The impact of a patient web communication intervention on reaching treatment suggested guidelines for chronic diseases: A randomized controlled trial☆
Introduction
Chronic diseases (CD) are a major health challenge for primary care in the 21st century [1], [2] and result in significant morbidity, mortality and healthcare costs [3], [4], [5], [6]. Some of this burden is preventable through proper disease management. The Chronic Care Model describes a systems-based approach toward improving health outcomes [7], [8], [9] and reducing the care gap between optimal and actual care [10]. This model speaks to the importance of productive interactions between health care providers and informed, activated patients.
Patient activation is defined as having the knowledge, skills and confidence to manage one's health [11], [12], [13], [14], [15]. Activated patients show better self-management behaviors [13], [14], [16], [17]. Studies promote patients’ active role in their care through self-management interventions [12], [18], [19].
Patient activation and self-management as defined go beyond the clinical encounter and into the daily lives of patients. Communication researchers are interested in patient participation, communication behaviors within the clinical encounter [20], [21], [22]. Patient participation within consultations has been defined as encompassing four components: information seeking (asking questions and checking understanding), assertive utterances, information provision, and expressing concern [21], [23], [24], [25].
Street et al.’s model of “how communication heals” posits that clinician-patient communication processes are related to health outcomes, through direct and indirect pathways [22], [26]. The PACE (Prepare, Ask, Check, Express) training approach [20], [27] is one way to improve physician–patient communication and patient participation [21], [28], [29]. However, limited studies targeting physician–patient communication have examined physiological values such as glycated hemoglobin (HbA1c), systolic and diastolic blood pressure (SBP and DBP), and lipid profiles such as low-density lipoprotein (LDL) and total-cholesterol/high-density lipoprotein (TC/HDL).
Systematic reviews relating to the question of clinician-patient communication and health outcomes demonstrate that few studies have a positive impact on these health outcomes [30], [31], [32], [33], [34], [35], [36], [37]. A recent meta-analysis, performed by Schoenthaler and colleagues [33], examined the impact of communication interventions on cardiovascular risk factors. Fourteen studies were included and only four found positive results. Out of the seven studies targeting patients, only two yielded significant results, one of which belonged to the oft cited studies by Greenfield et al. [38], [39]. These studies consistently appear as the exceptions in most systematic reviews examining the question of communication and outcomes. The Greenfield studies have particular characteristics that set them aside from most primary care (PC) communication studies. Firstly, their sample was recruited from specialized diabetes clinics. Eighty percent of patients were taking insulin and their baseline HbA1c was above 10%. They showed that a 20 min intervention promoting patient question asking and information-seeking skills, delivered in the waiting room, decreased HbA1c by 1.53%, an enormous difference considering mean changes in meta-analyses of self-management interventions range between 0.2 and 0.4% [12], [40], [41], [42].
Like the Greenfield studies, most interventions that aim to train patients on how to communicate within the medical encounter involve coaching by staff or other health care providers and are delivered immediately prior to consultations [31], [33]. Even if these interventions were to prove successful, they may not be feasible in resource scarce health care systems.
Therefore, health care interventions are increasingly being delivered through the web [43] and studies examining self-management and self-monitoring through web interventions have shown that they improve health outcomes [41], [44], [45], [46], [47], [48] and are just as effective as face-to-face or paper interventions [49], [50]. However, interventions delivered through the web are heterogeneous and multidimensional. Determining which aspects of these interventions are responsible for changes in self-management is difficult. Although one crucial aspect of these interventions is the promotion of improved communication between providers and patients [48], interventions specifically targeting patient participation have rarely been delivered through the web.
One of the possible critiques regarding this mode of intervention is that they do not provide experiential learning. A solution would be to add workshops to a web intervention [51].
The objective of this paper is to examine the impact of a PACE inspired web-based communication intervention alone or combined with a workshop, on reaching suggested treatment goals for health outcomes in primary care (PC) patients, as compared to usual care. Specifically, we examined patients suffering from hypertension, type II diabetes and/or dyslipidemia who did not meet treatment goals. We hypothesize that our two interventions will lead to a greater proportion of patients meeting treatment goals as compared to usual care. We report here on a planned secondary outcome of the original study, for which the primary outcome was physician–patient communication [52].
Section snippets
Study design
Patients were prospectively randomized using a 1:1:1 allocation into (a) usual care (UC), (b) e-Learning (e-L) or (c) e-Learning + workshop (e-L + W). Because the intervention targeted patients, and not physicians, patients were chosen as the unit of randomization, similar to most patient interventions conducted at the time of protocol elaboration [39], [53], [54]. The clinical trial, NCT00879736, was registered with ClinicalTrials.gov and the protocol received ethics approval from the Ontario
Physician description
The 18 participating PCPs were on average 51.2 (SD = 6.85) years old, predominantly male (14/18) and in practice for a mean of 25.2 (7.02) years (min/max: 15–39). A majority of these physicians worked in group practices (11/18) and saw a mean 4.5 (SD = 1.3) patients per hour (min–max: 2.5–8.0). Each physician contributed an average of 12.4 (SD = 7.1) patients to the study (min-max: 1–23). Physicians indicated no change to medication regimens in over 70% of off-target cases, with no differences
Discussion
This randomized control trial showed that a web-based communication intervention positively impacts reaching treatment targets for primary care patients. We focused on a patient population not often included in communication studies. Specifically our intervention was aimed at “non at target” chronic disease patients with hypertension, type II diabetes and/or dyslipidemia.
Patients who received the web intervention were more likely to be within guidelines as compared to patients who received
Contributors
MTL and CR designed the study. As principal investigators, they contributed to the planning and conduct of the study. They both supervised the data analyses and their interpretation. They contributed to the writing and reviewing of the manuscript. MTL was EG Master's thesis supervisor and overlooked EG's work on the study's dataset. EG updated the literature review, conducted the statistical analyses and contributed significantly to the interpretation of the data. EG wrote the first draft of
Funding
This project was sponsored by Astra Zeneca Canada. EG received two University of Montreal, Faculty of medicine summer research grants, an excellence grant from the University of Montreal Faculté des Études Supérieures, and a Fonds de recherche en santé du Québec (FRQS) grant for her ongoing masters’ degree (#31387).
Disclaimer
The sponsor had no role in the analysis and interpretation of data; in the writing of the report; and in the decision to submit the paper for publication.
Ethics approval
The protocol received ethics approval from the Ontario (Canada) Institutional Review Board using IRB Services, which allowed central ethics approval for all sites. The project also received ethics approval by the CERES committee at the University of Montreal.
Competing interests
MTL and CR were reimbursed for out of town study meetings as well as the travel expenses related to these meetings and to presentations of study results at various international conferences. CR also received honoraria for his work on the study protocol and the analyses of the data.
Acknowledgments
We would like to thank Dr. Janusz Kaczorowski for his methodological guidance and Dr. Perle Feldman for her helpful editing of this manuscript. Both of them were a great source of support throughout this project.
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ClinicalTrials.gov trial number: NCT00879736.