The Effect of Telemonitoring in CHF patients
Evidence Based Practice Project
Sacred Heart University

The Effect of Telemonitoring in CHF Patients
Evidence Based Practice Project

Question (PICOT)
Question: In elderly individuals over the age of 65, does the use of a mobile phone-based medication adherence application, compared to a mobile phone texting reminder, increase medication compliance by 25%, within 12 weeks of implementing the program?
Evidence Appraisal
Matrix
Source (APA) | Type of Study design (RCT, phenomenology, etc.)/Purpose | Level of Evidence(According toMelnyk & Fineout-Overholt) | Sample, settingInclusion/ExclusionCriteria | Methods, instruments, data analysis | Findings/Implications | Inglis, S. C. (2011). Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database Of Systematic Reviews, (6), doi:10.1002/14651858.CD007228.pub2 | Systematic Review | Level I | Twenty-five studies and five published abstracts were included. 16 evaluated structured telephone support, 11 evaluated telemonitoring, and two tested both interventions. Inclusion criteria:only peer reviewed, published RCTs comparing structured telephone support or telemonitoring to usual care of CHF patients were included. | Various search engines such as: MEDLINE, EMBASE, CINAHL, and AMED were searched from 2006 to November 2008.Relevant studies and systematic reviews and abstract conference proceedings were hand searched. No language limits were applied. | Telemonitoringreduced all-cause mortality (RR 0.66, 95% CI 0.54 to 0.81, P < 0.0001) with structured telephone supportBoth structured telephone support (RR 0.77, 95% CI 0.68 to 0.87, P < 0.0001) and telemonitoring (RR 0.79, 95% CI 0.67 to 0.94, P = 0.008) reduced CHF-related hospitalization. | Antonicelli, R., Mazzanti, I., Abbatecola, A., & Parati, G. (2010). Impact of home patient telemonitoring on use of β-blockers in congestive heart failure. Drugs & Aging, 27(10), 801-805. doi:10.2165/11538210-000000000-00000 | Randomized control trial | Level II | A total of 57 patients with CHF including 33 males and 24 females. Mean age of 78.2. Randomized to a control group (n=28) who received standard care based on routinely scheduled clinic visits from a team specialized in CHF patient management, or to a home telemonitoring group (n=29) managed by the same specialized CHF team. | Patients in the control group were contacted monthly by telephone to obtain data on new hospital admissions, cardiovascular complications and death. Seen routinely in the clinic once every 4 months.In the TM group, patients were contacted by telephone at least once a week by the CHF team in order to obtain information on symptoms and adherence. Also to obtain (1) blood pressure, (2) heart rate, (3) bodyweight, (4) 24-hour urine output data for the previous day, and (5) a weekly ECG transmission. Patients were followed up over 12 months. | The 12-month occurrence of the primary combined endpoint of mortality and hospital re-admission for CHF was significantly lower in the TM group than in the control group (p<0.01).Home telemonitoring of relevant clinical parameters are beneficial and can play a significant role in management of patients with CHF. Larger studies are required to confirm these findings. | Scherr, D., Kastner, P., Kollmann, A., Hallas, A., Auer, J., Krappinger, H., & ... Fruhwald, F. (2009). Effect of home-based telemonitoring using mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation: randomized controlled trial. Journal Of Medical Internet Research, 11(3), e34. doi:10.2196/jmir.1252 | Randomized control trial | Level II | 120 patients (85 male, 35 female) with a median age of 66 years were randomized. 54 patients in the control group (IQR 61-72) and 66 patients were randomized to the tele group (IQR 62-73).Inclusion criteria:-Acute worsening of heart failure with hospital admission lasting greater than 24 hours within the last 4 weeks -Received treatment according to the guidelines of the European Society of CardiologyExclusion criteria:-unstable coronary artery disease with revascularization within the last 6 months, planned revascularization (percutaneous or surgical) for coronary artery disease, planned heart valve surgery, planned or completed heart transplantation, uncontrolled arterial hypertension, acute myocarditis, inability to read the display of a handheld phone, or malignancy | The tele group was equipped with mobile phone-based terminals for data acquisition and data transmission to the monitoring center.Study physicians