Project design

De-identified secondary data previously collected during a clinical quality improvement project in the Heart Rhythm Services Clinic at a Midwestern academic medical center was used to evaluate the implementation of SMAs into routine clinical practice. Full details of the project design and implementation are reported elsewhere [26]. Survey data were collected from March 2016 through December 2017 and medical record data were extracted by two non-clinical research coordinators with random auditing performed by clinicians who were blinded to the group from which the data came.

For this project, patients were assigned to either standard care or a SMA based on the patient’s preferred appointment date. All pre-procedure consultation visits occurred within one week of the scheduled cardiac ablation procedure. Data were collected from patients on their appointment day (baseline) and at 3 and 6 months after baseline. Utilization of services subsequent to patient’s ablation procedure was extracted from patient charts to determine potential differences between patients receiving SMAs and standard care.

Participants

Patients that were 18 years of age or older with AF and had an appointment for evaluation for an AF ablation procedure were eligible for assignment to either SMA or standard care. Patients were excluded from the quality improvement project if they were unable to read and understand English, had documented cognitive impairments, were receiving active cancer treatment, or hemodialysis, had an implanted left ventricular assist device or if, after their appointment, they chose not to have an ablation. Patients receiving active cancer treatment, hemodialysis, or who had an implanted left ventricular assist devices were not included as study participants because: 1.) these patients are not generally suitable for the catheter ablation procedure, and 2.) the additional care required to treat and manage these diseases while also managing care for an ablative procedure would deviate considerably from the standard of care and potentially confound results.

The quality improvement project was reviewed by the Mayo Clinic Institutional Review Board and determined to not represent research. To analyze these secondary data, however, Mayo Clinic Institutional Review Board approval was obtained. Consent was waived because data was de-identified and patients previously gave consent to have data from their records used for research purposes.

Intervention

As previously noted, the development of the SMA curriculum, evaluation and implementation processes are detailed in a separate publication [26]. Briefly, patients assigned to SMAs participated in a SMA prior to the scheduled ablation procedure and again at their 3-months post procedure appointment (see Fig 1).

Fig 1

Pre-procedure and 3-month post-procedure visit flow for patients who underwent cardiac ablation.

The content of the pre-procedure and 3-month SMA education sessions is described in Table 1. Curriculum development was guided by the European Heart Rhythm Association Consensus document endorsed by the Heart Rhythm Society [6]. A nurse practitioner led the 90-minute session during the initial SMA. For each visit, per billing requirements, patients assigned to the SMA also had a short,10-minute one-on-one visit with a provider where individual questions and concerns were addressed. The SMA was designed to engage the participants and their family members to share their experiences, provide education about AF in an interactive manner, and create an individualized care plan with group support. As shown in Table 1, the curriculum in the initial and 3-month post-procedure SMAs differed and was intended to address the most salient issues for self-management of AF for those particular time points. A curriculum with sample scripts and slide presentation was developed for both the pre-procedure SMA appointment and 3-month post-procedure SMA appointment to assure consistency in the information presented.

Table 1

Topics discussed during the shared medical appointments for a cardiac ablation pre-procedure and post-procedure visit.

Pre-Procedure SMA	3-Month Post-Procedure SMA
Atrial fibrillation etiology and disease process	Results of post-procedure diagnostic testing
Impact of atrial fibrillation on everyday life	Current impact of atrial fibrillation on everyday life
Anticoagulation versus bleeding risk: shared decision-making tool	Anticoagulation versus bleeding risk: shared decision-making tool
Lifestyle modification research and impact of aggressive lifestyle modification (ie blood pressure, diabetes, cholesterol, weight, alcohol, smoking, and sleep hygiene management)	Follow-up and longitudinal care
Treatment options	Creating continuity of care with local providers
Technical aspects of catheter ablation	Perceived burden of treatment
Risks, benefits, alternatives	Tools for continued lifestyle modification self-management
Perceived burden of treatment	Longitudinal symptom management
What to expect during hospitalization
What to expect post-hospitalization
Stress management and meditation exercises

Standard care

As with the SMAs, standard care appointments occurred prior to the scheduled ablation procedure and at 3-months post procedure. Each visit was typically up to 60 minutes long. Patients met with an electrophysiologist, a certified nurse practitioner, fellow, or physician assistant. During the pre-procedure visit, the clinician reviewed results of diagnostic testing, conducted a history and physical examination, delivered patient education about AF, reviewed treatment options, and obtained signed consent for catheter ablation procedure. During the 3-month visit, the electrophysiologist, nurse practitioner, or physician assistant reviewed the results of diagnostic testing, conducted a history and physical examination, delivered patient education, and determined long term anticoagulation and anti-arrhythmic management.

