Background
Deficiencies in the care of multimorbid patients with polypharmacy
The German health system
Evidence-based care
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Recommendation 1 on communication: structured medication counseling (SMC): All patients with polypharmacy and additional risk factors for medication problems should receive SMC at least once per year. Beside medication-related information, SMC comprises a complete inventory of the actually taken medication (so called “brown bag review”) and the assessment of patient adherence and possible application problems. A separate appointment should be planned for SMC [29]. There is evidence that SMC increases patient satisfaction with health care [30] and adherence and reduce ADR and hospitalizations [8]. It has been shown that better physician-patient communication leads to better health outcomes [31, 32].
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Recommendation 2 on documentation: consequent use of medication lists: All patients with polypharmacy should take along an updated, complete, and comprehensible medication list, concordant with the template of the Drug Commission of the German Medical Association [14]. There is consensus that medication lists are an important and useful document for HCP as well as for patients [33, 34], which is emphasized by the fact that the patients’ right to receive a complete medication list has been regularized by the German E-Health law enacted in 2015 (German Social Security Code 5, §31). It is plausible that medication lists have a positive influence on health outcomes.
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Recommendation 3 on prescribing: medication reviews to reduce PIM: Physicians should review the medication regimens of patients with polypharmacy systematically with the aid of tools, such as the PRISCUS list [10] or the MAI [9]. Both tools integrate a substantial body of knowledge on drug treatment. There is evidence that systematic medication reviews reduce emergency department contacts at least in hospital settings [35].
Tailoring
Methods
Trial design
Participants and setting
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Patients older than 50 years
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Enrolment into the HzV AOK Baden-Wuerttemberg care contract
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Prescriptions for more than four different drugs in at least 2 quarters of the preceding year
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Diagnosis of at least three chronic conditions based on a previously published diagnosis list with a total of 42 diagnosis groups [44]
Intervention
Control
Primary outcome
Recommendation/implementation objective | Indicator | Data source | |
---|---|---|---|
Recommendation 1: SMC incl. brown bag review was performed at least once | 1a | Percentage of patients answering the item “Have you had an appointment for medication counseling with your GP within the last 9 months” in the affirmative | Patient questionnaire |
1b | Percentage of patients answering the item “If yes, have you brought all your medication packages to this appointment” in the affirmative | ||
Recommendation 2: patients take along medication lists meeting minimum standards | 2a | Percentage of medication lists specifying the name of the active substance of each drug | Medication lists generated by the practice |
2b | Percentage of medication lists specifying the reason for prescription for each drug | ||
2c | Percentage of medication lists specifying the exact dosage for drugs taken as needed | ||
2d | Percentage of medication lists containing instructions for the application of at least one drug | ||
2e | Percentage of medication list with a date not older than 9 months | ||
3 | Percentage of patients with long-term medication having a medication list with them | Oral survey in the practices | |
Recommendation 3: GPs review the medication systematically using tools to reduce PIM | 4a | The response scale of the item “Do you use the PRISCUS list” to review the medication of your patients?” was converted into a percentage value with always = 100%, frequently = 75%, sometimes = 50%, rarely = 25%, never = 0% | GP questionnaires |
4b | The response scale of the item “Do you use the MAI” to review the medication of your patients?” was converted into a percentage value with always = 100%, frequently = 75%, sometimes = 50%, rarely = 25%, never = 0% |
Secondary outcomes
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a self-developed questionnaire assessing the use of medication lists;
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the German Patient Activation Measure (PAM-13D) [47] consisting of 13 item with a mean score ranging from 1–5, higher values reflecting stronger patient activation
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the Medication Adherence Report Scale (MARS) [48] consisting of 5 items with a score ranging from 5 to 25, higher values indicating higher adherence
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the specific part of the German Beliefs About Medicine Questionnaire (BMQ-D) [49] measuring patients’ beliefs about the particular medication prescribed for them. It comprises two sub-scales: the specific necessity scale (SNS) assessing patients’ views on their personal need for their medication and the specific concerns scale (SCS) assessing patients concerns towards their medication. Both scales result in a mean score ranging from 1–5, higher values indication stronger concerns or a stronger belief in the necessity of the medication respectively.
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the PIM prescription rate based on the PRISCUS list was measured using insurance claim data (§300 social code book V).