had continuous access to the data via a secure Web portal. An email alert would be sent by physicians if transmitted values went outside individually adjustable borders. | Tele group patients who were hospitalized for worsening heart failure during the study had a significantly shorter length of stay (median 6.5 days, IQR 5.5-8.3) compared with control group patients (median 10.0 days, IQR 7.0-13.0; P= .04).Developing an adequate user interface for data acquisition and transmission for elderly patients remains a challenging component of this approach. | Clarke, M., Shah, A., & Sharma, U. (2011). Systematic review of studies on telemonitoring of patients with congestive heart failure: a meta-analysis. Journal Of Telemedicine & Telecare, 17(1), 7-14. | Meta-analysis | Level I | -13 publications were selected to evaluate the effectiveness of telemonitoring on patients with CHF.Inclusion criteria:(1) The studies were randomized controlled trials that included an intervention arm and a control arm at least; (2) The control arm had a clear definition of usual care; (3) The patients only had CHF; (4) The trials had at least 50 patients.Exclusion criteria:(1) There was no specific description of the care provided to patients in the control arm; (2) Only telephone support was used for follow-up, that is, no telemonitoring equipment was used; (3) Patients were not monitored at home, for example those transferred to a residential care facility from hospital. | Two investigators made the primary searches independently. Each researcher reviewed abstracts and full articles independently and publications that did not meet selection criteria were excluded. Independent lists were later combined and arbitration was used to select publications when researchers could not reach an agreement. | Systematic review and meta-analysis allowed for rigorous statistical evaluation on the benefits of using telemonitoring compared to usual care.Pooled estimate results showed that there was an overall reduction in all-cause mortality (P= 0.02). There was no overall reduction in all-cause hospital admission (P= 0.84), although there was a reduction in CHF hospital admission (P= 0.0004).These favorable patient outcomes support the wider use of telemonitoring in patients with CHF. | Smith, A. C. (2013). Effect of Telemonitoring on Re-Admission in Patients with Congestive Heart Failure. MEDSURG Nursing, 22(1), 39-44. | Systematic Review | Level I | 17 papers were included and critically appraised using tools from the Centre for Evidence Based Medicine (2012) and then divided into three categories: systemic reviews (n=5), RCTs and quasi-experimental studies (n=10), and preprocessed papers (n=2).Inclusion criteria:(1) Published or unpublished human research using systematic review, (2) randomized controlled trial (RCT), or (3) observational design.Exclusion criteria:Studies in which electronic transmission of physiologic variables was not specified clearly. | Three electronic databases (CINAHL, PubMed, Google Scholar) and three sources of preprocessed studies (Cochrane Collaborative, Joanna Briggs Institute, DARE database) were examined using selected search terms. No date restrictions or language restrictions were applied. | 25 studies and five abstracts found a statistically significant reduction in CHF-related admissions associated with telemonitoring compared to home self-care (RR 0.79, 95% CI 0.68-0.87, p<0.0001.Telemonitoring has many potential benefits for patients with CHF and may significantly reduce healthcare costs. |

Appraisal of Evidence A Matrix was created to easily appraise the evidence critically and in an organized manner. The matrix includes study information, level of evidence, purpose of the study, type of study, inclusion and exclusion criteria, data information, results, and implications of each study. Of the articles reviewed, there was variation amongst the findings in regards to the interventions. For example, in the study completed by Antonicelli et al. (2010), the researchers assessed the impact of contacting CHF patients in the control group monthly vs. the treatment group who received weekly telephone calls and close follow-up with the team; as compared to the Scherr et al. (2009) randomized control trial that looked at the use of MOBITEL technology to address important issues in the management of heart failure patients and ways to reduce the high risk of re-hospitalization for worsening CHF and how to detect early warning signs of impending decompensation.
