StrokeNCT00237757
Rehabilitation Team Functioning and Patient Outcomes
A study testing Information feedback in people with Stroke, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of the study is to determine if 1. Rehabilitation staff can be trained to work better together as a team; and 2. Better team work improves patient outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Information feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Sep 2009
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Randomized, controlled subjects were VA inpatient rehabilitation teams. Secondary data included telephone surveys from discharged patients treated by the rehabilitation teams.
Who cannot join
- VA sites which did not submit data to the VA-FSOD - the national functional outcomes database
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to determine if 1. Rehabilitation staff can be trained to work better together as a team; and 2. Better team work improves patient outcomes.
Read the detailed description
The benefits of team treatment are widely accepted. Prior research has shown that how rehabilitation teams go about their work makes a difference in the patients they treat. However, there is little information about what, specifically, the team does that results in patients who are able to do more for themselves. The objectives of this clinical trial was to test whether a team training intervention in stroke rehabilitation was associated with improved patient outcomes. We conducted a cluster randomized trial of 31 rehabilitation units comparing stroke outcomes between intervention and control groups. in thirty-one VA medical centers with 237 clinical staff on 16 control teams and 227 staff on 15 intervention teams. There were 487 stroke patients treated by these teams before and after the intervention.
The intervention consisted of a multiphase, staff training program delivered over six months, including: an off-site workshop emphasizing team dynamics, problem solving, and the use of performance feedback data; and action plans for process improvement; and telephone and videoconference consultations. Control and intervention teams received site- specific team performance profiles with recommendations to use this information to modify team process.
The main outcomes measures consisted of three patient outcomes: functional improvement as measured by the change in motor items of Function Independence Measure (FIM), community discharge, and length of stay (LOS). For both the primary (stroke only) and secondary analyses (all patients), there was a significant difference in improvement of functional outcome between the two groups, with the percentage of stroke patients gaining more than a median FIM gain of 23 points increasing significantly more in the intervention group (difference in increase = 13.6%, P=0.032). There was no significant difference on LOS or rates of community discharge. Stroke patients treated by staff who participated in a team training program were more likely to make functional gains than those treated by staff receiving information only. This study is a randomized cluster trial which tested used workshops to train rehabilitation staff. Patients treated by trained teams were compared with patients treated by teams that did not have workshop training. Stroke patients
- Conditions
- Stroke
- Being tested
- Information feedback
- Keywords
- Patient Care Team, Rehabilitation outcomes, Treatment outcomes
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information feedbackBehavioural
The experimental arm consisted of a six month staff training period. The core of the intervention consisted of a concentrated 2.5 day workshop in Atlanta for 29 rehabilitation team leaders from 15 VA hospitals. Several weeks after the workshop, participants received a custom action plan developed on issues discussed in the workshop. The experimental arm also received a summary of results of the initial survey along with comparative data from all other sites. During the subsequent 5 months after the workshop, research staff maintained regular contact with research participants through telephone and videoconferencing. The comparison arm (staff on 16 teams) completed the identical summary of staff, hospital, and team characteristics. The local PIs at the Comparison sites received summaries of the survey findings, comparative data from other participating VA sites, and suggestions on how this information could be used to improve patient outcomes.
