Background
Adherence and consequences of non-adherence
Medication review
The Polymedication Check
Rationale for the study
Methods
Trial design
Eligibility for study pharmacists
Screening for eligible patients
Patient recruitment
Randomisation process
Structure of the intervention vs usual care
Classification of detected drug-related problems and addressed interventions
Case report forms for study pharmacists
PMC protocol form
Patient self-report questionnaires
Telephone interviews
Objective adherence measurement
Subjective adherence measurement
Unplanned visits at the general practitioner/hospital
Sample size
Statistical methods
Handling missing data
Ethical approval
Results
Implementation of the study
Recruitment of study pharmacists and study pharmacies
Intervention group (N = 218) | Control group (N = 232) | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
D-CH (n = 146) | F-CH (n = 72) | Sum | D-CH (n = 160) | F-CH (n = 72) | Sum |
pValue | |||||||
Women (n/%) | 76 | 52.1 | 42 | 58.3 |
118
|
54.1
| 78 | 48.8 | 47 | 65.3 |
125
|
53.9
| 0.958 |
Living alone (n/%) | 53 | 36.3 | 25 | 34.7 |
78
|
36.5
| 42 | 26.3 | 31 | 43.1 |
73
|
31.9
| 0.310 |
Smoker (n/%) | 20 | 13.7 | 19 | 26.4 |
39
|
18.5
| 27 | 16.9 | 7 | 9.7 |
34
|
15.0
| 0.335 |
Age in years (Mean/SD) | 66.4 | 11.38 | 68.7 | 11.73 |
67.2
|
11.52
| 67.1 | 10.80 | 67.2 | 13.18 |
67.1
|
11.56
| 0.845 |
Dash-4 score (Mean/SD) | 4.7 | 1.72 | 5.3 | 2.43 |
4.9
|
2.01
| 4.7 | 1.48 | 5.3 | 2.40 |
4.9
|
1.83
| 0.323 |
Patient recruitment
Demographic data of recruited patients
Dropouts
Intervention | Control |
pValue | |
---|---|---|---|
Deceased
| 2 | 2 | |
Withdrawal by patient
| |||
- without information | 5 | 7 | |
- lack of motivation/interest | 1 | 1 | |
- poor health | 0 | 4 | |
Pharmacist was unable to collect data
| |||
- not achieved | 5 | 5 | |
- patient has moved away | 3 | 2 | |
- patient is in a nursing home | 2 | 0 | |
- poor health | 2 | 3 | |
Lost because pharmacist revoke study participation
| 17 | 17 | |
Total n (%) | 37 (47.4) | 41 (52.6) | 0.845 |
Intervention
N | % | |
---|---|---|
Drug-related problems | ||
Potential | 149 | 58 |
Manifest | 109 | 42 |
Urgency rated by the study pharmacist | ||
High | 36 | 14 |
Medium | 113 | 43 |
Low | 109 | 43 |
Recommendation accepted by patient | ||
Yes | 219 | 85 |
No | 25 | 10 |
Unclear | 14 | 5 |
Causes of pharmacists’ interventions | ||
Insufficient adherence | 69 | 26.7 |
Patient needs information about safe and effective use of his medicines | 50 | 19.4 |
Patient needs information about potential medicines’ adverse drug reaction | 19 | 7.4 |
Inappropriate timing or frequency of administration | 18 | 7.0 |
Under-dosed therapy | 15 | 5.8 |
Drug-drug/drug-food interaction | 14 | 5.4 |
Adverse effect | 12 | 4.7 |
Inappropriate therapy duration | 10 | 3.9 |
Inappropriate drug administration | 9 | 3.5 |
Patient needs information about lifestyle, nutrition or empowerment | 8 | 3.1 |
Not received treatment | 7 | 2.7 |
More cost-effective therapy available | 5 | 1.9 |
No concordance with guidelines or contraindication | 4 | 1.6 |
No dose adjustment because of pathological changes (renal/liver failure) | 4 | 1.6 |