The variation in the outcomes across each study analyzed varied somewhat. In the systemic review by Smith (2013) on the effects of telemonitoring on re-admission in patients with congestive heart failure the findings from the studies reviewed were mixed. Several studies found a significant reduction in all-cause re-admissions with telemonitoring while others noted a significant reduction only in CHF-related hospitalizations (p. 40); and furthermore one study-preprocessed paper found home telemonitoring reduced the risk of CHF-related re-admission but not all-cause re-admission of patients with CHF (p. 40).
In more than one study, evidence from randomized-controlled trials of moderate quality suggests that telemonitoring is useful for managing the symptoms of CHF patients, although there is very little evidence to support the effectiveness of mobile phone based applications for elderly patients with a diagnosis of congestive heart failure. The study completed by Scherr et al. (2009) yielded promising results; however, providing elderly patients with an adequate user interface remains a challenging component of such a concept. The findings in most of the studies suggest that telemonitoring in conjunction with nurse home visiting and specialist unit support can be effective in the clinical management of patients with CHF and help to improve their quality of life (Clarke et al, 2011).
Although, the research results across the spectrum are not concrete, some express mild to moderate improvement in medication compliance after interventions such as telemonitoring have been implemented. “Only three studies out of 11 evaluated the effectiveness of telemonitoring on adherence by patients with their treatment and to medication. Cleland et al. and Goldberg et al. reported no significant difference, whereas Antonicelli et al. reported improved compliance with treatment in the telemonitoring group” (Clarke et al, 2011, p. 11). These inconsistencies in the research prompt the need for further exploration and use of technology-based interventions.
Antonicelli et al. (2009) resulted in the most significant findings suggesting a clinically profound effect in the treatment of congestive heart failure with home patient telemonitoring. However, a majority of the studies using telemonitoring reported the need for studies of larger size in order to confirm the findings. Overall, the intervention methods posed no harm to the participants in these studies and helped improve quality of life in patients battling CHF.
The only article identified as being contradictory to the findings that telemonitoring can be used to decrease the risk of re-hospitalization in CHF patients was the systematic review by Smith (2013) on preventable readmissions. One significant missing link was noted in the literature reviewed: none of these studies addressed if any of the re-admissions were considered otherwise preventable, only that they occurred. This was of interest because root causes of re-admission are multi-faceted, and not all readmissions are avoidable or unplanned (p. 41). Although contradictory in nature, Smith (2013) identified a potential flaw in data collection that may have otherwise gone unnoticed.
The following studies are Level I evidence as the articles were systematic reviews or meta-analyses: Clarke et al., Inglis, and Smith. Systematic reviews are considered level I evidence as well as they are integrated from multiple randomized control trials using methodical and strict procedures (Polit & Beck, 2012, p. 27). Two studies were identified as level II evidence and those were Antonicelli et al. and Scherr et al. The randomized control trial is considered level II evidence as RCT’s are “very well suited for drawing conclusions about the effects of health care interventions” (Polit & Beck, 2012, p. 27).
The main consistency found in all of the articles is that telemonitoring is effective in reducing re-hospitalization and improving quality of life for patients with CHF. Of all the articles analyzed, two were clinically significant; these articles, which show the effectiveness of telemonitoring, are Antonicelli et al. and Scherr et al. Each of these studies showed evidence that telemonitoring and close follow-up with the medical team can lead to a beneficially significant reduction in CHF related hospitalizations and improved quality of life. No side effects or harm were associated with these interventions; however, it is important to note that some patients identified in the Scherr et al. (2009) study dropped out immediately after randomization due to inability to handle the telemonitoring equipment and were not included in the final results.
