Cluster recruitment
The numbers of care homes randomised and residents registered are summarised in Figure 1 by treatment arm, at baseline, at 6 months and at 16 months following randomisation for the original cohort and for the cross-sectional sample.
A total of 335 care homes were screened for entry into the trial. Of these, 241 randomly sampled care homes were approached and 94 homes expressing interest were formally assessed using the eligibility criteria. Of the 63 eligible care homes, 51 consented to take part and, following one consent withdrawal, 50 care homes were randomised into the trial (21 from Yorkshire, 15 from London and 14 from Oxford; see Appendix 1, Table 26). Nineteen care homes (38.0%) were randomised to the control group and 31 (62.0%) to the intervention group. Care homes were randomised over 16 months, from October 2014 to January 2016.
Resident participant flow and recruitment Original cohort
A total of 1564 residents were screened for eligibility from consenting care homes, of whom 1069 (68.4%) were eligible. Of those who were eligible, 781 (73.1%) were consented and, of those, 743 (95.1%) were registered. Finally, of those registered, 726 (97.7%) were consented and registered at the point of care home randomisation. The reasons for exclusion from the trial are summarised overall and by hub in Appendix 1, Table 27. Residents in the original cohort were registered over 15 months, from October 2014 to December 2015.
Additional resident recruitment at 16 months
Following the approved design change, a further 1444 residents were screened from 48 care homes 16 months after randomisation (see Appendix 1, Table 27). This included all residents already participating and those who had declined to take part when approached at baseline, who were then recorded as
ineligible, alongside participants failing to meet other eligibility criteria. The first two care homes randomised did not screen additional residents, as agreement for the design change was received after these care homes had completed the 16-month follow-up. Of the 1444 residents, 421 were eligible, 266 consented and 261 residents were subsequently registered (99 residents in control homes and 162 in intervention homes). A lower proportion of residents in London were ineligible as a result of being permanently bed-bound or terminally ill.
There was a higher proportion of ineligible residents of those screened (owing to not having a formal diagnosis of dementia) and of consent refusals in the intervention arm than in the control arm (see Appendix 1, Table 28). The additional residents were screened over 12 months, from June 2016 to May 2017.
Cross-sectional sample
Overall, at 16 months, a total of 675 residents were included in the cross-sectional sample: 414 residents from the original cohort who reached 16 months, and 261 additionally recruited residents. There were regional differences between hubs in resident ethnicity and funding type, with London reporting the lowest proportion of white residents and Oxford reporting the highest proportion of Local Authority funding (see Appendix 1, Table 29).
Baseline
• Residents died, n = 55 •Residents withdrawn, n = 0 • Residents moved out, n = 7 • No CMAI score at 6 months, n = 2
• Residents died, n = 54 • Residents withdrawn, n = 1 • Residents moved out, n = 6 • No CMAI score at 16 months, n = 0
• Residents died, n = 65 • Residents withdrawn, n = 1 • Residents moved out, n = 16 • No CMAI score at 6 months, n = 2 Care homes screened
(n = 335) Care homes not approached, as sufficient
number reached in area (n = 37; 11.0% of screened)
Approached (n = 241/335, 71.9%)
No response (n = 40; 16.6% of approached) (Several attempts at contact failed) Not interested
(n = 107; 44.4% of approached) • Not interested in research, n = 29 (27.1%) • Organisation declined, n = 27 (25.2%) • No/new manager, n = 11 (10.3%) • Too busy, n = 10 (9.3%) • Care home closed, n = 6 (5.6%)
• Taking part in other research, n = 4 (3.7%) • Ineligible, n = 4 (3.7%)
• Not interested in intervention, n = 4 (3.7%) • Other, n = 2 (1.9%)
• Reason not known, n = 10 (9.3%)
Interested
(n = 94/241, 39.0%) Not eligible (n = 31; 33.0% of interested) • Insufficient number of residents with dementia, n = 22 (71.0%)
• Had used DCM™ in last 18 months, n = 5 (16.1%) • Not suitable for participation (i.e. CQC status, admissions ban), n = 2 (6.5%)
• Staff unavailable to attend DCM™ training, n = 1 (3.2%)
• Involved in conflicting research, n = 1 (3.2%) Eligible (n = 63/94, 67.0%) Not consented (n = 12; 19.0% of eligible) • Staffing issues, n = 4 (33.3%) • Declined, n = 3 (25.0%)
• Care home being sold, n = 1 (8.3%) • Care home under administration, n = 1 (8.3%)
