Encouraging Self-Management in Cardiovascular Disease Prevention
A randomized controlled study of a structured advice and patient activation intervention in primary care
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Background: Cardiovascular diseases are among the most common causes of death in industrialized countries. The goal of the DECADE study (“decision aid, action planning, and follow-up support for patients to reduce the 10-year risk of cardiovascular diseases”) is to improve patient activation and health-related behavior by means of structured cardiovascular risk counseling and DECADE brochures. In this pilot study, the applicability of DECADE and the potential effects of the intervention on patients with cardiovascular risk factors were investigated.
Methods: 87 patients were included in the two-arm, randomized, controlled pilot study. All of them participated in four structured counseling sessions. The A+D group received DECADE brochures (intervention group), while the A group did not (control group). The change in patient activation four months later (PAM13-D) was the primary endpoint. Secondary endpoints included, among others, changes in health status and health-related behavior, goal achievement, and patient satisfaction. These changes were studied in an intention-to-treat analysis.
Results: Endpoint data were available for 78 patients (38 in the A+D group and 40 in the A group) at four months. The use of DECADE brochures had a significant beneficial effect on PAM13-D scores (an increase of 3.30 points, p = 0.023), corresponding to a moderate effect size of 0.54. Positive trends were seen in most of the other endpoints. The improved patient activation was associated with an overall reduction of risk factors.
Conclusion: This pilot study shows that DECADE can support patient activation. The effects can be expected to be stronger in a larger study and in comparison to usual care. If this can be confirmed, DECADE should be embedded in routine patient care.
Cardiovascular diseases are among the most common causes of death in industrialized countries (1) and the most common cause for seeking treatment from a primary care physician (2). Cardiovascular risk (CVR) consultations are therefore among the most important tasks of primary care physicians (3). Most patients, however, have difficulty in putting into practice health promoting behavior changes to lower their cardiovascular risk (CVR) (4, 5). Studies have found that patient activation in the sense of knowledge, skills and confidence in managing one’s own health (6) is associated with the willingness to adopt health-relevant behaviors (7, 8). Primary care physicians often experience physician–patient communication in this setting as demotivating (9, 10). At the same time, a lack of time on the physician’s part will prevent regular and patient-oriented risk consultations embedded in routine care (11, 12). Rehabilitation research and evaluations of different disease management programs, by contrast, have shown that structured treatments can have positive effects on patient-relevant endpoints and clinical parameters (13, 14).
In order to improve cardiovascular risk consultations, we developed in an iterative process the intervention DECADE—“decision aid, action planning, and follow-up support for patients to reduce the 10-year risk of cardiovascular diseases”. The study protocol includes details on the development process (15).
DECADE is based on the principles of evidence-based medicine, shared decision making (16) while using decision aids (17), and the health action process approach (HAPA) (18) and links these to structured follow-up consultations. The aim of DECADE is to support patients’ health literacy and self-management in a participatory process so that patients’ health is promoted in the long run.
DECADE links the use of the cardiovascular risk calculator Arriba (www.arriba-hausarzt.de/arriba) (3, 19)—which is recommended in the general practice guideline of the German Society of General Practice/Family Medicine—with structured follow-up consultations (Table 1). In these consultations, treatment objectives are agreed in a participatory process, and plans to change behaviors are discussed, as are successes or a lack thereof. In order to support patient activation and targeted communication between doctors and patients, the patients receive DECADE brochures, which are structured as modules. These brochures contain evidence-based decision aids and action plans and are matched to the follow-up consultations. In the sense of shared decision making, the brochures are intended as a support offering for the patients and may be used according to their own needs.
Readers who have an interest in viewing the DECADE brochures are advised to direct their request to the first author.
We are not aware of any other intervention that includes a similarly complex, but still easy-access, approach to cardiovascular risk consultations.
The research questions of this pilot study were:
- Can the DECADE intervention be successfully implemented in the primary care setting?
- Does using the DECADE brochures have a greater effect in terms of patient activation and health behaviors than structured follow-up consultations alone?
