Janet is the health care administrator at a major hospital who is tasked with addressing an issue with recent prescription requests of a particular drug and complaints of overdoses in

Patient Education and Counseling 84 (2011) 41–48

Intervention

Entertainment education for breast cancer surgery decisions: A randomized trial among patients with low health literacy

Maria L. Jibaja-Weiss a,*, Robert J. Volk b, Thomas S. Granchi c, Nancy E. Neff a, Emily K. Robinson d, Stephen J. Spann e, Noriaki Aoki f,g, Lois C. Friedman h, J. Robert Beck e,i

a Department of Family and Community Medicine, Baylor College of Medicine, USA b Department of General Internal Medicine, Ambulatory Treatment & Emergency Care, Houston Center for Education and Research on Therapeutics,

The University of Texas M. D. Anderson Cancer Center, USA c Acute Surgical Care Specialist, LLP, USA d Department of Surgery, The University of Texas Health Science Center, Houston, USA e Senior Vice-President and Dean of Clinical Affairs, Baylor College of Medicine, USA f School of Health Information Sciences, The University of Texas Health Science Center, Houston, USA g Center for Health Service, Outcomes Research and Development–Japan (CHORDJ), Japan h Department of Psychiatry, Case Medical Center, University Hospitals Ireland Cancer Center, USA i Office of the Vice President for Information Services, Fox Chase Cancer Center, USA

A R T I C L E I N F O

Article history:

Received 25 September 2009

Received in revised form 4 May 2010

Accepted 4 June 2010

Keywords:

Patient decision aids

Breast cancer surgery

Health literacy

A B S T R A C T

Objective: To evaluate an entertainment-based patient decision aid for early stage breast cancer surgery

in low health literacy patients.

Methods: Newly diagnosed female patients with early stage breast cancer from two public hospitals

were randomized to receive an entertainment-based decision aid for breast cancer treatment along with

usual care (intervention arm) or to receive usual care only (control arm). Pre-decision (baseline), pre-

surgery, and 1-year follow-up assessments were conducted.

Results: Patients assigned to the intervention arm of the study were more likely than the controls to

choose mastectomy rather than breast-conserving surgery; however, they appeared better informed and

clearer about their surgical options than women assigned to the control group. No differences in

satisfaction with the surgical decision or the decision-making process were observed between the

patients who viewed the intervention and those assigned to the control group.

Conclusions: Entertainment education may be a desirable strategy for informing lower health literate

women about breast cancer surgery options.

Practice Implications: Incorporating patient decision aids, particularly computer-based decision aids,

into standard clinical practice remains a challenge; however, patients may be directed to view programs

at home or at public locations (e.g., libraries, community centers).

� 2010 Elsevier Ireland Ltd. All rights reserved.

Contents lists available at ScienceDirect

Patient Education and Counseling

jo ur n al h o mep ag e: w ww .e lsev ier . co m / loc ate /p ated u co u

1. Introduction

Breast-conserving surgery (BCS) is a well-established alterna- tive to mastectomy (MT) for women with early stage breast cancer [1]. Data suggest, however, that many women with early stage disease who are eligible for BCS continue to undergo MT—a previous standard of surgical care for this cancer [2,3]. It has been suggested that women who are medically underserved, character- ized by lower income, socioeconomic status and educational level,

* Corresponding author at: Department of Family and Community Medicine,

Baylor College of Medicine, 3701 Kirby Drive, Suite 600, Houston, TX 77098, USA.

Tel.: +1 713 798 3636; fax: +1 713 798 7940.

E-mail address: [email protected] (M.L. Jibaja-Weiss).

0738-3991/$ – see front matter � 2010 Elsevier Ireland Ltd. All rights reserved.

doi:10.1016/j.pec.2010.06.009

non-English-speaking, older, and lacking private health insurance are less likely to undergo BCS [4–6]. Multiple factors have been shown to affect the choice of BCS or MT for surgical treatment of early stage breast cancer [5,7,8]; however, important determinants of type of breast cancer treatment decisions made are doctor- patient communication [8] and low patient knowledge with regard to treatment options [7].

