Abstract
Self-management is becoming an important part of treatment for patients with chronic obstructive pulmonary disease (COPD). We conducted a longitudinal survey of patients with COPD who attended a 7-week group-based lay and clinician co-delivered COPD self-management programme (SMP)to see whether they became more activated, enjoyed better health status, and quality of life, were less psychologically distressed and improved their self-management abilities. The main analysis was a per-protocol analysis (N = 131), which included only patients who attended ≥5 SMP sessions and who returned a 6-month follow-up questionnaires. Changes in the mean values of the patient outcomes were compared over time using paired t tests and general linear model for repeated measures. Patient activation significantly improved 6 months after the SMP (p < 0.001). There were also significant improvements in COPD mastery (p = 0.001) and significant improvements in a range of self-management abilities (self-monitoring and insight p = 0.03), constructive attitude shift (p = 0.04), skills and technique acquisition, (p < 0.001)). This study showed that a lay and clinician-led SMP for patients with COPD has the potential to produce improvements in important outcomes such as activation, mastery and self-management abilities.
Introduction
Long-term conditions (LTCs) are rapidly increasing worldwide, 1 and it is predicted that, by 2020, they will account for almost three quarters of all deaths worldwide. 2 Horizon 2020, the European Union research and innovation programme recognizes the importance of funding research into the self-management of LTCs. 3
Chronic obstructive pulmonary disease (COPD), the collective term for chronic respiratory conditions such as emphysema, bronchitis and asthma, affects an estimated 64 million people worldwide. 4 It is currently the fifth leading cause of death worldwide, and the World Health Organization estimates it will become the third leading cause by 2030. 5,6 Almost 90% of COPD-related deaths occur in low- and middle-income countries respectively. 7
It is estimated that in England approximately 3.5 million people suffer from COPD. An estimated 800,000 of these are currently diagnosed. The remaining 2.7 million have become known as the ‘Missing Millions’, 8 and their early diagnosis and treatment is a high strategic priority for the Department of Health. 9 The cost of National Health Service health care use for COPD is considerable. It is the second largest cause of emergency admissions in the United Kingdom. Furthermore, its economic impact extends beyond health services, representing 9% of all certified absence from work on the grounds of illness. 10
Numerous studies suggest that factors that impact upon quality of life, such as dyspnoea (breathlessness), depression, anxiety and exercise tolerance have a larger influence over self-reported quality of life than disease severity. 11 One way of improving quality of life is through well-designed self-management programmes (SMPs). Despite identifying ‘self-management advice’ as one of the key strategic recommendations for managing exacerbations in patients with COPD, 12 the Department of Health is yet to advocate a specific COPD SMP. Studies evaluating the effectiveness of COPD SMPs are scarce, and there is no consensus on what constitutes an SMP for patients with COPD and how their effectiveness should be measured. 13,14
A Cochrane review of self-management education for patients with COPD found clinically and statistically significant reductions in the probability of one or more hospital admissions post-intervention. 15 However, the studies in the review used a variety of interventions ranging from educational- to community- and home-based exercise programmes. A systematic review 16 concluded that SMPs that are delivered as a part of multi-component package (e.g. decision support and clinical information system) are effective in reducing health care utilization, whilst stand-alone SMPs are unlikely to result in a reduction of hospital admissions and emergency department visits. Online and face-to-face programmes have been shown to demonstrate similar clinically meaningful changes in dyspnoea, self-reported endurance exercise time, physical functioning and self-efficacy for managing dyspnoea. 17
The Co-creating Health (CCH) initiative, which is described in more detail elsewhere, 18 was a quality improvement programme commissioned by the Health Foundation. CCH provides support at the patient, clinician and service level. In this article, we describe a longitudinal evaluation of an SMP for patients with an LTC that took place in a real-world health care setting and so did not include a randomized control group. CCH clinician self-management support practices are reported elsewhere. 19,20
Phase 1 of the programme was delivered between November 2007 and September 2011. As a part of CCH, an SMP was developed for patients with four LTCs: COPD, pain, diabetes and depression. Each of the four patient groups attended separate condition-specific SMPs.
