CHAPITRE 3 : PRINCIPE DE COMMUNICATION
6. Erving Goffman : la communication refoulée
Pharmaceutical Care Practice and consequences on quality of life and satisfaction of diabetic patients: a randomized clinical trial
Patrícia Trindade C. Paulo1, Palas Atenéia D. de Medeiros2, Paulo Roberto M. de Azevedo3, Rodrigo dos Santos Diniz 4, Eryvaldo Sócrates T. do Egito5, Ivonete Batista de Araújo5
1Faculty of Pharmacy, State University of Paraiba, Campina Grande, Brazil.
2Postgraduate Collective Health Program, State University of Paraiba, Campina Grande, Brazil.
3 Department of Statistics, Federal University of Rio Grande do Norte, Natal, Brazil. 4 Postgraduate Health Science Program, Federal University of Rio Grande do Norte, Natal, Brazil.
5 Faculty of Pharmacy, Federal University of Rio Grande do Norte, Natal, Brazil.
Corresponding author: Ivonete Batista de Araújo Tel: 55-84-33425149, email: [email protected]
ABSTRACT
Objective – This study aimed at assessing the quality of life of patients with type 2
diabetes who received pharmaceutical care and their satisfaction with the service provided by Community Pharmacies.Methodology – This is a single-blind, randomized controlled clinical trial involving
100 patients of both sexes with type 2 diabetes followed for 6 months. Control group patients received standard treatment while the intervention group was submitted to the pharmacotherapy workup process. The primary outcome was quality of life as measured by the Diabetes Quality of Life Measure (DQOL) questionnaire – Brazil and the secondary outcome was satisfaction with the service provided, using an instrument validated and translated into Portuguese.Results –
Statistically significant differences were observed between the intervention and control groups for total DQOL score (-0.62 vs 1.57 95% CI for p = 0.000) and in all domains assessed at the end of follow-up. The goal was reached in terms of patient satisfaction with the care provided, with 100% frequency in the 14 questions and final scores of 96%.Conclusion –
The advice provided by pharmacists in community pharmacies using Pharmaceutical Care practices resulted in higher quality of life and satisfaction levels. Thus, consolidating pharmaceutical advice activities is a professional and human commitment in our profession. Moreover, the practice complements prevention and health recovery measures for the population.Trial Registration
Reference: Paulo PTC, Medeiros PAD, Azevedo PRM, Diniz RS, Egito EST, Araújo IB. Pharmaceutical Care Influencing the Quality of Life of Diabetic Patients and their Satisfaction with the Service Provided: Randomized Clinical Trial.
Author’s rights: © Paulo et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which allows unrestricted use, distribution and reproduction in any medium, provided the original author and source are referenced.
Financing: The authors received no financing or other support.
Introduction
The importance of quality of life (QOL)-related health and its value as a health outcome has evolved over the last 20 years [1]. The health-disease process has come to depend on external factors such as living, working, cultural and environmental conditions, among others [2].
The pursuit of quality of life, which has become evident in recent years, has translated into important health benefits for the population. Assessing quality of life- related health is vital in measuring the effect of therapy, currently measured using structured and validated psychometric instruments [3].
Another way of evaluating health considers the humanistic results and, therefore, the quality of interventions aimed at measuring the degree of patient satisfaction. Satisfaction is a subjective parameter that reflects patient preferences and expectations with the care provided, especially in terms of technical and interpersonal aspects, thereby allowing assessment of professional performance and health outcomes [4].
One of the practical activities by which pharmacists influence the health of patients is through the pharmaceutical care program. This was defined as “the responsible provision of drug therapy in order to obtain concrete results that improve the quality of life of patients” [5]. This definition suggests that in their capacity as health professionals, pharmacists assume responsibility for therapeutic results by playing an active role in patient care management, seeking to control infirmity and improve quality of life [6].
This strategy is more evident in the treatment of chronic diseases such as type 2 diabetes mellitus, due to its high prevalence and serious complications, which may lead to biological, psychological and social repercussions [7]. Possible health improvements should be measured using a suitable and sufficiently sensitive assessment instrument to reflect changes in quality of life over time [8].
The positive influence of pharmaceutical care practices on quality of life was demonstrated in a non-randomized study [9] and others with no control group [10 and 11]. Only one [12] used randomization and a control group, which establishes the need for further studies that assess quality of life and patient satisfaction, using a randomized clinical trial design.