There is widespread agreement that, to maximize understand- ing of the implications of treatment options and ability to make an informed decision, patients in a position to make a choice between treatment options should be systematically provided with just-in- time and sufficiently detailed information by several means [9– 11]. Both the National Cancer Institute and the Institute of Medicine have highlighted the importance of patient-centered care and informed decision-making in health care [9,11]. Making

M.L. Jibaja-Weiss et al. / Patient Education and Counseling 84 (2011) 41–4842

special efforts to educate underserved patients so they are more knowledgeable and become more involved in their treatment decisions are factors that are likely to contribute to the successful elimination of cancer treatment disparities [5,11]; particularly in light of the fact that the content of physician communication may vary by patient characteristics, which may lead to less information being transmitted to the patient [8].

Using decision aids is one way to provide information to patients and to involve them in making decisions about their treatment [12]. Decision aids are interventions designed to help people make deliberate choices among treatment options by providing, at a minimum, information on those options and any potential outcomes relevant to an individual’s disease or medical condition [13]. Decision aids may also include information on outcome probabilities tailored to health-risk factors, explicit values-clarification exercises and guidance through the process of decision-making [13]. Furthermore, decision aids have been advocated to promote patient involvement by standardizing communication between the patient and physician during the decision-making process [13]. Several studies have demonstrated how receptive patients are to using cancer-related decision aids, especially if they initially are uncertain about choosing between treatment options [14,15]. In a recent review and meta-analysis regarding the use of surgical patient decision aids for women diagnosed with early stage breast cancer, aids were found to be important adjuncts to counseling, increasing the likelihood that women will choose breast-conserving surgery and enhancing patients’ knowledge of treatment options [16]. However, as indicated by those authors, there is a paucity of studies conducted in the United States on this topic. Furthermore, the target populations of the studies included in the review articles usually had a high school level of education or better and, for those studies conducted in the United States and Canada, were English speakers. Thus, these findings may not be generalizable to all racial, ethnic and socioeconomic groups of women in the United States, in particular the underserved.

In this study of informed decision-making for breast cancer treatment among patients served at urban public hospitals, we compared a computerized, multimedia, interactive patient deci- sion aid (CPtDA) utilizing edutainment (a combination of soap opera episodes and interactive learning modules [ILMs]) along with usual care to receiving usual care alone. The CPtDA was designed specifically as a surgical treatment decision aid for women diagnosed with early stage (I–IIIA) breast cancer. The CPtDA walks women through the steps of making an informed breast cancer surgery decision (BCS or MT). The patient groups targeted were multi-ethnic, low-literacy women who received medical care at two urban public hospitals.

2. Methods

The study design was a randomized, controlled trial conducted in two public hospitals administered by the Harris County Hospital District. Patients at each hospital were randomized using permuted blocks. Patients assigned to the intervention group viewed the CPtDA and received usual care, and those assigned to the control group received usual care only. The Institutional Review Boards of Baylor College of Medicine, the University of Texas Health Science Center in Houston, the Harris County Hospital District and the US Department of Defense approved the project and the patients gave written informed consent.

2.1. Setting

Breast pathology clinics in two public hospitals were invited to participate in the study. Patients served at these public hospitals do not have medical insurance, and many have a high school education

or less. Data collection began October 2000, and continued through July 2005.

2.2. Subjects

Eligible subjects were female patients who visited one of the two breast pathology clinics, who were diagnosed with early stage breast cancer (I–IIIA), were candidates for breast-conserving surgery and who could speak English or Spanish. Those who had recurrent or inflammatory breast carcinoma, could not have BCS, or had additional serious medical conditions (e.g., heart disease) were excluded from the study.

