Figure 1 illustrates the patient flow for the study. A total of 1640 patients were screened (eligibility ratio was 20.4%). A total of 159 patients were invited to join the study (issued with study details) and 62 patients agreed to participate in this pilot (38.9% of those approached) while 79 patients (49.6%) declined participation after receiving the study information documentation; 18 patients (11.3%) were discharged before they decided.
Table 1 defines the patient characteristics at baseline. There were no statistically significant differences between control and intervention patients.
In total 13 patients attended the MOC once and 7 patients attended twice. In addition 4 patients attended the MOC once with 1 follow-up telephone call, 3 patients received a phone call and the remaining 4 intervention patients received no intervention but were included in the ITT approach for analysis
Primary outcome: 30-day readmission rate
No patients who received the clinic intervention were readmitted within 30-days, i.e. a 16.1% difference from the control group (PP analysis, Fig. 2). Due to the small sample size, this difference just failed to reach statistical significance (P = 0.055). Using the ITT approach, the 30-day readmission rate for the intervention group was 6.5% versus the 16.1% readmission rate for the control group (P = 0.42). The relative risk of 30-day readmissions was 0.40 (95% CI 0.084–1.91) in the ITT approach; it was 0.10 (95% CI 0.006–1.8) in the PP approach. The number of patients needed to treat (to receive intervention) to avoid one hospitalisation was 6.49 patients (95% CI 3.2–144.2).
Readmission rates at other time intervals
Table 2 lists readmission rates at 7, 14, 90, 180 and 365 days. The difference in readmission rates between control and the PP group was highest at the 180-day interval, i.e. 23.4% (P = 0.055) which resulted in a reduction of risk of readmission by 56% (RR = 0.44, 95% CI 0.18–1.08). The number of patients needed to treat (to prevent one hospitalisation within 180 days) was 4.27 patients (95% CI 2.15–311.80).
Data on multiple readmissions are presented in Table 3 for the 90, 180 and 365 day intervals. Data for the 180 day interval, as an illustrative sample, were as follows: No patients within the PP group (n = 27) had multiple readmissions during the 180-day follow-up period. The difference between the control group and the ITT group at 180 days was 29.1% (P = 0.003). The risk of multiple readmissions was significantly reduced by 90% (RR = 0.10, 95% CI 0.014–0.74; P = 0.024). For the PP group, the observed multiple readmission rate difference was 32.3% (P = 0.001). Relative risk reduction was 94.6% (RR = 0.054, 95% CI 0.003–0.89; P = 0.04). The number needed to treat to prevent multiple readmissions for the PP group was 3.22 patients (95% CI 2.04–7.67).
According to the Poisson regression presented in Table 3, at the 180-day interval the number of readmissions for the control group will be 2.42 times greater than the ITT group, Incidence Rate Ratio (IRR) = 2.42 (95% CI 1.13–5.21, P = 0.024). The regression model was statistically significant (Omnibus Test, P = 0.014). The IRR for the PP population was 2.77 (95% CI 1.09–7.06; P = 0.033); the predicted model was statistically significant (Omnibus Test, P = 0.016).
Length of hospital stay during the first readmission
Distribution of median (interquartile range) length of hospital stay during the first readmission was the same (P > 0.05) across the control and intervention groups, i.e. median of 5 days in all groups [Control = 5 (1.8–10.8); ITT = 5 (2.0–8.5); PP 5 (2.0–10.3)].
Time to readmission
Figure 3a presents the 365-day Kaplan–Meier survival curve of readmission events after the index discharge. The estimated marginal mean time to readmission for the ITT group was 276.3 days (95% CI 229.8–322.9), while it was 226.3 days (95% CI 176.6–276) for the control group. Nonetheless, this 50.0-day difference was not statistically significant (log rank P value was 0.19). When using the PP analysis, intervention patients who attended the MOC showed slightly longer ‘survival times’ prior to readmission, as the estimated marginal mean was 289.7 days (95% CI 245.0–334.4). However, when compared with the control group the difference of 63.4 days was not statistically significant (log rank P value: 0.15). (Figure 3b)
ED visits and unplanned GP consultations
The intervention resulted in a lower total number of emergency department visits (Table 4); 31 vs 51 in the ITT group and 21 vs 51 in the PP group, however, both cases did not reach statistical significance (P > 0.05).
