Background
Methods
Trial design
Study setting and participants
Intervention and control conditions
Procedure
Outcome measurement
Assessment of fidelity of delivery
Statistical analysis
Sample size
Deviations from published protocol
Results
Variable | Unique participants | All participant observations | ||
---|---|---|---|---|
Control period n = 82 | Intervention period n = 105 | Control period n = 210 | Intervention period n = 206 | |
Age (mean ± SD) (range) | 80.5 ± 10.7 (40–99) | 78.6 ± 12.9 (23–100) | 80.7 ± 10.2 (40–99) | 77.9 ± 13.5 (23–100) |
Women (n; %) | 49; 59.8 | 69; 65.7 | 148; 70.5 | 135; 65.5 |
Men (n; %) | 33; 40.2 | 36; 34.3 | 62; 29.5 | 71; 34.5 |
Length of stay (days) (mean ± SD) (range) | 54.0 ± 39.7 (9–171) | 49.6 ± 37.8 (8–171) | 60.7 ± 41.5 (9–171) | 52.9 ± 37.3 (9–171) |
Primary diagnosis at discharge (n): Medical disordersa
| 26 | 33 | 65 | 53 |
Orthopaedic, musculoskeletal upper limb and lower limb fractures, excluding hip) | 14 | 24 | 33 | 51 |
Hip fracture | 9 | 8 | 32 | 18 |
Stroke | 8 | 13 | 13 | 37 |
Other neurological disease (includes Parkinson’s disease and dementia) | 6 | 10 | 16 | 20 |
Cardiac | 5 | 4 | 15 | 6 |
Respiratory | 12 | 11 | 32 | 18 |
Other surgery | 2 | 1 | 4 | 3 |
Nutritional status: SGA A (well nourished) (n (%)) |
n = 81 41 (50.6) |
n = 101 48 (47.5) |
n = 208 111 (53.4) |
n = 200 96 (48.0) |
SGA B (mildly or moderately malnourished) (n (%)) | 37 (45.7) | 48 (47.5) | 92 (44.2) | 93 (46.5) |
SGA C (severely malnourished) (n (%)) | 3 (3.7) | 5 (5.0) | 5 (2.4) | 11 (5.5) |
Body mass index (kg/m2): n (%) | ||||
<18.5 |
n = 81 10 (12.3) |
n = 101 17 (16.8) |
n = 210 22 (10.5) |
n = 202 28 (13.9) |
≥18.5 | 71 (87.7) | 84 (83.2) | 188 (89.5) | 174 (86.1) |
Admission FIM |
n = 82 |
n = 103 |
n = 207 |
n = 204 |
Total score (range 18–126) (mean ± SD) | 66.0 ± 21.4 | 66.1 ± 21.5 | 65.0 ± 19.9 | 63.1 ± 23.3 |
Eating component (range 1–7) (mean ± SD) | 5.1 ± 1.5 | 5.2 ± 1.6 | 5.1 ± 1.4 | 5.0 ± 1.6 |
Discharge FIM |
n = 76 |
n = 100 |
n = 202 |
n = 203 |
Total score (range 18–126) (mean ± SD) | 82.3 ± 25.6 | 82.7 ± 27.2 | 83.5 ± 23.3 | 81.8 ± 28.4 |
Eating component (range 1–7) (mean ± SD) | 5.9 ± 1.4 | 5.8 ± 1.6 | 6.0 ± 1.3 | 5.7 ± 1.6 |
Hand grip strength (kg) (mean ± SD) |
n = 75 15.3 ± 9.0 |
n = 95 14.4 ± 8.1 |
n = 187 14.3 ± 7.6 |
n = 186 15.0 ± 9.1 |
Death during admission (n; %) | 4; 4.8 | 2; 1.9 | 7; 3.4 | 5; 2.4 |
Control period
n = 210 | Intervention period
n = 206 | Cumulative unit-level effect of intervention over timea (coefficient [robust 95% CI], p value) | Intracluster correlation coefficient: unit (95% CI) | Intracluster correlation coefficient: patient within unit (95% CI) | Cumulative unit-level effect of intervention over timea (adjusted coefficient [robust 95% CI], p value) | Intracluster correlation coefficient: unit (95% CI) | Intracluster correlation coefficient: patient within unit (95% CI) | |
---|---|---|---|---|---|---|---|---|