The aim of this study was to see whether attending the SMP improved patients with COPD activation, health status, quality of life, psychological distress and self-management ability. Outcomes for the other three LTCs are reported elsewhere. 18 There has been increasing attention in the self-management literature 21,22 about the importance of patient activation in predicting a range of outcomes. Improvements in patient activation have been associated with improved self-management behaviours, 21 medication adherence and patient outcomes including quality of life. 23,24 This shows the importance of developing and testing approaches for supporting activation. 25
Methods
Patients and procedure
Between February 2008 and June 2010, COPD patients from primary and secondary care who wished to attend the SMP registered their interest via a dedicated recruitment telephone helpline. The contact details of patients who consented to take part in the evaluation were passed to the evaluation team. Pre-course questionnaires (time 1) were mailed out to patients by the evaluation team. Reminder and follow-up calls prior to attendance were made to improve response rates. In keeping with the real-world setting of the evaluation, COPD patients who chose not to participate in the evaluation were not excluded from the SMP. All patients were mailed out 6-month follow-up questionnaires (time 2). Two reminder follow-up contacts were made. During the second attempt, patients were offered the option to verbally complete the primary outcome measure, the Patient Activation Measure. The study protocol was approved by the Brighton and Hove City Teaching Primary Care Trust Multi-Centre Research Ethics Committee 07/H1107/143.
Intervention
The COPD SMP was developed by the Expert Patient Community Interest Company and is based on the Stanford University Chronic Disease Self-management Course (CDSMC). 26 The COPD SMP is grounded in social learning theory 27 and includes four efficacy-enhancing strategies: skills mastery, social modelling, social persuasion and reinterpretation of symptoms. The SMP was co-delivered by a COPD health professional (e.g. physiotherapists, specialist nurses, occupational therapists and lay (i.e. COPD patient) tutor. The SMP ran for seven weekly sessions of three hours each and where possible comprised between 8-12 patients, although some groups ran with lower numbers. There is no planned follow-up support provided by the facilitators. Tutors are trained and accredited to a rigorous set of quality standards that focus on adhering to the timing, sequence and coverage of activities as set out in the manual, thus ensuring fidelity. All activities can be either delivered by the health professional or lay tutor. Tutors decide in advance which activities they would like to lead on. Our observations of the SMP (reported elsewhere) using process evaluation using a self-determination theory 28 showed co-delivery was a successful model and that lay and health professional tutors had similar motivational styles to promote participant engagement and learning. 29 The SMP included weekly COPD-specific content including managing breathlessness, COPD medication and managing COPD exacerbations. Table 1 presents SMP weekly content. The SMP contains 27 behaviour change techniques, including those identified in the behaviour change technique (BCT) taxonomy, which have a strong evidence base such as goal setting, action planning and problem-solving. 30 The BCT taxonomy provides a rigorous method of characterizing the active content of interventions arising from the Consolidated Standards of Reporting Trials 31 guidelines call for precise reporting of behaviour change interventions.
COPD SMP content.
COPD: chronic obstructive pulmonary disorder; SMP: self-management programme.
Data collection and analysis
Quantitative data
Patient Activation Measure
The primary outcome measure was the Patient Activation Measure (PAM), 32 which refers to the extent that patients have the knowledge, skills and confidence to use self-management support skills. It comprises 13 items that assess patient knowledge, skill and confidence for self-management. Each item has four response options: ‘disagree strongly’, ‘disagree’, ‘agree’ and ‘agree strongly’. The PAM has a theoretical range from 0 to 100. Higher scores indicate greater activation. An improvement in four points on the PAM scale is considered meaningful as this is the level of increase which is associated with performing a range of self-management behaviours. 21
EuroQol
The EuroQol index (EQ-5D index) 33 and the EuroQolVisual Analogue Scale (EQ VAS) 34 are widely used measures of health status and health-related quality of life respectively. The EQ-5D index assesses patients’ health state across five dimensions (self-care, mobility, anxiety/depression, usual activities and pain/discomfort) that are weighted to provide a utility value based on a population tariff, scores range from 0 (death) to 1 (perfect health). The EQ VAS is a vertical rating scale health scored between 0 (worst imaginable health) and 100 (best imaginable health).
Hospital Anxiety and Depression Scale
Psychological distress was assessed in terms of anxiety and depression. The Hospital Anxiety and Depression Scale (HADS) 35 provides separate scores for anxiety and depression ranging from 0 to 21, with higher scores indicating greater anxiety and greater depression.
