Abstract
Objectives
The Chronic Disease Self-Management Program (CDSMP) is a standardized self-management intervention for patients with various chronic diseases. CDSMP provides self-management skills to enhance patient health, well-being, and coping skills. The present study evaluates the effectiveness of CDSMP delivered in routine clinical services on health, health behaviors and healthcare utilization in patients with various chronic illnesses.
Methods
A pragmatic single group pre-post design evaluated the effectiveness of the CDSMP in an Irish cohort using self-report data collected by service providers in hospital, community health and patient organizations. Data on health, health behavior and healthcare utilization were collected at baseline (n = 263), immediately post-program (n = 102), and six months (n = 81) after enrollment.
Results
CDSMP participants reported statistically significant increases in activity levels, self-efficacy, energy and quality of life, and a significant decrease in depression scores at six months follow-up. There was a significant decrease in self-reported visits to the GP and in total nights spent in hospital.
Discussion
This national pre–post study provides preliminary evidence for the potential effectiveness of CDSMP delivered during routine care in improving important health outcomes and reducing health care utilization among a heterogeneous sample of chronic disease patients.
With aging populations, the burden of chronic illness will rapidly increase worldwide.1,2 People living with chronic disease play an active role in managing their disease, secondary conditions, and healthcare. The individual has the most important role in managing their chronic disease; hence, increasing the individual’s perceived abilities to self-manage their symptoms and healthcare behaviors can empower clients to take control in the management of their chronic illness. Support programs that incorporate self-care and self-efficacy have the potential to significantly reduce morbidity, mortality, and the cost of chronic illness.
The Chronic Disease Self-Management Program (CDSMP) provides patients with diverse self-management skills to meet their various needs. 3 Based on their experiences delivering an effective community-based education program for patients with Aarthritis,4,5 the Stanford Patient Education Research Center developed the CDSMP in the early 1990s to examine the effects of providing a common intervention to patients with different chronic conditions such as heart disease, lung disease, diabetes, stroke, or arthritis. The program has subsequently been adapted to meet the needs of other chronic illness populations including HIV, chronic pain, and cancer. 6 The program’s content and process were based on findings from a series of focus groups with patients with various chronic illnesses such as heart disease, lung disease, stroke, or arthritis; the patients noted their need for managing symptoms (e.g. fatigue, stress, pain, anger, and depression), and the program designed self-management tools that patients could develop in a supportive and facilitative group context. A key component of the program is that it is peer-led with at least one of the two facilitators (“leaders”) having a chronic condition; of note, all facilitators are trained and accredited to a rigorous set of quality standards by Stanford program. The high level of training enhances adherence to protocol to ensure content and delivery fidelity. The program is delivered according to a structured protocol by trained facilitators to groups of 6–10 participants, many of whom have multiple chronic conditions.
The CDSMP was developed on the assumption that people with different chronic illnesses have similar self-management and disease-related challenges, and the program assumes that effective self-care strategies work across different conditions. 7 The overall goal of CDSMP is to enable participants enhance their self-efficacy in their ability to manage their health, illness symptoms, and healthcare utilization. CDSMP is based on Bandura’s Self-Efficacy theory, which proposes that a patient’s confidence in achieving a behavior predicts successful performance of the behavior. 8 Self-efficacy theory highlights four means to increase a person’s self-efficacy: skills mastery (goal setting, problem solving, relaxation), modeling (lay leader’s and other participants attitudes and behaviors), reinterpretation (changing beliefs about one’s symptoms, abilities and confidence), and persuasion (education and group support).3,6 CDSMP incorporates all of these processes throughout the program. For example, action planning regarding an achievable goal setting is shared with the other participants and this allows patients to successfully perform behaviors in a socially supported context. Mastering low level behaviors (e.g. walk for 10 min twice a week) gives confidence that one can then attempt more challenging behaviors (e.g. walk for 10 min five times a week). In line with Self-Efficacy Theory, as one’s confidence grows, then one’s behavioral goals for self-management can become more aligned with recommended preventive behaviors. The patient determines the goal to be attempted, and where it proves too challenging or the level of self-efficacy is low, the CDSMP process focuses on problem-solving; the goal might be scaled back or the rest of the participants can offer their advice on how to feel more confident in pursuing the goal or provide practical tips to help overcome barriers. Action planning as a self-management strategy is integral to the program and is included in every session. Participants report back to the group on their achievements at the next weekly session: feedback and problem-solving in relation to plans are present every week after the initial action plan has been made.