Sample size
Randomization and allocation concealment
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The two QCs with the largest number of GPs are not assigned to the same group.
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The number of enrolled patients is approximately equal in both groups.
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The number of GPs is approximately equal in both groups.
Blinding
Statistical methods
Deviations from study protocol
Results
Participant flow diagram
Recruitment
Baseline data
Total | Intervention | Control | |
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Number of GPs | 22 | 11 | 11 |
Number of practices | 18 | 7 | 11 |
GPs organized in group practices | 8 | 8 | 0 |
Mean Age in years (range; SD) | 54.9 (44 – 68; 6.8) | 54.2 (44–63; 6.0) | 55.6 (44–68; 7.8) |
Sex male in % (n) | 81.8 (18) | 63.3 (7) | 100 (11) |
Mean professional experience as GP in years (range; SD) | 22 (8–33; 7.6) | 18.8 (8–39; 7.5) | 20.1 (11–33; 7.9) |
Number of patient contacts per GP per week | 222 (120–450; 79.2) | 208 (120–450; 94.1) | 236 (150–300; 62.2) |
Number of MA per practice | 4.64 (1–9; SD 2.8) | 4.45 (1–9;2.7) | 4.82 (1–9; 3.0) |
Total | Intervention | Control |
p value* | |
---|---|---|---|---|
Total number of patients | 273 | 143 | 130 | – |
Mean Age [years] | 72.2 (SD 8.9) | 70.8 (SD 9.1) | 73.8 (SD 8.38) | 0.006 |
Sex female % (n) | 55.7 (152) | 55.9 (80) | 55.4 (72) | 0.93 |
Single % (n) | 31.7 (85) | 30.1 (43) | 33.6 (42) | 0.54 |
Living alone % (n) | 27.7 (74) | 24.6 (35) | 31.2 (39) | 0.23 |
Not working % (n) | 87.2 (232) | 85.9 (122) | 88.7 (110) | 0.5 |
Graduation from high school or university % (n) | 4.8 (13) | 4.9 (7) | 4.6 (6) | 0.91 |
Highest number of prescribed drugs in one quarter of the year (range; SD) | 7.3 (5–18; 2.6) | 7.0 (5–18; 2.6) | 7.7 (5–18; 2.6) | 0.03 |
Mean number of diagnosed chronic diseases (range; SD) | 5.7 (3–19; 2.8) | 5.5 (3–14; 2.2) | 6.0 (3–19; 3.2) | 0.08 |
Outcomes
Indicatora
| Baseline T0 | Follow-up T1 | Treatment effect |
p value | ||
---|---|---|---|---|---|---|
Control | Intervention | Control | Intervention | |||
MEAN % (SD) | MEAN % (SD) | MEAN % (SD) | MEAN % (SD) | Estimate (95% CI) | ||
1a | 61.8 (27.6) | 59.1 (28.6) | 49.0 (30.0) | 82.7 (20.4) | 34.2 (12.4, 55.9) | 0.017 |
1b | 43.4 (36.0) | 45.7 (37.8) | 20.9 (20.9) | 59.2 (33.9) | 38.8 (15.0, 62.7) | 0.012 |
2a | 0 (0) | 0.01 (0.02) | 4.0 (7.5) | 2.6 (6.3) | −3.4 (−8.0, 1.2) | 0.18 |
2b | 0 (0) | 0.01 (0.02) | 0 (0) | 1.9 (5.6) | 2.1 (−1.4, 5.5) | 0.28 |
2c | 1.4 (0.4) | 1.7 (0.3) | 48.4 (36.7) | 25.0 (35.4) | −23.2 (−63.2, 16.8) | 0.24 |
2d | 27.4 (43.8) | 25.6 (33.3) | 31.2 (47.6) | 8.2 (22.1) | −21.5 (−50.9, 8.0) | 0.18 |
2e | 70.9 (35.0) | 55.3 (41.1) | 93.9 (12.0) | 92.7 (9.2) | 0.1 (−9.2, 9.3) | 0.99 |
3 | 10.9 (5.9) | 13.7 (4.7) | 20.8 (5.1) | 14.5 (19.3) | −8.1 (−15.0, 1.2) | 0.08 |
