Improving Post-Discharge Medication Adherence in Patients with CVD: A Pilot Randomized Trial

Oliveira-Filho, Alfredo D.; Morisky, Donald E.; Costa, Francisco A.; Pacheco, Sara T.; Neves, Sabrina F.; Lyra-Jr, Divaldo P.

doi:10.5935/abc.20140151

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Original Articles • Arq. Bras. Cardiol. 103 (06) • Dec 2014 • https://doi.org/10.5935/abc.20140151 copy

Improving Post-Discharge Medication Adherence in Patients with CVD: A Pilot Randomized Trial

Authorship SCIMAGO INSTITUTIONS RANKINGS

Background:

Effective interventions to improve medication adherence are usually complex and expensive.

Objective:

To assess the impact of a low-cost intervention designed to improve medication adherence and clinical outcomes in post-discharge patients with CVD.

Method:

A pilot RCT was conducted at a teaching hospital. Intervention was based on the four-item Morisky Medication Adherence Scale (MMAS-4). The primary outcome measure was medication adherence assessed using the eight-item MMAS at baseline, at 1 month post hospital discharge and re-assessed 1 year after hospital discharge. Other outcomes included readmission and mortality rates.

Results:

61 patients were randomized to intervention (n = 30) and control (n = 31) groups. The mean age of the patients was 61 years (SD 12.73), 52.5% were males, and 57.4% were married or living with a partner. Mean number of prescribed medications per patient was 4.5 (SD 3.3). Medication adherence was correlated to intervention (p = 0.04) and after 1 month, 48.4% of patients in the control group and 83.3% in the intervention group were considered adherent. However, this difference decreased after 1 year, when adherence was 34.8% and 60.9%, respectively. Readmission and mortality rates were related to low adherence in both groups.

Conclusion:

The intervention based on a validated patient self-report instrument for assessing adherence is a potentially effective method to improve adherent behavior and can be successfully used as a tool to guide adherence counseling in the clinical visit. However, a larger study is required to assess the real impact of intervention on these outcomes.

Cardiovascular Diseases; Medication Adherence; Patient Discharge; Patient Discharge Summaries; Randomized Controlled Trial