The evidence picture is sufficiently complete as the knowledge that telemonitoring is associated with better patient outcomes is identified in all five articles chosen for this EBP project. The two articles, Scherr et al. (2009) and Antonicelli et al. (2010) clearly defined and stated the interventions, benefits, and specifics in regards to how methods were used to provide psychosocial support and ultimately help prevent further complications associated with congestive heart failure. Despite these compelling results, perhaps not enough evidence is present to adequately answer the PICOT question. Further research is required in this area to develop an integrated care concept that will allow for an optimal combination of telemonitoring tasks into the existing workflows of clinicians.
Implement a Change in Clinical Practice The change to be implemented is to have evidence-based telemonitoring interventions provided for all CHF patients who agree to treatment. The most important aspect of change will begin with the education of clinical staff members through in-services and online classes. The environment to spark a change would be on all cardiac care units with the target population consisting of patients experiencing an acute CHF exacerbation.
The available resources for implementing the change are the nurse administrators, the cardiologists, and all cardiac care nurses. These people would also be the members of the Change Team. The physicians and nurses are the individuals who work in close proximity with these CHF patients and nurse managers have the greatest access to policy change. These clinical staff members have the highest level of expertise and insight on the subject of congestive heart failure, while the administrators have knowledge and experience with implementing practice change and developing policies and procedures.
Change Strategy
EBP Model In order to implement the change successfully, The Model for Evidence-Based Practice Change will be followed. As Melnyk and Fineout-Overholt (2011) explain, the model has six steps to utilize. The steps are to assess the need for change in practice, locate the best evidence, critically analyze the evidence, design practice change, implement and evaluate change in practice, and integrate and maintain change in practice. The objectives, methods, responsibility, completion dates, and measurable outcomes are discussed in the table below, created to develop a change strategy.
Plan
Objective | Method/Plan | Responsibility | Completion/Date | MeasurableOutcomes | To identify patients who are currently experiencing an acute CHF exacerbation. | Perform a physical exam and obtain tests such as: chest x-ray, echocardiogram, and blood work including a BNP level which indicates the severity of heart failure. | The physician responsible for the admission of the patient, and the charge nurse for compiling a list of patients currently experiencing complications from a CHF exacerbation. | 2-month rollout period with adequate teaching on how to identify CHF patients who would benefit most from telemonitoring interventions upon discharge. | The amount of patients currently experiencing an acute CHF exacerbation who agree to telemonitoring education during their hospitalization compared to patients who decline this educational opportunity. | To implement specific interventions as identified by the Change Team. | This would include: education on the telemonitoring equipment, counseling, and recommending pharmacological treatment in collaboration with the physician and nursing staff. | The nurse providing primary care to the patient will implement the education and collaborate with care management to set up any VNA services at the time of discharge. | 1-month should be a sufficient amount of time to identify and implement these interventions. | Weekly phone calls during that 1-month period after discharge should be made to patients in order to closely monitor the progression of their symptoms and answer any questions or concerns they may have regarding the equipment. |

Evaluation Plan

Measurable Outcomes | Method and Tools for Measuring | Responsibility | Timelines | The amount of patients currently experiencing an acute CHF exacerbation who agree to telemonitoring education during their hospitalization compared to patients who decline this educational opportunity. | Using a chart to plot the data over the 2-month rollout period. Comparing the CHF patients agreeable to education and those that are opposed. | Certain members of the Change Team including: the charge nurse and nurse administrators working on these designated cardiac units. | Data collected over 1 month should be sufficient to show trends of CHF patients who agree to education and follow-up could be done to find out why certain patients declined this educational opportunity. | Weekly phone calls during that 1-month period after discharge should be made to patients in order to closely monitor the progression of their symptoms and answer any questions or concerns they may have regarding the equipment. | Graphs plotting the number of patients with improved or worsening symptoms vs. symptoms that remained unchanged from discharge. This will help determine the effectiveness of the pilot program. | Members of the Change Team, specifically those assigned to closely monitor patient progress after discharge. | Preferably, data should be collected over a period of time to show the long-term effectiveness of the intervention. 3 to 6 months of data collection should be feasible for this program. |

Resources A quality improvement measure and intervention study like this project is piloted in the clinical setting, usually several cardiac nursing units, and then disseminated to the entire organization. The initiation and sustainability of the evidence-based practice requires funding to carry out the project. Generally, Medicaid reimbursement and federally funded grants are excellent resources to help initiate and implement evidence-based practice within the first year. Most organizations pay for direct costs required to conduct the study, such as telemonitoring equipment lease or purchase, transmission fees, personnel training, patient education, tech support, and nurse follow-up. An estimated projection of cost per unit would be between $180,000 and 200,000 dollars, which requires an initial financial investment for these facilities. However, it will substantially reduce costs in the long term by reducing frequent readmissions for CHF related events. Ideally, evidence-based practice initiates in a profit organization, rather a Magnet status organization with the aid of foundation grants. These particular organizations encourage and support the need for evidence-based practice, projecting lower costs to sustain practice changes over an extended period of time.
