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Journal of Cardiovascular Nursing:
doi: 10.1097/JCN.0b013e31824b2105
Articles

The Development, Refinement, and Psychometric Testing of the Attitude Toward Advanced Directive Survey in Implantable Cardioverter Defibrillator Patients

Conelius, Jaclyn PhD, FNP-BC

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Author Information

Jaclyn Conelius, PhD, FNP-BC Assistant Professor, School of Nursing, Fairfield University, Connecticut.

The author has no funding or conflicts of interest to disclose.

Correspondence Jaclyn Conelius, PhD, FNP-BC, School of Nursing, Fairfield University, 1078 North Benson Rd, Fairfield, CT 06824 ( jconelius@fairfield.edu).

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Abstract

Implantable cardioverter defibrillators (ICDs) have been the treatment of choice for those who experienced or are at risk of sudden cardiac arrest. Many patients who receive these devices experience progressive comorbid and cardiac conditions and may not want the additional survival provided by an ICD. Clinicians will need to counsel patients and families about advanced directives when their ICD is no longer beneficial, to prevent unnecessary suffering near the end of life. The Attitude Towards Advanced Directive Survey was developed to assess patients’ level of knowledge and identify the barriers that prevent them from completing advanced directives. This will help clinicians promote completion of advanced directives by addressing barriers and increasing knowledge of them. The purpose of this study was to develop and evaluate the psychometric properties of the survey and investigate reliability and validity from its use among ICD patients. A convenience sample of 200 patients who have an ICD participated in this study. Psychometric testing of the Attitude Towards Advanced Directive Survey provided evidence to support the validity and reliability of the survey. Moderate to strong factor intercorrelations and conceptual meaningfulness led to the combination of 5 factors. The 5 factors were as follows: factor 1: communication barriers; factor 2: informed confidence; factor 3: timing of discussion; factor 4: patient-family relationship; and factor 5: patient-provider relationship. Reliability coefficient α ranged from .67 to .95 for the factors and .75 for the total scale. Stability reliability of the survey was analyzed through test-retest of the survey, with a response rate of 34% (n = 68), and revealed a significant positive correlation (r = .62; P < .001) between the first and second testing. The participants reported communication barriers and demonstrated poor understanding of their medical condition/treatments and were not comfortable discussing advanced directives with their families. They preferred to discuss advanced directives when they were first diagnosed and at every office visit because they felt more comfortable discussing advanced directives with their healthcare provider. This survey has the potential to be used in clinical practice and future research.

In the United States, approximately 350 000 people die of malignant ventricular arrhythmias.1,2 Malignant ventricular arrhythmias can be attributed to many causes such as congestive heart failure, coronary artery disease, valvular heart disease, and cardiomyopathies.3 Implantable cardioverter defibrillators (ICDs) have been the treatment of choice for patients at risk of these arrhythmias. Since increased advanced technology is being made available through supporting clinical trials, ICD therapy is recommended for primary and secondary prevention.4–10 Defibrillator therapy alone reduces the incidence of sudden cardiac death, but when combined with resynchronization therapy, it improves symptoms, exercise capability, and systolic function.8–10 It is because of this improvement that patients with ICDs are more likely to die of other causes, such as cancer, lung disease, and progressive heart failure. Many patients who receive these devices experience progressive comorbid and cardiac conditions, which may significantly decrease their quality of life.2 Many of these ill and incapacitated patients may not want the additional survival provided by an ICD and would like the therapy withdrawn. The procedure to deactivate the device is simple and painless.11,12 Clinicians will need to counsel patients and families about advanced directives when their ICD is no longer beneficial, to prevent unnecessary suffering near the end of life. An advanced directive can be the document that will state patients’ wishes when their quality of life is no longer acceptable to them.