Patient activation as the primary endpoint was assessed by using the Patient Activation Measure (PAM13-D) (20). The changes in health behaviors were elicited by direct questioning (21) and documented using questions on risk factors, such as smoking and lack of exercise (22). Additionally, we asked about health status (EQ-VAS, European quality of life—visual analogue scale) (23), whether health goals had been achieved (24), and about satisfaction, and we analyzed changes in clinical parameters.
Details of the methods are described in the eMethods section.
Adult patients with at least one risk factor for cardiovascular diseases were included in the two-arm, randomized controlled pilot study. All patients received an Arriba printout for patients, and four structured follow-up consultations. The patients in the A+D group also had DECADE brochures at their disposal, whereas no further interventions were made available to patients in group A (control group).
Data collection and endpoints
At the time of inclusion in the study (T0) and after four months (T1), patients completed a questionnaire. At the end of the study, primary care physicians were interviewed.
The primary endpoint was the change in patient activation (PAM13-D) (20). Secondary endpoints were:
- Improvement in health status (EQ-VAS) (23).
- Change in risk factors (22)
- Change in general health behaviors (21)
- Achieving self-determined goals (24)
- Satisfaction with achieved goals and structured consultations
- Usefulness of patient information materials (usefulness scale for patient information material, USE) (25).
Changes in clinical parameters were studied as additional endpoints.
The analyses were conducted in the intention-to-treat (ITT) population, which included all patients with available data according to the randomized intervention. We used linear regression models to analyze the effects of the DECADE brochures on the endpoints. Goal attainment, satisfaction, and associations of the PAM13-D score with patient characteristics were analyzed descriptively. We qualitatively evaluated subjects’ free-text responses (to open questions) and interviews with the primary care physicians.
The use of the DECADE brochures was found to have a positive effect on patient activation (difference 3.30 points on a scale of 1–100, 95% confidence interval CI: [0.47; 6.14], p = 0.023 with a moderate effect size of 0.54). Health status in the A+D group compared with the A group improved by 5.79 points on a scale of 0–100 (95% CI: [–0.69; 12.21], p = 0.076 with a small effect size of 0.44). We did not see any relevant effects on the clinical parameters (Table 2a). Altogether, the descriptive analyses in the A+D group showed tendentially improved health behaviors compared with the A group, in general (55.9% versus 43.2%) as well as in terms of exercise (40.5% versus 25.6%) and stress (40.5% versus 12.5%) (Table 2b).
We tested these results in per protocol analyses and observed only small deviations compared with the ITT analyses (eMethods).
In six primary care practices, 143 adult patients were informed about the study. 87 patients consented to participation, received the Arriba consultation, and were randomized (A group: n = 45; A+D group: n = 42). Eight subjects did not complete the study (dropout rate 9.2%). Deviations from the study protocol (n = 16) were documented and per protocol analyses were conducted for 71 patients. Details on dropouts and per protocol analyses are in the annotations of the flow diagram (Figure 1) and in the eMethods section. One questionnaire was returned to the data management team after the data evaluation had been completed.
The patients in the A+D group were a mean of 6 years older than those in the A group. All other characteristics did not differ materially between the study arms (Table 3). The mean PAM13-D score of 88 points, measured on a scale of 0 (lowest level of activation) to 100 (highest level of activation), exceeded in both study arms the expected baseline score by about 20 points.
The effect of the DECADE brochures on the primary endpoint patient activation
The patients in the A+D group increased their mean patient activation score (PAM13-D), which had been high at the start of the study, by 1.50 points after four months, whereas the mean PAM13-D score in the A group fell by 1.81 points. The use of the DECADE brochures showed a significant effect of 3.30 points (95%-CI [0.47; 6.14], p = 0.023; effect size 0.54) on patient activation (Table 2a).
Health status (EQ-VAS) scored better during the course of the study than at the start of the study: by a mean of 6.84 points in the A+D group and by 1.05 points in the A group. The estimated effect of the DECADE brochures was 5.79 points (95% CI: [−0.63; 12.21], p = 0.076; effect size 0.44) (Table 2a).
