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Shared decision-making and patient engagement program during acute exacerbation of COPD hospitalization: A randomized control trial
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Patient Education and Counseling journal homepage: www.elsevier.com/locate/pateducou
Shared decision-making and patient engagement program during acute exacerbation of COPD hospitalization: A randomized control trial María Granados-Santiago, Marie Carmen Valenza* , Laura López-López, Esther Prados-Román, Janet Rodríguez-Torres, Irene Cabrera-Martos Faculty of Health Sciences, University of Granada, Granada, Spain
A R T I C L E I N F O
A B S T R A C T
Article history: Received 28 March 2019 Received in revised form 6 November 2019 Accepted 9 December 2019
Objective: To evaluate the effectiveness of a shared decision-making and patient engagement (SDM-PE) program concerning in-hospital stay during acute exacerbation of COPD and determine its impact on patients’ perceived health status. Methods: Patients were randomly allocated to a control group that received standard treatment or an intervention group that received an individualized SDM-PE program in addition to standard treatment. The SDM-PE program included personalized health care focused on information about the disease, healthcare management, and reinforcement of behaviors regarding nutrition and exercise taking into account patients’ preferences. Results: A comparative analysis between groups showed a significant improvement in perceived health status at discharge in patients included in the experimental group compared to those in the control group (60.28 21.65 vs. 54.13 22.69, p = 0.036). In addition, perceived health status, COPD knowledge, adherence to pharmacological treatment, general functionality, and healthy lifestyle measures were significantly better at 3-month follow-up in the intervention group. Conclusion: An SDM-PE program significantly enhanced all the clinical measures assessed during hospitalization at 3-month follow-up. Practice implications: COPD patients and professionals need to work together to select the best care and treatment model for patients, taking into account individual values and preferences. © 2019 Published by Elsevier B.V.
Keywords: Pulmonary disease Chronic obstructive Decision making Hospital medicine Patient participation
1. Introduction Chronic diseases affect more than 90 million American adults and are responsible for approximately 70 % of health care expenditure [1]. These values are expected to grow in the next decades, with pulmonary diseases (38 %) and cancer (17 %) as the most expensive diseases [2]. Among respiratory diseases, chronic obstructive pulmonary disease (COPD) is the leading one in hospital care cost, physician services, and prescription drugs [3]. Patients with COPD experience a progressive decline in functional capacity and health-related quality of life (HRQoL) [4] with a significant burden in terms of disability [5]. The clinical course of COPD includes frequent exacerbation episodes, which are clinically characterized by a worsening of dyspnea, cough, sputum production, and airflow obstruction [6].
* Corresponding author at: Departamento de Fisioterapia, Facultad de Ciencias de la Salud, Universidad de Granada, Av. De la Ilustración, 60, 18016, Granada, Spain. E-mail address: [email protected] (M.C. Valenza).
The main treatment for COPD across clinical stages (i.e., stable and exacerbation) is a combination of medical and pharmacological treatment (i.e., short-acting bronchodilators, systemic corticosteroids, and antibiotics) [7], showing variable results in symptoms, exercise capacity, and quality of life. During hospitalization, patients with COPD need supportive, medical, and rehabilitative care to cope with symptoms and functional impairment [8]. To minimize the time and costs involved by such supportive care services in response to the raising number of COPD patients, it may be useful to enhance patient self-management strategies [9]. Shared decision programs have emerged in recent decades as a new way to change the role of patients and their relationship with medical practitioners [10]. They are described as an interpersonal and interdependent process in which the health care provider and the patient jointly make making specific decisions about health care. Patient engagement implies recognizing and understanding the importance of playing an active role in one’s health and having the knowledge, skills, and confidence for this purpose. In patients with COPD, these programs could support patients’ involvement in their own pharmacological management (i.e., inhalers and ‘rescue
https://doi.org/10.1016/j.pec.2019.12.004 0738-3991/© 2019 Published by Elsevier B.V.
Please cite this article in press as: M. Granados-Santiago, et al., Shared decision-making and patient engagement program during acute exacerbation of COPD hospitalization: A randomized control trial, Patient Educ Couns (2019), https://doi.org/10.1016/j.pec.2019.12.004
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medications’), symptom control, and promotion of positive lifestyle changes [11,12]. COPD patients show significantly lower functionality levels and higher symptomatic burden after hospitalizations [13]. Frequent hospitalizations provide opportunities for the implementation of behavioral changes [14]. In this regard, hospitalization has been proposed as an adequate clinical time and space to prescribe changes in treatments [15]. However, no previous studies have implemented an in-hospital SDM-PE program in patients with an acute exacerbation of COPD. The main objective of this study was to evaluate the effectiveness of an SDM-PE program concerning in-hospital stay and determine its impact on patients’ perceived health status and specifically on their knowledge of COPD, pharmacological management, general functionality, and lifestyle. 2. Methods 2.1. Study design The study was designed as a randomized controlled trial in hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Patients assigned to the control group received a standard treatment (i.e., medical and pharmacological therapy) and patients in the intervention group received an individualized SDM-PE program added to standard treatment. The ethics approval for this study was obtained from the Biomedical Research Ethics Committee of Granada. This research was conducted in accordance with the amended Declaration of Helsinki reviewed in 2013. The study was registered in Clinicaltrials.gov with identifier NCT03772639. The CONSORT guidelines [16] were followed during the course of the research. 2.2. Participants Patients were recruited in the Pulmonology Service of Virgen de las Nieves and San Cecilio hospitals in Granada, Spain. Those who agreed to participate received an explanation of the research protocol and gave written informed consent. The inclusion criteria were being patients hospitalized due to AECOPD. Exclusion criteria were inability to provide informed consent, the presence of psychiatric or cognitive disorders, progressive neurological disorders, organ failure, cancer, or inability to cooperate. Patients who had experienced another exacerbation of COPD in the previous month were also excluded.
was assessed with the Five Times Sit-to-Stand (STS) test [20], comorbidities were assessed with the Charlson Comorbidity Index [21], and anxiety and depression levels were evaluated with the Hospital Anxiety and Depression Scale (HADS) [22]. The primary outcome measure was perceived health status. Secondary outcomes were knowledge of the disease, pharmacological management, general functionality, and healthy lifestyle. Health status was measured with the EuroQol-5D (EQ-5D) tool. This measure contains two sections: a descriptive questionnaire about health impairment and a numerical scale about health status perception. The descriptive section includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/ depression. The numerical scale ranges from 0 (defined as the worst imaginable health state) to 100 (defined as the best imaginable health state) [23]. Knowledge of the disease was assessed with the Chronic Obstructive Pulmonary Disease Knowledge Questionnaire (COPD-Q). The COPD-Q is a valid and reliable questionnaire that assesses COPD knowledge. It has a maximum score of 13, indicating the best COPD knowledge [24]. Pharmacological management in COPD patients was assessed with the Test of Adherence to Inhalers (TAI) [25]. The TAI measures adherence to treatment scored using the first 10 items of the questionnaire, with higher scores indicating greater adherence. General functionality was evaluated with the Functional Independence Measure (FIM) [26]. It measures two dimensions: motor and cognitive. The total score ranges from 18 points (total dependence) to 126 points (complete independence). Lifestyle changes included physical activity [27] and nutrition [28]. Physical activity was measured using a pedometer (Fitbit Flex 2) with great validity in patients with chronic lung disease, specifically COPD [29]. The device collects daily steps as physical activity levels. Patients were instructed to wear the device on their wrist continuously during a complete day at baseline, discharge, and 3-month follow-up. The Mini Nutritional Assessment (MNA) was also used. It includes questions about food intake, weight loss, mobility, stress, neuropsychological problems, and BMI to evaluate individuals’ nutrition state in the last month. Scores lower than 17 in the MNA are considered malnutrition [30]. The MNA was assessed at baseline and at 3-month follow-up using these values for the statistical analysis given that patients received a standard hospital menu during hospitalization. A blinded assessor evaluated the main outcomes in the hospital at baseline, discharge, and 3-month follow-up. 2.5. Control group
2.3. Randomization Participants who signed the informed consent form were randomly assigned to the control group or the intervention group. In each case, researchers opened a sequentially numbered, sealed envelope to determine whether the patient was allocated to the intervention or the control group. The randomization sequence was prepared by a statistician using computer-generated random numbers. 2.4. Outcome measures Descriptive data of participants included age, body mass index, and length of hospital stay. Additionally, forced expiratory volume in the first second (FEV1%) was assessed with a spirometer (CareFusion, Micro Spirometer, Basingstoke, UK) following the criteria of the ATS [17]. Dyspnea perception was recorded using the modified Borg Scale [18] and fatigue perception was assessed with the Fatigue Severity Scale (FSS) [19]. Additionally, exercise capacity
All patients received the standard treatment (i.e., medical and pharmacological care) including systemic steroids, antibiotics, inhaled bronchodilators, and oxygen therapy. The antibiotic therapy included an inhibitor of β-lactam/β-lactamase or fluoroquinolone in each case. Inhaled β2 short-acting agonists and anticholinergic agents were used to reduce the symptoms and improve airflow obstruction. Inhaled glucocorticoids included beclomethasone dipropionate, budesonide, flunisolide, fluticasone propionate, and triamcinolone acetonide. In addition, during hospitalization patients received nutritionally complete menus and special attention was given to the use of diuretics, anticoagulants, and cardiovascular agents [31]. 2.6. Intervention group All patients included in the intervention group received an individualized SDM-PE program added to the standard treatment during the hospitalization period. The program was tailored to
Please cite this article in press as: M. Granados-Santiago, et al., Shared decision-making and patient engagement program during acute exacerbation of COPD hospitalization: A randomized control trial, Patient Educ Couns (2019), https://doi.org/10.1016/j.pec.2019.12.004
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a minimal clinically important difference of 15 points with 80 % power for the VAS health-related quality of life outcome in both groups [32]. We anticipated that approximately 10 % of the participants might fail the initial screening or drop out; therefore, we needed to enroll 20 participants per group to account for this loss. 3. Results
Fig. 1. The key elements of each SDM-PE program.
