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. 2022 Jul 8;2022(7):CD013116. doi: 10.1002/14651858.CD013116.pub2

1. Participant numbers in trials.

Participant numbers Agar 2017 Au 2012 Bernacki 2019 Clayton 2007 Epstein 2017 Lautrette 2007 Reinhardt 2014 Walczak 2017
Eligible for inclusion Nursing homes: 111 eligible
Participants:
148 UC
171 intervention
1292
1173 mailed introductory letter
Clinicians: 133 recruited
Patients:
9182 screened UC (8530 ineligible)
9395 screened
intervention (8842 ineligible)
196 Physicians: 38 eligible
Patients: 453 eligible
132 214 363
Excluded Nursing homes:
91 (55 did not meet criteria; 36 declined)
14 UC
11 intervention
30 screened out (did not meet criteria)
21 declined participation prior to screening
Clinicians: 6 pilot clinicians ineligible
Patients:
8987 UC
9211 intervention
22 Patients: 137 excluded (38 ineligible, 99 refused)
Refused to take part 645 (did not wish to participate)
101 (did not keep appointment)
Clinicians: 36
Patients: unclear
18 99 6 104 253
Randomised to intervention group(s) 10 homes, 160 participants
156 received allocated intervention
194 Clinicians: 48 (20 clusters)
Patients: 184 (20 clusters)
92 Physicians: 19
Patients: 139
Carers: 105
63 58 61
Randomised to control (usual care) group 10 homes, 134 participants
130 received allocation intervention
182 Clinicians: 43 (21 clusters)
Patients: 195 (19 clusters)
82 Physicians: 19
Patients: 142
Carers: 99
63 52 49
Excluded post‐randomisation (for each group; with reasons if relevant) UC 66
Intervention 89
All excluded because did not die during the study period
96 (intervention)
Death; lost to follow‐up; declined further surveys; completed 2 years
118 (UC)
Death; lost to follow‐up; declined further surveys; completed 2 years
Intervention: 184 (20 clusters) enrolled:
134 analysed (18 clusters); (50 total: no family/friend response, no baseline survey, withdrew)
34 (13 clusters) analysed: 74 died, 11 lost to follow‐up; 17 declined further surveys; 32 completed 2 years
UC: 195 (19 clusters) enrolled:
144 analysed (17 clusters); (51 total: no family/friend response, no baseline survey, withdrew)
26 patients (13 clusters) analysed: 77 died. 12 lost to follow‐up, 21 declined further surveys; 34 completed 2 years
Withdrawn (for each group; with reasons if relevant) UC 4
Intervention 4 (died before intervention)
Control 27 (14.5%)
3 patient‐clinician relationship changed
6 refuse to continue
9 not contactable
8 no target visit
1 too ill/deceased
Intervention 43 (22.2%)
4 patient‐clinician relationship changed
15 refuse to continue
8 not contactable
10 no target visit
3 too ill/deceased
3 other
Intervention 12
Control 8
None Intervention 6
Control 5
Intervention 11
Control 7
Lost to follow‐up (for each group; with reasons) Intervention: 11, no reason given
Control 12, no reason given
Intervention:
2, 1 mistakenly seen by a junior physician who was not participating in the study,
1 due to mechanical failure of tape recorder
Control: 2,
1 mistakenly seen by a junior physician who was not participating in the study
1 due to mechanical failure of tape recorder
Intervention: 3 died
Control:
1 died
1 lost to follow‐up
Intervention: did not answer telephone n = 4; experiencing severe emotional distress n = 5; refused interview n = 2
Control: did not answer telephone n = 3; experiencing severe emotional distress n = 1; refused interview n = 2; patient still alive n = 1
Total numbers reported at each time point
N = 96/110 completed 3‐month measures
N = 90/110 completed 6‐month measures
Plus an additional 3 where complete data were not available
NB also for several outcomes data for slightly lower numbers in total are available i.e. table 3 – ranges from n = 65 to n = 81. Not clear what happened to these missing measures
Intervention: 21 (34%)
Unclear; data collection hampered by declining health, attrition high (higher in intervention group) but no systematic reasons for differential dropout identified. Reasons for loss not reported specifically
Control: 9 (18%)
Reasons for loss not reported specifically
Included in the analysis (for each group, for each outcome) Intervention 67
Control 64