Patients rated their own health behaviors regarding smoking, weight, diet, exercise, stress, and alcohol as low risk or moderate risk. At the start of the study, the mean risk factor scores in the A group were 1.5 (standard deviation SD = 0.8) points, and in the A+D group, 1.1 (SD = 0.6) points. The changes in risk factor scores were altogether small, but in the A+D group 40.5% of patients each improved their risk behaviors relating to lack of exercise and stress/hecticness. In the A group, this was the case for 25.6% and 12.5%, respectively (Figure 2).
The question relating to general modifications in health behaviors since the start of the study was answered by 34 patients in the A+D group and 37 patients in the A group. 55.9% (n = 19) in the A+D group and 43.2% (n = 16) in the A group agreed with the statement that they now “lived altogether more healthily”. One patient (A+D group) communicated that at the end of the study, he “lived altogether less healthily”. The mean sums of goals attained were 20.8 points in the A+D group (SD = 10.1) and 19.3 points (SD = 11.1) in the A group. Subjects in the A+D group were on average slightly more satisfied with attaining their goals (14.2, SD = 5.9) than in the A group (13.1, SD = 7.2). The patients in the A+D group scored the usefulness of the information materials (USE) as 65.0 points (SD = 17.3) on a scale of 0–90; this was slightly higher than among participants in the A group (62.4, SD = 18.9). The mean values for the subscales on cognition, emotions, and behaviors in both study arms were between 19.2 points and 22.8 points.
The patients in the A+D group scored the consultations with their primary care physicians on a scale of 1 (very satisfied) to 4 (very dissatisfied) similar to the patients in the A group, with mean scores of 1.36 (SD = 0.4) and 1.47 (SD = 0.8), respectively.
Table 2a shows changes in clinical parameters and body mass index (BMI) at T1 versus T0. The estimated effects of the DECADE brochures on these parameters were small. In altogether 30 patients with diabetes mellitus, the number of hemoglobin measurements (HbA1C) collected was too small to be analyzed. We conducted exploratory analyses independently of the study arm and detected inverse correlations between the PAM13-D score at T0 and health behaviors relating to an unhealthy diet, lack of exercise, stress and hecticness, as well as alcohol consumption. Relevant correlations between PAM13-D scores and patients’ sociodemographic characteristics, clinical parameters, or health status (EQ-VAS) did not exist (eMethods, eTable 1). An increase in PAM13-D scores between T0 and T1 was correlated with a reduction in risk factors and total cholesterol concentrations (eMethods, eTable 2).
Qualitative responses from patients and primary care physicians
We report our qualitative results only briefly here as they will be published in greater detail elsewhere. 34 patients in the A+D group answered most of the free-text questions on the evaluation of the DECADE brochures.
The overwhelming majority of these rated the clear presentation, the content of the information and its comprehensibility, as well as the design of the DECADE brochures as positive and reported that the brochures motivated them to keep an eye on their own health behaviors in the long term. 25 patients were altogether (very) satisfied with the DECADE brochures and four patients partly satisfied. One patient was dissatisfied.
Doctors’ opinions on the brochures were more divergent and were, among others, shaped by their own expectations of their patients’ willingness to modify their behaviors and adherent processing of the materials. They were under the impression that the uptake and processing of information, as well as the willingness to engage in self-management, depended more on the individual patient and less on the materials made available. Overall, primary care physicians rated the structured follow-up consultations as positive.
The positive course of the study and patients’ positive ratings of the consultations and the DECADE brochures showed that the intervention DECADE is feasible in general practice. The use of the DECADE brochures, in addition to structured follow-up consultations, had an amplifying effect on patient activation (PAM13-D + 3.3 points, 95% CI: [0.47; 6.14], p = 0.023).
Several studies showed that high PAM13-D scores were associated with positive health behaviors and willingness to modify behaviors (7, 8, 26, 27). A study including 4865 patients with chronic disorders showed a gain in patient activation of 2.8 points on the PAM13-D scale. This was regarded as a remarkable score since improved health behaviors can be expected (7). The exploratory analyses of the DECADE pilot study partly support this finding. In the entire sample (independently of the study arm), an association was observed between increased PAM13-D scores and a reduction in risk factors and cholesterol concentrations.