Techniques to manage symptoms are discussed in four out of the six weeks. Other topics addressed over the six sessions include an overview of self-management in chronic health conditions, managing difficult emotions, fitness/exercise, better breathing, pain, fatigue, nutrition, future plans for health care, communication, medications, making treatment decisions, depression, working with one’s health care professional, working with the health care system, and one’s future plans. During sessions, facilitators direct participants to specific sections in the Living a Healthy Life with Chronic Conditions manual that are relevant to the session content. Participants are encouraged to read it during the week to extend and reinforce their knowledge beyond the basics covered during the session.
The format of the course is largely interactive, with short ‘lectures’ to introduce topics, group discussion, problem-solving, role-plays, and mastery experiences (i.e., trying out the skills introduced on the course). Patients receive practice and feedback in decision-making and problem-solving skills. In addition to increasing patients’ self-efficacy, the participants also develop skills to enhance their recognition and responses to symptoms, their communication of symptoms, and to interact appropriately with healthcare providers. Participants are encouraged to apply these generic skills to their own situation.
The program aims to provide individuals with the confidence, skills and knowledge to manage their condition, its symptoms and negative psychological responses effectively. Several randomized controlled trials (RCTs) have demonstrated the program’s efficacy for patients with various chronic illnesses (e.g. heart disease, lung disease, diabetes, stroke, arthritis) in improving levels of exercise, symptom management, communication with physicians, self-reported general health, health distress, fatigue, disability, and social/role activities limitations.3,9,10 Some of these benefits persist for up to two years following intervention. 10 A defining feature of CDSMP research is that participants are very heterogeneous and many have multiple co-morbidities.
Meta-analysis reported that CDSMP participants experienced significant improvements in self-efficacy, health distress, social limitations, and cognitive symptoms. 11 However, although the RCT efficacy evidence is essential for evidence-based practice, such efficacy studies in tightly controlled research contexts may often fail to translate their benefits when examined in less rigorous real-world settings. Effectiveness trials are most valuable to test whether the results of efficacy trials can be reproduced in actual clinical practice. 12 Furthermore, it has been noted that despite research documenting the efficacy of many health promoting interventions, such as CDSMP, in well-controlled research, few of these interventions are consistently implemented in applied settings. 13 Ideally, an efficacious intervention should be readily available and accessible, healthcare providers should identify the target population and recommend the intervention, and patients must accept and adhere to the intervention. 14 However, poor access to interventions and low levels of acceptance by patients, and poor adherence rates can result in efficacious interventions being less effective in actual routine clinical practice. In addition, a large proportion of the relevant literature is associated with the program developers, leading to potential bias and the vast majority of studies have been conducted in the USA and the UK. 15
Current study
As noted above, RCTs have established the efficacy of CDSMP; however, its effectiveness in various healthcare contexts and systems requires further study. We sought to examine the effectiveness of the standardized manualised CDSMP intervention delivered in the context of routine clinical care by various healthcare providers across multiple sites in an Irish patient cohort.
Methods
Design
A pre–post pragmatic design was used and data were collected at baseline, immediately post-program, and six months later across seven settings in hospitals (n = 4; two large urban and wo large sub-urban university affiliated hospitals), community health (n = 1; a community based initiative provided in collaboration by the national health service, a regional Centre of Independent Living, a national Disability Federation and a national Multiple Sclerosis Society), and patient support organizations (n = 2; Multiple Sclerosis and Kidney Disease) . An RCT was not used given the meta-analysis evidence that CDSMP was effective 11 and it was not deemed ethical to withhold the intervention. As the aim of the study was to examine the effectiveness of CDSMP as delivered in various community and healthcare settings, the study adopted a pragmatic design based on its high external validity, large sample size, and simple design in diverse settings.16,17 Ethical approval was provided the University Ethical Research Committee (SPREC number: 03/02/16).
