A nurse-based intervention for improving medication adherence in cardiovascular patients: an evaluation of a randomized controlled trial

Figures & data

Table 1 Process evaluation: Method, corresponding determinants, techniques, practical applications, and the materials of the developed intervention (1=Determinants of the Health Belief Model, 2=Definitions according to the taxonomy of behavior change techniques by Abraham and Michie⁴⁶ and de Bruin et al⁴⁸)

Health Belief Model	Determinant^1	Technique^2	Practical applications/strategy	Materials
Perceived susceptibility Beliefs about the chances of getting another cardiovascular event	Knowledge Lack of knowledge regarding prescribed medications and the influence on risk reduction	Increase understanding Provide general information Risk communication Persuasive communication Group sessions with peers	Group consultation: Providing general information about atherosclerosis Providing written material with information about cardiovascular medication and how it should be taken Providing general information about cholesterol and blood pressure and their influence on cardiovascular risk. Providing general information about cardiovascular medication and how it works. Discussion within a group of cardiovascular patients about being adherent and nonadherent to medication	The group consultation was led by a pharmacist and a nurse. A PowerPoint was made containing information about the need for low cholesterol and low blood pressure and how to use the most common cardiovascular medication. All these information is also given to the patients in a brochure. Patients are invited to discuss their personal beliefs about their cardiovascular medication and the practical implications of taking medication on a daily base.
Perceived severity Beliefs about the seriousness of that event and its consequences	Patients beliefs, perception, and management of their illness (awareness, outcome expectations) Personal judgement of need for the medication influenced by perception and management of the disease: Not accepting their illness Thinking it is more benign than it is (because of absence of symptoms).	Risk communication Feedback of clinical outcome Revaluation of outcomes, self-evaluation	Personalized website: Visualization of the personal cardiovascular risk through a risk monitor Individual consultation: Evaluating the filled out questionnaires BMQ and MMS. Evaluating a medication taking diary	A website where patients can log in to see their own cholesterol and blood pressure level was built. These levels are visualized as a speedometer. When at target level, an arrow is in the green part of the scale and when not at target level an arrow is in the red part of the scale. An intervention chart was created. It contained different topics according to the determinants of poor adherence with subsequent questions the nurse can ask specified for each topic.
Perceived benefits Beliefs about the effectiveness of taking action to reduce risk.	Patients beliefs, perception, and management of their medication(awareness) Personal judgement of need for the medication influenced by perception of prescribed medication. Negative associations with medication (in general or specific) and/or health care providers	Persuasive communication Verbal persuasion Revaluation of outcomes, self-evaluation Feedback on clinical outcome	Individual consultation: Consultations are given based on motivational interviewing and goal setting Evaluating the filled out questionnaires BMQ and MMS . Evaluating target levels Personalized website: Providing a risk monitor that will be green if outcome targets are achieved	Nurses participating in this intervention (already trained in motivational interviewing) were trained .The program contained general information of poor adherence and the most common cardiovascular medication. Information was provided on how to achieve behavioral change and what the specific change objectives were in this intervention. The nurses then performed these consultations in a role play and were given feedback by the medical psychologist. At the end of the training day, documents which contained all the given information were provided.
Perceived barriers Cue to action Self-efficacy	Memory loss or forgetfulness Lack of knowledge or skills how to order new prescriptions or to set up memory cues	Self-report of behavior Goal setting Plan coping responses Set graded tasks Use of cues Cope with side effects	Let the patient keep a diary of his medication taking 2 weeks for each individual consultation Individual consultation: Talk with the patients about the barriers and effect and side effects of the medication If necessary the nurse and patient make a plan together how to overcome the barriers (eg, alarm devices, doses of medication at visible location) or when side effects occur switch medication The patient and nurse formulate a goal at the end of each consultation reflecting the barriers they evaluated	In the brochure, there is a section where patients can fill in when they took their medication. Patients are asked to do at least 10 days before their individual consultation. In the individual consultation, the intervention chart also contains topics according to memory and skills (eg, ordering medication on time, forgetting medication) and possible solutions (eg, help ordering a dosette box) are provided.

Abbreviations: MMS, Modified Morisky Scale; BMQ, Beliefs about Medicines Questionnaire.

Figure 1 Patient enrollment and participation.

Note: LCHC depicts lipoprotein analysis with determination of high density lipoproteine-cholesterol and low density lipoproteine-cholesterol calculation.

