Background
Methods
Quantitative
Design
Population
Eligibility was assessed at 3 levels: LTC facility, resident, and wound
Randomisation
Time (Months) | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Facility number
|
12
| - | - | - | - | - | - | - | c | c | c | c | c | c |
P1
|
P1
|
P1
|
P2
|
11
| - | - | - | - | - | - | c | c | c | c | c |
P1
|
P1
|
P1
|
P2
|
P2
|
P2
| |
10
| c | c | c | c | c | c | c | c | c | c | c | c |
P1
|
P1
|
P1
|
P2
|
P2
| |
9
| c | c | c | c | c | c | c | c | c | c | c |
P1
|
P1
|
P1
|
P2
|
P2
|
P2
| |
8
| c | c | c | c | c | c | c | c | c | c |
P1
|
P1
|
P1
|
P2
|
P2
|
P2
|
P2
| |
7
| c | c | c | c | c | c | c | c | c |
P1
|
P1
|
P1
|
P2
|
P2
|
P2
|
P2
|
P2
| |
6
| c | c | c | c | c | c | c | c |
P1
|
P1
|
P1
|
P2
|
P2
|
P2
|
P2
|
P2
|
P2
| |
5
| c | c | c | c | c | c | c |
P1
|
P1
|
P1
|
P2
|
P2
|
P2
|
P2
|
P2
|
P2
|
P2
| |
4
| c | c | c | c | c | c |
P1
|
P1
|
P1
|
P2
|
P2
|
P2
|
P2
|
P2
|
P2
|
P2
|
P2
| |
3
| c | c | c | c | c |
P1
|
P1
|
P1
|
P2
|
P2
|
P2
|
P2
|
P2
|
P2
|
P2
|
P2
|
P2
| |
2
| c | c | c | c |
P1
|
P1
|
P1
|
P2
|
P2
|
P2
|
P2
|
P2
|
P2
|
P2
|
P2
|
P2
|
P2
| |
1
| c | c | c |
P1
|
P1
|
P1
|
P2
|
P2
|
P2
|
P2
|
P2
|
P2
|
P2
|
P2
|
P2
|
P2
|
P2
|
Intervention: Enhanced Multi-Disciplinary Team (EMDT)
Control: "Usual" care
Outcome measures
Sample size estimation
Statistical methods
Qualitative evaluation
Economic evaluation
Results
Quantitative
Facility and resident recruitment
LTC facility | PU prevalence (%) based on Q42009 MDS from CIHI | PU prevalence (%) based on PUs reported to study staff at study start (i.e. Oct 2010 for facilities 1-10; April 2011 for facility 11; May 2012 for facility 12) | PU prevalence (%) based on PUs reported to study staff 2 wks. prior to Intervention start | PU prevalence (%) based on PU identification by APNs at Intervention start (i.e. bedside audit) | PU prevalence (%) based on PUs reported to study staff at study end |
---|---|---|---|---|---|
1
| 9.9 | 4.4 | 6.2 | 6.8 | 4.4 |
2
| 10.2 | 5.9 | 2.5 | 3.5 | 2.0 |
3
| 5.9 | 3.3 | 9.2 | 9.2 | 8.3 |
4
| 7.0 | 4.4 | 1.0 | 3.9 | 0** |
5
| 8.4 | 5.6 | 2.5 | 2.5 | 0 |
6
| 6.3 | 3.8 | 2.9 | 3.8 | 0.8 |
7
| 7.9 | 2.4 | 2.4 | 5.7 | 3.3 |
8
| 6.8 | 0.6 | 0.6 | 5.7 | 4.4 |
9
| 12.3 | 2.5 | 6.0 | 6.0 | 4.3 |
10
| 6.7 | 1.9 | 3.8 | 3.8 | 4.4 |
11
| 9.5 | 6.3 | 3.1 | 4.4 | 3.1 |
12
| 6.8 | 3.7 | 2.1 | 2.1* | 1.6 |
Mean(SD)
|
8.1 (1.9)
|
3.7 (1.7)
|
3.5 (2.5)
|
4.7 (2.0)
|
3.0 (2.4)
|
Variable | Control (N = 67*) | Intervention (N = 94*) |
---|---|---|
Age
| 81 (12) | 83 (12) |
Sex (Female)