Participants
Patients across the various sites were made aware of the program though routine care. Patients recruited for the hospital-based programs were typically informed of the CDSMP by their healthcare teams, suggestions from peers, and through posters in hospital public spaces. Those participating in the community health program were recruited through advertisements by both a national Disability Federation and the national Multiple Sclerosis Society, suggestions from peers and through GP and hospital healthcare team recommendations. Those participating in CDMP through the patient support organizations were recruited through advertisements by the organization on mailing lists and newsletters, suggestions from peers, and GP and hospital healthcare team recommendations. The specific referral pathways for participants were not recorded. Participant eligibility criteria included having at least one self-reported chronic disease and being able to attend the program. The program was open to all those with a chronic disease who wanted to participate and no eligible participants were refused a program.
CDSMP
The CDSMP ran for six weeks, with each participative session lasting 2½ h. The sessions were facilitated by two trained leaders, at least one of whom was a person with chronic illness. Each participant received a copy of the program manual, Living a Healthy Life With Chronic Conditions (4th Edition), and the program was delivered in accordance with the developers’ recommendations. The CDSMP is outlined in Table 1 using the TIDIER guidelines for intervention description. 18
Descriptive characteristics of sample.
Intervention reporting in line with the Template for Intervention Description and Replication (TiDieR) guidelines.
Measurement
Following receipt of informed consent, participants completed a battery of scales as recommended by the program developers. 19
Self-rated health
A single item asks for a general rating of self-perceived health, ranging from “Excellent” (1) to “Poor” (5). Higher scores indicate better self-rated health; of note, this item is used in the US National Health Interview Survey and is a reliable predictor of future health. 20 Test–retest reliability of .92 was reported in the original validation of the scale. 21
Activity levels
A five-item scale assessed exercise behaviors (e.g. walking, swimming, bicycling, other exercise) in the past week. Items that were coded to that higher scores indicate higher levels of activity. Previous research reported acceptable test–retest reliability (r = .72) 21 and high levels of internal consistency (Cronbach’s α = .91). 22 In the current sample, Cronbach’s α of .82 was found.
Self-efficacy
The five-item scale assessed confidence to perform self-management behaviors, to manage disease in general, and to achieve health outcomes. Higher scores indicate higher levels of self-efficacy. Self-efficacy has been found to predict healthcare utilization in previous CDSMP studies. 10 Previous research reported acceptable levels of test–retest reliability for the items (r = .72–.88) and high level of internal consistency (Cronbach’s α = .91). 21 The present sample had a Cronbach’s α of .87.
Energy
A five-item scale based on from the Medical Outcomes Study 23 assesses energy and fatigue levels in the past month. Higher scores indicate higher levels of energy. Previous research reported acceptable levels of test–retest reliability for the items (r = .85) 21 and high level of internal consistency (Cronbach’s α = .87). 22 In the present study, Cronbach’s alpha was .82.
Pain
A single-item visual numeric scale was used to measure pain in the past two weeks, ranging from 0 (no pain) to 10 (severe pain). Previous research reported acceptable levels of test–retest reliability for the items (r = .79). 21
Quality of Life
A single-item visual numeric scale was used to measure quality of life the past week, ranging from 0 (very poor) to 10 (excellent). Such single-item scales have high levels of test–retest reliability (r = .87) and correlate with longer QOL scales. 24
Social/role activities limitations
A four-item scale adapted from the Medical Outcomes Study 23 measures how much illness interferes with participants’ social/role activities (i.e. normal activities, recreational activities, household chores, and errands) during the past week. Higher scores indicate greater activity limitations. Previous research reported acceptable levels of test–retest reliability for the items (r = .68) and high level of internal consistency (Cronbach’s α = .91). 21 In the present study, Cronbach’s alpha was .88.