Not indicated drug or duplication | 3 | 1.2 |
Incomplete patient documentation | 3 | 1.2 |
Over-dosed therapy | 3 | 1.2 |
Prescribed drug not available | 2 | 0.8 |
Inappropriate monitoring | 1 | 0.4 |
Not classifiable | 2 | 0.8 |
Description of pharmacist's interventions | ||
Counseling of patient, training | 152 | 58.9 |
Optimisation of administration | 40 | 15.5 |
Information to other caregivers | 24 | 9.3 |
Dose adjustment | 12 | 4.7 |
Substitution of a therapy | 10 | 3.9 |
Therapy started/restarted | 7 | 2.7 |
Therapy stopped | 7 | 2.7 |
Therapy monitoring | 3 | 1.2 |
Clarification in the patient history | 2 | 0.8 |
Not classifiable | 1 | 0.4 |
Intervention | Control |
pValue | |||
---|---|---|---|---|---|
T-0 (assessed through pharmacist during PMC) | 72a
|
N = 218 | - | - | |
T-2 (assessed through telephone interview) | 83 |
N = 202 | 90 |
N = 214 | 0.838 |
T-16 (assessed through telephone interview) | 90 |
N = 198 | 98 |
N = 203 | 0.699 |
Objective adherence
Intervention | Control | ||||||
---|---|---|---|---|---|---|---|
Mean % | SD | N | Mean % | SD | N |
pValue | |
All therapies | 88.3 | 19.03 | 493 | 87.5 | 20.75 | 527 | 0.811 |
Antiplatelets (B01AC) | 91.3 | 16.24 | 61 | 85.4 | 23.75 | 64 | 0.119 |
Proton pump inhibitors (A02BC) | 91.8 | 13.36 | 43 | 87.7 | 18.27 | 33 | 0.493 |
Intervention (N = 146) | Control (N = 147) | ||||
---|---|---|---|---|---|
Mean | SD | Mean | SD |
pValue | |
DPPR (%) | 88.0 | 13.31 | 87.5 | 20.75 | 0.906 |
Number of medicines eligible for DPPR calculation per patient | 3.4 | 1.68 | 3.6 | 1.86 | 0.425 |
Subjective adherence
Intervention | Control | ||||||
---|---|---|---|---|---|---|---|
Mean % | SD | N | Mean % | SD | N |
pValue | |
Patient questionnaire T-0 | 96.2 | 8.62 | 211 | 96.8 | 7.05 | 232 | 0.204 |
Telephone interview T-2 | 97.2 | 9.31 | 202 | 96.4 | 10.24 | 213 | 0.118 |
Telephone interview T-16 | 98.5 | 5.56 | 198 | 97.8 | 7.64 | 202 | 0.400 |
Patient questionnaire T-28 | 95.5 | 10.28 | 178 | 96.3 | 9.51 | 186 | 0.338 |
Intervention | Control | ||||||
---|---|---|---|---|---|---|---|
Mean | SD | N | Mean | SD | N |
pValue | |
T-2 | |||||||
BMQ Beliefs | 20.58 | 4.463 | 171 | 20.99 | 4.301 | 181 | 0.328 |
BMQ Concerns | 9.95 | 4.249 | 171 | 10.30 | 4.949 | 181 | 0.726 |
Difference Beliefs - Concerns | 10.64 | 5.554 | 171 | 10.69 | 6.494 | 181 | 0.612 |
T-16 | |||||||
BMQ Beliefs | 20.66 | 4.630 | 188 | 21.23 | 3.958 | 183 | 0.369 |
BMQ Concerns | 9.89 | 5.020 | 188 | 9.72 | 4.583 | 183 | 0.872 |
Difference Beliefs - Concerns | 10.77 | 6.360 | 188 | 11.51 | 5.705 | 183 | 0.337 |
MMAS-8D Scorea
| 6.85 | 1.226 | 198 | 6.82 | 1.237 | 202 | 0.817 |
Use of health care resources by patients and unplanned visits at a general practitioner or hospital
Intervention | Control | ||||
---|---|---|---|---|---|
Unplanned visits … | NYES
| NTotal
| NYES
| NTotal
|
pValue |
… from T-0 - > T-2 | 14 | 202 | 10 | 214 | 0.324 |
… from T-2 - > T-16 | 50 | 198 | 44 | 203 | 0.398 |
… from T-16 - > T-28 | 46 | 181 | 45 | 191 | 0.678 |
Incidence of at least one fall until T-28 | 31 | 17.7 % | 30 | 15.9 % | 0.638 |
… thereby injured | 17 | 54.8 % | 15 | 50.0 % | 0.705 |