Recruitment and retention
Between November 2021 and March 2022, the four selected care homes (see Table 1) ran the CONTACT program 24/7 for two months. Despite ending as planned, the feasibility study did not meet its pre-determined progression criteria for a full RCT (Randomized Control Trial).
Of 156 screened residents, 105 consented (either personally or through a nominee) to wear a device, with 102 (97%) wearing them at the start of the two-month intervention. Of the 225 staff deemed eligible, 82.4% (n = 178) agreed to participate, but 20 dropped out before the intervention started.
Ineligibility among residents was solely due to staff concerns that wearing the device could pose a risk of harm. Of the residents who declined to wear the devices, 14 did not give a reason, two were disinterested, four did not receive consent from their nominees, and two passed away before they could return their consent forms.
Of staff, 17 opted not to participate, with eight outright declining, seven not providing a reason, one objecting to wearing the device, and one simply expressing a lack of enthusiasm. Contextual factors for non-participating staff included six leaving the care home, five with imminent maternity leave, and seven categorized by managers as "rarely present" (sic.) bank staff.
The demographic profiles of the homes were female and white. Most residents had been in the homes for an extended period, and both staff and residents had been vaccinated against COVID-19. More than a third of residents lived with a dementia diagnosis (see Table 4).
Table 4
baseline characteristics of staff and residents
| Residents (n = 102) | Staff (n = 158) |
Mean Age (SD) | 86.1 (8.58) | 42.1 (14.75) |
Male | 27 (27.00%) | 20 (12.66%) |
Female | 73 (73.00%) | 137 (86.71%) |
Ethnicity: White | 101 (100.00%) | |
Length of time in care home in weeks Median (range) | 99.5 (2, 590) | |
Previous + COVID-19 test | 20 (20.00%) | 41 (26.28%) |
Weeks since + test, Median (range) | 47.0 (22, 65) | 46.0 (3, 88) |
COVID-19 Vaccinated | 99 (99.00%) | 154 (99.35%) |
dementia diagnosis | 38 (37.62%) | |
dementia severity: mild | 9 (24.32%) | |
dementia severity: moderate | 18 (48.65%) | |
dementia severity: severe | 10 (27.03%) | |
Length of employment in home in weeks, median (range) | | 123.5 (0, 1302) |
Employment status |
Permanent | | 140 (90.32%) |
Bank | | 15 (9.68%) |
Role |
Direct care/nursing staff | | 101 (64.33%) |
Specialist non-clinical role | | 1 (0.64%) |
Manager | | 6 (3.82%) |
Estates/maintenance | | 3 (1.91%) |
Clerical/administrative | | 7 (4.46%) |
Catering | | 17 (10.83%) |
Cleaner | | 11 (7.01%) |
Other (please specify) | | 11 (7.01%) |
Work in more than one home: yes | | 1 (0.63%) |
Work in more than one home: no | | 157 (99.37%) |
Acceptability and feasibility of intervention delivery
Ease of administering devices to residents, staff, and external visitors.
Getting devices to participants was moderately successful, with 69.5% of screened residents and 86.9% of staff receiving BLE wearables. But, participation in CONTACT was burdensome and added to regular. Staff highlighted screening processes, obtaining consent, and registering participants as particularly laborious. COVID-19 restrictions meant homes conducted recruitment themselves. Their limited digital and data infrastructure meant screening was manual and time-consuming. Larger homes bore a heavier burden. Apart from home four however, all homes managed to complete screening on time.
Recruiting residents lacking mental capacity25 to make decisions for themselves, and thus provide consent, meant contacting designated consultees and further adding to the workload. In some instances, the homes found the workload associated with the study outweighed the perceived benefits.
“I find I have to shuffle things around to make it work. When things were heavier, I would usually finish at 5, but during the screening and consent time I had to stay late at night to contact the families. It was hard it fit it into an already hard day” (Home 1, study champion)
The study’s research governance requirements contributed to CONTACT’s complexity. Every BLE wearable device's unique number (used by the study team) needed to be cross-referenced against a 'master log' in each home for the home to identify the wearer. Communications involving identifiable data were carried out via a secure file transfer system. However, university secure databases for registering participants and reporting Covid-19 cases encountered technical issues, adding further to delays.
Homes 1–3 successfully dispensed devices within a month from consent and before the feasibility start date. Conversely, home four managed to issue only 66% of their BLE wearables after the study start date, with a mean delay of 58.3 days (SD = 26.57). Because of Home 4, the mean time from consent to issuing resident devices was 41 days (SD = 23.87). Several reasons were given for the 10 resident withdrawals, including residents not wanting to wear a device or feeling distressed or confused by them.
Issuing staff devices was efficient. Homes distributed them within an average of 36 days (SD = 15.31). Home 4 took slightly longer with an average of 41.5 days (SD = 20.32). Reasons for staff withdrawals included no longer wanting to wear the device and finding the device irritating or inconvenient.
An original study objective was assessing the feasibility of BLE wearables for tracking visitors’ (relatives and community professionals) movements within the homes. All the homes conveyed that implementing the necessary procedures for this was not possible due to staffing constraints. Homes one and two did not have permanent reception staff, and the other homes judged the procedures involved too burdensome. Consequently, tracing visitors had to be dropped from study procedures.
We successfully appointed study champions in each home. But it was clear that CONTACT related work was in addition to existing work and so deprioritised:
It was the time element. I don’t have an administrator or anyone else to help me with my tasks; it’s just me. CONTACT wasn’t at the top of the list by far. We said we would try our best with it, but we couldn’t” (Home 3, manager and champion)
Home managers’ NoMaD scored aspects of CONTACT familiarity, and current and future chances of “normalisation” (see Table 5). Managers from Homes 1 and 2 had more familiarity with CONTACT at the end of the study, and the manager of Home 1 believed CONTACT could become a regular part of their operations. Feedback from Homes 2 and 4 was less optimistic (see Table 5).