• No response from care home, n = 1 (8.3%) • Care home not required; sufficient number reached in area, n = 1 (8.3%) • Could not recruit minimum number of residents, n = 1 (8.3%)
Consented (n = 51/63, 80.9%)
Randomised 50 care homes and 726 residents registered
at randomisation
Withdrawn prior to randomisation (n = 1, 2.0%)
• Staffing issues, n = 1 (100%) No longer eligible (n = 57; 17.0% of screened) • CQC status, n = 36 (63.2%)
• Insufficient number of residents with dementia, n = 14 (24.6%)
• Insufficient number of permanent residents, n = 2 (3.5%)
• Participating in conflicting trial, n = 1 (1.8%) • Other, n = 4 (7.0%) Residents screened (n = 1564) • Eligible, n = 1069/1564 (68.4%) • Consented, n = 781/1069 (73.1%) • Registered, n = 743/781 (95.1%) Control Care homes (n = 19) • Assessed residents, n = 308
• Median residents/home (min., max.) = 14 (9, 36)
Intervention Care homes (n = 31) • Assessed residents, n = 418
• Median residents/home (min., max.) = 13 (8, 21)
Care homes (n = 19)
• Assessedresidents (closed cohort), n = 244 • Median residents/home (min., max.) = 11 (5, 25)
Care homes (n = 31)
• Assessedresidents (closed cohort), n = 334 • Median residents/home (min., max.) = 10 (5, 19) 6-month
follow-up
16-month follow-up (primary) Care homes withdrawn from intervention
(n = 0)
• Residents died, n = 92 • Residents withdrawn, n = 0 • Residents moved out, n = 22 • No CMAI score at 16 months, n = 2
Care homes withdrawn from intervention (n = 2)
Care homes (n = 19)
• Assessedresidents (closed cohort), n = 185 • Median residents/home (min., max.) = 9(4, 19) • Registered residents (additional), n = 99 and registered residents (cross-section), n = 287 • Median residents/home (min., max.) = 12 (4, 34) • Assessed residents (cross-section), n = 284
Care homes (n = 31)
• Assessedresidents (closed cohort), n = 220 • Median residents/home (min., max.) = 7 (1, 12) • Registered residents (additional), n = 162 and registered residents (cross-section), n = 388 • Median residents/home (min., max.) = 12 (5, 24) • Assessed residents (cross-section), n = 382
Investigation into potential recruitment bias of additional residents
As the additional residents for the cross-sectional sample were recruited following care home randomisation, age, gender, ethnicity, length of stay in care home and funding type were compared for all screened and registered residents (Table 4). Overall, there was a shorter length of stay in the additional cohort than in the original cohort, as was expected. Of the 726 residents included in the original cohort, 145 (20.0%) consented themselves, 263 (36.2%) were consented by a Personal Consultee and 318 (43.8%) were consented by a Nominated Consultee (see Appendix 1, Table 30). By contrast, of the 261 residents recruited at 16 months, 58 (22.2%) consented themselves, 73 (28.0%) were consented by a Personal Consultee and 130 (59.8%) were consented by a Nominated Consultee. There was no difference by arm in the proportion of residents who consented themselves, but a higher proportion were consented by Nominated Consultees in the intervention arm (n = 87, 53.7%) than in the control arm (n = 43, 43.4%).
Staff recruitment
There was a very poor return rate of staff questionnaire booklets (see Appendix 1, Table 31), despite the changes made to encourage return rates [i.e. removal of the GHQ-12 and personal data (see Chapter 2, Summary of changes to project protocol)]. Following consultation with oversight committees, it was agreed that persistence with obtaining staff data was important, as the intervention was designed to effect a ‘whole-home’ change. However, owing to low return rates, planned statistical analyses could not be conducted.
Relative/friend recruitment
At baseline, 197 relatives/friends were registered to the trial, with 96 in the control arm and 101 in the intervention arm. This reflects a larger proportion in the control arm, given the 2 : 3 randomisation allocation. The total number of relatives/friends registered to the trial reduced at 6 months (N = 170; control, n = 85; intervention, n = 85) and 16 months (N = 118; control, n = 63; intervention, n = 55) (see Appendix 1, Table 32), as might be expected with the high loss to follow-up rates. It was agreed by the oversight committees that, given the low percentage of data received, these data would not be useful when undertaking statistical analyses, with the exception of some of the health economic analyses (see Chapter 2, Health economic analysis). New relative/friend informants were therefore not identified at follow-up. When relatives/friends agreed to take part at baseline, we continued to request their follow-up data.