Information feedbackBehavioural
The comparison arm (staff on 16 teams) completed the identical summary of staff, hospital, and team characteristics. The local PIs at the Comparison sites received summaries of the survey findings, comparative data from other participating VA sites, and suggestions on how this information could be used to improve patient outcomes. In addition, participants in the comparison arm were invited to contact the research staff for help in interpreting data or to set-up a process improvement initiative.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | The experimental arm consisted of a six month staff training period with an emphasis on effective team functioning to improve patient outcomes. The core of the intervention consisted of a concentrated 2.5 day workshop in Atlanta for 29 rehabilitation team leaders from 15 VA hospitals. Several weeks after the workshop, participants received a custom action plan developed on issues discussed in the workshop. The experimental arm also received a summary of results of the initial survey along with comparative data from all other sites. During the subsequent 5 months after the workshop, research staff maintained regular contact with research participants through telephone and videoconferencing Receives: Behavioral: Information feedback |
| Arm 2 | Active comparator | The comparison arm (staff on 16 teams) completed the identical summary of staff, hospital, and team characteristics. The local PIs at the Comparison sites received summaries of the survey findings, comparative data from other participating VA sites, and suggestions on how this information could be used to improve patient outcomes. In addition, participants in the comparison arm were invited to contact the research staff for help in interpreting data or to set-up a process improvement initiative. Receives: Behavioral: Information feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional gain as measured by motor FIM score
Measured: One year post team training intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startJan 2002
- Primary completionJan 2004
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Dale Christian Strasser, MD, Principal investigator, VA Medical Center, Decatur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237757
- Sponsor's protocol ID
- O3225-R
- Status last verified
- Jul 2013
- First submitted
- 7 Oct 2005
- Last updated
- 3 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Strasser DC, Falconer JA, Uomoto JM. Can quality of care indicators measure quality of care? Arch Phys Med Rehabil. 2012 Nov;93(11):2130-1; author reply 2131-2. doi: 10.1016/j.apmr.2012.04.035. No abstract available.
PubMed 23101971Stevens AB, Strasser DC, Uomoto J, Bowen SE, Falconer JA. Utility of Treatment Implementation methods in clinical trial with rehabilitation teams. J Rehabil Res Dev. 2007;44(4):537-46. doi: 10.1682/jrrd.2006.09.0120.
PubMed 18247250Strasser DC, Uomoto JM, Smits SJ. The interdisciplinary team and polytrauma rehabilitation: prescription for partnership. Arch Phys Med Rehabil. 2008 Jan;89(1):179-81. doi: 10.1016/j.apmr.2007.06.774.
PubMed 18164351Strasser DC, Smits SJ, Falconer JA, Herrin JS, Bowen SE. The influence of hospital culture on rehabilitation team functioning in VA hospitals. J Rehabil Res Dev. 2002 Jan-Feb;39(1):115-25.
PubMed 11926323Strasser DC, Falconer JA, Herrin JS, Bowen SE, Stevens AB, Uomoto J. Team functioning and patient outcomes in stroke rehabilitation. Arch Phys Med Rehabil. 2005 Mar;86(3):403-9. doi: 10.1016/j.apmr.2004.04.046.
PubMed 15759219Strasser DC, Burridge AB, Falconer JA, Herrin J, Uomoto J. Measuring team process for quality improvement. Top Stroke Rehabil. 2010 Jul-Aug;17(4):282-93. doi: 10.1310/tsr1704-282.
PubMed 20826416Strasser DC, Falconer JA, Stevens AB, Uomoto JM, Herrin J, Bowen SE, Burridge AB. Team training and stroke rehabilitation outcomes: a cluster randomized trial. Arch Phys Med Rehabil. 2008 Jan;89(1):10-5. doi: 10.1016/j.apmr.2007.08.127.
PubMed 18164324Smits SJ, Falconer JA, Herrin J, Bowen SE, Strasser DC. Patient-focused rehabilitation team cohesiveness in veterans administration hospitals. Arch Phys Med Rehabil. 2003 Sep;84(9):1332-8. doi: 10.1016/s0003-9993(03)00197-7.
PubMed 13680570Strasser DC, Burridge AB, Falconer JA, Uomoto JM, Herrin J. Toward spanning the quality chasm: an examination of team functioning measures. Arch Phys Med Rehabil. 2014 Nov;95(11):2220-3. doi: 10.1016/j.apmr.2014.06.013. Epub 2014 Jul 4.