Health Education Impact Questionnaire
Self-management ability was measured using the Health Education Impact Questionnaire (hei-Q), which is a measure that has been specifically developed to assess the self-management skills and techniques taught on SMPs. 36 Patients are asked to rate items on a 4-point Likert-type scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores represent higher levels of self-management abilities. The eight scales are positive and active engagement in life; health-directed behaviour; skill and acquisition technique; constructive attitudes and approaches; self-monitoring and insight; health services navigation; social integration and support and emotional well-being.
The Chronic Respiratory Questionnaire Self- Report
The Chronic Respiratory Questionnaire Self-Report (CRQ-SR) 37 assessed dyspnoea, emotional function, mastery and fatigue. All four dimensions are scored from 1 to 7 with higher scores indicating better functioning.
The main analysis was a per-protocol analysis, which means we included only patients who attended ≥5 SMP sessions and who returned a 6-month follow-up questionnaires. The level of statistical significance was set at p = 0.05. Intention to treat (ITT) analysis was also performed to ensure that the effectiveness of the programme has not been overestimated. 38 ITT analyses included all patients in the analysis regardless of the number of sessions they attended. Missing 6-month follow-up data (time 2) were replaced with baseline data.
Changes in the mean values of the patient outcomes were compared over time using paired t tests and general linear model for repeated measures. For the per-protocol analysis, important prognostic factors such as age, gender, long-term condition, co-morbidity, number of sessions attended and socio-economic factors (education and employment status) were adjusted for using analysis of covariance. Effect sizes (Cohen’s d) were calculated using the following calculation: the mean score at 6 months minus the mean score at baseline divided by the standard deviation at baseline. Boundaries recommended by Cohen 39 were used to determine small (0.2), moderate (0.5) and large effect sizes (ES; 0.8). The hei-Q scale developers recommend a distribution-based cut-off of ES = 0.5 as a standardized cut-off. Based on this cut-off, three categories of change were defined: ‘substantial improvement’ (ES ≥ 0.5), ‘minimal/no change’ (−0.50 < ES < 0.50), ‘substantial decline’ (ES ≤ −0.5). We also examined the proportion of patients with COPD who achieved meaningful improvement of PAM score (i.e. ≥4 points).
Results
Survey and SMP completion rates
In total, 312 patients with COPD contacted the recruitment helpline, and of these, 107 (34%) did not register to attend the SMP. In total, 205 patients with COPD completed baseline questionnaires, and 131 (64%) patients completed 6 months follow-up questionnaires. In all, 69% of patients with COPD completed the SMP (attended ≥5 SMP sessions; i.e. 141/205). Where we were missing attendance data for 8 patients with COPD and these were deemed to have attended ≤4 sessions. Where we could establish direct pairing of data from patients who completed baseline and 6-month surveys and who attended ≥5 SMP sessions for the main analysis, there were 105 matched PAM scores (Figure 1). Response rates were lower for other outcome measures as we only collected PAM data at 6 months follow-up among those patients who were subject to repeat follow-up attempts. There were no differences in any demographic or outcome variable between patients with COPD who responded at both time points and those who responded at baseline only. At baseline, patients with COPD who completed the SMP (attended (≥ 5 sessions) compared to those who dropped out (attended 0–4 sessions) were significantly more activated (mean 57.2 compared to 52.4, p = 0.02), significantly less depressed (mean 6.4 compared to 8.0, p = 0.09), had better health-related quality of life (mean 0.58 compared to 0.48, p = 0.05) and better health status (mean 60.2 compared to 52.8, p = 0.04). There were no demographic differences between patients who completed the SMP and those patients who did not complete the SMP on variables of gender, ethnicity, house ownership, living arrangements, education, employment and co-morbidity.
COPD SMP study flow chart. COPD: chronic obstructive pulmonary disorder; SMP: self-management programme.
Demographic characteristics of patients with COPD
As shown in Table 2, mean age of patients with COPD was 68.3 years (SD 9.3). There were more female (55.9%) than male patients (44.1%). Almost all patients with COPD described their ethnicity as White (95.7%), over two-thirds (67.9%) owned their own homes, just over a third (34.8%) lived alone, more than a half (57.6%) completed their education below 16 years of age, the vast majority (92.2%) were retired and most patients (70.5%) with COPD had a co-morbidity.
Patients’ characteristics of those enrolling on the COPD SMP and who also returned a baseline questionnaire (N = 205).