Thus, the aim of the present study was to assess the quality of life of patients with type 2 diabetes who received pharmaceutical care and their satisfaction with the service received in Community Pharmacies.
Methods
The protocol for this trial and the CONSORT checklist, along with support information, are available. The study was approved by the Research Ethics Committee of the Paraiba State University-Brazil and registered in Clinical Trials.gov under identifier NCT01580904.
This is a single blind randomized controlled clinical trial involving 100 patients with type 2 diabetes mellitus, at two Community Pharmacies in João Pessoa, Paraíba state, between September 2009 and December 2011. These facilities had the necessary infrastructure to develop the research, including an exclusive room for pharmacists to treat patients.
Patients who gave their informed consent were divided into two groups, both of which received monthly treatment, totaling six sessions for each patient. In the intervention group, the pharmacist conducted pharmacotherapy follow-up based on the Pharmacotherapy Workup adopted by the Minnesota Pharmaceutical Care Project [13], and the control group received standard treatment, with no added service.
Patient Selection Criteria
Patient selection took place at pharmacies at the moment patients purchased medication for type 2 diabetes medication. The following inclusion criteria were adopted: age greater than or equal to 30 years, type 2 diabetes mellitus, use of oral hypoglycemic agents with the addition or not of insulin and having been submitted to biochemical tests in a previously determined laboratory. Individuals with infectious and contagious diseases during the study, those who missed three consecutive interviews, or who suspended hypoglycemia medication, as mandated by a physician, were excluded.
Interventions Used
Personal and clinical data, family history, life habits and clinical conditions were collected from the intervention group at the first session. Patients were also instructed to bring the medication they were currently taking. At the end of each session, they were given a card containing the date of the next meeting.
Afterwards, the clinical history and drug use of each patient were analyzed to determine whether there were any medication-related problems (MRP), and, when identified, an attempt was made to resolve and prevent potential MRPs.
The MRPs were classified according to Pharmacotherapy Workup methodology [13] in the following domains: indication (unnecessary medication or need for additional medication), effectiveness (different medication is required, need for low- dose synergic pharmacotherapy) safety (adverse reaction to high-dose medication) and adherence (patient prefers not to take medication).
Interventions were divided into MRP resolution, pharmaceutical advice and educational measures. To resolve MRPs medication times were changed, patients were encouraged to adhere to drug treatment and possible adverse reactions were resolved. In regard to problems involving the prescriber, the pharmacist sent a letter to the physician via the patient, who delivered it at the next meeting. A number of patients were referred to the Family Health Strategy (FHS to schedule an appointment with an endocrinologist through a community health agent or nurse. Next, a health care plan containing information on recommended practices and medication use was prepared for each patient. This plan was initially discussed and agreed upon with the patient, registered and documented on individual charts, and evaluated in successive meetings.
In educational measures, attempts to resolve health problems were directed towards changing lifestyle, stimulating healthy eating habits and encouraging physical activity. Pamphlets on diabetes, heart health, a food guide for diabetics, and the proper drug use were handed out.
The control group also received pamphlets, in addition to medication and a brief explanation regarding its use.
Outcomes Assessed
As primary outcome the quality of life of patients was assessed and as secondary their satisfaction with pharmaceutical services.
Quality of life was measured by the Diabetes Quality of Life Measure (DQOL), a questionnaire validated in Brazil for Portuguese [8]. It is composed of 44 multiple- choice questions, divided into four domains: satisfaction (15 questions), impact (20), social/vocational concern (7), and diabetes-related concerns (4). A 5-point Likert scale was used to measure satisfaction (1 - excellent satisfaction, 2 – very satisfied, 3 – moderately satisfied, 4 – slightly satisfied, 5 – not satisfied), or frequency (1 - never, 2 – hardly ever, 3 - sometimes, 4 - frequently, 5 – always).
The DQOL-Brazil was applied at the onset and 6 months after follow-up in both groups, using a self-completion questionnaire or structured interview for patients with limited reading or writing skills. The pharmacists were trained to maintain a neutral stance during questionnaire completion, only encouraging patients to respond to every question.
With respect to satisfaction with the care provided, we used a structured instrument [14], translated and validated into Portuguese [15], composed of four dimensions: quality of advice, humanistic treatment on the part of the pharmacist, professional competence and pharmacotherapy management, in addition to overall satisfaction with the care received. It consists of 14 questions on a scale containing five alternatives (5 = always, 4 = almost always, 3 = sometimes, 2 = hardly ever, 1= never).
