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

Pressure Ulcers Clinical Trial

— PUMTT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01232764
• Other study ID #: 25048
• Status: Completed
• Phase: Phase 3
• First received: October 29, 2010
• Last updated: September 27, 2012
• Start date: October 2010
• Est. completion date: March 2012

Study information

• Verified date: September 2012
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ministry of Health & Long Term Care, Ontario
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Digital Wound Photography
• Multi-disciplinary Wound Care Teams
• Pressure Ulcer
• Pressure Ulcers
• Remote Support
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
Canada	12 Long Term Care Facilities	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
University of Toronto	Canadian Patient Safety Institute, Central Community Care Access Center, Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of reduction in wound surface area (cm2/days)		6 mths
Secondary	Percentage of wounds healed		6 mths

External Links

•   Toronto Health Economic Technology Assessment collaborative