MMAS-4 question	Do you ever forget to take your medicine?	Do you ever have problems remembering to take your medicine?	When you feel better do you sometimes stop taking your medicine?	When you sometimes feel worse when you take the medicine, do you stop taking it?
Specific goal	To improve memory for medication taking	To adapt the regimen to the patient's daily schedule to address carelessness	To avoid stopping the treatment when feeling better	To avoid stopping the treatment when feeling worse
	Procedure 1		Procedure 2	Procedure 3
	Provide an easy reminder and identify a daily activity or cue that the patient does regularly at about the time he or she should take medications and explain to the patient to take medications at this time		Explain fundamentals of hypertension and its management to patient in terms he or she can understand. Explain how the medication works in a simple way and what are the specific consequences or effects if the patient stops taking it.	Teach patient how to monitor the most common side effects of his or her treatment (withdrawal rates due to side effects must be investigated). Support and encourage patient to report the problem to the physician.
	Therapeutic class information
Agents acting on the renin- angiotensin system, Beta blocking agents and Calcium channel blockers	This medicines act by dilating the blood vessels (and, in some cases, reducing heart muscles contractility). Therefore amlodipine and losartan may take a few weeksto show* noticeable effects.
	Linking medication taking to patient's daily schedule³¹31 Zhu LL, Zhou Q, Yan XF, Zeng S. Optimal time to take once-daily oral medications in clinical practice. Int J Clin Pract. 2008;62(10):1560-71.		Withdrawal symptoms	Potential causes of withdrawal
Amlodipine	Optimal dosing time: in the morning, around breakfast time (there is little evidence of what is the optimal time to take once-daily amlodipine, however the optimal dosing time may be morning).		Abrupt withdrawal of this agent can precipitate coronary vasospasm, which may result in myocardial infarction.	Peripheral edema, fatigue, palpitation, headache, dyspepsia, nausea.
Amlodipine	May be taken with food.
Atenolol	Optimal dosing time: uncertain.		Tachycardia, palpitation, excessive sweating, chest pain, heart attack, death.	Hypotension, bradycardia, bronchospasm, cold extremities.
Atenolol	May be taken with food (although the presence of food may reduce the bioavailability of atenolol by 20%).			Hypotension, bradycardia, bronchospasm, cold extremities.
Captopril	Optimal dosing time: uncertain (although there is fair evidence that bedtime dosing may constitute an effective option to reduce cardiovascular risk)		Abrupt withdrawal of these agents can precipitate hypertensive rebound in diabetic patients with chronic renal failure	Dry cough, hyperkalemia (especially if used with spironolactone; main symptoms: palpitations and muscle weakness), postural hypotension.
Captopril	May be taken without food.
Carvedilol	Optimal dosing time: evening.		Tachycardia, palpitation, excessive sweating, chest pain, heart attack, death.	Fatigue, hypotension, diarrhea, asthenia, bradycardia, dizziness, edema.
Carvedilol	May be taken with food.
Enalapril	Optimal dosing time: evening.		Abrupt withdrawal of these agents can precipitate hypertensive rebound in diabetic patients with chronic renal failure	Hypotension, dry cough.
Enalapril	May be taken with food.			Hypotension, dry cough.
Losartan	Optimal dosing time: administration time-dependent effects of losartan have not been documented.		There is little evidence of rebound effect after abrupt withdrawal of losartan therapy	Dizziness, diarrhea, tiredness.
Losartan	May be taken with food (concurrent use of losartan and grapefruit juice may result in increased half-life and decreased area under the concentration time curve of losartan's active metabolite).			Dizziness, diarrhea, tiredness.
	Therapeutic class information
Diuretics	These medications increase water loss by inhibiting sodium and chloride resorption in the kidneys. When taking these antihypertensives, one will urinate a lot because of the increased water loss.
	Linking medication taking to patient's daily schedule		Withdrawal symptoms	Potential causes of withdrawal
Hydrochlorothiazide	Optimal dosing time: before 6 pm and preferably in the morning		If diuretics are withdrawn suddenly in patients with a normal sodium intake, there will be rebound retention of sodium and water (with consequent edema), because compensatory mechanisms that maintain sodium balance in the face of diuretics continue to act for several days after diuresis has worn off.	Hypokalemia (symptoms include muscular weakness, myalgia, and muscle cramps), weakness.
Hydrochlorothiazide	May be taken with food.
Furosemide	Optimal dosing time: no significant difference related to dosing time was observed between morning and evening trials.			Hypokalemia (symptoms include muscular weakness, myalgia, and muscle cramps), hyperglycemia, hyponatremia (symptoms include nausea and vomiting, headache, fatigue, appetite loss).
Furosemide	May be taken with food.
Spironolactone	Optimal dosing time: administration time-dependent effects of spironolactone have not been documented.		There is no apparent rebound effect after abrupt withdrawal of spironolactone therapy	Hyperkalemia (main symptoms: palpitations and muscle weakness).
Spironolactone	May be taken with food.
	Therapeutic class information
Platelet aggregation inhibitors	Treatment with blood thinners prevents blood clots from forming in blood vessels. It may be used to prevent or treat heart attacks and stroke.
	Linking medication taking to patient's daily schedule		Withdrawal symptoms	Potential causes of withdrawal
Acetylsalicylic acid	Optimal dosing time: in the morning and/or in the evening with food (bedtime administration of aspirin decreases morning surge of platelet aggregation while kept same antiplatelet efficacy during other time of the day compared to taking these drugs at day-time).		The withdrawal of acetylsalicylic acid may be associated with traditional cardiovascular risk factors and thrombosis.	Gastrointestinal side effects (pain, heartburn, indigestion), bleeding.
Clopidogrel	Optimal dosing time: in the morning and/or in the evening with food (bedtime administration of clopidogrel decreases morning surge of platelet aggregation while kept same antiplatelet efficacy during other time of the day compared to taking these drugs at day-time).		Clopidogrel withdrawal is associated with a rebound prothrombotic and/ or proinflammatory response. Premature cessation of clopidogrel in patients receiving drug-eluting stents is a clear risk factor for stent thrombosis.	Bleeding, Gastrointestinal side effects (pain, heartburn, indigestion, diarrhea), rash.
	Therapeutic class information
Lipid modifying agent	These agents are used along with a proper diet to help lower 'bad' cholesterol and fats and raise 'good' cholesterol in the blood
	Linking medication taking to patient's daily schedule		Withdrawal symptoms	Potential causes of withdrawal
Rosuvastatin	Optimal dosing time: in the morning or in the evening (there are sufficient data to support evening administration of simvastatin to achieve optimal effect, however the elimination half-life of rosuvastatin is significantly longer and this is probably significant in the ability to take it in the morning with non-significant changes in lipid lowering compared to evening administration).		Statin withdrawal abrogates this beneficial effect in patients initially responsive to this therapy and may cause rebound inflammatory effect.	Muscle pain, fatigue and weakness, myalgia, cognitive loss.
Rosuvastatin	May be taken without food.			Muscle pain, fatigue and weakness, myalgia, cognitive loss.