meet the needs of each patient during the AECOPD. The SDM-PE program was developed focusing on COPD self-management goals, although other characteristics such as health care competence were also considered taking into account the clinical profile of patients and their priorities, interests, and preferences. The key elements of each SDM-PE program are shown in Fig. 1. The SDM-PE program goals [11] included pharmacological management, symptomatic control, and healthy lifestyle promotion. The decision-making process was developed collaboratively among professionals and patients by providing information, explaining the advantages and disadvantages, and promoting the active role of COPD patients. The contents of the program were developed jointly with each patient in a problem-solving format in order to detect potential misbeliefs, considering the best available evidence concerning the risks and benefits of each option. 2.7. Statistical analysis The data obtained were analyzed using the Statistical Package for Social Sciences, version 20.0 (International Business Machines, Armonk, NY). Descriptive statistics (mean standard deviation) were used to determine participant characteristics. Prior to the statistical analysis, the Kolmogorov-Smirnov test was performed to assess the normality of continuous data. Categorical variables were analyzed using descriptive statistics and compared with contingency tables. Normally distributed baseline demographic variables were compared using a one-way analysis of variance (ANOVA). Non-normally distributed variables were compared using the Kruskal-Wallis test, with an alpha level of significance of 0.05. For each outcome variable measured, a two (treatment groups) x three (pre-intervention, post-intervention, and follow up) two-way mixed one-way ANOVA was performed. If the twoway one-way ANOVA showed a significant interaction for each variable, Bonferroni’s post-hoc test was used to identify the specific mean differences. The statistical analysis was conducted at 95 % confidence level. A p-value of less than 0.05 was considered as statistically significant. 2.8. Sample size calculation The sample size calculation was guided by estimates of the minimal clinically important difference (cut-off point 80) in the EQ-5D visual analog scale (VAS). Our analysis indicated that a sample size of 57 participants (19 per group) was needed to detect
The recruitment, selection, and distribution of patients across the study is presented in Fig. 2. Finally, 42 patients were included and randomized in both intervention groups. The baseline characteristics of each group are shown in Table 1. Both groups were similar in all variables. Clinical variables showed a moderate to severe profile in both groups measured with predicted FEV1 (37.15 and 33.24 in the control and intervention groups) and the modified Borg Scale (5.6 and 5.33 respectively). The length of hospital stay showed no statistical differences between groups (8.53 2.29 days in the intervention group vs. 9.17 3.93 days in the control group) but was slightly shorter in the intervention group. Changes in measurements from baseline to discharge are shown in Table 2. At baseline, all measured outcomes showed no significant differences between groups. At discharge, both groups showed improvements in most variables, with a reduction in activity level evaluated with the IPAQ questionnaire. Moreover, significant improvements were reported in both groups in measures of perceived health status subscores, overall health state, and physical symptoms, with better results in the intervention group. When both groups were compared at discharge, perceived health status subscores and overall health state, activity level, COPD knowledge, and adherence to pharmacological treatment had improved significantly in the intervention group. Results of the main outcome values from discharge to 3-month follow-up are explained in Table 3. From discharge to follow-up, both groups showed changes in all variables measured. In the control group, the values of all measured variables were worse; these changes were significant in the pain subscore (p = 0.045). In the intervention group, all measured variables were maintained or improved at follow-up. The improvement was significant in physical activity level. Small significant reductions were found in usual activities and pain, anxiety, and depression subscores in perceived health status. When both groups were compared at follow-up, all outcomes showed higher values in the intervention group, with significant between-group differences (p < 0.05) in the modified Borg Scale, perceived health status, COPD knowledge, adherence to treatment, functionality, activity level, and nutrition. In terms of patients’ health status, both groups achieved a significant improvement (p < 0.05) after the intervention. These improvements persisted 3 months after discharge only in the intervention group. The mean change in overall health status after the intervention measured by the EuroQol-5D was 12 points, 16 5.6 points in the intervention group, and 8 3.4 points in the control group. The mean change in both groups exceeded the minimal clinical difference for the EuroQol-5D, which lies between 6.5 and 10 [33]. At 3-month follow-up, only the intervention group maintained this minimal clinical difference (15 4.9 points). Additionally, this study showed that disease knowledge, healthy style habits, and pharmacological management improved in the intervention group when compared with the control group at all timeline points.
Please cite this article in press as: M. Granados-Santiago, et al., Shared decision-making and patient engagement program during acute exacerbation of COPD hospitalization: A randomized control trial, Patient Educ Couns (2019), https://doi.org/10.1016/j.pec.2019.12.004
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Fig. 2. Flowchart of COPD patients across the study`. Table 1 Baseline characteristics of patients in each group.
Age (years) BMI (kg/cm2) FEV1 % Modified Borg Scale FSS 5-STS test (sec.) Charlson Index HAD Scale Length of hospital stay (days)
Control Group (n = 21)
Intervention Group (n = 21)
p-value
74.20 9.25 26.17 5.33 37.15 16.33 5.60 3.74 42.73 15.94 31.79 21.86 5.67 1.56 9.80 4.75 9.17 3.93
69.33 9.89 28.13 5.33 33.24 12.88 5.33 2.72 48.06 12.23 24.02 18.40 4.76 1.82 11.56 6.75 8.53 2.29
0.155 0.322 0.484 0.820 0.299 0.290 0.164 0.389 0.621
Data expressed as mean SD. BMI: Body Mass Index; FEV1%, Forced expiratory volume in the first second (predicted value); FSS: Fatigue Severity Scale; 5-STS: Five-Times Sitto-Stand test; HAD: Hospital Anxiety and Depression Scale.
4. Discussion and conclusion 4.1. Discussion The objective of this study was to analyze the effectiveness of an SDM-PE program developed during an in-hospital stay in patients with AECOPD. The main results of this study showed that the SDM-PE program significantly enhanced overall health status, knowledge of the disease, and adherence to pharmacological treatment. At three months from discharge there were significant differences between groups in perceived health status, COPD knowledge, pharmacological management, general functionality, and lifestyle values, with higher values in the intervention group. Thus, these results prove that applying an SDM-PE program added to standard treatment during an acute exacerbation period can be a useful strategy for COPD patients, with changes that persist after three months post-intervention.