Results from individual studies give rise to the assumption that changes in patient activation are associated with the duration and intensity of individually tailored patient care. Merely making available information materials did not increase patient activation in a study reported by Boyle et al. (28). By contrast, Hibbard et al. showed in a study of 357 patients with chronic disorders that tailoring their care increased PAM13-D scores after two to three months by +2.5 points versus 1.8 points compared with usual care. After a further three months, the scores rose by +4.6 points versus +2.6 points (29). Further studies have shown similar results (26, 30).
A higher proportion of patients in the A+D group said that at the end of the study they were “living generally more healthily” (55.9% versus 43.2%) and rated their health status (EQ-VAS) after four months tendentially as better than those in the A group (+6.84 points versus +1.05 points). Further secondary endpoints such as goal attainment (adapted goal attainment scale) and satisfaction with this, the usefulness of patient information materials (USE), and satisfaction with the consultations scored slightly better in the A+D group than in the A group. The clinical parameters of the two groups differed to a negligible degree.
Because of the pilot character of this study, the sample size was small (n = 87). Six primary care practices participated, which meant that we were able to realize a two-arm study only, so that the intervention was not compared with routine care. It was not possible to blind the study nor the scientists involved (eMethods). Some questionnaire instruments were newly developed for this study, or existing ones were adapted. Their validity is therefore limited.
Our findings on patient activation (primary endpoint) were based on patients’ self-reported information, and scores were higher at the start of the study (mean value 88.2) than in other studies (means between 61.2 and 67.2 points) (31). Since patients were consecutively included (study protocol ), it is fair to assume that our subjects differed from the patients of other doctors. One reason for this might be that only primary care physicians from teaching practices with a great interest in the topic of cardiovascular diseases participated in the study. It is possible that patients in such practices are better informed about the relevance of adequate health behaviors than is usually the case. If this is indeed so, the additional rise in the PAM13-D scores in the A+D group should be interpreted even more positively.
As in all surveys, it can be assumed in this study that social desirability has an influence on the self-reported information, as do expectations associated with the study. Even though we cannot report the qualitative results of the study in detail here, we can say in sum that patients in the A+D group rated the DECADE brochures as mostly very positive in their free-text responses. By comparison, the primary care physicians responded in a clearly more differentiated fashion in the interviews. The structure follow-up consultations were rated positively by both primary care physicians and patients.
The DECADE pilot study was conducted successfully. It showed that structured consultations in the primary and secondary prevention of cardiovascular diseases were rated positively by primary care physicians and patients, and that the DECADE brochures increased patient activation. Relevant effects on clinical parameters were not seen, however. These results should now be tested in a study with a longer intervention period in different regions of Germany and in comparison with usual care. If successful it would make sense to implement DECADE in routine healthcare service provision. Until that is the case, primary care physicians should determine cardiovascular risk in at-risk patients, discuss evidence-based treatment options, and show a sustained interest in their patients’ health behaviors.
We thank all patients and practice teams that participated in the DECADE pilot study. We thank Britta Seifer and Inna Shara for their administrative support and data entry.
The study received ethics approval from the ethics committee at the Albert Ludwig University Freiburg and was registered with the German Clinical Trials Register (DRKS) on 7 July 2016: DRKS00010584.
Conflict of interest statement
Dr. Maun is a board member of the Arriba cooperative and holds shares in the cooperative, which supports the maintenance and further development of the software used in the study.
The other authors declare that they have not received any support from commercial organizations relating to this study or intervention. They also declare that no other conflict of interest exists.
Manuscript received on 21 December 2017, revised version accepted on 12 April 2018.
Translated from the original German by Birte Twisselmann, PhD.
Iris Tinsel, M.A.
Elsässer-Str. 2m, 79110 Freiburg, Germany
health treatment or screening decisions. Cochrane Database Syst Rev 2017: CD001431 CrossRef
Clinical Trials Unit, Medical Center—University of Freiburg, Faculty of Medicine: Claudia Schmoor, Ph.D., Inga Poguntke, M.Sc.