Characteristic	Intervention Group (n = 30)	Control Group (n = 31)	p values
Sex, N°. (%)
Male	16 (53.3)	16 (51.6)	0.90^a a Chi-square test
Female	14 (46.7)	15 (48.4)	0.90^a a Chi-square test
Age, mean (SD)	60.93 (12.69)	61.07 (12.99)	0.96^b b ANOVA
Married or living with partner, N°. (%)	18 (60.0)	17 (54.8)	0.36^a a Chi-square test
N°. of prescribed medications at discharge, mean (SD)	4.46 (1.72)	4.5 (1.93)	0.94^b b ANOVA
Underwent surgery during hospitalization, N° (%)	10 (33.3)	9(29.0)	0.93^a a Chi-square test
Main diagnosis, N°. (%)
Hypertension	16 (53.3)	15 (48.4)	0.70^a a Chi-square test
Heart failure	6(20.0)	8(25.8)
Coronary artery disease	5 (16.7)	7(22.6)
Diabetes mellitus	7(23.3)	5 (16.1)
Other	2(6.7)	0

Value (%)
Variable	Intervention Group (n = 30)	Control Group (n = 31)	p Values
Readmissions	6 (20%)	15 (48%)	0.20
Deaths	3 (10%)	6 (19%)	0.43

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1. Do you ever forget to take your (name of health condition) medicine?	Yes / No
2. Do you ever have problems remembering to take your (name of health condition) medicine?	Yes / No
3. When you feel better, do you sometimes stop taking your (name of health condition) medicine?	Yes / No
4. Sometimes if you feel worse when you take your (name of health condition) medicine, do you stop taking it?	Yes / No

1. Do you sometimes forget to take your high blood pressure pills?	Yes / No
2. Over the past two weeks, were there any days when you did not take your high blood pressure medicine?	Yes / No
3. Have you ever cut back or stopped taking your medication without telling your doctor because you felt worse when you took it?	Yes / No
4. When you travel or leave home, do you sometimes forget to bring along your medications?	Yes / No
5. Did you take your high blood pressure medicine yesterday?	No / Yes
6. When you feel that your blood pressure is under control, do you sometimes stop taking your medicine?	Yes / No
7. Do you ever feel hassled about sticking to your blood pressure treatment plan?	Yes / No
8. How often do you have difficulty remembering to take all your blood pressure medication?	Never-Rarely/Once in a while/ Sometimes/Usually/All the time