Conclusion
In conclusion, the evidence-based practice question pertaining to telemonitoring interventions for patients with CHF delineated minimal conclusive evidence supporting the effectiveness of this particular treatment. From the literature and research studies reviewed, it was found that telemonitoring interventions have been moderately effective in the management of congestive heart failure symptoms in elderly individuals. It is very evident that further research is necessary to establish a combined benefit of telemonitoring and close follow-up with the medical team. Future research should include larger studies to gain more knowledge and determine what works best for patients upon discharge from an acute care setting. Also, in the future, specific policies and procedures will be in place to assist clinicians in knowing which CHF patients would benefit most from home telemonitoring and how long to implement this intervention.

References
Antonicelli, R., Mazzanti, I., Abbatecola, A., & Parati, G. (2010). Impact of home patient telemonitoring on use of β-blockers in congestive heart failure. Drugs & Aging, 27(10), 801-805. doi:10.2165/11538210-000000000-00000
Clarke, M., Shah, A., & Sharma, U. (2011). Systematic review of studies on telemonitoring of patients with congestive heart failure: a meta-analysis. Journal Of Telemedicine & Telecare, 17(1), 7-14.
Inglis, S. C. (2011). Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database Of Systematic Reviews, (6), doi:10.1002/14651858.CD007228.pub2
Melnyk, B.M., & Fineout-Overholt, E. (2011). Evidence-based practice in nursing and health care: A guide to best practice (2nd ed.). Philadelphia, PA: Lippincott Williams and Wilkins.
Polit, D.F. & Beck, C. T. (2012). Nursing Research: Generating and Assessing Evidence for Nursing Practice (9th ed.). Philadelphia, PA: Lippincott Williams and Wilkins.
Scherr, D., Kastner, P., Kollmann, A., Hallas, A., Auer, J., Krappinger, H., & ... Fruhwald, F.
(2009). Effect of home-based telemonitoring using mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation: randomized controlled trial. Journal Of Medical Internet Research, 11(3), e34. doi:10.2196/jmir.1252
Smith, A.C. (2013). Effect of telemonitoring on re-admission in patients with congestive heart failure. MEDSURG Nursing, 22(1), 39-44.

Grading Rubric for Part 1 of EBP Paper Criteria | Points Earned | Comments | PICOT Question (5 pts.) | | | Evidence Matrix (10 pts.) | | | Evidence Appraisal – address each criterion in the guidelines (20 pts.) | | | Implement a Change in Clinical Practice – identify available resources, stakeholders, members of change team (10 pts.) | | | Change Strategy:EBP Model with rationale (10 pts.) | | | Change Strategy: Plan -using table in guidelines (10 pts.) | | | Evaluation of Plan –using table in guidelines (10 pts.) | | | Resources – cost of equipment, personnel, estimated savings (5 pts.) | | | Conclusion (5 pts.) | | | APA/Grammar/Spelling/Organization/Writing Style – title and reference page (15 pts.) | | | TOTAL 100 pts. | | |