Institute of Occupational Medicine, Social Medicine and Health Services Research, University Hospital Tübingen: Dr. phil. Achim Siegel, MPH
Section of Health Care Research and Rehabilitation Research, Medical Center—University of Freiburg, Faculty of Medicine: Iris Tinsel, M.A., Dr. Andy Maun, PhD
Primary care group practice, Titisee-Neustadt: Prof. Dr. med. Wilhelm Niebling
|1.||World Health Organisation (WHO): Cardiovascular diseases. www.euro.who.int/en/health-topics/noncommunicable-diseases/cardiovascular-diseases (last accessed on 16 May 2018).|
|2.||Federal health reporting: Most frequent diagnoses in percent of all cases of treatment in medical practices in the region North Rhine (2015). www.gbe-bund.de/oowa921-install/servlet/oowa/aw92/dboowasys921. xwdevkit/xwd_init?gbe.isgbetol/xs_start_neu/&p_aid=i&p_aid=15988 906&nummer=638&p_sprache= ‧D&p_indsp=-&p_aid=19947716 (last accessed on 8 May 2017).|
|3.||Ludt S, Angelow A, Baum E, et al.: Hausärztliche Risikoberatung zur kardiovaskulären Prävention. S3-Leitlinie. Deutsche Gesellschaft für Allgemeinmedizin und Familienmedizin (DEGAM) 2017. www.degam.de/degam-leitlinien-379.html (last accessed on 21 December 2017).|
|4.||Kelly MP, Barker M: Why is changing health-related behaviour so difficult? Public Health 2016; 136: 109–16 CrossRef MEDLINE PubMed Central|
|5.||Schmitz R, Jordan S, Muters S, Neuhauser H: Population-wide use of behavioural prevention and counselling programmes for lifestyle-related cardiovascular risk factors in Germany. Eur J Prev Cardiol 2012; 19: 849–56 CrossRef MEDLINE|
|6.||Hibbard JH, Mahoney ER, Stockard J, Tusler M: Development and testing of a short form of the patient activation measure. Health Serv Res 2005; 40: 1918–30 CrossRef MEDLINE PubMed Central|
|7.||Hibbard JH, Greene J, Shi Y, Mittler J, Scanlon D: Taking the long view: how well do patient activation scores predict outcomes four |
years later? Med Care Res Rev 2015; 72: 324–37 CrossRef MEDLINE
|8.||Sacks RM, Greene J, Hibbard J, Overton V, Parrotta CD: Does patient activation predict the course of type 2 diabetes? A longitudinal study. Patient Educ Couns 2017; 100 1268–75 CrossRef MEDLINE|
|9.||Neuner-Jehle S, Schmid M, Gruninger U: [Short time counseling in medical practice for improving health behaviour: problems and solutions]. Praxis 2014; 103: 271–7 CrossRef CrossRef MEDLINE|
|10.||Geense WW, van de Glind IM, Visscher TL, van Achterberg T: Barriers, facilitators and attitudes influencing health promotion activities in general practice: an explorative pilot study. BMC Fam Pract 2013; 14–20 CrossRef|
|11.||von Poellnitz PB: [Implementation of shared decision making in ‧general practice: experiences of doctors during in a study with hypertensive patients]. Freiburg in Breisgau. Medical dissertation. Medical Center – University of Freiburg, Faculty of Medicine 2014. freidok.uni-freiburg.de/data/9695 (last accessed on 21 December 2017).|
|12.||Lager KE, Mistri AK, Khunti K, Haunton VJ, Sett AK, Wilson AD: Interventions for improving modifiable risk factor control in the secondary prevention of stroke. Cochrane Database Syst Rev 2014: CD009103 CrossRef|
|13.||Fleig L, Pomp S, Schwarzer R, Lippke S: Promoting exercise maintenance: how interventions with booster sessions improve long-term rehabilitation outcomes. Rehabil Psychol 2013; 58: 323–33 CrossRef MEDLINE|
|14.||Pimouguet C, Le Goff M, Thiebaut R, Dartigues JF, Helmer C: Effectiveness of disease-management programs for improving diabetes |
care: a meta-analysis. CMAJ 2011; 183: E115–27 CrossRef MEDLINE PubMed Central
