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Clinical Trials/NCT01232764
NCT01232764CompletedPhase 3

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

University of Toronto1 site in 1 country137 target enrollmentStarted: October 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
137
Locations
1
Primary Endpoint
Rate of reduction in wound surface area (cm2/days)

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Multi-disciplinary wound care team

Experimental

Stepped wedge study design i.e. start date of exposure is randomized.

Intervention: Exposure to multi-disciplinary wound care team (Other)

Outcomes

Primary Outcomes

Rate of reduction in wound surface area (cm2/days)

Time Frame: 6 mths

Secondary Outcomes

  • Percentage of wounds healed(6 mths)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Anita Stern

Researcher

University of Toronto

Study Sites (1)

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