Background
Methods
Trial design
Patient/public involvement
Participants
Intervention description
Intervention arm
Intervention component | How delivered | Behaviour Change Techniques |
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Case finding | Reception staff identified patients who had not yet registered for organ donation by checking the back of every patient’s health card for their donor status | 4 BCTs: instruction on how to perform the behaviour; social support [practical]; prompt/cues; information about others’ approval |
Address previously identified barriers and enablers to organ donor registration | Reception staff provided pamphlets | 10 BCTs: instruction on how to perform the behaviour; information about others’ approval; credible source; social comparison; prompts/cues; verbal persuasion of capability; vicarious consequences; information about social and environmental consequences; salience of consequences; information about emotional consequences |
Immediate and available opportunity to register | An Internet-enabled tablet in the waiting rooms | 2 BCTs: adding objects to the environment; prompts/cues |
Control arm
Outcomes
Planned subgroup analyses
Sample size
Data collection methods
Randomization, blinding and inclusion criteria
Statistical methods
Post-trial process evaluation
Results
Recruitment and participants
Characteristics | Control (n=12,132) | Intervention (n=12,484) |
---|---|---|
Median age (25th, 75th percentile) | 55 (37–69) | 59 (41–72) |
Age category, % | ||
16 to 29 years | 1734 (14%) | 1599 (13%) |
30 to 40 years | 1768 (15%) | 1488 (12%) |
41 to 65 years | 4775 (39%) | 4647 (37%) |
66 to 80 years | 2774 (23%) | 3223 (26%) |
80+ years | 1081 (9%) | 1527 (12%) |
Female, % | 7696 (63%) | 7976 (64%) |
Rural, % | 1052 (9%) | 2027 (16%) |
Neighbourhood income quintilea, % | ||
1 (lowest quintile) | 2365 (20%) | 1789 (14%) |
2 | 2349 (19%) | 2119 (17%) |
3 | 2174 (18%) | 2317 (19%) |
4 | 2456 (20%) | 3143 (25%) |
5 (highest quintile) | 2743 (23%) | 3077 (25%) |
Comorbid conditions, % | ||
Diabetes | 2084 (17%) | 2071 (17%) |
Cancer | 3119 (26%) | 3436 (28%) |
Congestive heart failure | 670 (6%) | 834 (7%) |
Chronic kidney disease | 249 (2%) | 288 (2%) |
Chronic liver disease | 528 (4%) | 493 (4%) |
Chronic lung disease | 2594 (21%) | 2540 (20%) |
Median family pPhysician visits in the past year, #, (Q1–Q3) | 5 (2–9) | 5 (3–9) |
Primary trial outcome
Adverse events
Secondary trial outcomes
Subgroup analyses
Post-trial process evaluation results
Barriers and enablers to intervention delivery interviews
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Theme 1: The tablet, its placement as a visual cue and website user-friendliness (Environmental Context and Resources). Healthcare staff reported that the Internet-enabled tablet (iPad) placed in the waiting room acted as both an enabler and a barrier. It was seen as an enabler as reception staff reported that witnessing patients register for organ donation in the waiting room motivated them to continue to prompt additional patients. The tablets also served as a reminder for some reception staff, particularly when placement was in their line of vision. While placement of the tablet at each site was informed by waiting room practicalities and staff preferences, future studies could better ensure a direct line of sight for reception staff if possible. It was also seen as a barrier, with staff reporting that the central registration website was not as user-friendly as hoped, especially among older patients.
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Theme 2: Caution and sensitivity to harness rapport in delivering the intervention (Beliefs about consequences, Social influences, Emotion, Professional Role and Identity) Some reported being selective about to whom they delivered the intervention. Reception staff felt that they did not want to bother patients with an acute illness regarding organ donor registration, and intervention training emphasized that they should use their best judgement for a given patient. Reception staff were optimistic and motivated during training for delivering the intervention, but during post-trial interviews, some staff reported being worried about the sensitivity of the topic and about causing worry or distress especially when they did not know the reason for a patient visit. Such experiences led to some feeling as if it was not always their role to promote organ donation because “[they] don’t see what’s happening with the actual person with their health”. Some reception staff recommended that it may be more appropriate for nurses and physicians who have access to patient charts to bring up organ donation. Nevertheless, some reception staff thought that their existing relationship with their patients was a facilitator to discussing organ donation, while other staff did not wish to harm their trust. Several reception staff reported it was “uncomfortable” and “awkward” to discuss organ donation with patients.
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Theme 3: Competing priorities (Environmental Context and Resources). Our intervention occurred as the same time as the flu and holiday season (September to December). Reception staff thought that this was a particularly busy time of the year for them, which may have prevented them from fully delivering the intervention.
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Theme 4: Already registered (Reinforcement). Some mentioned a greater proportion of patients were already registered for organ donation than they expected, which demotivated them from delivering the intervention.
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Theme 5: Confidence and motivation to deliver the intervention (motivation; beliefs about capabilities). Many reception staff noted that the training sessions provided helped to improve their confidence in delivering the intervention and that they were motivated to participate. However, a participant from a site that was randomized to an earlier start date noted that the length of intervention was too long and recommended that a week-long intervention may have been preferred.