The patients included in our study showed little knowledge of COPD at hospitalization, although several studies have highlighted the importance of implementing the provision of education and information in chronic patients [34]. SDM programs require the knowledge and skills – with a focus on education – that can lead patients to play an active role and implement their own health behavior changes [35–37]. Specifically, our SDM-PE program resulted in significant improvements in patients’ knowledge (p < 0.001) that remained after 3-month follow-up. In addition, patients’ health behaviors regarding activity and nutrition were included in our intervention program. Our results showed changes in the intervention group only at 3-month followup in both variables, but no changes in the control group. Such changes may be due to an increase in motivation to follow the individualized health care plan designed [38]. However, elderly patients with COPD lose motivation, which may decrease the success of their health care and healthy lifestyles [39]. Elderly patients are likely to have a sedentary lifestyle [40]
Please cite this article in press as: M. Granados-Santiago, et al., Shared decision-making and patient engagement program during acute exacerbation of COPD hospitalization: A randomized control trial, Patient Educ Couns (2019), https://doi.org/10.1016/j.pec.2019.12.004
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Table 2 Between-group comparisons in main outcomes from baseline to discharge. Control Group (n = 21) Baseline Physical symptoms FEV1 % 37.15 16.33 Modified Borg Scale 5.60 3.74 FSS 42.73 15.94 Perceived health status 1.93 0.53 Mobility Self–care 1.96 0.76 Usual activities 2.22 0.75 Pain/discomfort 1.65 0.80 Anxiety/depression 1.94 0.81 Overall health state 46.50 21.30 Knowledge of COPD COPD-Q 8.47 1.68 Pharmacological management Adherence to treatment score 47.6 4.78 General functionality Motor score 77.75 12.51 Cognitive score 33.48 2.00 FIM total 112.13 7.99 Lifestyle Physical activity (steps/day) 1144.44 1966.54 Nutrition 22.30 4.64
Intervention Group (n = 21)
Between group p-value at discharge
Discharge
95 % CI
Baseline
Discharge
95 % CI
41.25 18.15 3.87 1.83 31.03 18.79
[ 6.47, 0.35] [0.11, 3.74]* [–0.94, 17.49]
33.24 12.88 5.33 2.72 48.06 12.23
40.33 21.03 2.03 1.97 35.66 16.04
[–9.97, –0.73]* [1.21, 4.09]** [1.17, 15.23]*
0.862 0.049 0.475
1.59 0.63 1.73 0.80 2.03 0.87 1.21 0.37 1.51 0.29 54.13 22.69
[–0.83, 0.55] [–1.01, 0.25] [–0.94, 0.33] [–0.81, –0.07]* [– 0.72, –0.14]* [11.94, 30.93]*
1.85 0.59 1.93 0.77 2.14 0.80 1.67 0.72 1.88 0.72 44.55 20.67
1.43 0.74 1.23 0.65 1.49 0.50 1.02 0.58 1.45 0.34 60.28 21.65
[–1.16, 0.48] [–1.47, –0.05]** [–1.48, –0.03]** [–1.23, –0.06]** [–0.74, – 0.08]** [8.94, 32.43]**
0.437 <0.001 <0.001 <0.001 0.153 0.036
8.77 1.55
[–1.38, 1.85]
8.72 1.74
12.66 0.29
[3.64, 4.24]**
<0.001
48.96 3.21
[–1.47, 1.51]
46.4 5.58
49.98 4.12
[0.62, 1.66]**
0.527
81.15 13.80 34.08 3.86 115.74 9.77
[–0.32, 17.9] [–1.5, 2.26] [–5.88, 9.66]
79.74 10.12 32.56 3.16 112.30 8.74
84.65 14.01 36.48 2.31 120.97 10.35
[–11.53, 13.82] [0.39, 3.23] [–5.68, 11.0]
0.647 0.562 0.062
734.35 1971.2 [–103.7, 587.11] 1047.68 2617.32 698.53 2615.3 [–253,52, 466,17] 0.874 – – 19.75 5.66 – – –
Data expressed as mean SD, n(%). * Significant differences between groups from baseline to discharge p < 0.05. ** Significant differences between groups from baseline to discharge p 0.001. FEV1%, Forced expiratory volume in the first second (predicted value); FSS: Fatigue Severity Scale; COPD-Q: Chronic Obstructive Pulmonary Disease Knowledge Questionnaire; FIM: Functional Independence Measure.
Table 3 Change in main outcome values from discharge to 3-month follow-up. Control Group (n = 21) Discharge Physical symptoms FEV1 % 41.25 18.15 Modified Borg Scale 3.87 1.83 FSS 31.03 18.79 Perceived health status Mobility 1.59 0.63 Self-care 1.73 0.80 Usual activities 2.03 0.87 Pain/discomfort 1.21 0.37 Anxiety/depression 1.51 0.29 Overall health state 54.13 22.69 Knowledge of COPD COPD-Q 8.77 1.55 Pharmacological management Adherence to treatment 48.96 3.21 score General functionality Motor score 81.15 13.80 Cognitive score 34.08 3.86 FIM total 115.74 9.77 Lifestyle Physical activity (steps/day) 734.35 1971.2 Nutrition
22.30 4.64
Intervention Group (n = 21)
Between groups p-value at follow-up
Follow-up
95 % CI
Discharge
Follow-up
95 % CI
37.39 16.84 5.09 2.3 41.02 17.06
[–1.49, 7.33] [–4.25, –0.21]* [–14.89, 1.05]
40.33 21.03 2.03 1.97 35.66 16.04
38.22 15.87 2.7 1.19 37.98 18.51
[–2.37, 8.5] [–2.83, 2.12] [–3.14, 1.71]
0.831 0.014 0.401
1.82 0.55 1.85 0.72 2.15 0.62 1.52 0.32 1.75 0.72 51.13 28.28
[–0.32, 0.78] [–0.53, 0.92] [–0.68, 1] [–0.02, 0.64]* [–0.96, 0.43] [–25.67, 19.95]
1.43 0.74 1.23 0.65 1.49 0.50 1.02 0.58 1.45 0.34 60.28 21.65
1.33 0.51 1.20 0.73 1.74 0.84 1.34 0.74 1.62 0.13 59.41 20.57
[–0.60, 0.42] [–0.67, 0.72] [–0.05, 0.98]* [–1.03, 0.04]* [–0.03, 0.32]* [–20.52, 22.78]
<0.001 <0.001 0.050 0.045 0.221 <0.001
8.69 1.62
[–1.7, 1.55]
12.66 0.29
12.57 0.34
[–0.47, 0.25]
<0.001
47.84 2.73
[–2.16, 0.03]
49.98 4.12
49.64 0.32
[–0.66, 0.31]
0.032
77.50 6.25 32.24 0.67 112.74 7.77
[–1.76, 3.26] [–0.51, 0.83] [–5.12, 0.94]
84.65 14.01 36.48 2.31 120.97 10.35
82.79 15.62 34.6 0.27 118.7 5.9
[–10.86, 13.05] [–0.15, 0.39] [–6.63, 10.03]
0.024 0.723 0.041
1354.53 1983.7 [–803.89, 163.51] 18.87 4.52 [–2.85, 3.87]
698.53 2615.3 2070.54 1720.11 [707.02, 2893.12] ** 19.75 5.66 23.9 5.78 [2.85, 4.87]
0.047 0.034
Data expressed as mean SD, n(%). * Significant differences between groups from baseline to discharge p < 0.05. ** Significant differences between groups from baseline to discharge p 0.001. FEV1%, Forced expiratory volume in the first second (predicted value); FSS: Fatigue Severity Scale; COPD-Q: Chronic Obstructive Pulmonary Disease Knowledge Questionnaire; FIM: Functional Independence Measure.