2.3. Procedures

Eligible patients were identified from the outpatient appoint- ment system, pathology reports and inpatient surgery schedule. After the physician had informed the eligible patient of her biopsy results, he or she referred the patient to the case manager, who explained the study and asked for informed consent. Patients who agreed to participate were then randomized to either the intervention or control group using a permuted blocks table. At the initial data collection point, the pre-decision visit, patients assigned to the intervention group were asked to complete some demographic and baseline measures which included the Breast Cancer Knowledge Questionnaire and the Decisional Conflict Scale. The case manager then escorted each patient who consented to a quiet room adjacent to the waiting area, where the CPtDA was located. She then explained the use of the computer and asked the patient to begin using the system. Because most of the women in our target population were novice computer users and often needed emotional support immediately after learning of their diagnosis, the case manager was available to assist patients throughout the session. Although uncommon, some patients viewed the CPtDA with family members who had accompanied them. All patients who viewed the CPtDA completed it during this session. The case manager gave each a copy of the CPtDA- generated printout and placed a second copy in each patient’s medical record. Patients then answered a series of questions about the program (Satisfaction with Program Questionnaire) designed to evaluate its usability and satisfaction. The questions were adapted from those used in other evaluative studies of decision aids [17,18] and were administrated in both English and Spanish.

Patients assigned to the control group at the pre-decision visit were asked to complete the same demographic and baselines measures as the intervention group. The case manager then provided participants with breast cancer treatment educational materials which are generally provided to patients in these hospitals. English speaking patients were provided with National Cancer Institute printed informational material on breast cancer treatment, while Spanish speakers were provided with similar material (in Spanish) from the American Cancer Society. Both intervention and control group participants were asked to arrive 45 minutes early for their pre-op screening clinic appointment so they could participate in the second data collection point, the pre- surgery visit.

At the pre-surgery visit, participants from the intervention and control groups were asked to indicate their surgical treatment preference and complete the Breast Cancer Knowledge Question- naire, the Decisional Conflict Scale, the Satisfaction with Decision Scale, and the Satisfaction with the Decision-Making Process Questionnaire. The time between the pre-decision and pre-surgery visits did not differ between the two groups (see Table 1). Participants were contacted 1 year after the pre-decision visit to administer the Knowledge Questionnaire and Decisional Conflict Scale.

Table 1 Characteristics of the sample.

Patient meeting eligibility

criteria (n = 138)a,b

Patients completing 1-year assessment P-valuec

CPtDA (n = 40) Control (n = 36)

Age

Mean 51.0 49.5 52.4 0.258

Standard deviation 10.9 10.3 12.0

Language of administration

English 89 23 21 0.563

Spanish 49 17 15

Ethnicity

White 22 7 5 0.708

African American 52 11 13

Hispanic 62 22 18

Asian American 2 0 0

Breast cancer stage at diagnosis

I na 7 7 0.973

II na 13 10

IIb na 9 9

IIIA na 11 10

Menopausal status

Pre-menopausal na 17 13 0.569

Post-menopausal na 23 23

Time lag between pre-decision visit and pre-surgery visit

30 days or less na 23 20 0.684

31–90 days na 11 8

91 days or more na 6 8

a Eligible patients missing six cases where medical records were no longer available. b na, data not available for these patients. c P-values compare CPtDA and controls using t-test for age and chi-square test for other characteristics.

M.L. Jibaja-Weiss et al. / Patient Education and Counseling 84 (2011) 41–48 43

2.4. Intervention decision aid

As described in detail elsewhere, we developed the CPtDA titled ‘A Patchwork of Life: One Woman’s Story for Making Breast Cancer Treatment Decisions’, to aid lower literate and multi-ethnic women in making an initial surgery decision for breast cancer treatment [19,20]. Development of the CPtDA was grounded on entertainment education concepts and theory [21–24], and the Ottawa Decision Support Framework [14]. Furthermore, in order to create a learning environment acceptable to our target population, who were for the most part novice computer users and of lower health literacy, special design considerations were taken into account to make the human–computer interface and usability of the program as user-friendly and familiar as possible (i.e., similar to a television screen). Navigational instructions were provided throughout with voice-over narration, and on-screen text was used as little as possible. The CPtDA had two major components: (1) didactic soap opera episodes that were seamlessly linked to (2) interactive learning modules (ILMs) to enhance the content of the episodes. We utilized the edutainment decision aid model (EDAM) to assist us in designing the CPtDA [25]. The storyline of the didactic soap opera episodes walks women through a breast cancer journey – from the time of the main character’s initial diagnosis, to pondering about making an informed treatment decision, cele- brating months later with family and friends after she has completed treatment. In order not to bias the viewing audience toward mastectomy or BCS, she does not reveal which surgery option she chooses. The CPtDA includes a novel, explicit values- clarification exercise utilizing a jewelry box designed to assist women in (1) reflecting on and recording issues of concern regarding possible treatments, (2) deliberating over the surgery decision and (3) communicating with physicians and significant others [19]. The CPtDA has been updated recently and is available to the public at www.bcm.edu/patchworkoflife. The updated

online version conforms to recent published guidelines of the International Patient Decision Aid Standards (IPDAS) Collaboration [26] for the development of patients decision aids.