PubMed 25007707
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Team Functioning and Patient Outcomes
- ClinicalTrials.gov ID
- NCT00237757
- Acronym / sponsor ID
- O3225-R
- Conditions
- Stroke
- Keywords
- Patient Care Team, Rehabilitation outcomes, Treatment outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jan 2002
- Primary completion
- Jan 2004 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 12 Oct 2005 (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 the study is to determine if 1. Rehabilitation staff can be trained to work better together as a team; and 2. Better team work improves patient outcomes.
Detailed description
The benefits of team treatment are widely accepted. Prior research has shown that how rehabilitation teams go about their work makes a difference in the patients they treat. However, there is little information about what, specifically, the team does that results in patients who are able to do more for themselves. The objectives of this clinical trial was to test whether a team training intervention in stroke rehabilitation was associated with improved patient outcomes. We conducted a cluster randomized trial of 31 rehabilitation units comparing stroke outcomes between intervention and control groups. in thirty-one VA medical centers with 237 clinical staff on 16 control teams and 227 staff on 15 intervention teams. There were 487 stroke patients treated by these teams before and after the intervention.
The intervention consisted of a multiphase, staff training program delivered over six months, including: an off-site workshop emphasizing team dynamics, problem solving, and the use of performance feedback data; and action plans for process improvement; and telephone and videoconference consultations. Control and intervention teams received site- specific team performance profiles with recommendations to use this information to modify team process.
The main outcomes measures consisted of three patient outcomes: functional improvement as measured by the change in motor items of Function Independence Measure (FIM), community discharge, and length of stay (LOS). For both the primary (stroke only) and secondary analyses (all patients), there was a significant difference in improvement of functional outcome between the two groups, with the percentage of stroke patients gaining more than a median FIM gain of 23 points increasing significantly more in the intervention group (difference in increase = 13.6%, P=0.032). There was no significant difference on LOS or rates of community discharge. Stroke patients treated by staff who participated in a team training program were more likely to make functional gains than those treated by staff receiving information only. This study is a randomized cluster trial which tested used workshops to train rehabilitation staff. Patients treated by trained teams were compared with patients treated by teams that did not have workshop training. Stroke patients
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Information feedbackThe experimental arm consisted of a six month staff training period with an emphasis on effective team functioning to improve patient outcomes. The core of the intervention consisted of a concentrated 2.5 day workshop in Atlanta for 29 rehabilitation team leaders from 15 VA hospitals. Several weeks after the workshop, participants received a custom action plan developed on issues discussed in the workshop. The experimental arm also received a summary of results of the initial survey along with comparative data from all other sites. During the subsequent 5 months after the workshop, research staff maintained regular contact with research participants through telephone and videoconferencing |
| Arm 2 | Active comparator | Behavioral: Information feedbackThe comparison arm (staff on 16 teams) completed the identical summary of staff, hospital, and team characteristics. The local PIs at the Comparison sites received summaries of the survey findings, comparative data from other participating VA sites, and suggestions on how this information could be used to improve patient outcomes. In addition, participants in the comparison arm were invited to contact the research staff for help in interpreting data or to set-up a process improvement initiative. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Randomized, controlled subjects were VA inpatient rehabilitation teams. Secondary data included telephone surveys from discharged patients treated by the rehabilitation teams.
Key exclusion criteria (1 listed)
- VA sites which did not submit data to the VA-FSOD - the national functional outcomes database
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 |
|---|---|---|
| Information feedbackThe experimental arm consisted of a six month staff training period. The core of the intervention consisted of a concentrated 2.5 day workshop in Atlanta for 29 rehabilitation team leaders from 15 VA hospitals. Several weeks after the workshop, participants received a custom action plan developed on issues discussed in the workshop. The experimental arm also received a summary of results of the initial survey along with comparative data from all other sites. During the subsequent 5 months after the workshop, research staff maintained regular contact with research participants through telephone and videoconferencing. The comparison arm (staff on 16 teams) completed the identical summary of staff, hospital, and team characteristics. The local PIs at the Comparison sites received summaries of the survey findings, comparative data from other participating VA sites, and suggestions on how this information could be used to improve patient outcomes. | Behavioural | Arm 1 |
| Information feedbackThe comparison arm (staff on 16 teams) completed the identical summary of staff, hospital, and team characteristics. The local PIs at the Comparison sites received summaries of the survey findings, comparative data from other participating VA sites, and suggestions on how this information could be used to improve patient outcomes. In addition, participants in the comparison arm were invited to contact the research staff for help in interpreting data or to set-up a process improvement initiative. | Behavioural | Arm 2 |
Primary outcome
functional gain as measured by motor FIM score
Time frame: One year post team training intervention
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 3 Jul 2013.