Energy intake (kJ/day) (mean ± SD) | 6532 ± 2328 | 6479 ± 2486 | -51 (-699 to 597), p = 0.876 | 1.14 × 1011 (NA to 1) | 0.43 (0.37 to 0.50) | 515 (-237 to 1269), p = 0.179 | 2.37 × 1021 (2.37 × 1021 to 2.37 × 1021) | 0.31 (0.24 to 0.40) |
Protein intake (g/day) (mean ± SD) | 67.0 ± 25.2 | 68.6 ± 26.0 | -0.63 (-7.585 to 6.334), p = 0.860 | 1.43 × 1016 (1.43 x 1016 to 1.43 × 1016) | 0.005 (3.52 × 109 to 1.00) | 2.53 (-5.56 to 10.62), p = 0.540 | 3.06 × 1014 (NA to 1) | 0.002 (1.47 × 1018 to 1) |
Energy deficitb (kJ/day) (mean ± SD) | 1392 ± 3037 | 1116 ± 2967 | -291 (-1104 to 521), p = 0.483 | 0.04 (0.005 to 0.28) | 0.73 (0.65 to 0.79) | -1405 (-2354 to -457), p = 0.004 | 0.015 (0.0003 to 0.44) | 0.73 (0.65 to 0.79) |
Protein deficitb (g/day) (mean ± SD) | 7.1 ± 32.1 | 2.6 ± 30.1 | -0.44 (-6.69 to 5.80), p = 0.890 | 0.01 (0.0002 to 0.38) | 0.67 (0.59 to 0.75) | -0.44 (-6.69 to 5.81), p = 0.890 | 1.86 × 106 (NA to 1) | 0.33 (0.25 to 0.42) |
Protected Mealtimes policy component | Control period | Intervention period |
---|---|---|
Mealtime interruptions: | ||
Number of positive interruptions | 805 | 1016 |
Length of positive interruptions (seconds)(median, IQR)a
| 18 (5–50) | 20 (8–52) |
Reason for positive interruptions; n (%) | ||
Mealtime assistance | 167 (20.7) | 227 (22.3) |
Encouragement with eating | 180 (22.4) | 268 (26.4) |
Re-positioning | 124 (15.4) | 183 (18.0) |
Assistance with opening food packaging | 111 (13.8) | 176 (17.3) |
Other reason | 219 (27.2) | 158 (15.6) |
No reason recorded | 4 (0.5) | 4 (0.4) |
Number of negative interruptions | 579 | 477 |
Length of negative interruptions (seconds)(median, IQR) | 50 (23–132) | 54 (23–140) |
Reason for negative interruptions: n (%) | ||
Medications | 235 (40.6) | 206 (43.2) |
Ward round | 12 (2.1) | 1 (0.2) |
Patient observations (e.g. temperature, BP) | 42 (7.3) | 39 (8.2) |
Non-essential treatment | 68 (11.7) | 36 (7.5) |
Interview | 64 (11.0) | 32 (6.7) |
Support staff role (e.g. menu completion) | 33 (5.7) | 26 (5.4) |
Telephone call | 7 (1.2) | 17 (3.6) |
Other | 115 (19.9) | 120 (25.2) |
Missing | 3 (0.5) | 0 |
Non-nurses providing mealtime assistance (mean per meal) | 1.3 | 2.9 |
Nurses providing mealtime assistance (mean per meal) | 0.9 | 1.3 |
Patient required toilet during meals (n) | 7 | 15 |
Observation of patient hand washing prior to food consumption (where hands could be washed) n (%) | 73 (11.8) | 63 (9.9) |
Observation of patient in an upright position to eat meal; n (%) | 591 (95.9) | 593 (94.4) |
Ability to reach food within 10 minutes of meal commencement; n (%) | 581 (93.4) | 588 (92.5) |
Functional Independence Measure completed (of unique participants) n (%) | 81 (98.8) | 104 (99.0) |
Meal sign displayed (during meals observed) n (%) | 13 (48.1) | 31 (93.9) |
Ward entry doors closed (during meals observed) n (%) | 9 (33.3) | 23 (69.7) |
Staff providing mealtime assistance being called to the telephone (n) | 2 | 2 |
Dining room in use | Not measured | No change |
Dining room clean and set up for dining | 11 of 11 | 12 of 12 |