The questionnaire was completed at the end of follow-up without the presence of the research pharmacist. When patients found it difficult to respond, another pharmacist spoke with them to put them at ease and then left them to complete the questionnaire.
At this stage, appropriate participation by the interviewer will minimize interference in the study results. For ethical reasons, responses remained confidential and questionnaires were anonymous until the end of the study, at which time only data analysis was revealed.
Sample Size
Sample size was calculated for 100 patients with a view to detecting a statistically significant reduction in the results, considering α=0.05 and β=0.2 and a loss rate of 10% [16].
Randomization and Allocation
The randomization process used a table of random numbers [17]. The patients selected in the pharmacies were referred to the central laboratory and received an individual registration number on their arrival, which was used to identify them on their final exam report. These exams were given to the researchers and, based on the order of the registration numbers, each patient was allocated a constant number on the random table in a continuous sequence. It was previously established that even numbers from the table would be members of the intervention group and odd numbers would be from the control group. There were members of both intervention and control groups in the two pharmacies, and patients remained masked from the onset to the end of the study, without knowing which group they belonged to.
Data Analysis
The R system, version 2.14, was used for statistical analysis. Tests for comparing proportions and the student’s t-test for independent populations and paired observations were conducted. Confidence intervals of 95% were established for the means and hypothesis tests were performed with a p-value < 0.05.
RESULTS
The study was initially composed of 100 patients, 89% of whom (89/100) concluded the study, 47 and 42 from the intervention and control group respectively. Eleven patients did not conclude the study for the following reasons: 5 from the intervention group due to a change in address (2), profession (1), heart attack (1) and death (1); and 6 from the control group owing to change in address (3) and
profession (3). One patient was excluded from the control group for physician- mandated suspension of oral hypoglycemic drug treatment (Figure 1).
A total of 562 meetings were held between pharmacists and patients, 292 from the intervention group. Table 1 shows the demographic and clinical variables of the study groups.
We conducted and documented 158 pharmaceutical interventions, with a mean of 3.4 interventions per patient. Of these, 50 with a problem resolution rate of 84% (42/50) were referred to a doctor and 108 were resolved directly with the patient. For 27 of these the goal was to improve medication adherence, with an acceptance of 70% (19/27), and for 81 lifestyle changes were implemented with a 79% improvement (64/81).
Quality of Life
The 44-question DQOL-Brazil questionnaire was applied at the onset and end of follow-up, in both groups. Table 2 shows initial and final scores, grouped in the following domains: impact, social/vocational and diabetes-related concerns.
The results demonstrate that initially there were no statistically significant differences between the intervention and control group in total score (2.26 vs 2.28 respectively, with p= 0.865) or in any of the four domains, showing group homogeneity.
In the sixth month of follow-up, all DQOL indices in the intervention group improved. Statistically significant differences were observed in total score (-0.62 vs 1.57 p=0.000), satisfaction (-0.88 vs 1.33 p=0.000), impact (-0.54 vs 2.02 p=0.000), social/vocational concerns (-0.28 vs 0.75 p=0.020) and diabetes concerns (-0.65 vs 1.89 p=0.000). See Table 2.
Patient satisfaction
Forty-seven intervention group patients were assessed for satisfaction with the care received and performance of the researcher pharmacist. A response instrument with a number of dimensions was used and all were assessed.
Table 3 demonstrates that the researcher pharmacist and care provided to patients obtained high satisfaction scores. Nine of the 14 questions (1, 2, 3, 4, 6, 8, 9,
12, 14) showed excellent satisfaction, where the goal was to achieve response 5 (always) with 100% frequency for each question, and the results of the study approached these values. In 5 questions (5, 7, 10, 11, 13), the best response was 1 (never), also with 100% frequency, thereby attaining scores that were quite similar to these values.
DISCUSSION
This study demonstrated that pharmaceutical care improved the quality of life of patients after a 6-month follow-up and that they were satisfied with the service provided, showing that it is an important activity with a positive impact on the life of individuals.
Complications caused by type 2 diabetes and medication-related problems (MRP) compromise quality of life. Most MRPs were linked to pharmacotherapy for diabetes, current therapy being the most effective, corroborating another study [18]. The meetings held between pharmacists and the intervention group before the occurrence of MRPs indicate that increased care raises the possibility of preventing MRPs, as observed in a study conducted in the United States [19].
With respect to quality of life, as measured by the DQOL-Brazil questionnaire, in all the domains and the overall score, intervention group patients obtained statistically significant results after six months follow-up compared to the control group. This contrasts with the study by Cassyano et al. [20], who did not obtain significant results in social/vocation or diabetes-related concerns.