and thus a higher risk of non-adherence to treatment [41]. In fact, our study reported few differences in healthy lifestyle and adherence to treatment between groups at discharge, although significant differences were observed after 3-month follow-up. A recent review has suggested that patient engagement should be included in the assessment given its value in helping individuals to effectively self-manage chronic disease. Patient engagement measures should include assessment of the knowledge and skills to prevent and
manage chronic disease [42]. The benefits reported could be explained by patients’ engagement in their treatment, which supports an increase in patient satisfaction measured by quality of life [43,44]. In patients with COPD, other studies have previously proposed engagement programs including education, activity and nutrition contents, with significant improvements in quality of life [45,46]. Functionality improved in both groups during hospitalization, but differences between groups were found only at 3-month
Please cite this article in press as: M. Granados-Santiago, et al., Shared decision-making and patient engagement program during acute exacerbation of COPD hospitalization: A randomized control trial, Patient Educ Couns (2019), https://doi.org/10.1016/j.pec.2019.12.004
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follow-up in the motor subscore and total functionality, with better results in the intervention group. Improvements in functionality may also be the result of improvements in perceived health status and lifestyle changes resulting in more active and skilled patients. Several systematic reviews of SDM have observed significant changes in functionality enhanced by long-term decisions [47,48]. Patient-reported outcomes have shown an increase in affectivecognitive domains, with greater satisfaction and less decisional conflict after the intervention [48]. Various programs have been developed during hospitalization in COPD patients with a focus on education [49–51]. Collinsworth et al. [50] developed a COPD education and self-management program during hospitalization. Although their results were positive, no clinical or functional individual improvements were found in the readmission rate. By contrast, our study showed significant changes in the intervention group in attitudinal and functional outcomes. Several limitations of this study should be considered. First, it is important to mention the difficulty to control the readmission frequency or symptomatic changes over time during follow-up. Second, the sample size was relatively small but sufficient to detect statistical differences in quality of life assessments. Third, rehospitalization data were not collected because subsequent exacerbations were sometimes referred to patient home care services. Moreover, nutritional status was only measured at baseline and follow-up given that patients received a standard menu during hospitalization. Besides, the population included in the study had a moderate to severe COPD profile. Further studies are needed to determine whether the benefits of adding a SDM-PE program to standard treatment persist over time in the different stages of COPD. 4.2. Conclusion An SDM-PE program significantly enhanced overall health status, disease knowledge, adherence to pharmacological treatment, and healthy lifestyle habits. This intervention can be a useful strategy for patients with COPD during hospitalization. 4.3. Practice implications Interventions that improve patients’ abilities to manage disease may counteract a decline in physical health and prevent COPD symptoms. This study showed that chronically ill patients may benefit from SDM-PE interventions that enhance overall health status, adherence to pharmacological treatment, healthy lifestyle habits, generality functionality, and disease knowledge. Patients and professionals need to work together to select the best model of care and treatment focused on improvements in quality of life. SDM-PE interventions can be seen as an addition to traditional interventions, which focus only on reducing chronic symptoms with pharmacological and medical treatment. In addition, SDM-PE could be an important clinical tool for the prevention of exacerbations, enhancing self-care with illnessrelated concerns, knowledge, healthy lifestyles, and adherence to treatment. Author contributions MCV had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis, particularly including any adverse effects. MGS contributed substantially to the study design, data analysis and interpretation, and the writing of the manuscript. LLL had full access to all the data in the study and takes responsibility for the
integrity of the data and the accuracy of the data analysis. JRT contributed substantially to the study design, data analysis and interpretation, and the writing of the manuscript. RRF contributed substantially to the study design, data analysis and interpretation, and the writing of the manuscript. ICM had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Funding sources This research was financed jointly by Fundación Progreso y Salud (FPS), Boehringer Ingelheim España, S.A. (project code: PI-0370-2014), and Oximesa, Praxair. The authors JRT and LPP received financial support through grants for the training of university lecturers (grant numbers FPU: 16/01531 and FPU: 17/00408 respectively) of the Spanish Ministry of Education. Declaration of Competing Interest The authors declare that there is no conflict of interest. References [1] C. Hoffman, D. Rice, H.Y. Sung, Persons with chronic conditions: their prevalence and costs, JAMA 276 (18) (1996) 1473–1479, doi:http://dx.doi.org/ 10.1001/jama.1996.03540180029029. [2] C. Vogeli, A.E. Shields, T.A. Lee, et al., Multiple chronic conditions: prevalence, health consequences, and implications for quality, care management, and costs, J. Gen. Intern. Med. 22 (3) (2007) 391–395, doi:http://dx.doi.org/ 10.1007/s11606-007-0322-1. [3] A.A. Dalal, L. Christensen, F. Liu, A.A. Riedel, Direct cost of chronic obstructive pulmonary disease among managed care patients, Int. J. Chron. Obstruct. Pulmon. Dis. 5 (2010) 341–349, doi:http://dx.doi.org/10.2147/COPD.S13771. [4] K.F. Rabe, S. Hurd, A. Anzueto, et al., Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary, Am. J. Respir. Crit. Care Med. 176 (6) (2007) 532–555, doi: http://dx.doi.org/10.1164/rccm.200703-456SO. [5] J.M. Antó, P. Vermeire, J. Vestbo, J. Sunyer, Epidemiology of chronic obstructive pulmonary disease, Eur. Respir. J. 17 (2001) 982–994. [6] J.A. Wedzicha, T.A. Seemungal, COPD exacerbations: defining their cause and prevention, Lancet 370 (2007) 786–796, doi:http://dx.doi.org/10.1016/S01406736(07)61382-8. [7] J. Vestbo, S.S. Hurd, A.G. Agusti, P.W. Jones, C. Vogelmeier, A. Anzueto, Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary, Am. J. Respir. Crit. Care Med. 187 (2013) 347–365, doi:http://dx.doi.org/10.1164/rccm.201204-0596PP. [8] N.A. Matínez-González, P. Berchtold, K. Ullman, A. Busato, M. Egger, Integrated care programmes for adults with chronic conditions: a meta-review, Int. J. Qual. Health Care 26 (5) (2014) 561–570, doi:http://dx.doi.org/10.1093/intqhc/ mzu071. [9] K.L. Kirschner, When written advance directives are not enough, Clin. Geriatr. Med. 21 (1) (2005) 193–209, doi:http://dx.doi.org/10.1016/j.cger.2004.08.006. [10] S. Vahdat, L. Hamzehgardeshi, S. Hessam, Z. Hamzehgardeshi, Patient involvement in health care decision making: a review. Iran, Red. Crescent Med. J. 16 (1) (2014) e12454, doi:http://dx.doi.org/10.5812/ircmj.12454. [11] T.W. Effing, J. Bourbeau, J. Vercoulen, et al., Self-management programmes for COPD: moving forward, Chron. Respir. Dis. 9 (1) (2012) 27–35, doi:http://dx. doi.org/10.1177/1479972311433574. [12] R. Kayyali, S.N. Gebara, I. Hesso, et al., Shared decision making and experiences of patients with long-term conditions: has anything changed? BMC Health Serv. Res. 18 (2018) 763, doi:http://dx.doi.org/10.1186/s12913-018-3575-y. [13] S.H. Landis, K. Wurst, H.V. Le, K. Bonar, Y.S. Punekar, Can assessment of disease burden prior to changes in initial COPD maintenance treatment provide insight into remaining unmet needs? a retrospective database study in UK primary care, COPD 14 (1) (2017) 80–85, doi:http://dx.doi.org/10.1080/ 15412555.2016.1240159. [14] D.D. Sin, F.A. McAlister, S.F. Man, N.R. Anthonisen, Contemporary management of chronic obstructive pulmonary disease: scientific review, JAMA 290 (17) (2003) 2301–2312, doi:http://dx.doi.org/10.1001/jama.290.17.2301. [15] P.M. Calverley, A.R. Anzueto, D. Dusser, A. Mueller, N. Metzdorf, R.A. Wise, Treatment of exacerbations as a predictor of subsequent outcomes in patients with COPD, Int. J. Chron. Obstruct. Pulmon. Dis. 13 (2018) 1297–1308, doi: http://dx.doi.org/10.2147/COPD.S153631. [16] K.F. Schulz, D.G. Altman, D. Moher, CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials, BMC Med. 8 (1) (2010) 18, doi:http://dx.doi.org/10.1186/1741-7015-8-18. [17] H. Watz, B. Waschki, T. Meyer, H. Magnussen, Physical activity in patients with COPD, Eur. Respir. J. 33 (2) (2009) 262–272, doi:http://dx.doi.org/10.1183/ 09031936.00024608.