Outcomes

Table 2 outlines all outcomes and the data collection schedule.

Table 2

Data collection schedule of patient outcomes.

Patient Outcomes	Prior to pre-procedure visit	After pre-procedure visit	3-month post-ablation visit	6 months post-ablation
Confidence of self-management (PAM)	x		x	x
Knowledge of AF & AF treatment (KAF)	x	x
Satisfaction with provider communication/interaction (PACIC)	x			x
Symptom Severity (AFSS)	x		x	x
Demographics (marital status, etc.)	x
Health care utilization*			x	x
Dietitian appointment
Physiology appointment
3-month post-ablation appointment
Triage calls
Hospitalizations
Emergency department visits

*Health care utilization between ablation procedure and 3 months and between 3 months and 6 months was extracted from the medical record at 6 months.

Instruments and data collection

Consistent with Social Cognitive Theory, the theoretical basis of the intervention, we captured data on the different theoretical domains using different, psychometrically-sound scales. Other scales, such as the AF Effect on Quality of life (AFEQT), capture important aspects of quality of life, but are devoid of domains included in our framework, such as patient activation, knowledge of atrial fibrillation, patient provider communication, and severity of symptoms experienced by patients. These specific domains were important in understanding the ability of the patient and provider to exchange information bidirectionally during the medical encounter in order to evaluate potential differences between standard care and the SMA group.

Perceived self-management of AF was measured using the Patient Activation Measure (PAM)-Short Form at baseline (pre-ablation appointment), 3 and 6 months after ablation [24, 26]. The PAM has demonstrated validity and acceptable reliability when used in populations with chronic illness. The Rasch person reliability for the preliminary 21-item measure was between .85 (real) and .87 (model). Cronbach’s alpha was .87 [26]. Scores were categorized into levels of activation with Level 1 indicating low knowledge, motivation, and skill for self-management and Level 4 high motivation, knowledge and skill for self-management. Level 1 scores ranged from 0–47.0; Level 2, 47.1–55.1; Level 3, 55.2–72.4; and Level 4, 72.5–100 [25–27]. PAM data from the baseline, 3-month and 6-month assessments are reported in Table 4.

Patient perceptions of the quality of their healthcare team’s chronic disease management, including satisfaction of provider communication about AF management, was measured using the Patient Assessment of Chronic Illness Care (PACIC) [28] and was collected at baseline and at 6 months. The PACIC is a validated tool that assesses indicators of quality that are included in the Chronic Care Model (e.g., activation; delivery system/practice design; goal setting; follow-up/coordination; problem solving) [10]. Psychometric evaluation of the PACIC has shown construct validity and acceptable internal consistency reliability for the entire scale (α = .93) and for subscales (ranging from α = 0.77 to 0.90)

Patient knowledge about AF was assessed using the Knowledge of Atrial Fibrillation (KAF) test [29]. Because the majority of educational material was presented for the first time in the initial SMA, data were collected prior to and following only the initial SMA or the pre-ablation appointment, depending on the assigned group. Content validity for the KAF has been assessed by expert review and has acceptable internal consistency reliability for the subscales (ranging from α = 0.64–0.87) [29].

Self-reported severity of symptomatic episodes were measured using Part C of the University of Toronto Atrial Fibrillation Symptom Severity scale, or AFSS [30]. Response options for AFSS items ranged from not at all to a great deal to assess how often they have been bothered by the symptom in the past 4 weeks. A sum of responses is calculated, with higher scores reflecting greater symptoms severity. Content, construct and criterion validity of the AFSS have been reported, as has its internal consistency reliability (as 94 α = .72) [30]. This scale has been included in other large-scale studies, including the ARREST-AF study [9], which was intended to allow comparability of findings across studies.