The clinic intervention resulted in a reduction in the number of unplanned GP consultations. The risk was reduced by 47% (RR = 0.53, 95% CI 0.27–1.07) for the ITT group, and 54% (RR = 0.46, 95% CI 0.21–1.02) for the PP group. The latter risk reduction demonstrated a borderline significant value (P = 0.054). The number needed to treat was calculated at 3.82 patients (95% CI 2.00–43.47) in the PP group.
Table 4 also shows that the Incidence Rate Ratio was 1.65 (95% CI = 1.05–2.57; P = 0.029) for ED visits using the ITT data. The prediction model had an acceptable fit to the data (Omnibus Test, P = 0.026). Results for the PP group were as follows: the IRR was 2.12 (95% CI = 1.27–3.52; P = 0.004) and the Omnibus Test was significant (P = 0.003). Unplanned GP consultations gave rise to similar positive outcomes resulting from the MOC engagement.
Economic evaluation of the MOC intervention
Table 5 shows the cost–benefit analysis using both analytical approaches. A positive benefit to cost ratio was exhibited: 20.72 for the ITT group and 21.85 for the PP approach respectively.
At baseline in the management of usual activity and pain domains, seven (22.6%) and five patients (16.1%) respectively in the intervention group reported extreme problems, while in the control group the comparative data were three (9.7%) and four patients (12.9%) respectively. For the intervention group, improvement was noted at both the 30-day and 90-day assessment points for these parameters. Only one intervention patient reported extreme problems with usual activities and no patients reported extreme pain at the 90-day assessment.
In contrast, control patients exhibited a decline in their EQ-5D-3L scores, e.g. the number of patients who reported extreme problems was doubled at the 30-day assessment. Moreover, in the control arm four patients reported severe anxiety at the 30-day post-discharge assessment, while no intervention patients were in this category. Due to the small sample size, statistically significant differences between the intervention and control groups were seen only in the pain domain at the 30 day assessment (3.7% vs 27.6%; P = 0.026) and at the 90 day assessment (0% vs 23.1%; P = 0.01).
Figure 4 shows the mean index (calculated using the time-trade-off technique) for the intervention and control groups at different time points. In general, the data indicate that the HRQOL index improved post intervention in the intervention group, but initially declined in the control group. There were no statistically significant differences at baseline (P = 0.16) and at 365 days (P = 0.15); differences were, however, statistically significant at the 30-day (P < 0.001), 90-day (P < 0.001) and 180-day (P = 0.036) time points.
Patient beliefs about medicines questionnaire (BMQ)
Data collected using the beliefs about medicine questionnaire at baseline showed no statistically significant differences between groups. Intervention patients showed notable benefits in relation to their concerns about medicines at the 30-day assessment point, which was maintained throughout the study. The highest impact of the pharmacist intervention, on patient beliefs about medicines, was detected in two statements within the concern scale (I sometimes worry about the long-term effects of my medicines and my medicines are a mystery to me), with favourable mean differences for the intervention group, being 61.5% (P = 0.001) and 48.7% (P = 0.001) respectively.
Figure 5 shows the calculated mean difference between the necessity and the concern scale for both intervention and control groups. After baseline, intervention patients showed significant improvement in their necessity-concern differential compared with the control group. Statistically significant differences were demonstrated at the 30-day (P < 0.001), 90-day (P < 0.001), 180-day (P < 0.001) and 365-day (P < 0.001) assessments.
Within group differences for the necessity-concern differential were significant for the intervention group (P = 0.018), but not for the control group (P = 0.23). Post hoc pairwise analysis within group indicated statistically significant differences between baseline and the following time points: 90-day (P = 0.024) and 365-day (P = 0.001), although there was a general trend of improvement across the complete follow-up period.
Medication adherence report scale (MARS)
Mean medicine adherence report scale scores exceeded 20 out of 25 throughout the study period in both control and intervention patients, which indicates acceptable adherence. There was a slight positive differential between and within groups (Fig. 6). Although some of the comparisons reached statistical significance, it is clear from the mean data that acceptable levels of adherence were evident throughout the study in both groups.
A bespoke patient satisfaction evaluation was posted to the PP patient group after receiving the MOC intervention. A total of 24 patients completed the questionnaire (response rate 88.9%). It was clear that the services were appreciated by patients, with only two patients being uncertain on one aspect, i.e. whether the number of clinic appointments was sufficient.