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Contents lists available at ScienceDirect
Patient Education and Counseling journal homepage: www.elsevier.com/locate/pateducou
Shared decision-making and patient engagement program during acute exacerbation of COPD hospitalization: A randomized control trial María Granados-Santiago, Marie Carmen Valenza* , Laura López-López, Esther Prados-Román, Janet Rodríguez-Torres, Irene Cabrera-Martos Faculty of Health Sciences, University of Granada, Granada, Spain
A R T I C L E I N F O
A B S T R A C T
Article history: Received 28 March 2019 Received in revised form 6 November 2019 Accepted 9 December 2019
Objective: To evaluate the effectiveness of a shared decision-making and patient engagement (SDM-PE) program concerning in-hospital stay during acute exacerbation of COPD and determine its impact on patients’ perceived health status. Methods: Patients were randomly allocated to a control group that received standard treatment or an intervention group that received an individualized SDM-PE program in addition to standard treatment. The SDM-PE program included personalized health care focused on information about the disease, healthcare management, and reinforcement of behaviors regarding nutrition and exercise taking into account patients’ preferences. Results: A comparative analysis between groups showed a significant improvement in perceived health status at discharge in patients included in the experimental group compared to those in the control group (60.28 21.65 vs. 54.13 22.69, p = 0.036). In addition, perceived health status, COPD knowledge, adherence to pharmacological treatment, general functionality, and healthy lifestyle measures were significantly better at 3-month follow-up in the intervention group. Conclusion: An SDM-PE program significantly enhanced all the clinical measures assessed during hospitalization at 3-month follow-up. Practice implications: COPD patients and professionals need to work together to select the best care and treatment model for patients, taking into account individual values and preferences. © 2019 Published by Elsevier B.V.
Keywords: Pulmonary disease Chronic obstructive Decision making Hospital medicine Patient participation
1. Introduction Chronic diseases affect more than 90 million American adults and are responsible for approximately 70 % of health care expenditure [1]. These values are expected to grow in the next decades, with pulmonary diseases (38 %) and cancer (17 %) as the most expensive diseases [2]. Among respiratory diseases, chronic obstructive pulmonary disease (COPD) is the leading one in hospital care cost, physician services, and prescription drugs [3]. Patients with COPD experience a progressive decline in functional capacity and health-related quality of life (HRQoL) [4] with a significant burden in terms of disability [5]. The clinical course of COPD includes frequent exacerbation episodes, which are clinically characterized by a worsening of dyspnea, cough, sputum production, and airflow obstruction [6].
* Corresponding author at: Departamento de Fisioterapia, Facultad de Ciencias de la Salud, Universidad de Granada, Av. De la Ilustración, 60, 18016, Granada, Spain. E-mail address: [email protected] (M.C. Valenza).
The main treatment for COPD across clinical stages (i.e., stable and exacerbation) is a combination of medical and pharmacological treatment (i.e., short-acting bronchodilators, systemic corticosteroids, and antibiotics) [7], showing variable results in symptoms, exercise capacity, and quality of life. During hospitalization, patients with COPD need supportive, medical, and rehabilitative care to cope with symptoms and functional impairment [8]. To minimize the time and costs involved by such supportive care services in response to the raising number of COPD patients, it may be useful to enhance patient self-management strategies [9]. Shared decision programs have emerged in recent decades as a new way to change the role of patients and their relationship with medical practitioners [10]. They are described as an interpersonal and interdependent process in which the health care provider and the patient jointly make making specific decisions about health care. Patient engagement implies recognizing and understanding the importance of playing an active role in one’s health and having the knowledge, skills, and confidence for this purpose. In patients with COPD, these programs could support patients’ involvement in their own pharmacological management (i.e., inhalers and ‘rescue
https://doi.org/10.1016/j.pec.2019.12.004 0738-3991/© 2019 Published by Elsevier B.V.
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medications’), symptom control, and promotion of positive lifestyle changes [11,12]. COPD patients show significantly lower functionality levels and higher symptomatic burden after hospitalizations [13]. Frequent hospitalizations provide opportunities for the implementation of behavioral changes [14]. In this regard, hospitalization has been proposed as an adequate clinical time and space to prescribe changes in treatments [15]. However, no previous studies have implemented an in-hospital SDM-PE program in patients with an acute exacerbation of COPD. The main objective of this study was to evaluate the effectiveness of an SDM-PE program concerning in-hospital stay and determine its impact on patients’ perceived health status and specifically on their knowledge of COPD, pharmacological management, general functionality, and lifestyle. 2. Methods 2.1. Study design The study was designed as a randomized controlled trial in hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Patients assigned to the control group received a standard treatment (i.e., medical and pharmacological therapy) and patients in the intervention group received an individualized SDM-PE program added to standard treatment. The ethics approval for this study was obtained from the Biomedical Research Ethics Committee of Granada. This research was conducted in accordance with the amended Declaration of Helsinki reviewed in 2013. The study was registered in Clinicaltrials.gov with identifier NCT03772639. The CONSORT guidelines [16] were followed during the course of the research. 2.2. Participants Patients were recruited in the Pulmonology Service of Virgen de las Nieves and San Cecilio hospitals in Granada, Spain. Those who agreed to participate received an explanation of the research protocol and gave written informed consent. The inclusion criteria were being patients hospitalized due to AECOPD. Exclusion criteria were inability to provide informed consent, the presence of psychiatric or cognitive disorders, progressive neurological disorders, organ failure, cancer, or inability to cooperate. Patients who had experienced another exacerbation of COPD in the previous month were also excluded.
was assessed with the Five Times Sit-to-Stand (STS) test [20], comorbidities were assessed with the Charlson Comorbidity Index [21], and anxiety and depression levels were evaluated with the Hospital Anxiety and Depression Scale (HADS) [22]. The primary outcome measure was perceived health status. Secondary outcomes were knowledge of the disease, pharmacological management, general functionality, and healthy lifestyle. Health status was measured with the EuroQol-5D (EQ-5D) tool. This measure contains two sections: a descriptive questionnaire about health impairment and a numerical scale about health status perception. The descriptive section includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/ depression. The numerical scale ranges from 0 (defined as the worst imaginable health state) to 100 (defined as the best imaginable health state) [23]. Knowledge of the disease was assessed with the Chronic Obstructive Pulmonary Disease Knowledge Questionnaire (COPD-Q). The COPD-Q is a valid and reliable questionnaire that assesses COPD knowledge. It has a maximum score of 13, indicating the best COPD knowledge [24]. Pharmacological management in COPD patients was assessed with the Test of Adherence to Inhalers (TAI) [25]. The TAI measures adherence to treatment scored using the first 10 items of the questionnaire, with higher scores indicating greater adherence. General functionality was evaluated with the Functional Independence Measure (FIM) [26]. It measures two dimensions: motor and cognitive. The total score ranges from 18 points (total dependence) to 126 points (complete independence). Lifestyle changes included physical activity [27] and nutrition [28]. Physical activity was measured using a pedometer (Fitbit Flex 2) with great validity in patients with chronic lung disease, specifically COPD [29]. The device collects daily steps as physical activity levels. Patients were instructed to wear the device on their wrist continuously during a complete day at baseline, discharge, and 3-month follow-up. The Mini Nutritional Assessment (MNA) was also used. It includes questions about food intake, weight loss, mobility, stress, neuropsychological problems, and BMI to evaluate individuals’ nutrition state in the last month. Scores lower than 17 in the MNA are considered malnutrition [30]. The MNA was assessed at baseline and at 3-month follow-up using these values for the statistical analysis given that patients received a standard hospital menu during hospitalization. A blinded assessor evaluated the main outcomes in the hospital at baseline, discharge, and 3-month follow-up. 2.5. Control group
2.3. Randomization Participants who signed the informed consent form were randomly assigned to the control group or the intervention group. In each case, researchers opened a sequentially numbered, sealed envelope to determine whether the patient was allocated to the intervention or the control group. The randomization sequence was prepared by a statistician using computer-generated random numbers. 2.4. Outcome measures Descriptive data of participants included age, body mass index, and length of hospital stay. Additionally, forced expiratory volume in the first second (FEV1%) was assessed with a spirometer (CareFusion, Micro Spirometer, Basingstoke, UK) following the criteria of the ATS [17]. Dyspnea perception was recorded using the modified Borg Scale [18] and fatigue perception was assessed with the Fatigue Severity Scale (FSS) [19]. Additionally, exercise capacity
All patients received the standard treatment (i.e., medical and pharmacological care) including systemic steroids, antibiotics, inhaled bronchodilators, and oxygen therapy. The antibiotic therapy included an inhibitor of β-lactam/β-lactamase or fluoroquinolone in each case. Inhaled β2 short-acting agonists and anticholinergic agents were used to reduce the symptoms and improve airflow obstruction. Inhaled glucocorticoids included beclomethasone dipropionate, budesonide, flunisolide, fluticasone propionate, and triamcinolone acetonide. In addition, during hospitalization patients received nutritionally complete menus and special attention was given to the use of diuretics, anticoagulants, and cardiovascular agents [31]. 2.6. Intervention group All patients included in the intervention group received an individualized SDM-PE program added to the standard treatment during the hospitalization period. The program was tailored to
Please cite this article in press as: M. Granados-Santiago, et al., Shared decision-making and patient engagement program during acute exacerbation of COPD hospitalization: A randomized control trial, Patient Educ Couns (2019), https://doi.org/10.1016/j.pec.2019.12.004
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a minimal clinically important difference of 15 points with 80 % power for the VAS health-related quality of life outcome in both groups [32]. We anticipated that approximately 10 % of the participants might fail the initial screening or drop out; therefore, we needed to enroll 20 participants per group to account for this loss. 3. Results
Fig. 1. The key elements of each SDM-PE program.