2.5. Measures

2.5.1. Surgical treatment preference

At the outset of the pre-surgery visit, patients were asked about their surgical treatment preference. Their options were breast- conserving surgery, modified radical mastectomy, or uncertain.

2.5.2. Breast cancer knowledge

A measure of breast cancer knowledge was adapted from one used previously in evaluating breast cancer treatment educational materials [27]. Items reflect knowledge about mastectomy, breast- conserving surgery, radiation therapy, chemotherapy, tamoxifen, no treatment, and life after treatment. A questionnaire format was used, and response options were ‘‘yes,’’ ‘‘no,’’ and ‘‘unsure.’’ Of the 31 draft questions, 16 were selected to be used in the analysis as representing core knowledge needed to make a decision about treatment for breast cancer.

2.5.3. Satisfaction with Surgical Decision

The Satisfaction with Decision Scale (SWD) was modified for this project [28]. This six-item scale measures patients’ satisfaction with health care decisions and was adapted for decisions about breast cancer treatment. The scale has excellent internal consis- tency and reliability, and correlates with other aspects of the decision-making process such as confidence in the decision and satisfaction with the healthcare provider.

2.5.4. Satisfaction with Decision-Making Process

The seven-item Satisfaction with the Process of Making a Treatment Decision scale (SWDMP) was modified for this study

M.L. Jibaja-Weiss et al. / Patient Education and Counseling 84 (2011) 41–4844

[29]. This scale addresses satisfaction with explanations about treatment, one’s doctor’s personal interest in helping with the decision, reassurance and support from others, and the amount of time, help, information and attention offered by the doctor during the decision-making process. The scale has good internal consistency and reliability.

2.5.5. Decisional Conflict Scale

A 10-item low-literacy version of the Decisional Conflict Scale (DCS) [30] was used in this study. The low-literacy version includes four subscales: (1) uncertainty or lack of assuredness about the decision, (2) feeling informed about one’s options and their risks and benefits, (3) feeling clear about one’s personal values in making the decision, and (4) experiencing social support in making one’s decision. The low-literacy version uses a question-and-answer format with three response options: ‘‘yes,’’ ‘‘no,’’ or ‘‘unsure.’’ Good internal consistency and reliability and evidence of responsiveness to change after using a decision aid have been demonstrated. Scoring conventions followed the new DCS manual, wherein scores

Fig. 1. Sample enrollment st

are expressed on a 0 (low decisional conflict) to 100 (high decisional conflict) scale [30].

2.6. Data analysis

Characteristics of patients who completed all follow-up assessments were compared to those who missed one or more of the follow-ups. Surgical preferences of the two groups were compared using the chi-square test statistic. For the knowledge and DCS outcomes, repeated measures analysis of variance (ANOVA) was used where a significant assessment period (pre- decision, pre-surgery and 1-year follow-up) by group interaction served as the test of interest. For the SWD and SWDMP scales, analysis of covariance was used to compare scores at the time of the pre-surgery assessment. As the amount of time between the pre-decision and pre-surgery assessments varied, the relationship between the time lag and outcome measures was examined for each group. None of these correlations reached statistical significance and therefore the subsequent analyses were not

atistics and study flow.

Fig. 2. Surgical preferences of patients at pre-surgery visit.

Fig. 3. Breast cancer knowledge and Decisional Conflict Scale (DCS)

M.L. Jibaja-Weiss et al. / Patient Education and Counseling 84 (2011) 41–48 45

adjusted for the time lag. The analysis was conducted using SPSS Version 16.