|15.||Tinsel I, Siegel A, Schmoor C, Buchholz A, Niebling W: DECADE-pilot: decision aid, action planning, and follow-up support for patients to reduce the 10-year risk of cardiovascular diseases-a protocol of a randomized controlled pilot trial. Pilot Feasibility Stud 2017; 3: 32 CrossRef MEDLINE PubMed Central|
|16.||Elwyn G, Frosch D, Thomson R et al.: Shared decision making: a model for clinical practice. J Gen Intern Med 2012; 27: 1361–7 CrossRef MEDLINE PubMed Central|
|17.||Stacey D, Légaré F, Lewis K, et al.: Decision aids for people facing |
health treatment or screening decisions. Cochrane Database Syst Rev 2017: CD001431 CrossRef
|18.||Schwarzer R: Modeling health behavior change: how to predict and modify the adoption and maintenance of health behaviors. Applied Psychology 2008; 57: 1–29 CrossRef|
|19.||Krones T, Keller H, Sonnichsen A, et al.: Absolute cardiovascular disease risk and shared decision making in primary care: a randomized controlled trial. Ann Fam Med 2008; 6: 218–27 CrossRef MEDLINE PubMed Central|
|20.||Brenk-Franz K, Hibbard JH, Herrmann WJ, et al.: Validation of the German version of the patient activation measure 13 (PAM13-D) in an international multicentre study of primary care patients. PLoS One 2013; 8: e74786 CrossRef MEDLINE PubMed Central|
|21.||Siegel A, Stößel U, Zerpies E: GEKIM- Gesundes Kinzigtal. Mitgliederbefragung 2012/2013. Medizinische Psychologie und Medizinische Soziologie, Albert-Ludwigs-Universität Freiburg 2013; 94.|
|22.||Frey C, Bührlen B, Gerdes N, Jäckel W: Handbuch zum IRES-3. Indikatoren des Reha-Status, Version 3 mit IRES-24 (Kurzversion). Regensburg: Roderer 2007.|
|23.||Oemar M, Oppe M: EQ-5D-3L User guide. Basic information on how to use the EQ-5D-3L instrument. www.euroqol.org/wp-content/uploads/2016/09/EQ-5D-5L_UserGuide_2015.pdf (last accessed on 21 December 2017).|
|24.||Schaefer I, Kolip P: Leitfaden Goal Attainment Scaling (Zielerreichungsskalen). Universität Bilefeld 2015. www.uni-bielefeld.de/gesundhw/ag4/GAS_Leitfaden.pdf (last accessed on 21 March 2018).|
|25.||Hölzel LP, Ries Z, Dirmaier J, et al.: Usefulness scale for patient information material (USE)—development and psychometric properties. BMC Med Inform Decis Mak 2015; 15: 34 CrossRef MEDLINE PubMed Central|
|26.||Fowles JB, Terry P, Xi M, Hibbard J, Bloom CT, Harvey L: Measuring self-management of patients‘ and employees‘ health: further validation of the patient activation measure (PAM) based on its relation to employee characteristics. Patient Educ Couns 2009; 77: 116–22 CrossRef MEDLINE|
|27.||Hibbard JH, Greene J: What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff 2013; 32: 207–14 CrossRef MEDLINE|
|28.||Boyle F, Mutch A, Dean J, Dick M, Del Mar C: The contribution of consumer health organisations to chronic disease self management in the context of primary care. Canberra: Australian Primary Health Care Research Institute 2009. www.researchgate.net/publication/46422100_The_Contribution_of_Consumer_Health_Organisations_ to_Chronic_Disease_Self_Management_in_the_Context_of_Primary_Care (last accessed on 21 December 2017).|
|29.||Hibbard JH, Greene J, Tusler M: Improving the outcomes of disease management by tailoring care to the patient‘s level of activation. Am J Manag Care 2009; 15: 353–60 MEDLINE|
|30.||Hibbard JH, Mahoney ER, Stock R, Tusler M: Do increases in patient activation result in improved self-management behaviors? Health Serv Res 2007; 42: 1443–63 CrossRef MEDLINE PubMed Central|
|31.||Rademakers J, Maindal HT, Steinsbekk A, Gensichen J, Brenk-Franz K, Hendriks M: Patient activation in Europe: an international comparison of psychometric properties and patients‘ scores on the short form Patient Activation Measure (PAM-13). BMC Health Serv Res 2016; 16: 570 CrossRef MEDLINE PubMed Central|