meet the needs of each patient during the AECOPD. The SDM-PE program was developed focusing on COPD self-management goals, although other characteristics such as health care competence were also considered taking into account the clinical profile of patients and their priorities, interests, and preferences. The key elements of each SDM-PE program are shown in Fig. 1. The SDM-PE program goals [11] included pharmacological management, symptomatic control, and healthy lifestyle promotion. The decision-making process was developed collaboratively among professionals and patients by providing information, explaining the advantages and disadvantages, and promoting the active role of COPD patients. The contents of the program were developed jointly with each patient in a problem-solving format in order to detect potential misbeliefs, considering the best available evidence concerning the risks and benefits of each option. 2.7. Statistical analysis The data obtained were analyzed using the Statistical Package for Social Sciences, version 20.0 (International Business Machines, Armonk, NY). Descriptive statistics (mean standard deviation) were used to determine participant characteristics. Prior to the statistical analysis, the Kolmogorov-Smirnov test was performed to assess the normality of continuous data. Categorical variables were analyzed using descriptive statistics and compared with contingency tables. Normally distributed baseline demographic variables were compared using a one-way analysis of variance (ANOVA). Non-normally distributed variables were compared using the Kruskal-Wallis test, with an alpha level of significance of 0.05. For each outcome variable measured, a two (treatment groups) x three (pre-intervention, post-intervention, and follow up) two-way mixed one-way ANOVA was performed. If the twoway one-way ANOVA showed a significant interaction for each variable, Bonferroni’s post-hoc test was used to identify the specific mean differences. The statistical analysis was conducted at 95 % confidence level. A p-value of less than 0.05 was considered as statistically significant. 2.8. Sample size calculation The sample size calculation was guided by estimates of the minimal clinically important difference (cut-off point 80) in the EQ-5D visual analog scale (VAS). Our analysis indicated that a sample size of 57 participants (19 per group) was needed to detect
The recruitment, selection, and distribution of patients across the study is presented in Fig. 2. Finally, 42 patients were included and randomized in both intervention groups. The baseline characteristics of each group are shown in Table 1. Both groups were similar in all variables. Clinical variables showed a moderate to severe profile in both groups measured with predicted FEV1 (37.15 and 33.24 in the control and intervention groups) and the modified Borg Scale (5.6 and 5.33 respectively). The length of hospital stay showed no statistical differences between groups (8.53 2.29 days in the intervention group vs. 9.17 3.93 days in the control group) but was slightly shorter in the intervention group. Changes in measurements from baseline to discharge are shown in Table 2. At baseline, all measured outcomes showed no significant differences between groups. At discharge, both groups showed improvements in most variables, with a reduction in activity level evaluated with the IPAQ questionnaire. Moreover, significant improvements were reported in both groups in measures of perceived health status subscores, overall health state, and physical symptoms, with better results in the intervention group. When both groups were compared at discharge, perceived health status subscores and overall health state, activity level, COPD knowledge, and adherence to pharmacological treatment had improved significantly in the intervention group. Results of the main outcome values from discharge to 3-month follow-up are explained in Table 3. From discharge to follow-up, both groups showed changes in all variables measured. In the control group, the values of all measured variables were worse; these changes were significant in the pain subscore (p = 0.045). In the intervention group, all measured variables were maintained or improved at follow-up. The improvement was significant in physical activity level. Small significant reductions were found in usual activities and pain, anxiety, and depression subscores in perceived health status. When both groups were compared at follow-up, all outcomes showed higher values in the intervention group, with significant between-group differences (p < 0.05) in the modified Borg Scale, perceived health status, COPD knowledge, adherence to treatment, functionality, activity level, and nutrition. In terms of patients’ health status, both groups achieved a significant improvement (p < 0.05) after the intervention. These improvements persisted 3 months after discharge only in the intervention group. The mean change in overall health status after the intervention measured by the EuroQol-5D was 12 points, 16 5.6 points in the intervention group, and 8 3.4 points in the control group. The mean change in both groups exceeded the minimal clinical difference for the EuroQol-5D, which lies between 6.5 and 10 [33]. At 3-month follow-up, only the intervention group maintained this minimal clinical difference (15 4.9 points). Additionally, this study showed that disease knowledge, healthy style habits, and pharmacological management improved in the intervention group when compared with the control group at all timeline points.
Please cite this article in press as: M. Granados-Santiago, et al., Shared decision-making and patient engagement program during acute exacerbation of COPD hospitalization: A randomized control trial, Patient Educ Couns (2019), https://doi.org/10.1016/j.pec.2019.12.004
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Fig. 2. Flowchart of COPD patients across the study`. Table 1 Baseline characteristics of patients in each group.
Age (years) BMI (kg/cm2) FEV1 % Modified Borg Scale FSS 5-STS test (sec.) Charlson Index HAD Scale Length of hospital stay (days)
Control Group (n = 21)
Intervention Group (n = 21)
p-value
74.20 9.25 26.17 5.33 37.15 16.33 5.60 3.74 42.73 15.94 31.79 21.86 5.67 1.56 9.80 4.75 9.17 3.93
69.33 9.89 28.13 5.33 33.24 12.88 5.33 2.72 48.06 12.23 24.02 18.40 4.76 1.82 11.56 6.75 8.53 2.29
0.155 0.322 0.484 0.820 0.299 0.290 0.164 0.389 0.621
Data expressed as mean SD. BMI: Body Mass Index; FEV1%, Forced expiratory volume in the first second (predicted value); FSS: Fatigue Severity Scale; 5-STS: Five-Times Sitto-Stand test; HAD: Hospital Anxiety and Depression Scale.
4. Discussion and conclusion 4.1. Discussion The objective of this study was to analyze the effectiveness of an SDM-PE program developed during an in-hospital stay in patients with AECOPD. The main results of this study showed that the SDM-PE program significantly enhanced overall health status, knowledge of the disease, and adherence to pharmacological treatment. At three months from discharge there were significant differences between groups in perceived health status, COPD knowledge, pharmacological management, general functionality, and lifestyle values, with higher values in the intervention group. Thus, these results prove that applying an SDM-PE program added to standard treatment during an acute exacerbation period can be a useful strategy for COPD patients, with changes that persist after three months post-intervention.