Depression
The PHQ-8 is used for criteria-based diagnoses of depressive disorder for population-based studies as well as clinical diagnoses. 25 A PHQ-8 score of ≥10 has an 88% sensitivity and 88% specificity for major depression. 26 Cronbach’s alpha was .88 in the present sample.
Health care utilization
Health care utilization in the past six months was measured by a series of standard self-reported items that asked participants to indicate the number of GP visits, number of out of hours GP visits, number of Accident and Emergency hospital visits, number of times hospitalized for one night or longer (hospital stays), and the number of total nights spent in an acute care hospital (length of stays). Acceptable levels of test–retest reliability for the items (r = .76–97) have been reported. 21 The self-reports of medical visits and hospital stays correlated (r = .70 to .83) with chart audit data in a previous CDSMP study. 27
The measures were administered by the CDSMP facilitators at the first (time 1) and last session (time 2); the six-month follow-up (time 3) assessment was completed by posting the questionnaire battery to the participants with stamp addressed envelopes included.
Analyses
Baseline characteristics were compared between the completers and non-completers (i.e. those who missed more than two sessions) of the follow-up assessment using χ2 tests for categorical variables and MANOVA for continuous variables. Similar analyses were conducted to compare those who completed all three questionnaire time points with those who only completed two or one questionnaires. The data were not analyzed using ITT and a per protocol analysis was applied for this pragmatic trial. ITT analysis results are affected by the trial-specific pattern of adherence to the treatment under study and therefore may not be directly relevant for guiding decisions in clinical settings. 28 Bootstrapped hierarchal multi-level modeling (MLM) for continuous data and Poisson models for the health care utilization count data were used to examine the changes over time, controlling for age, gender and the number of comorbidities. Missing data can be handled flexibly in MLM as opposed to standard repeated measures ANOVA. 29 Missing data can arise for many reasons in longitudinal research such as the present study: if a research participant is missing for even a single time period, all of the participant’s data are removed from standard repeated measures ANOVA analysis. Unbalanced data and unequal spacing conditions can be flexibly handled under MLM. Consequently, the capacity of MLM (using likelihood-based estimation) to incorporate all available data in an analysis can be especially useful in conducting longitudinal studies. 29 Hierarchal regression modeling explored the predictors of significant changes in health care utilization. For all analysis, p<.05 was set as statistically significant.
Results
During the course of study, the response rate for the different settings across the different programs ranged from 20% to 85% (mean response rate = 63%). Data were collected on 263 participants nationwide at time 1, 102 at time 2, and 81 at time 3. The sample were predominantly female (73%) and the mean age was 52.2 (SD = 13.5, range 17–89 years). The most frequent diagnoses (endorsed by over one third of participants) were anxiety, depression, and arthritis; participants reported a high degree of comorbidity: the average number of comorbid conditions per participant was 2.6 (SD = 1.62, range 0–8).
Comparisons of those who completed surveys at all time points versus those who only completed time 1 data or time 1 and 2 revealed no significant differences across all measured variables.
Health outcomes
After controlling statistically for age and number of comorbidities, there were statistically significant increases from time 1 in activity levels, F(2,168.31) = 4.23, p<.05; self-efficacy, F(2,184.77) = 17.46, p<.001; energy, F(2,165.89) = 3.94, p<.05; and quality of life, F(2,206.91) = 6.91, p<.005 (see Table 3).
Changes in health, health behaviors and psychological variables over time.
*p < .05 vs. pre-CDSMP. Boldface values represent variables with statistically significant changes over time.
Health care utilization over time.
*p < .05 vs. pre-CDSMP.
Of note, there was a significant decrease in mean depression levels over the program. Furthermore, over half (53%) of the participants scored above the threshold for clinical depression on the PHQ-8 at baseline. This rate decreased to 43% post-CDSMP (p=NS) and 33% (p<.01) at follow-up.