| 43 (64.2%) | 65 (69.1%) |
Charlson co-morbidities
| ||
Alzheimer's/Dementia | 38 (56.7%) | 62 (66.0%) |
Diabetes | 22 (32.8%) | 36 (38.3%) |
Stroke/TIA | 20 (29.9%) | 29 (30.9%) |
Diabetes with end organ damage | 10 (14.9%) | 22 (23.4%) |
Paraplegia/Hemiplegia | 11 (16.4%) | 15 (16.0%) |
Any solid tumour | 6 (9.0%) | 16 (17.0%) |
COPD | 10 (14.9%) | 7 (7.4%) |
Congestive Heart Failure | 4 (6.0%) | 11 (11.7%) |
Peripheral Vascular Disease | 5 (7.5%) | 6 (6.4%) |
Myocardial Infarction | 3 (4.5%) | 6 (6.4%) |
Moderate or severe renal disease | 1 (1.5%) | 4 (4.3%) |
Charlson Co-morbidity Index | 3 (2) | 3 (2) |
Other co-morbidities
| ||
Hypertension | 37 (55.2%) | 55 (58.5%) |
Osteoarthritis | 36 (53.7%) | 42 (44.7%) |
Osteoporosis | 23 (34.3%) | 33 (35.1%%) |
Coronary Artery Disease | 15 (22.4%) | 18 (19.1%) |
Parkinson's disease | 7 (10.4%%) | 9 (9.6%) |
Contractures | 5 (7.5%) | 6 (6.4%%) |
Spasticity | 4 (6.0%) | 5 (5.3%) |
PU Risk factors
| ||
Incontinence (urine) | 66 (98.5%) | 91 (96.8%) |
Incontinence (stool) | 58 (86.6%) | 79 (84.0%) |
Bedbound | 49 (81.7%%) | 71 (87.7%) |
Mental Status (Not alert/not oriented) | 52 (77.6%) | 78 (83.0%) |
Nutritional supplement | 55 (82.1%) | 80 (85.1%) |
Tube Feed | 5 (7.5%) | 7 (7.4%) |
Body Mass Index | 25 (8) | 24 (6) |
Outcomes
Primary outcome
Description of model | Pre-intervention slope (β) NB: negative values indicate healing | Effect of intervention | |||
---|---|---|---|---|---|
Change in slope (Δ0) NB: values < 0 indicate benefit | Relative effect on healing NB: values < 1 indicate benefit | p-value | |||
Estimate | 95% CI | ||||
Random effect for intercept and slope, common treatment effect, wound stage, CCI, recurrence, bedbound, any incontinence | -0.116 | 0.0055 | 1.006 | 0.985-1.027 | 0.605 |
Random effect for intercept and slope, common treatment effect* | -0.114 | 0.0062 | 1.006 | 0.985-1.027 | 0.539 |
Random effect for intercept slope, and treatment effect* | -0.122 | 0.0171 | 1.020 | 0.993-1.042 | 0.161 |
Random effect for intercept and slope, common treatment effect, control for stage at diagnosis | -0.115 | 0.0053 | 1.006 | 0.985-1.026 | 0.615 |
Models run by stage*
| |||||
Stage II: Random effect for intercept and slope, common treatment effect | -0.116 | -0.040 | 0.968 | 0.882-1.062 | 0.079 |
Stage III: Random effect for intercept and slope, common treatment effect | -0.126 | 0.005 | 1.005 | 0.958-1.055 | 0.828 |
Stage IV: Random effect for intercept and slope, common treatment effect | -0.125 | 0.050 | 1.050 | 1.014-1.088 | 0.006 |