The patients included in our study showed little knowledge of COPD at hospitalization, although several studies have highlighted the importance of implementing the provision of education and information in chronic patients [34]. SDM programs require the knowledge and skills – with a focus on education – that can lead patients to play an active role and implement their own health behavior changes [35–37]. Specifically, our SDM-PE program resulted in significant improvements in patients’ knowledge (p < 0.001) that remained after 3-month follow-up. In addition, patients’ health behaviors regarding activity and nutrition were included in our intervention program. Our results showed changes in the intervention group only at 3-month followup in both variables, but no changes in the control group. Such changes may be due to an increase in motivation to follow the individualized health care plan designed [38]. However, elderly patients with COPD lose motivation, which may decrease the success of their health care and healthy lifestyles [39]. Elderly patients are likely to have a sedentary lifestyle [40]
Please cite this article in press as: M. Granados-Santiago, et al., Shared decision-making and patient engagement program during acute exacerbation of COPD hospitalization: A randomized control trial, Patient Educ Couns (2019), https://doi.org/10.1016/j.pec.2019.12.004
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Table 2 Between-group comparisons in main outcomes from baseline to discharge. Control Group (n = 21) Baseline Physical symptoms FEV1 % 37.15 16.33 Modified Borg Scale 5.60 3.74 FSS 42.73 15.94 Perceived health status 1.93 0.53 Mobility Self–care 1.96 0.76 Usual activities 2.22 0.75 Pain/discomfort 1.65 0.80 Anxiety/depression 1.94 0.81 Overall health state 46.50 21.30 Knowledge of COPD COPD-Q 8.47 1.68 Pharmacological management Adherence to treatment score 47.6 4.78 General functionality Motor score 77.75 12.51 Cognitive score 33.48 2.00 FIM total 112.13 7.99 Lifestyle Physical activity (steps/day) 1144.44 1966.54 Nutrition 22.30 4.64
Intervention Group (n = 21)
Between group p-value at discharge
Discharge
95 % CI
Baseline
Discharge
95 % CI
41.25 18.15 3.87 1.83 31.03 18.79
[ 6.47, 0.35] [0.11, 3.74]* [–0.94, 17.49]
33.24 12.88 5.33 2.72 48.06 12.23
40.33 21.03 2.03 1.97 35.66 16.04
[–9.97, –0.73]* [1.21, 4.09]** [1.17, 15.23]*
0.862 0.049 0.475
1.59 0.63 1.73 0.80 2.03 0.87 1.21 0.37 1.51 0.29 54.13 22.69
[–0.83, 0.55] [–1.01, 0.25] [–0.94, 0.33] [–0.81, –0.07]* [– 0.72, –0.14]* [11.94, 30.93]*
1.85 0.59 1.93 0.77 2.14 0.80 1.67 0.72 1.88 0.72 44.55 20.67
1.43 0.74 1.23 0.65 1.49 0.50 1.02 0.58 1.45 0.34 60.28 21.65
[–1.16, 0.48] [–1.47, –0.05]** [–1.48, –0.03]** [–1.23, –0.06]** [–0.74, – 0.08]** [8.94, 32.43]**
0.437 <0.001 <0.001 <0.001 0.153 0.036
8.77 1.55
[–1.38, 1.85]
8.72 1.74
12.66 0.29
[3.64, 4.24]**
<0.001
48.96 3.21
[–1.47, 1.51]
46.4 5.58
49.98 4.12
[0.62, 1.66]**
0.527
81.15 13.80 34.08 3.86 115.74 9.77
[–0.32, 17.9] [–1.5, 2.26] [–5.88, 9.66]
79.74 10.12 32.56 3.16 112.30 8.74
84.65 14.01 36.48 2.31 120.97 10.35
[–11.53, 13.82] [0.39, 3.23] [–5.68, 11.0]
0.647 0.562 0.062
734.35 1971.2 [–103.7, 587.11] 1047.68 2617.32 698.53 2615.3 [–253,52, 466,17] 0.874 – – 19.75 5.66 – – –
Data expressed as mean SD, n(%). * Significant differences between groups from baseline to discharge p < 0.05. ** Significant differences between groups from baseline to discharge p 0.001. FEV1%, Forced expiratory volume in the first second (predicted value); FSS: Fatigue Severity Scale; COPD-Q: Chronic Obstructive Pulmonary Disease Knowledge Questionnaire; FIM: Functional Independence Measure.
Table 3 Change in main outcome values from discharge to 3-month follow-up. Control Group (n = 21) Discharge Physical symptoms FEV1 % 41.25 18.15 Modified Borg Scale 3.87 1.83 FSS 31.03 18.79 Perceived health status Mobility 1.59 0.63 Self-care 1.73 0.80 Usual activities 2.03 0.87 Pain/discomfort 1.21 0.37 Anxiety/depression 1.51 0.29 Overall health state 54.13 22.69 Knowledge of COPD COPD-Q 8.77 1.55 Pharmacological management Adherence to treatment 48.96 3.21 score General functionality Motor score 81.15 13.80 Cognitive score 34.08 3.86 FIM total 115.74 9.77 Lifestyle Physical activity (steps/day) 734.35 1971.2 Nutrition
22.30 4.64
Intervention Group (n = 21)
Between groups p-value at follow-up
Follow-up
95 % CI
Discharge
Follow-up
95 % CI
37.39 16.84 5.09 2.3 41.02 17.06
[–1.49, 7.33] [–4.25, –0.21]* [–14.89, 1.05]
40.33 21.03 2.03 1.97 35.66 16.04
38.22 15.87 2.7 1.19 37.98 18.51
[–2.37, 8.5] [–2.83, 2.12] [–3.14, 1.71]
0.831 0.014 0.401
1.82 0.55 1.85 0.72 2.15 0.62 1.52 0.32 1.75 0.72 51.13 28.28
[–0.32, 0.78] [–0.53, 0.92] [–0.68, 1] [–0.02, 0.64]* [–0.96, 0.43] [–25.67, 19.95]
1.43 0.74 1.23 0.65 1.49 0.50 1.02 0.58 1.45 0.34 60.28 21.65
1.33 0.51 1.20 0.73 1.74 0.84 1.34 0.74 1.62 0.13 59.41 20.57
[–0.60, 0.42] [–0.67, 0.72] [–0.05, 0.98]* [–1.03, 0.04]* [–0.03, 0.32]* [–20.52, 22.78]
<0.001 <0.001 0.050 0.045 0.221 <0.001
8.69 1.62
[–1.7, 1.55]
12.66 0.29
12.57 0.34
[–0.47, 0.25]
<0.001
47.84 2.73
[–2.16, 0.03]
49.98 4.12
49.64 0.32
[–0.66, 0.31]
0.032
77.50 6.25 32.24 0.67 112.74 7.77
[–1.76, 3.26] [–0.51, 0.83] [–5.12, 0.94]
84.65 14.01 36.48 2.31 120.97 10.35
82.79 15.62 34.6 0.27 118.7 5.9
[–10.86, 13.05] [–0.15, 0.39] [–6.63, 10.03]
0.024 0.723 0.041
1354.53 1983.7 [–803.89, 163.51] 18.87 4.52 [–2.85, 3.87]
698.53 2615.3 2070.54 1720.11 [707.02, 2893.12] ** 19.75 5.66 23.9 5.78 [2.85, 4.87]
0.047 0.034
Data expressed as mean SD, n(%). * Significant differences between groups from baseline to discharge p < 0.05. ** Significant differences between groups from baseline to discharge p 0.001. FEV1%, Forced expiratory volume in the first second (predicted value); FSS: Fatigue Severity Scale; COPD-Q: Chronic Obstructive Pulmonary Disease Knowledge Questionnaire; FIM: Functional Independence Measure.
