NCT01232764

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

September 28, 2012

Status Verified

September 1, 2012

Enrollment Period

1.4 years

First QC Date

October 29, 2010

Last Update Submit

September 27, 2012

Conditions

Pressure UlcersMulti-disciplinary Wound Care TeamsRemote SupportDigital Wound Photography

Outcome Measures

Primary Outcomes (1)

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

    6 mths

Secondary Outcomes (1)

  • Percentage of wounds healed

    6 mths

Study Arms (1)

Multi-disciplinary wound care team

EXPERIMENTAL

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

Other: Exposure to multi-disciplinary wound care team

Interventions

Exposure to multi-disciplinary wound care teamOTHER

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.

Multi-disciplinary wound care team

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

12 Long Term Care Facilities

Toronto, Ontario, Canada

Location

Related Publications (1)

  • Stern A, Mitsakakis N, Paulden M, Alibhai S, Wong J, Tomlinson G, Brooker AS, Krahn M, Zwarenstein M. Pressure ulcer multidisciplinary teams via telemedicine: a pragmatic cluster randomized stepped wedge trial in long term care. BMC Health Serv Res. 2014 Feb 24;14:83. doi: 10.1186/1472-6963-14-83.

    PMID: 24559218DERIVED

Related Links

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

October 29, 2010

First Posted

November 2, 2010

Study Start

October 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

September 28, 2012

Record last verified: 2012-09

Locations

CA(1)