4a | 25.0 (29.6) | 15.0 (26.9) | 20.5 (18.8) | 22.5 (18.5) | 5.6 (−5.6, 16.7) | 0.35 |
4b | 0 (0) | 10.0 (24.2) | 2.3 (7.5) | 10.0 (21.1) | 2.5 (−7.5, 12.4) | 0.62 |
Primary outcome | 24.1 (6.7) | 22.8 (13.0) | 27.9 (6.5) | 31.5 (8.0) | 4.2 (−0.3, 8.6) | 0.10 |
Validated instruments | Baseline T0 | Follow-up T1 | Estimate (95% CI) |
p value | ICC | ||
Control | Intervention | Control | Intervention | ||||
MEAN (SD) | MEAN (SD) | MEAN (SD) | MEAN (SD) | ||||
MARS score (adherence) | 23.3 (2.3) | 23.3 (3.7) | 23.3 (2.6) | 22.3 (3.3) | −1.2 (−2.8, 0.3) | 0.11 | 0.18 |
PAM score (patient activation) | 3.3 (0.4) | 3.3 (0.5) | 3.3 (0.5) | 3.3 (0.5) | 0.1 (−0.1, 0.2) | 0.48 | 0.08 |
BMQ necessity score | 4.5 (0.5) | 4.2 (0.6) | 3.3 (0.5) | 3.3 (0.6) | −0.1 (−0.4, 0.3) | 0.68 | 0.20 |
BMQ concerns score | 2.5 (0.9) | 2.5 (0.9) | 1.4 (0.8) | 1.8 (0.9) | 0.2 (−0.2, 0.6) | 0.24 | 0.11 |
Number of PIM prescriptions per year [range] | 0.9 (1.8) [0–9] | 0.8 (1.8) [0–10] | 1.0 (1.9) [0–9] | 0.8 (1.8) [0–11] | −0.1 (−0.4, 0.2) | 0.37 | <0.01 |
Number of patients with ≥1 PIM prescription per year | 32.3% (n = 42) | 27.7% (n = 39) | 30.0% (n = 39) | 26.2% (n = 37) | 0.9 (0.4, 2.0) | 0.81 | 0.02 |
Self-developed survey (items with binary response categories)a
| Control | Intervention | Control | Intervention | Estimate (95% CI) |
p value | ICC |
% (n) | % (n) | % (n) | % (n) | ||||
Do you have a written medication list? | 91.5 (118) | 91.6 (131) | 93.0 (119) | 95.8 (137) | 1.5 (0.2–12.3) | 0.69 | 0.36 |
I use my medication list as a reminder | 53.4 (62) | 60.0 (78) | 61.0 (72) | 65.0 (89) | 1.0 (0.2–4.8) | 0.98 | 0.32 |
I usually show my medication list at doctor’s appointments | 19.8 (23) | 42.7 (56) |
22.0 (26)
|
46.0 (63)
| 4.7 (0.8–29.6) | 0.09 | 0.39 |
I usually show my medication list in the pharmacy | 0.0 (0) | 7.7 (10) |
5.1 (6)
|
28.5 (39)
| 12.9 (1.4–117.7) | 0.03 | 0.42 |
I use my medication list when taking my medicaments | 55.2 (64) | 45.4 (59) |
63.6 (48.5)
|
59.1 (81)
| 0.6 (0.2–2.1) | 0.43 | 0.20 |
Self-developed survey (items with five-point Likert response scale)b
| Control | Intervention | Control | Intervention | Estimate (95% CI) |
p value | ICC |
% (n) | % (n) | % (n) | % (n) | ||||
Do you find your medication list comprehensible? | 96.6 (114) | 93.1 (122) | 89.8 (106) | 90.9 (130) | 1.3 (0.2–10.9) | 0.77 | 0.41 |
Do you dispose of the old medication list after receiving a new one? | 78.0 (92) | 69.5 (89) | 77.1 (91) | 75.9 (107) | 0.8 (0.3–1.8) | 0.51 | 0.04 |
Do you carry your medication list with you (e.g., in your purse?) | 33.9 (40) | 36.9 (48) | 37.3 (44) | 48.3 (69) | 1.3 (0.4–4.8) | 0.64 | 0.21 |
Do you note down on your medication list if you take a medicament which you have bought yourself? | 13.8 (16) | 18.3 (24) | 16.9 (20) | 25.0 (35) | 1.3 (0.4–5.0) | 0.65 | 0.19 |