and thus a higher risk of non-adherence to treatment [41]. In fact, our study reported few differences in healthy lifestyle and adherence to treatment between groups at discharge, although significant differences were observed after 3-month follow-up. A recent review has suggested that patient engagement should be included in the assessment given its value in helping individuals to effectively self-manage chronic disease. Patient engagement measures should include assessment of the knowledge and skills to prevent and
manage chronic disease [42]. The benefits reported could be explained by patients’ engagement in their treatment, which supports an increase in patient satisfaction measured by quality of life [43,44]. In patients with COPD, other studies have previously proposed engagement programs including education, activity and nutrition contents, with significant improvements in quality of life [45,46]. Functionality improved in both groups during hospitalization, but differences between groups were found only at 3-month
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follow-up in the motor subscore and total functionality, with better results in the intervention group. Improvements in functionality may also be the result of improvements in perceived health status and lifestyle changes resulting in more active and skilled patients. Several systematic reviews of SDM have observed significant changes in functionality enhanced by long-term decisions [47,48]. Patient-reported outcomes have shown an increase in affectivecognitive domains, with greater satisfaction and less decisional conflict after the intervention [48]. Various programs have been developed during hospitalization in COPD patients with a focus on education [49–51]. Collinsworth et al. [50] developed a COPD education and self-management program during hospitalization. Although their results were positive, no clinical or functional individual improvements were found in the readmission rate. By contrast, our study showed significant changes in the intervention group in attitudinal and functional outcomes. Several limitations of this study should be considered. First, it is important to mention the difficulty to control the readmission frequency or symptomatic changes over time during follow-up. Second, the sample size was relatively small but sufficient to detect statistical differences in quality of life assessments. Third, rehospitalization data were not collected because subsequent exacerbations were sometimes referred to patient home care services. Moreover, nutritional status was only measured at baseline and follow-up given that patients received a standard menu during hospitalization. Besides, the population included in the study had a moderate to severe COPD profile. Further studies are needed to determine whether the benefits of adding a SDM-PE program to standard treatment persist over time in the different stages of COPD. 4.2. Conclusion An SDM-PE program significantly enhanced overall health status, disease knowledge, adherence to pharmacological treatment, and healthy lifestyle habits. This intervention can be a useful strategy for patients with COPD during hospitalization. 4.3. Practice implications Interventions that improve patients’ abilities to manage disease may counteract a decline in physical health and prevent COPD symptoms. This study showed that chronically ill patients may benefit from SDM-PE interventions that enhance overall health status, adherence to pharmacological treatment, healthy lifestyle habits, generality functionality, and disease knowledge. Patients and professionals need to work together to select the best model of care and treatment focused on improvements in quality of life. SDM-PE interventions can be seen as an addition to traditional interventions, which focus only on reducing chronic symptoms with pharmacological and medical treatment. In addition, SDM-PE could be an important clinical tool for the prevention of exacerbations, enhancing self-care with illnessrelated concerns, knowledge, healthy lifestyles, and adherence to treatment. Author contributions MCV had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis, particularly including any adverse effects. MGS contributed substantially to the study design, data analysis and interpretation, and the writing of the manuscript. LLL had full access to all the data in the study and takes responsibility for the
integrity of the data and the accuracy of the data analysis. JRT contributed substantially to the study design, data analysis and interpretation, and the writing of the manuscript. RRF contributed substantially to the study design, data analysis and interpretation, and the writing of the manuscript. ICM had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Funding sources This research was financed jointly by Fundación Progreso y Salud (FPS), Boehringer Ingelheim España, S.A. (project code: PI-0370-2014), and Oximesa, Praxair. The authors JRT and LPP received financial support through grants for the training of university lecturers (grant numbers FPU: 16/01531 and FPU: 17/00408 respectively) of the Spanish Ministry of Education. Declaration of Competing Interest The authors declare that there is no conflict of interest. References [1] C. Hoffman, D. Rice, H.Y. Sung, Persons with chronic conditions: their prevalence and costs, JAMA 276 (18) (1996) 1473–1479, doi:http://dx.doi.org/ 10.1001/jama.1996.03540180029029. [2] C. Vogeli, A.E. Shields, T.A. Lee, et al., Multiple chronic conditions: prevalence, health consequences, and implications for quality, care management, and costs, J. Gen. Intern. Med. 22 (3) (2007) 391–395, doi:http://dx.doi.org/ 10.1007/s11606-007-0322-1. [3] A.A. Dalal, L. Christensen, F. Liu, A.A. Riedel, Direct cost of chronic obstructive pulmonary disease among managed care patients, Int. J. Chron. Obstruct. Pulmon. Dis. 5 (2010) 341–349, doi:http://dx.doi.org/10.2147/COPD.S13771. [4] K.F. Rabe, S. Hurd, A. Anzueto, et al., Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary, Am. J. Respir. Crit. Care Med. 176 (6) (2007) 532–555, doi: http://dx.doi.org/10.1164/rccm.200703-456SO. [5] J.M. Antó, P. Vermeire, J. Vestbo, J. Sunyer, Epidemiology of chronic obstructive pulmonary disease, Eur. Respir. J. 17 (2001) 982–994. [6] J.A. Wedzicha, T.A. Seemungal, COPD exacerbations: defining their cause and prevention, Lancet 370 (2007) 786–796, doi:http://dx.doi.org/10.1016/S01406736(07)61382-8. [7] J. Vestbo, S.S. Hurd, A.G. Agusti, P.W. Jones, C. Vogelmeier, A. Anzueto, Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary, Am. J. Respir. Crit. Care Med. 187 (2013) 347–365, doi:http://dx.doi.org/10.1164/rccm.201204-0596PP. [8] N.A. Matínez-González, P. Berchtold, K. Ullman, A. Busato, M. Egger, Integrated care programmes for adults with chronic conditions: a meta-review, Int. J. Qual. Health Care 26 (5) (2014) 561–570, doi:http://dx.doi.org/10.1093/intqhc/ mzu071. [9] K.L. Kirschner, When written advance directives are not enough, Clin. Geriatr. Med. 21 (1) (2005) 193–209, doi:http://dx.doi.org/10.1016/j.cger.2004.08.006. [10] S. Vahdat, L. Hamzehgardeshi, S. Hessam, Z. Hamzehgardeshi, Patient involvement in health care decision making: a review. Iran, Red. Crescent Med. J. 16 (1) (2014) e12454, doi:http://dx.doi.org/10.5812/ircmj.12454. [11] T.W. Effing, J. Bourbeau, J. Vercoulen, et al., Self-management programmes for COPD: moving forward, Chron. Respir. Dis. 9 (1) (2012) 27–35, doi:http://dx. doi.org/10.1177/1479972311433574. [12] R. Kayyali, S.N. Gebara, I. Hesso, et al., Shared decision making and experiences of patients with long-term conditions: has anything changed? BMC Health Serv. Res. 18 (2018) 763, doi:http://dx.doi.org/10.1186/s12913-018-3575-y. [13] S.H. Landis, K. Wurst, H.V. Le, K. Bonar, Y.S. Punekar, Can assessment of disease burden prior to changes in initial COPD maintenance treatment provide insight into remaining unmet needs? a retrospective database study in UK primary care, COPD 14 (1) (2017) 80–85, doi:http://dx.doi.org/10.1080/ 15412555.2016.1240159. [14] D.D. Sin, F.A. McAlister, S.F. Man, N.R. Anthonisen, Contemporary management of chronic obstructive pulmonary disease: scientific review, JAMA 290 (17) (2003) 2301–2312, doi:http://dx.doi.org/10.1001/jama.290.17.2301. [15] P.M. Calverley, A.R. Anzueto, D. Dusser, A. Mueller, N. Metzdorf, R.A. Wise, Treatment of exacerbations as a predictor of subsequent outcomes in patients with COPD, Int. J. Chron. Obstruct. Pulmon. Dis. 13 (2018) 1297–1308, doi: http://dx.doi.org/10.2147/COPD.S153631. [16] K.F. Schulz, D.G. Altman, D. Moher, CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials, BMC Med. 8 (1) (2010) 18, doi:http://dx.doi.org/10.1186/1741-7015-8-18. [17] H. Watz, B. Waschki, T. Meyer, H. Magnussen, Physical activity in patients with COPD, Eur. Respir. J. 33 (2) (2009) 262–272, doi:http://dx.doi.org/10.1183/ 09031936.00024608.
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Please cite this article in press as: M. Granados-Santiago, et al., Shared decision-making and patient engagement program during acute exacerbation of COPD hospitalization: A randomized control trial, Patient Educ Couns (2019), https://doi.org/10.1016/j.pec.2019.12.004