Electronic medical record data abstraction

As part of the quality improvement project, a medical record review and abstraction was conducted at 6 months post-ablation appointment to assess healthcare utilization, defined as emergency room visits for treatment of AF during the 3-month blanking period and patient-initiated nurse triage calls. Other factors that may affect the relationship between appointment type and outcomes were also abstracted, including chronic comorbidities, body mass index (BMI), smoking status, medication usage and demographic characteristics. Likewise, attendance at appointments with a dietitian and exercise physiologist at the time of the pre-ablation appointment and the 3-month follow-up appointment and the number of hospitalizations and emergency room visits for reasons other than AF were abstracted from the medical record.

Data analysis

De-identified data from patients that met inclusion criteria, had an ablation, and completed the pre-baseline survey were used for analysis. Baseline characteristics are reported as means and standard deviations for continuous variables, or median and interquartile ranges if data were skewed, and counts and frequencies for categorical data. Outcomes for the data collected at 6 months were modeled as continuous outcomes and adjusted baseline scores using analysis of covariance to account for the correlated nature of the data [31]. Comparisons by assigned condition and utilization were analyzed with the chi-square test. All analyses were conducted in SAS 9.4 (Cary, NC) and p-values reported are based off a two-sided hypothesis. The level of significance was set at p < .05.

Patient activation measure

At baseline, both groups’ average score was high on patient activation (stage 3), meaning that these patients had reached a point where they were already beginning to make changes and motivated to take accountability for their health [26]. As shown in Table 4, scores between the SMA and standard care groups were not significantly different at baseline (p = 0.73), nor were they different at 6 months (p = 0.21) after adjusting for baseline PAM score, education and antiarrhythmic use.

Table 4

Patient reports of outcomes collected at prior to pre- catheter ablation appointment, immediately following pre- catheter ablation appointment, 3-months post catheter ablation, and 6-months post catheter ablation.

	Baseline			3 –month follow-up†			6-month follow-up†
Mean (95% CI)	SMA (N = 59)	Standard care (N = 64)	Mean Difference (95% CI)*	SMA (N = 41)	Standard care (N = 39)	Mean Difference (95% CI)* †‡	SMA (N = 37)	Standard care (N = 42)	Mean Difference (95% CI)* †‡
PAM Score	67.9 (62.7, 73.1)	67.7 (63.1, 72.3)	0.2 (-6.7, 7.1)	68.1 (59.0, 77.3)	72.8 (64.3, 81.3)	-4.7 (-13.1, 3.8)	65.3 (54.3, 76.4)	71.8 (61.9, 81.8)	-6.5 (-16.6, 3.6)
KAF Pre	16.2 (15.2, 17.3)	16.5 (15.4, 17.6)	-0.2 (-1.7, 1.3)
KAF Post	19.8 (18.9, 20.8)	18.7 (17.8, 19.6)	1.1 (0.3, 2.0)
AFSS	12.2 (10.4, 14.0)	12.6 (10.8, 14.5)	-0.5 (-3.0, 2.1)	5.1 (2.3, 7.9)	6.1 (3.5, 8.7)	-1.0 (-3.6, 1.6)	4.2 (1.9, 6.5)	5.9 (3.8, 8.0)	-1.7 (-3.7, 0.4)
PACIC Overall	2.7 (2.5, 3.0)	2.9 (2.7, 3.2)	-0.2 (-0.5, 0.2)				3.4 (3.0, 3.8)	3.0 (2.7, 3.4)	0.3 (-0.04, 0.7)
Patient Activation	3.5 (3.2, 3.8)	3.7 (3.4, 4.0)	-0.2 (-0.7, 0.2)				4.1 (3.5, 4.6)	3.9 (3.4, 4.4)	0.1 (-0.4, 0.7)
Decision Support	3.3 (3.0, 3.6)	3.5 (3.2, 3.7)	-0.2 (-0.6, 0.2)				3.8 (3.3, 4.2)	3.5 (3.1, 3.9)	0.3 (-0.2, 0.7)
Goal Setting	2.4 (2.1, 2.6)	2.7 (2.5, 3.0)	-0.4 (-0.7, 0.01)				3.7 (3.2, 4.2)	3.0 (2.5, 3.4)	0.7 (0.2, 1.2)
Problem Solving	3.0 (2.7, 3.4)	3.2 (2.9, 3.5)	-0.2 (-0.6, 0.3)				3.7 (3.1, 4.2)	3.3 (2.8, 3.8)	0.3 (-0.2, 0.9)
Follow-up	2.0 (1.8, 2.3)	2.1 (1.8, 2.4)	-0.1 (-0.5, 0.3)				2.2 (1.7, 2.6)	2.1 (1.7, 2.5)	0.0 (-0.4, 0.5)

PAM, Patient Activation Measure; KAF, Knowledge about Atrial Fibrillation; AFSS, Atrial Fibrillation Severity Score; PACIC, Patient Assessment of Chronic Illness Care; SMA, Shared Medical Appointment.