Advanced directives are specific instructions, prepared in advance, intended to direct a person’s medical care in the event he/she is unable to do so in the future.13 These instructions allow the healthcare provider to expedite patients’ wishes when they are not able to do so themselves. However, advanced directives are not always available.14 The Patient Self-determination Act of 1991 required that healthcare institutions give patients information about advanced drectives.13 Fewer than 1 in 4 patients admitted to hospitals actually have completed an advanced directive.15,16 Not having this information can delay care and/or cause suffering at the end of a patient’s life.17,18 Healthcare providers need to understand and assess what patient knowledge is lacking regarding advanced directives and which barriers the patient feels are preventing him/her from completing one.19 A survey to assess a patient’s level of knowledge and barriers that prevent him/her from completing advanced directives would be time saving and informative to the healthcare provider. However, there is limited available information regarding the ICD patient population and advanced directive implementation and use.20 This survey can be time saving for the clinician and included in the patient’s regular follow-up when he/she is seen in an office or clinic environment. Instead of avoiding the subject of advanced directives, this survey assessment would prompt healthcare providers to not only remember to discuss advanced directives but also have a guide as to what to address during their visits with the patient.21,22 The purpose of this study was to develop and evaluate the psychometric properties of the Attitude Towards Advanced Directive Survey and investigate the reliability and validity from its use among ICD patients. This instrument was proposed to assess the knowledge of the preferences, barriers, and understanding that ICD patients have regarding advanced directives to complete one.

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Method

The methodological design of this study was completed in 3 phases. Phase 1 included the development stage of the instrument and an assessment of content validity. During phase 2, the instrument was administered to a sample of 218 participants to determine the psychometric properties of the survey regarding construct validity of data interpretations and the internal consistency and reliability of the obtained data. Phase 3 consisted of a follow-up administration of the survey 2 weeks later to examine the test-retest reliability of the scores.

The setting for the research was the Greater Fairfield County, Connecticut, area. The participants in the study were sampled and recruited through a cardiology office with the permission of the chief electrophysiologist. Participation in the study was open to all patients who were willing to participate and who met the inclusion criteria, which included (1) older than 18 years, (2) have an ICD, and (3) English speaking. The sample did not restrict when the ICD was placed. The sample for this study included patients who (1) met the inclusion criteria and (2) consented to complete the questionnaire after reading the information cover page.

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Ethical Considerations and Data Collection

Before beginning the study, the proposal was submitted to and approved by the University of Connecticut Internal Review Board. Each participant received an information sheet, the demographic sheet, and the Attitude Towards Advanced Directive Survey. The information sheet included a brief description of the purpose of the study and who was included in the study and an explanation that there was no harm or risk associated with participation, that the study was completely voluntary, and that participants may quit at any time. The process of reading the information sheet and completing the anonymous survey indicated consent to participating in the survey. Two weeks after the completion of the survey in the office, patients received a second survey by mail.

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Content Validity

The examination of content validity was concerned with item content sampling sufficiency. The items selected for the questionnaire were derived from relevant quantitative and qualitative research. The literature reviewed yielded 3 major themes.13,15–25 The themes that emerged included (a) knowledge/understanding of advanced directives, (b) personal preferences of advanced directives, and (c) barriers to completing an advanced directive. Barriers to completing advanced directives included (a) lack of support and (b) lack of resources from family and healthcare providers. Items were written in clear, brief sentences. The use of multiple ideas was avoided in all of the items to avert confusion. A 5-point Likert-type response survey was used to allow participants to discriminate among response options. The participants were asked to indicate their degree of disagreement or agreement on a range from 1 (strongly disagree) to 5 (strongly agree).