Pharmaceutical care practices in this clinical trial improved the quality of life of intervention group patients, resulting from the program developed by pharmacists at Community Pharmacies, according to the study conducted by Melchiors et al. [21]. In contrast to the control group, which did not receive additional care from the pharmacist, most scores in the domains assessed remained unchanged or slightly altered between the onset and end of follow-up, showing no improvement in quality of life.
To assess patient satisfaction with the pharmaceutical care provided, a questionnaire with various dimensions was used, all of which obtained excellent satisfaction scores with respect to the service and the researcher pharmacist. These
results were better when compared to satisfaction with traditional dispensing practices [22] and equivalent [15] with this same type of instrument.
In the responses collected for the quality of advice domain (Table 3), most patients considered that the research pharmacists satisfactorily explained the correct use of medication. To that end, the following communication strategies and skills were used: visual, auditory, verbal and written [23]. This was confirmed by patients through the following statements: “just by coming here, I felt better after our conversation” (APS, woman, 61 years old); her husband came to pick her up and said: “did you ask everything you wanted to know so you won`t forget?”.... the patient answered “yes, about simvastatin and AAS; now I know” (MTLA, woman, 66 years olds); “I didn’t take the flu vaccine because I thought that diabetics couldn’t, but now I take it” (LVT, man, 55 years old), “I used to keep my drugs in the fridge, but after your advice I don’t anymore” (JES, man, 67 years old).
However, 5 (11%) patients had difficulty understanding the pharmacist (question 11), but this was because some of them had little or no schooling and cognitive impairment, whether visual or auditory.
The quality of advice is often not material, but rather sensitive and perceptive. Satisfaction is a combination of values that interact, where personal care supersedes any other type of care provided in the orientation process. Not only should health issues be discussed, but also interrelationships with the “real world” of the family, work, leisure and others [24].
The mean time spent on meetings with the pharmacist was 41 (±3) minutes, considered sufficient by the patients (questions 1 and 10). The 5 individuals (11%) who responded that the time was insufficient (question 7) exhibited personal and family problems - “doctor, I don’t need a doctor, I need a priest” (UFC, man, 57 years old), and were referred to a psychologist.
In the healthcare context, the commitment of both parties, the use of communication and humanization resources mediated the process that resulted in the construction of therapeutic relationships, in the co-responsibility of health and in obtaining positive results [25], confirmed in the following statements: “my diabetes is only under control when I’m here with you” (AJL, man, 68 years old); “now I see the importance of the pharmacists with this study” (VPM, woman, 66 years old). Thus, building good therapeutic relationships is important for successful pharmaceutical care.
In the professional competence and pharmacotherapy management domains (questions 2 and 9) excellent satisfaction scores were recorded. The pharmacist correctly explained the possible side effects that new medication could entail. By contrast, 4 (4%) patients responded that the professional was not clear enough (question 5), which may have compromised understanding the safe and rational use of medication.
A crucial point in patient follow-up was the availability of a room exclusively for pharmaceutical care at the community pharmacies investigated. In regard to this issue, 13 (6%) reported there were no distractions in the room that hindered good understanding, ensuring their confidentiality (question 12) and privacy, as in the following example: a patient comes to the pharmacy with her son, preferring to relate her family history rather than talking about her diabetes (MFLC, woman, 59 years old). In this environment, patients received the necessary information, as demonstrated in the following statement: “you explain the exams better, the doctor doesn’t explain anything, he says everything is fine” (MGGP, woman, 60 years old); another patient (SG, woman, 65 years old) arrived feeling ill, and it was found she was taking the wrong drug, which had been erroneously sold to the patient, hydrochlorothiazide instead of digoxin, thereby resolving the problem.
Pharmaceutical care is important in preventing medication errors, as well as in promoting humanized and social activities, fulfilling its role and collaborating with other health professionals [26].
Finally, for overall satisfaction with the program, measured in question 14, 47 (100%) responded that they were satisfied with the care provided by the research pharmacist, as follows: “we won’t see each other again”, adding “my wife died and I’m managing to survive...I’ll manage to live without your care, but please don’t change your cell phone number” (ATS, man, 76 years old); “I want to pay for the treatment, how much is it anyway?” (JMS, man, 58 years old). Thus, we can observe that this follow-up model was effective, with a high degree of satisfaction and a real improvement in the quality of life of these patients.