3. Results

3.1. Study flow and sample characteristics

Enrollment numbers and a flow chart of the study are shown in Fig. 1. Of the 144 eligible patients approached, 125 (86.8%) agreed to participate. No-shows and withdrawals after enrollment left 100 patients for randomization. By the pre-surgery assessment, 44 of the 51 CPtDA patients (86.3%) and 39 of the 49 control patients (80.0%) remained in the study. An additional four CPtDA patients and three control patients were lost by the 1-year follow- up.

at pre-decision, pre-surgery and 1-year follow-up assessments.

M.L. Jibaja-Weiss et al. / Patient Education and Counseling 84 (2011) 41–4846

Characteristics of the eligible subjects and the intervention and control subjects who completed the 1-year follow-up are shown in Table 1. There were no differences in any of the characteristics measured between the CPtDA intervention and control partici- pants, or between those patients who participated in each data collection period and those who were lost to follow-up.

3.2. Surgical preference

Fig. 2 shows the surgical preferences of patients in the study at the pre-surgery assessment point. Patients who viewed the CPtDA program were less likely than control patients to indicate a preference for breast-conserving surgery (40.5% vs. 50.0%), and more likely than control patients to indicate a preference for modified radical mastectomy (59.5% vs. 39.5%, P = 0.018). None of the CPtDA patients were unsure about their surgical preference, while 10.5% of controls were unsure.

3.3. Breast cancer knowledge

Fig. 3 displays average scores on the 16-item breast cancer knowledge measure at the pre-decision, pre-surgery, and 1-year follow-up assessments. There was no significant difference in knowledge between the CPtDA and control groups at the pre- decision point. At the pre-surgery assessment, however, the CPtDA patients showed a significant improvement in knowledge, while knowledge among the control patients had not changed (P < 0.001); but at the 1-year follow-up assessment, the control patients’ knowledge had increased nearly to the level of the CPtDA patients.

3.4. Satisfaction with Surgical Decision and Decision-Making Process

Table 2 shows scores for the satisfaction with decision-making [28] and Satisfaction with Decision-Making Process Scores [29]. No differences were observed on either measure between the CPtDA and control groups at the pre-surgery assessment.

3.5. Decisional conflict

Findings for the Decisional Conflict Scale (DCS) are shown in Fig. 3. Both groups showed decreased decisional conflict over the assessment periods (P < 0.001 for all DCS scales), but the patterns differed for CPtDA and control patients. Specifically, by the pre-surgery assessment CPtDA patients reported being more informed about their surgical options and risks related to their decision-making (P = 0.007) and being clearer about their personal values (trend at P = 0.053) related to the surgical decision than were control patients. These differences were not apparent at the 1-year follow-up assessment. No differences were observed on the uncertainty or social support scales (P- levels > 0.05).

Table 2 Satisfaction with Decision Scale and Satisfaction with Decision-Making Process

Scale Scores at pre-surgery assessment.

n Mean Standard deviation P-value

Satisfaction with decision

CPtDA* 43 2.87 0.24 0.65

Control 38 2.85 0.30

Satisfaction with Decision-Making Process

CPtDAa 43 1.12 0.34 0.70

Control 38 1.15 0.34

P-values from one-way analysis of variance. a CPtDA is computerized patient decision aid.

4. Discussion and conclusion

4.1. Discussion

We evaluated a patient decision aid utilizing an entertain- ment education strategy to assist patients of low health literacy at two public hospitals in making breast cancer surgery decisions. Although use of this strategy for supporting deci- sion-making in conditions of uncertainty appears to be promis- ing, only few studies have utilized it [19,20,31]. This study compared viewing the patient decision aid along with receiving usual care (intervention group) to receiving only usual care (control group).

The surgical preference finding was unexpected among this patient population. Women assigned to the intervention group who viewed the CPtDA were better informed and clearer about their surgical options than women assigned to the control group, but nevertheless were more likely than controls to choose mastectomy over breast-conserving surgery. None of the women in the intervention group were unsure about their surgery choice, while 10.5% of the controls were unsure. What makes these findings unexpected is that a recent systematic review of patient decision aids for breast surgery found that their use increased the likelihood that women would choose breast-conserving surgery [16]. Our findings suggest that patients who become more informed about their surgical options do not necessarily choose the less radical option, and that other factors ar

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