The preliminary survey consisted of 30 items. This was given to a pool of 7 experts to be reviewed and returned to the primary investigator with their comments. Expertise of the panel represented multiple disciplines that encompassed areas such as research, industry, psychology, nursing, and medicine. They all received a cover page that included the purpose of the research, the reason for choosing each expert, and the utility of the instrument. The definition of each of the domains was included to increase consistency. All of the experts reviewed the survey and returned it to the primary investigator with their comments. The whole survey was reviewed for consistency, content, and clarity. Based on their suggestions, 10 items were deleted and 5 items were reworded. For example, item 11 was reworded to include the wording “I am aware of and understand what a living will and durable power of attorney is”; before the panel’s suggestions, “durable power of attorney” was not included. In addition, item 1, “I believe I fully understand my cardiac condition,” did not contain the word “fully.” The items that were deleted were done so because of repetitiveness and not content. For example, there were several items that asked whether patients understood their medical condition and treatments. There were no additional items added.

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Construct Validity

Of the 218 surveys collected, 18 were excluded from analysis because of incompleteness. The final sample consisted of 200 participants. Most of the sample was male (76%, n = 152). Participants who fell within the age group of 70 to 80 years accounted for 33.5% (n = 67) of the sample, and only 15 participants (7.5%) were younger than 50 years old. Most of the sample (83.5%, n = 167) were white, and the highest percentage were Catholics (46%, n = 92). Of the participants, 55% had completed a high school degree and 30% (n = 60) completed a college degree. The sample represented a large number of married persons (67%, n = 134), who had children (84.5%, n = 169). Most of the participants felt that their current health condition was “good” (49.5%, n = 99). Demographics are summarized in Table 1.

Table 1
Table 1
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Exploratory factor analysis was performed because the scale was in the early stages of development. The Statistical Package for Social Science program version 16.0 was used to analyze data.26 Exploratory factor analysis was used on the sample (n = 200) to explore the underlying dimensions of the construct of the Attitude Towards Advanced Directive Survey.

The statistical data reduction used was principal axis factoring. The varimax and oblimin (oblique) rotation of each of these methods revealed that the oblimin rotation yielded the most meaningful factor solution. The oblimin solution revealed a factorial structure that was the most consistent of the study’s conceptualization with regard to the Attitude Towards Advanced Directive Survey. Some of items did double load on factors; however, the secondary loadings were weak (<0.35). Therefore, when the items did load on 2 factors, the higher loading was included in the factor. The initial examination of the Kaiser eigenvalues and the Cattell scree plot suggested 6 components or factors. The 6-factor solution explained 72.5% of the cumulative variance. Twenty items loaded on the 6 factors with values of /0.47/ to /0.96/.

Factor 6 was deleted because the items that loaded on that factor had low loadings and loaded on more than 1 factor. None of the items were placed in other factors because of their low loadings and content. With factor 6 deleted, the scale explained 67.4% of the variance. Factors 2 and 5 were considered for collapsing based on a moderate correlation but were kept separate because of content. Table 2 summarizes the 5 extracted factors, number of items, eigenvalues, factor loadings, and percentage of variance. The results of the exploratory factor analysis provided evidence to support the construct validity of the Attitude Towards Advanced Directive Survey.

Table 2
Table 2
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The overall α coefficient for the total set of items on the Attitude Towards Advanced Directive Survey was .75. The α coefficient for the total score was important to the total scale variance that is attributed to the latent variable. Coefficients of the 5 factors ranged from .67 to .95. Factor 5, patient-provider relationship, had the lowest α. This could be due to the fact that there were only 2 items in that factor and/or that there was not as much variance within that factor. Table 3 summarizes the coefficient α values for the 5 factors and for the total survey.

Table 3
Table 3
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The analysis of reliability for the Attitude Towards Advanced Directive Survey revealed α coefficients of .67 to .95. The overall scale α coefficient was .75. Analysis of α values if an item was deleted revealed that α values were not increased with the elimination of any items. The item-total correlations ranged from .50 to .92, demonstrating moderate to high correlations among items and their factors. The results of the reliability analysis of the Attitude Towards Advanced Directive Survey, with 5 factors and 17 items, provided evidence to support its internal reliability.