- Background: PubMed 23101971Strasser DC, Falconer JA, Uomoto JM. Can quality of care indicators measure quality of care? Arch Phys Med Rehabil. 2012 Nov;93(11):2130-1; author reply 2131-2. doi: 10.1016/j.apmr.2012.04.035. No abstract available.
- Background: PubMed 18247250Stevens AB, Strasser DC, Uomoto J, Bowen SE, Falconer JA. Utility of Treatment Implementation methods in clinical trial with rehabilitation teams. J Rehabil Res Dev. 2007;44(4):537-46. doi: 10.1682/jrrd.2006.09.0120.
- Background: PubMed 18164351Strasser DC, Uomoto JM, Smits SJ. The interdisciplinary team and polytrauma rehabilitation: prescription for partnership. Arch Phys Med Rehabil. 2008 Jan;89(1):179-81. doi: 10.1016/j.apmr.2007.06.774.
- Background: PubMed 11926323Strasser DC, Smits SJ, Falconer JA, Herrin JS, Bowen SE. The influence of hospital culture on rehabilitation team functioning in VA hospitals. J Rehabil Res Dev. 2002 Jan-Feb;39(1):115-25.
- Results publication: PubMed 15759219Strasser DC, Falconer JA, Herrin JS, Bowen SE, Stevens AB, Uomoto J. Team functioning and patient outcomes in stroke rehabilitation. Arch Phys Med Rehabil. 2005 Mar;86(3):403-9. doi: 10.1016/j.apmr.2004.04.046.
- Results publication: PubMed 20826416Strasser DC, Burridge AB, Falconer JA, Herrin J, Uomoto J. Measuring team process for quality improvement. Top Stroke Rehabil. 2010 Jul-Aug;17(4):282-93. doi: 10.1310/tsr1704-282.
- Results publication: PubMed 18164324Strasser DC, Falconer JA, Stevens AB, Uomoto JM, Herrin J, Bowen SE, Burridge AB. Team training and stroke rehabilitation outcomes: a cluster randomized trial. Arch Phys Med Rehabil. 2008 Jan;89(1):10-5. doi: 10.1016/j.apmr.2007.08.127.
- Results publication: PubMed 13680570Smits SJ, Falconer JA, Herrin J, Bowen SE, Strasser DC. Patient-focused rehabilitation team cohesiveness in veterans administration hospitals. Arch Phys Med Rehabil. 2003 Sep;84(9):1332-8. doi: 10.1016/s0003-9993(03)00197-7.
- Derived from this study: PubMed 25007707Strasser DC, Burridge AB, Falconer JA, Uomoto JM, Herrin J. Toward spanning the quality chasm: an examination of team functioning measures. Arch Phys Med Rehabil. 2014 Nov;95(11):2220-3. doi: 10.1016/j.apmr.2014.06.013. Epub 2014 Jul 4.
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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.
Dale Christian Strasser, MD principal investigator
VA Medical Center, Decatur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information feedback in people with Stroke, run by US Department of Veterans Affairs at 1 site in United States.
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 1 inclusion and 1 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 3 Jul 2013. 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 United States. 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.
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?
functional gain as measured by motor FIM score (time frame: One year post team training intervention). 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 NCT00237757, which also lists 9 linked publications.
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 3 Jul 2013.