Table 5
selected adapted NoMaD scores from home managers
NoMaD ITEM | Home (Start, End) |
| 1+ (S) | 2 (S) | 2(E) | 3 (S) | 3 (E) | 4 (S) | 4 (E) |
When you use devices how familiar does it feel* | 10 | 8 | 5 | 6 | 10 | 8 | 10 |
CONTACT is currently a normal part of your work* | 5 | 5 | 5 | 6 | 7 | 8 | 10 |
CONTACT will become a normal part of your work* | 10 | 2 | - | 9 | 7 | 10 | 10 |
*Rated from 0 (unfamiliar) to 10 (completely familiar) |
+ No completion point data for Home 1 as home manager left before completion.
Device loss and damage were noteworthy. 11% of resident devices (n = 12) and 6.5% of staff devices (n = 7) were lost. Almost half (47.4%, n = 9) of lost or damaged devices were replaced. Fewer staff devices were lost (3.2%, n = 5) or damaged (4.4%, n = 7). Just 8.3% (n = 1) were renewed.
Fob wearables required frequent battery changes: 15% (n = 38) in Homes 3 and 4. These were supposed to be done by the homes, but Home 4’s delays meant a research team member undertook these over two visits. Card wearables in Homes 1 and 2 required no battery changes.
Acceptability and feasibility of structured CONTACT feedback
Home (1, 2 and 4) managers provided assessments of the i) understandability; ii) influence on IPC thought and iii) likelihood of changes based on the report (Fig. 4).
Figure 4 suggests certain study aspects were challenging and of limited usefulness. Understanding changes in contacts over time, assessing individual risk presentation, and gathering location information were particularly difficult and the least helpful aspects of the intervention.
No home managers were likely to instigate changes based on CONTACT’s structured reports. CONTACT’s research study context, alongside competing pressures such as maintaining staffing and pre-existing infection prevention and control (IPC) requirements, reduced the perceived value of the study's information; contributing to an overall perception that the study was of limited value:
“The triggered report covered mostly what we knew already. The scheduled report identified which residents are most at risk, but what can you really do with that information? We can make people isolate but then you lose staff. The staff do a lateral flow test before work every morning, that’s the protection we already have without losing too many staff” (Home 4, study champion)
“…it could work, preventing us having to close because we’ve got 2 cases out of 80 for any infection. We can easily isolate pockets of people if we needed to and staff as well. So, I can see if we didn’t have the national guidelines in place, where it would give me research-based information to make risk assessment decisions…. In the guidelines, it does say that registered managers are accountable for decisions. Outside of a trial, it would have given me the confidence to say this is what the infection is doing, and we can safely isolate that and carry on doing what we are doing with the other residents, so the residents don’t suffer from lack of visitors” (Home 4, manager)
A significant barrier to feasibility was a staff concern of, “being tracked”. A fear that affected trust and compliance with the study. As a result, scheduled reports were not shared by Home 4’s management with other staff. Reports were disseminated in the other homes. The follow-up support call from researchers after each report was perceived as highly beneficial by managers and champions.
Delivering the intervention required training for study champions and home staff. Of the 34 individuals invited to attend virtual training across 9 sessions, almost two-thirds (64.71%) participated.
Table 6
CONTACT training session attendance
Home | invited | attended | % |
1 | 9 | 3 | 33.33% |
2 | 4 | 4 | 100.00% |
3 | 7 | 5 | 71.43% |
4 | 14 | 10 | 71.43% |
Total | 34 | 22 | 64.71% |
Acceptability and feasibility of study design/implementation processes
Despite securing the necessary ethical and research governance approvals, we were unable to link residents in the homes to NHS (National Health Service) data. Dialogue with NHS Digital began a year before the intervention period, but linkage proved impossible in the timeframe. DSHC infection and mortality data for the homes was eventually secured - after the intervention period.
Data capture
Only around 28.7% (n = 70) of the devices functioned as expected, with only minor differences between resident (29.17%) and staff (28.38%) devices. Differences between (Fig. 5) and within homes (Fig. 6) existed. Apparent device malfunction could be due to battery failure, inappropriate device placement, or staff not updating weekly logs for active devices - a crucial element for correctly processing the dataset. Data transmission from our commercial partner to the university's secure database experienced no issues.
During the feasibility period, 33 (32.35%) of 102 residents and 53 (33.54%) of 158 staff reported COVID-19 infections, suggesting self-reported COVID-19 was a feasible primary outcome. However, the single reported case of staff gastroenteritis suggests, "other infections" was a less feasible outcome. Although all homes provided reported deaths (n = 7, 7.14%) during the intervention, only two homes (3 and 4) shared data regarding whether the deaths were COVID-19 related and the months from registration or device issue to death. Despite 86 infection notifications, only 52 (60.46%) contact reports were requested by the homes.
Progress against predefined criteria
The study did not meet any of our quantitative criteria for progression to a definitive RCT. Additionally, qualitative data from the homes indicated study demands were too burdensome and excessive. Projected compliance and participation rates were too low to justify a definitive trial.
Criterion
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Acceptability of the intervention
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The number (%) of residents consenting to wearing the device and issued a device at any time during their study period.
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62.8%
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The number (%) of staff consenting to wearing the device and issued a device at any time during their study period.
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67.7%
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Provision of the intervention
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The proportion of issued resident devices recording “correctly” during the study period.
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29.17%
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Acceptability of scheduled feedback report
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Demonstrated acceptability of outputs ascertained through manager interviews
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