COPD: chronic obstructive pulmonary disorder; SMP: self-management programme.
Patient activation
Per-protocol analysis showed that patients with COPD activation significantly improved 6 months after completing the SMP (t = 4.02 (104); p < 0.001; ES = 0.36). ITT analysis produced similar results (t = −4.63 (201); p < 0.001; Table 3). Almost a half (49.5%) of patients showed a meaningful improvement (i.e. ≥4 points) in patient activation scores.
Baseline and 6 months post-course scores (mean and SD).
ES: effect size; ITT: intention to treat; PAM: Patient Activation Measure; EQ VAS: EuroQolVisual Analogue Scale; HADS: Hospital Anxiety and Depression Scale; CRQ-SR: Chronic Respiratory Questionnaire Self-Report; hei-q: Health Education Impact Questionnaire.
aThis sample size is for PAM, sample size was smaller for other outcome measures.
None of the prognostic and socio-economic factors predicted changes in patient activation over time.
Health status, health-related quality of life and COPD-specific quality of life
Per-protocol analysis showed that patients’ health status did not change after completing the SMP (t = −1.15 (88); p = 0.25; ES = 0.00). ITT analysis provided similar results (Table 3). Per-protocol analysis showed that patients’ health-related quality of life (EQ-VAS) did not change after completing the SMP (t = −1.41 (74); p = 0.16; ES = 0.00). ITT analysis produced showed significant improvement in patients’ health status 6 months after completing the SMP (t = −2.28 (161); p = 0.02; Table 3). None of the prognostic and socio-economic factors predicted health status over time.
Both per protocol and ITT analysis showed significant improvement in one out of four CRQ-SR subscales – mastery (t = −3.42 (68); p < 0.001; ES = 1.00; t = 6.46 (189); p < 0.001, respectively). There were no significant improvements in dyspnoea, emotional function or fatigue.
Psychological distress
Per-protocol analysis showed that no improvement in patients anxiety and depression (t = 0.93 (80); p = 0.35 and t = 0.29 (80); p = 0.76, ES = −0.07 and 0.02, respectively). ITT analysis produced similar results (Table 3).
Self-management ability
Per-protocol analysis showed that patients’ self-management skills in three out of eight hei-Q domains significantly improved 6 months after attending the SMP; self-monitoring and insight (t = −2.16 (81) p = 0.03), constructive attitude shift (t = −2.00 (74); p = 0.04) and skills and technique acquisition (t = −3.83 (80); p < 0.001). ESs ranged from 0.20 for constructive attitude shift to 0.40 for skills and technique acquisition and self-monitoring and insight (Table 3). ITT analysis produced similar results. None of the prognostic and socio-economic factors predicted changes in self-management skills over time.
As shown in Table 4, about a quarter of patients showed substantial improvements in a range of self-management abilities (health-directed behaviour, positive and active engagement, emotional well-being, self-monitoring and insight, constructive attitude shift, skills and technique acquisition), the exceptions being social integration and support (19%) and health service navigation (10.7%).
Distribution of the proportion of patients with ‘substantial improvement’, ‘minimal/no improvement’ or ‘substantial decline’ on the hei-q scale.
hei-q: Health Education Impact Questionnaire; ES: effect size.
Discussion
This study evaluated a lay and clinician co-delivered SMP for patients with COPD. The SMP completion rate (attended >5 sessions) among the 205 patients with COPD who completed baseline questionnaires was 69%, which is higher than completion rates (48%) among COPD patients who registered on a community-based COPD version of the Expert Patients Programme (EPP). 40 Factors affecting completion, such as being referred by a known clinician, who also co-delivered the SMP, may have contributed to the high completion rates achieved. We have reported elsewhere that the co-delivery model was well received by patients with LTCs. 29 Patients with COPD who were less activated, more depressed and had lower health-related quality of life and health status were more likely to drop out of the SMP. This is unfortunate as research shows that these patients are likely to benefit the most from attending a group-based SMP. 41
COPD self-management researchers have described the importance of assessing self-efficacy and patient activation. 42 –44 Patients with COPD were significantly more activated after attending the SMP. Almost a half of patients with COPD (49.5%) achieved meaningful improvement (i.e. ≥4 points). Improved activation on the PAM is an important finding as research has shown that activated patients with a range of long-term conditions are more likely to participate in collaborative decision-making with their clinicians, report improved health-related behaviours and clinical outcomes and adhere to physical therapy. 23,24 Further research is needed to confirm these associations in patients with COPD. Qualitative evaluations of group-based SMPs have shown that the weekly goal setting, action planning, feedback and follow-up are instrumental in motivating patients with LTCs to change their behaviour and increase their confidence to self-manage. 45 –47 Patients with COPD reported improved mastery over their COPD as measured by CRQ-SR. This is similar to a study 48 that showed significant improvement in two CRQ-SR scales of fatigue and mastery 12 months after completing a chronic disease management programme.