These numbers were analysed throughout, with losses for particular scales/assessments noted where applicable
Intervention 194
Control 182
Intervention
38 patients (13 clusters)
Control
26 patients (13 clusters)
Intervention 90
Control 80
Intervention 19 physicians, 130 patients
Control 19 physicians, 135 patients
Intervention 52 (83%)
Control 56 (89%)
6‐month data (longest time point)
Intervention 47
Control 40
Intervention 39
Control 40
Assessment of attrition bias for RoB ratings Assessed as low risk
Large proportion of data (participants randomised) missing. However, these were comparable for the 2 study groups, and was due to participants not dying during the study period (outcomes assessed for this study were focused on those around death)
Withdrawal rates for other reasons were low and comparable across groups
Assessed as unclear risk
Withdrawal 15% to 22% respectively control and intervention arms
Reasons for withdrawal/dropout were reasonably comparable except that more (15 versus 6) refused to continue participation in the intervention group
Authors report no differences in baseline characteristics regarding whether patients completed the study or were lost to follow‐up
ITT analysis was used; effect of imputed data on results was examined in analysis models with authors reporting similar results where imputed and non‐imputed data were used in analysis
Assessed as unclear risk
Patient participation rates and numbers analysable were low but comparable between arms
Authors note non‐participants and those not analysed were not significantly different from those who were analysed, and groups were still comparable (based on randomisation), although non‐participants were older, and less likely to have breast cancer than participants; and those patients with analysable data were more likely to be married and have higher incomes than those with non‐analysable data
Assessed as low risk
Low levels of loss to follow‐up 4/174; balanced across groups (n = 2 each), with comparable reasons
Assessed as low risk
"Fewer than 3% of follow‐up questionnaires were missing" (page 95)
Data seem otherwise complete for outcomes reported in main paper and in supplement 3
Assessed as low risk
Loss to follow‐up and withdrawals were acceptably low and comparable across study groups:
52/63 (83%) completed interviews at 90 days intervention group, 56/63 (89%) in control group
Reasons for withdrawal/loss were similar across groups (not answering telephone, refused interview), although higher rates of severe emotional distress in intervention group (n = 5) than control group (n = 1)
Assessed as unclear risk
Missing data were reported
110 were randomly assigned and completed baseline interviews; 96 (87%) completed 3 month outcomes; 90 (82%) completed 6 month outcomes
Losses were fairly comparable across groups and no major differences between those who completed the study and those who dropped out (on key demographic features) were noted by the authors
However, numbers were lower for some outcomes (such as ratings of care management) where n = 65 (numbers fairly comparable between the 2 groups)
Not clear what impact this may have had on the result, or what the reasons for this missing data were
Assessed as high risk
Attrition was high (31/110 (28%) lost to follow‐up), possibly largely explained by declining health of participants (patients)
Higher in intervention group. No systematic reasons for differential attrition were identified by authors but 34% dropout in intervention group is substantial and may introduce bias
Authors state that ITT analysis was used (according to group assignment) but dropout rates may be problematic
Additional notes The study was underpowered for the primary outcome because fewer participants died during the study period than predicted
Predicted sample size required recruitment of 272 participants (assuming 10% dropout rate) (17 per site)
Sample size calculated as 200 evaluable patients per arm for required power, assuming 6% dropout Trial is underpowered (sample size calculated at 140; 110 recruited; 79 completed) to detect differences between groups

ITT: intention to treat; RoB: risk of bias; UC: usual care.