Health care utilization
At six-month follow-up, there was a significant decrease from time 1 in self-reported visits to the GP, F(2,233.30) = 3.49, p < .05, and in total nights spent in hospital, F(2,155.44) = 4.87 p <.01. Hierarchal regression modeling, controlling for frequency of GP use prior to the CDSMP, revealed that increases in energy levels over the course of the program were a statistically significant independent predictor (Standard B= −.55, p < .01) of decreased GP use in the six-month period after the program was completed. No significant independent predictors were found for predicting changes in total nights spent in hospital at follow-up.
Discussion
This national pre–post study provides preliminary evidence of the potential effectiveness of CDSMP in hospital and community settings in improving important health outcomes and reducing health care utilization among a heterogenous sample of chronic disease patients. These findings are consistent with the results from previous international research, which had stronger research designs.3,6,9,10 The CDSMP is based on the principles of self-efficacy 8 and had a significant effect on increasing patients’ confidence to successfully manage their condition. Previous research consistently demonstrates the importance of self-efficacy for enhanced patient outcome and adaptation to chronic illness. 30
Improvements in activity levels, energy, and overall quality of life represent important clinical outcome for chronic illness populations. As depression has negative effects on health outcomes among patients with chronic disease, 31 the statistically significant decrease in its levels is noteworthy. Furthermore, by increasing confidence and activity in a supported social context, the program addresses some key maintaining factors in depression. The program supports and empowers participants to become active self-managers in their care.
The significant decrease in GP visits and nights in hospital from baseline to the six-month follow-up is consistent with other studies showing a decrease in health care utilization.10,32 These findings are indicative of the potential saving in health care costs; however, CDSMP’s healthcare utilization effects are inconsistent. 33 The possibility of recall bias regarding healthcare use must be acknowledged and future effectiveness research would benefit from objectively assessing healthcare use. Furthermore, research is required to examine the potential self-selection and attritional biases that might impact on the generalizability of the findings.
There are a number of threats to the generalizability of the results. There was considerable loss of participants over time; of the original 263 who provided time 1 data, only 30% completed time 3 data. This drop-out rate is higher than typical rate of between 15% and 20%3,10 reported in previous CDSMP studies, which limits the generalizability of the findings and raises concerns regarding a potential participant bias. Although we found no significant differences regarding baseline data between those who completed the three assessments with those who completed only Time 1, or Time 1 and 2, it must be acknowledged that such post hoc comparisons may have lacked statistical power to detect differences. Similarly, those who completed all data may have differed on some unmeasured variable (e.g. conscientiousness), which may limit generalizability. Unfortunately, the present pragmatic study did not have the resources to collect data for those who declined participation in the CDSMP; thus the extent to which the findings reflect a biased sub-sample of the original sample remains unclear. Similarly, reasons for non-attendance or drop-out were not systematically recorded; however, anecdotal reports from the group facilitators and from evidence from previous CDSMP research 34 has documented that common reasons include feeling that the group format was not appropriate, not wanting to talk about themselves with others, logistic concerns such as lack of time or transportation issues, symptoms becoming better controlled, or poor health. Future effectiveness trials should include the routine collection of such data. In addition, the process for collecting time 3 data relied on postal questionnaires; it would be beneficial to use a broader variety of media (e.g. telephone interviews, online surveys) to enhance data response rates after completing the CDSMP.
The emphasis on enhancing confidence (self-efficacy) and inclusion of topics such as managing fatigue, problem solving, and dealing with depression, indicate that the CDSMP is relevant for people living with various chronic illnesses. The intervention is acceptable to patients and the present pragmatic pre–post study research replicates efficacy research findings from RCTs and provides preliminary evidence of the potential effectiveness that CDSMP may have on important clinical and healthcare utilization outcomes in real-world clinical settings. 10 Self-management programs can both reduce the burden of chronic illness and enhance patients’ health and well-being.
Footnotes
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