Cronbach coefficient α was calculated to measure internal consistency. Test-retest reliability was analyzed using Pearson coefficient, r for a small subset of research participants (34%, n = 68) who completed the Attitude Towards Advanced Directive Survey a second time at least 2 weeks after the first measurement. All participants were mailed a survey 2 weeks after completing the initial survey, and only 68 (34%) returned the survey. The stability of the instrument revealed a significant, positive correlation (r = 0.62, P < .001) between the first and second testing. This demonstrates a moderate correlation between the first and second testing and provides supporting data as to the reliability of the Attitude Towards Advanced Directive Survey.

An analysis of patient’s attitudes toward advanced directives was performed on the Attitude Towards Advanced Directive Survey data by calculating the mean scores for the 5 factors. The range of scores for the total scale is 17 to 85 because there are a total of 17 items rated on a 5-point Likert scale. Overall, the highest possible score that can be obtained is an 85, which indicates that participants have less perceived barriers and an increased knowledge of advanced directives. The possible range of scores for each subscale depends on the number of items in that subscale. For example, factor 1 has 5 items; therefore, the range of scores for that subscale is 5 to 25. Based on this, the participants of the Attitude Towards Advanced Directive Survey demonstrated communication barriers (mean [SD], 2.94 [0.30]) and poor understanding of their medical condition/treatments (mean [SD], 2.5 [0.73]) and were not comfortable discussing advanced directives with their families (mean [SD], 2.23 [0.10]). They would like to discuss advanced directives when they are first diagnosed and at every office visit because they felt more comfortable discussing advanced directives with their healthcare provider (mean [SD], 4.47 [0.50]).

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Discussion

The present study provides evidence to support the content, construct validity, and reliability of the Attitude Towards Advanced Directive Survey. As previously stated, the participants of the study demonstrated communication barriers. They supported the claim that healthcare providers rarely have conversations regarding advanced directives or they could not recall a conversation with their healthcare provider before or after implantation of their ICD.20,27 The participants also demonstrated low levels of informed confidence. They had a poor understanding of their medical condition/treatments and did not have confidence in healthcare providers to decide their treatments. It has been noted in the literature that patients do not understand the particulars of their device with regard to their medical condition.20–24 Furthermore, it has been found that some healthcare providers either do not understand the advanced directives themselves or do not believe they are useful.18,25

The participants would like to discuss advanced directives when they are first diagnosed with their heart problem requiring the ICD and at every subsequent office visit because they felt more comfortable discussing advanced directives with their healthcare provider. There have been two thoughts to timing of discussion in the literature. First, healthcare providers felt that patients are too anxious when they are diagnosed and would not be receptive to the discussion, and second, they feel that patients might change their minds regarding treatment.17,19 This supports discussing advanced directives at every visit but not discussing when they are first diagnosed, which is what this patient population favored. In addition, most patients actually preferred to receive the information from their regular healthcare provider during an office visit and were much more receptive to their healthcare provider.19,21,22 The most universally expressed finding of this survey is that patients were not comfortable discussing advanced directives with their families. There were two trials addressing the turmoil that family members had to face fighting for what they thought the patient would have wanted at the end of his/her life.12,14 These decisions are very difficult and demanding on a family and can easily be avoided if an advanced directive were at hand.

The expansion of indications for the implantation of ICDs increases the number of older adults with these devices. These patients are at risk of developing chronic conditions and suffering at the end of life, and the options of deactivating the device should be discussed with patients before implantation. This survey was developed to help clinicians identify patient’s knowledge of and what the barriers were for completing an advanced directive. Continued analysis of the psychometric properties of this survey is necessary to gain further evidence of its validity and reliability. Continued research with its use in clinical practice is also imperative because existing research on this subject is limited and undertaken from 2000–2009, and this research addresses a significant clinically relevant concern.