Abbreviations: BMI, body mass index; PRD,pharmacy refill dates; FU, follow up; MMS, Modified Morisky Scale; BMQ, Beliefs about Medicines Questionnaire; CVRM, cardiovascular risk management; BP, blood pressure.

Table 2 Patient characteristics at baseline

	Usual care (UC) N=133	UC+website N=138	UC+website+consultations N=148
Socio-demographic characteristics
Age, in years^a	60.4 (10.0)	60.2 (8.8)	60.9 (11.8)
Sex Female^b	36 (27.1)	38 (27.5)	49 (33.1)
Education level^b
Primary	28 (21.9)	20 (16.4)	18 (14.4)
Secondary	65 (50.8)	65 (53.3)	55 (44)
University	35 (27.3)	37 (30.3)	52 (41.6)
Labour^b
Paid labour	45 (33.8)	61 (44.2)	47 (31.7)
Unemployed	7 (5.2)	4 (3)	2 (1.3)
Unfit for work	21 (16.0)	24 (17.4)	28 (19)
Retired	50 (37.5)	42 (30.4)	63 (24.3)
Housewife	10 (7.5)	7 (5.0)	8 (5.4)
Country of origin is the Netherlands^b	110 (89.4)	108 (91.5)	109 (88.6)
Clinical Characteristics
Reason referral^b		51 (37.0)	53 (36.0)
Acute coronary syndrome	46 (34.5)	64 (46.4)	69 (46.5)
Stroke or transient ischemic attack	65 (49.0)	23 (16.6)	26 (17.5)
Peripheral arterial disease	22 (16.5)
Blood pressure, mmHg^a		135.5 (17.5)	136.7 (19.7)
Systolic	137.3 (16.8)	78.2 (9.6)	76.5 (10.7)
Diastolic	78.1 (11.3)
Lipids mmol/L^a		4.5 (1.0)	4.5 (1)
Total cholesterol	4.6 (1.2)	1.7 (0.9)	1.8 (1.1)
Triglyceriden	1.9 (1.0)	1.1 (0.3)	1.2 (0.3)
High- density cholestrol	1.2 (0.3)	2.6 (0.9)	2.5 (0.9)
Low-density lipoprotein	2.6 (1.0)	27.5 (4.0)	27.1 (4)
Body mass index, kg/m^2,a	27.2 (4.0)
Medication use^b
Medication (ATC) used
Antithrombotic agents (B01)	128 (98.5)	132 (97.1)	144 (98.0)
Diuretics (C03)	36 (26.5)	36 (26.5)	37 (25.1)
Beta blocking agents (C07)	72 (55.4)	85 (62.5)	82 (55.8)
Calcium channel blockers (C08)	20 (15.4)	21 (15.4)	24 (16.3)
Agents acting on the angiotensin system (C09)	76 (58.5)	83 (61.0)	85 (57.8)
Lipid modifying agents (C10)	120 (92.3)	129 (95.0)	138 (93.9)
Chronic users^(b+c+d)	85 (64.4)	85 (62)	90 (61.2)
Questionnaires
The Modified Morisky Scale (MMS)
Adherence^b
Low	23 (18.9)	21 (17.1)	26 (20.5)
Medium	63 (51.6)	54 (43.9)	53 (41.7)
High	36 (29.5)	48 (39)	48 (37.8)
Beliefs about medication questionnaire
Necessity concern differential^a	3.9 (4.9)	3.9 (4.4)	3.6 (4.6)
Categories^b
Accepting	35 (28.7)	33 (26.6)	32 (25)
Ambivalent	81 (66.4)	87 (70.2)	87 (68)
Sceptical	4 (3.3)	2 (1.6)	3 (2.3)
Indifferent	2 (1.6)	2 (1.6)	6 (4.7)
Mean possesion ratio^d,e
Cardiovascular medication total	0.74	0.73	0.72
Antithrombotic agents (B01)	0.79	0.75	0.73
Diuretics (C03)	0.77	0.81	0.73
Beta blocking agents (C07)	0.86	0.87	0.83
Calcium channel blockers (C08)	0.96	0.95	0.94
Agents acting on the angiotensin system (C09)	0.80	0.80	0.79
Lipid modifying agents (C10)	0.82	0.79	0.76

Notes: ^aData are presented as mean (±SD). ^bData are presented as number (%). ^cChronic use =starting medication > 2 months before baseline. ^dData from imputated data. ^eMean number of days dispended divided by the mean number of days between prescription refill.