A quarter of patients showed substantial improvements (ES≥0.5) in self-management skills and statistically significant change was observed in three out of eight hei-Q including Self Monitoring, Insight, Constructive Attitude Shift and Skills and Technique Acquisition. This result is important given that the primary aim of the SMP is to enhance patients’ ability and capacity to self-manage their condition.
The current study provided no evidence that attending COPD SMP results in improved health-related quality of life or health status as measured by EQ-5D index and EQ-VAS respectively. Similarly, a recent randomized controlled trial (RCT) of the modified version of the EPP for patients with COPD found that EQ-5D index scores decreased at a lower rate than those in the control group. 40 In other studies described in the Cochrane review, 15 health-related quality of life did not improve. COPD patients usually experience worsening health over time, and it would be helpful to conduct trials to test whether the COPD SMP maintains health outcomes relative to a control group, which may be a positive outcome.
The current study did not show any improvement in depression and anxiety after completing the SMP, which is consistent with an evaluation of the modified version of the EPP for COPD patients. 40 Mean scores for both anxiety and depression were below the recommended cut-off scores ≥8 for mild distress, and so, there was little scope for significant improvement. A recent study examined the impact of attending pulmonary rehabilitation (PR) on anxiety and depression scores as measured by HADS and showed that patients with ‘probable’ (HADS score 8–10) and ‘presence’ (HADS score 11–21) symptoms of anxiety and depression showed significant improvement after completing PR. 49 The CCH COPD SMP taught managing breathlessness and relaxation techniques that could potentially reduce anxiety level, but its impact was clearly not sufficient to produce significant decreases in negative mood states. The issues of panic attacks and anxiety should be covered in more depth along with practical skills that can help reduce its impact on patients’ everyday life and overall well-being.
Limitations
The results need to be interpreted with caution for several reasons. The response rate at 6 months follow-up was low (47%). We are unsure as to the exact reasons why this low rate occurred and can only speculate that the greater emphasis the sites participating in the CCH initiative gave to implementation over evaluation may have had an impact. The primary analysis was conducted on SMP completers (per-protocol). We conducted ITT analysis to prevent overestimating of the programme effectiveness. There was no control group, and follow-up data were only collected at 6 months follow-up. Due to the pragmatic nature of the CCH initiative, the sites involved in recruiting the patients did not collect clinical outcome data such as forced expiratory volume in 1 second, nor record health care use, prior to patients enrolling on the SMP or at the 6 months follow-up time point. The clinical significance of the findings, other than for patient activation, was negligible. This could be due to COPD patients who attended the SMP having a reasonable quality of life and health status that left little room for improvement. As previously discussed, it may be unreasonable to expect large improvements for COPD patients attending a brief self-management intervention. A recent large-scale RCT of self-management support for LTC patients in primary care in the United Kingdom found little improvement. 50 The authors suggest that a better understanding of the active ingredients of effective self-management support are needed and that greater effort is required to make self-management support more relevant to patient’s everyday lives.
Implications for practice
The COPD SMP is based on the Stanford University CDSMC, which has been successfully delivered in over 20 countries. 51 This suggests that the SMP COPD has the potential to be adopted and tested in an international context. This study showed that a lay and clinician-led SMP for patients with COPD has the potential to produce improvements in important outcomes such as activation, mastery and self-management abilities. Further research including a control group and a longer follow-up period (e.g. 12 months) are required. Patients with COPD who are less activated and more depressed should be actively recruited to and then further supported to complete the SMP.
Footnotes
Acknowledgements
We would like to thank all the patients with COPD who generously gave their time and effort to complete the research questionnaire.
Funding
This study was supported by the Health Foundation through its Co-Creating Health Initiative.