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Limitations

A threat to the internal validity of this study was due to convenience sampling. All of the patients sampled were from Fairfield County and received their medical care at 1 particular cardiology office. This sample was not a representation of a larger population of patients with an ICD. Furthermore, patients in this study were not near their end of life. Most of the patients (49.5%) stated that they felt they were in “good” health condition. This could have created a selection bias against patients who had many comorbid conditions. In addition, there were no demographic questions that asked the number of comorbid conditions present in the sample.

Another limitation of the study was time. Patients were given the survey while they were scheduled for the interrogation of their defibrillator. Patients could have felt that they did not have enough time to consider each of the statements completely. Patients may have not remembered information they were given or information discussed by their healthcare provider. Moreover, the sample was also limited to English-speaking patients and thereby excluded patients who did not speak English.

Another limitation was the possibility that the respondents did not complete the questionnaire themselves or had their family member help them with the questionnaire. This can interfere with the representativeness of the sample, and it was difficult to know if it occurred or not. The meaning of an advanced directive may vary in the individual patients as the laws change. Specific laws of the State of Connecticut could have been included in the information sheet. Discrepancies could have been formulated from the interpretation of the concepts.

Finally, in complying with institutional review board guidelines, it was difficult to contact participants to complete the survey a second time. Consequently, there was a low response rate of 34%. The response rate could have possibly increased if the patients were sent another reminder to complete the survey a second time.

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Implications for Clinical Practice

Physicians report that they do not have the time to discuss these issues with patients.16 This survey can be used as a guideline for the providers in their assessment of the patient. It would allow for a plan regarding the patient’s wishes when nearing end of life; this in turn would reduce the patient’s and the family’s stress level. Withdrawing devices at the end of life is complex, and there are limited resources to guide clinicians. This survey would also allow appropriate communication between the patient and his/her healthcare team. It can be used as a screening tool for healthcare providers to use to assess the knowledge and barriers that patients have when initially seen by the provider. The provider can then take the results from the survey and educate the patient based on the results of the survey. This can save time for the provider and the patient. This information can become a part of the patient’s medical chart and the provider can use it as a point of reference and as a continuous assessment tool when planning the patient’s care. Because not all patients have the same educational needs, this would allow for patient specific care and preparation.

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Implications for Future Research

Further research is needed to assess the psychometric properties of the Attitude Towards Advanced Directive Survey because 3 items were deleted and there could be additional items added to several of the factors. This survey will be further developed for additional content analysis and exploratory factor analysis. The content analysis will include a content validity index.28 Criteria for the content validity will be used for item retention on a rating scale of 3 or 4 on the relevance scale and a 90% interrater agreement regarding each dimension. Another form of content analysis will include cognitive interviewing. It is used to evaluate sources of response error in survey questionnaires. It focuses on cognitive processes that respondents use to answer survey questions.29 A subset of patients will be recruited that fit the inclusion criteria to perform the cognitive interviewing to further validate the survey.

For exploratory factor analysis, the survey will include the item “I am aware and understand what a living will and a durable power of attorney is”; however, because it is a double-barreled item, it will be broken up into 2 items. In addition, the item “I want my healthcare provider to discuss advanced directives: when my health status changes” will be added and made into 1 statement along with 2 similar items, “I want my healthcare provider to discuss advanced directives: at every visit” and “I want my healthcare provider to discuss advanced directives when first diagnosed with my heart condition.” These items will then be scattered throughout the survey. Finally, the negatively stated item 5, “I do not want life-sustaining treatments if the burden of treatment outweighs the benefits,” will be changed to a positive statement to maintain consistency throughout the survey.

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What’s New and Important

* There are an increasing number of patients living longer with implantable cardioverter defibrillators (ICDs).

* ICD therapy may not be beneficial with certain comorbid conditions.

* Patients with ICDs should be counseled on completing advanced directives.

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Keywords:

advanced directives; implantable cardioverter defibrillators; quality of life; survey development

© 2013 Lippincott Williams & Wilkins, Inc.

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