Table 3A Differences in medication adherence, beliefs about medication, and clinical outcome between usual care and intervention groups at baseline, after intervention and at follow-up of 12 months (all after imputation)

	Group I+II Usual care (UC) N=271	Group II UC+consultations N=148	p-value^a
Mean possesion ratio^b
Total of cardiovascular medication
Baseline (T1)	0.74	0.73
After intervention (T2)	0.93	0.89	0.08
Follow up of 12 months (T3)	0.81	0.76	0.23
Per ATC-code
Baseline (T1)
Antithrombotic agents (B01)	0.77	0.73
Diuretics (C03)	0.79	0.73
Beta blocking agents (C07)	0.87	0.83
Calcium channel blockers (C08)	0.95	0.94
Agents acting angiotensin (C09)	0.80	0.79
Lipid modifying agents (C10)	0.80	0.76
After intervention (T2)
Antithrombotic agents (B01)	0.92	0.91	0.65
Diuretics (C03)	0.88	0.82	0.40
Beta blocking agents (C07)	0.91	0.91	0.89
Calcium channel blockers (C08)	0.89	0.87	0.57
Agents acting angiotensin (C09)	0.92	0.91	0.56
Lipid modifying agents (C10)	0.90	0.89	0.06
Follow up of 12 months (T3)
Antithrombotic agents (B01)	0.86	0.82	0.27
Diuretics (C03)	0.83	0.76	0.12
Beta blocking agents (C07)	0.80	0.80	0.87
Calcium channel blockers (C08)	0.93	0.91	0.34
Agents acting angiotensin (C09)	0.84	0.80	0.48
Lipid modifying agents (C10)	0.84	0.78	0.06
Adherent^c
Baseline (T1)	53.5	48
After intervention (T2)	86.3	76.4	0.17
Follow up of 12 months (T3)	64.9	76.4	0.38
Modified Morisky Scale^d
Baseline (T1)
Low	19.6	21.6
Medium	46.5	41.2
High	32.7	37.2
After intervention (T2)
Low	28.7	31	0.94^e
Medium	38	38.5
High	33.3	30.5
Beliefs about medication questionnaire
Necessity concern differential^f
Baseline (T1)	3.7	3.4
After intervention (T2)	3.8	3.9	0.86
Categories^g
Baseline (T1)
Accepting	27.3	25
Ambivalent	62.7	60.1
Sceptical	4.4	5.4
Indifferent	5.5	9.5
After intervention (T2)
Accepting	26.6	32.8
Ambivalent	43.2	37.1
Sceptical	14.8	17.6
Indifferent	15.2	12.6
Clinical outcomes
Systolic blood pressure (mmHg)
Baseline (T1)	136.4	136.7
After intervention (T2)	155	155	0.71
Adherent^h	25	20.9	0.52
Low- density cholestrol (mmol/L)
Baseline (T1)	2.5	2.5
After intervention (T2)	2.2	2.2	0.74
Adherent^i	90.4	86.4	0.4

Notes: ^aUsual care and usual care + are combined and compared with usual care ++ group. ^bMean number of days dispended divided by the mean number of days between prescription refill. ^cPercentage of patients (%) considered adherent according to PRD total of the cardiovascular medication (PRD was above or equal to 0.8). ^dPercentage of patients (%) who had low, medium, or high adherent scores. ^eLow and medium adherence are combined and compared with high adherence group. ^fDifferences between concern and necessity scores (means). ^gPercentage of patients (%) who are classified in the four different categories of the BMQ. ^hPercentage of patients (%) considered adherent according to systolic blood pressure (<135 mmHg) and percentage (%) of patients using antihypertension drugs. ⁱPercentage of patients (%) considered adherent according to LDL level (the recorded LDL level after intervention was 20% lower of baseline LDL cholesterol).

Table 3B Differences in mean medication adherence in time

All participants (N=419)	Baseline (T1)	After intervention (T2)	Follow-up 12 months (T3)
Mean possesion ratio Total of cardiovascular medication	0.72	0.92*	0.80**

Notes: *p-value <0.05 relative to T1. **p-value<0.05 relative to T2.

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