Unstageable: Random effect for intercept and slope, common treatment effect | -0.158 | 0.013 | 1.013 | 0.972-1.056 | 0.534 |
Group | Healing rate (Standard error) | Difference in healing rates (Standard error) NB: negative values indicate benefit | Relative effect on healing (95% CI) | p-value |
---|---|---|---|---|
(a) Pre-intervention
| -0.156 (0.087) | 0.050 (0.094) | 1.051 (0.874-1.263) | 0.5916 |
(b) Post-intervention
| -0.106 (0.030) | |||
(c) Pre-and post-intervention
| N/A | -0.070 (0.047) | 0.932 (0.850-1.022) | 0.1363 |
Secondary outcomes
Time to healing
Variable | Hazard ratio (95% CI) | p-value |
---|---|---|
Intervention
| 1.48 (0.79,2.78) | 0.22 |
Log(initial PU area)
| 0.65 (0.51,0.83) | 0.00045 |
Para/hemiplegia or CVA
| 0.76 (0.43,1.36) | 0.36 |
CCI = 3-5 vs. CCI = 0-2
| 1.54 (0.90,2.64) | 0.12 |
CCI ≥ 6 vs. CCI = 0-2
| 0.68 (0.31,1.49) | 0.34 |
Recurrent PU
| 1.55 (0.41,5.85) | 0.52 |
Wound stage | Hazard ratio (95% CI) | p-value |
---|---|---|
II
| 1.02 (0.40,2.63) | 0.96 |
III
| 2.16 (0.87,5.34) | 0.096 |
IV
| 1.58 (0.20,12.67) | 0.66 |
Unstageable
| 1.00 (0.24,4.17) | 1.0 |
Facility | Intervention |
---|---|
1 | 0.94 |
2 | 0.48 |
3 | 1.62 |
4 | 1.94 |
5 | 0.93 |
6 | 2.20 |
7 | 2.29 |
8 | 0.49 |
9 | 0.64 |
10 | 0.92 |
11 | 0.68 |
12 | 0.76 |
Percentage of Wounds Healed
Incidence rate
Wound pain
PU prevalence
Hospitalizations
Emergency department (ED) visits
Utility
Process measure: expert wound team referrals
Qualitative
Economic
Cost category | UC | EMDTs | Difference |
---|---|---|---|
Personnel costs
| |||
Study nurse | N/A | $101 | $101 |
MDT | N/A | $20 | $20 |
ET | $357 | $18 | -$340 |
Facility nurse | $1,094 | $1,486 | $392 |
Total personnel costs
|
$1,451
|
$1,624
|
$173
|
Treatments and supplies costs
| |||
Antibiotics | $84 | $38 | -$46 |
Dressings | $1,623 | $2,284 | $661 |
NPWT | $3,142 | $0 | -$3,142 |
Total treatments and supplies costs
|
$4,849
|
$2,322
|
-$2,527
|
Hospital costs
| |||
Inpatient | $4,147 | $5,792 | $1,645 |
Ambulatory (ER) | $250 | $310 | $60 |
Total hospital costs
|
$4,397
|
$6,102
|
$1,705
|
Grand Total
|
$10,697
|
$10,048
|
-$649
|
Grand total (w/o Dressings costs)
|
$9,074
|
$7,764
|
-$1,310
|
Grand total (w/o NPWT costs)
|
$7,555
|
$10,048
|
$2,493
|
Grand total (w/o Hospital costs)
|
$6,300
|
$3,946
|
-$2,354
|
Grand total (w/o Dressings, NPWT costs)
|
$5,932
|
$7,764
|
$1,832
|
Grand total (w/o Dressings, Hospital costs)
|
$4,677
|
$1,662
|
-$3,015
|
Grand total (w/o NPWT, Hospital costs)
|
$3,158
|
$3,946
|
$788
|
Grand total (w/o Dressings, NPWT, Hospital costs)
|
$1,535
|
$1,662
|
$127
|