTC facility staff remotely via telephone and online communication, visiting the facilities on an as needed basis only.

All PU treatment will be based on RNAO evidence-based guidelines (updated in 2007)contextualized to the LTC setting.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • LTC facility must be located within the Toronto Central or Central LHIN geographic boundaries.
  • LTC facility must be <100 km from the St. Michael's Hospital wound care team.
  • LTC facility must be entering data into MDS.
  • LTC facility administrator must consent to participate.
  • LTC facility must report a PU prevalence rate >5.5% in the 4th quarter 2009 MDS. [This is the average pressure ulcer prevalence rate for Ontario LTC facilities as reported by the Canadian Institute of Health Information (CIHI) in the 4th quarter 2009.]
  • Individual with PU (or Substitute Decision Maker (SDM)) must provide informed consent.

Exclusion Criteria:

  • LTC facility <100 beds.
  • LTC facility >100 km from the St. Michael's Hospital wound care team
  • LTC facility reporting a PU prevalence rate < 5.5% in the 4th quarter 2009 MDS.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01232764

Locations
Canada, Ontario
12 Long Term Care Facilities
Toronto, Ontario, Canada
Sponsors and Collaborators
University of Toronto
Ontario Ministry of Health and Long Term Care
Canadian Patient Safety Institute
Central Community Care Access Center
  More Information

Additional Information:
Toronto Health Economic Technology Assessment collaborative  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Anita Stern, Researcher, University of Toronto
ClinicalTrials.gov Identifier: NCT01232764     History of Changes
Other Study ID Numbers: 25048
Study First Received: October 29, 2010
Last Updated: September 27, 2012
Health Authority: Canada: Ministry of Health & Long Term Care, Ontario

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013