Pressure UlcersPhase 3PUMTTNCT01232764
Pressure Ulcer Multi-disciplinary Teams Via Telemedicine (PUMTT): A Trial in Long Term Care
A Phase 3 study testing Exposure to multi-disciplinary wound care team in people with Pressure Ulcers and Multi-disciplinary Wound Care Teams, run by University of Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcers, Multi-disciplinary Wound Care Teams, Remote Support
- What is being tested?
- Exposure to multi-disciplinary wound care team
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2010to Mar 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pressure Ulcer Multi-disciplinary Teams Via Telemedicine (PUMTT): A Cluster Pragmatic Randomised Controlled Trial in Long Term Care
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.
- Conditions
- Pressure Ulcers, Multi-disciplinary Wound Care Teams, Remote Support, Digital Wound Photography
- Being tested
- Exposure to multi-disciplinary wound care team
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Multi-disciplinary wound care team | Experimental | Stepped wedge study design i.e. start date of exposure is randomized. Receives: Other: Exposure to multi-disciplinary wound care team |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of reduction in wound surface area (cm2/days)
Measured: 6 mths
Secondary outcomes (1)
Percentage of wounds healed
Measured: 6 mths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcersStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care, Canadian Patient Safety Institute, Central Community Care Access Center
- Responsible party
- Principal investigator, Anita Stern, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232764
- Sponsor's protocol ID
- 25048
- Acronym
- PUMTT
- Status last verified
- Sep 2012
- First submitted
- 29 Oct 2010
- Last updated
- 28 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24559218
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Ulcer Multi-disciplinary Teams Via Telemedicine (PUMTT): A Cluster Pragmatic Randomised Controlled Trial in Long Term Care
- ClinicalTrials.gov ID
- NCT01232764
- Acronym / sponsor ID
- PUMTT / 25048
- Conditions
- Pressure Ulcers, Multi-disciplinary Wound Care Teams, Remote Support, Digital Wound Photography
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care, Canadian Patient Safety Institute, Central Community Care Access Center
- Study start
- Oct 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 2 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi-disciplinary wound care team | Experimental | Other: Exposure to multi-disciplinary wound care teamStepped wedge study design i.e. start date of exposure is randomized. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.]
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure to multi-disciplinary wound care teamPhase 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. | Other | Multi-disciplinary wound care team |
Primary outcome
Rate of reduction in wound surface area (cm2/days)
Time frame: 6 mths
1 secondary outcome
Percentage of wounds healed
Time frame: 6 mths
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2012.
- Derived from this study: PubMed 24559218Stern 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.
- Toronto Health Economic Technology Assessment collaborativeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exposure to multi-disciplinary wound care team in people with Pressure Ulcers and Multi-disciplinary Wound Care Teams, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of reduction in wound surface area (cm2/days) (time frame: 6 mths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01232764, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2012.