†Adjusted by baseline scores for scale along with patient education level and antiarrhythmic medication use.

‡Difference between Follow-up assessments of SMA–Standard Care.

Knowledge of atrial fibrillation

Compared to the standard care group, patients in the SMA group reported greater improvement in knowledge of AF scores from pre-to post- appointment after controlling for pre-visit knowledge score, education and anti-arrhythmic use (SMA = 3.6 vs. standard care = 2.2; p = 0.01).

Patient assessment of chronic illness care

Baseline PACIC scores were not significantly different between the two arms. While the overall PACIC score was not different between groups at 6 months, the goal setting subscale of the instrument showed a statistically significant difference between the two groups (Table 4) after controlling for covariates. On a 4-point scale, patients in the SMA intervention had goal setting scores, on average, 0.7 points higher than those in standard care [95% CI, 0.2, 1.2] (Table 4). None of the other PACIC sub-scales scores were significantly different between assigned conditions at 6 months. For all PACIC subscale scores, the baseline score was found to be a strong univariate predictor for 6-month scores (Patient Activation p = 0.0004, Decision Support p = 0.0001, Problem Solving p = 0.0005, Follow-up p = <0.0001, Goal setting p = 0.0015).

Atrial fibrillation severity score

At baseline, both groups reported symptoms that placed them in the highest tertile for symptom severity, but scores were not significantly different (SMA = 12.2; standard care = 12.6; p = 0.72). Likewise, at 3 and 6 months post-ablation, both groups experienced an improvement in symptoms, scoring in the moderate tertile (3 months: SMA = 5.1; standard care = 6.1, p = 0.44; 6 months: SMA = 4.2; standard care = 5.9, p = 0.11), yet, again, no significant differences were noted between the groups.

Utilization

The SMA group had a higher proportion that attended a dietitian appointment than those in standard care (25% vs. 3%, p < .001) (Table 5). No statistical differences were seen in the number who attended exercise physiologist appointments prior to ablation. Of the SMA patients, 78% attended the scheduled 3-month follow-up visit, while only 63% of standard care patients attended the follow-up clinical visit (p = 0.06). No difference was found in the average number of triage calls, hospitalizations or emergency room visits from baseline to 6 months between the SMA and standard care groups.

Table 5

Differences in healthcare utilization between patients in SMA and standard care*.

	SMA (N = 59)	Standard Care (N = 64)	P-Value
Completed dietitian appointment prior to ablation	15 (25.4%)	2 (3.1%)	< .0011
Completed exercise physiology appointment prior to ablation	27 (46.6%)	35 (54.7%)	0.371
Completed 3 Month post-ablation appointment	46 (78.0%)	40 (62.5%)	0.061
Average number of triage calls 6 months after pre-ablation appointment	27 (45.8%)	32 (50.0%)	0.641
Hospitalizations since pre-ablation appointment	9 (15.3%)	10 (15.6%)	0.951
Number of emergency visits since pre-ablation appointment	9 (15.3%)	7 (10.9%)	0.481

¹Chi-Square ²Kruskal Wallis.

*Health care utilization between ablation procedure and 3 months and between 3 months and 6 months was extracted from the medical record at 6 months.

Limitations

Because of the unique setting and quality improvement design for our study, our findings may not be generalizable in other settings, either because of the lack of diversity in our study sample, the amount of time spent with patients or because patients who seek evaluation for a procedure at a major academic health center may be more motivated to change than patients at community health centers or those with less pronounced or disruptive symptoms. However, our results do demonstrate the feasibility of implementing an SMA approach in a busy and complex clinical setting.

Our approach underlines the importance of understanding patient readiness for self-management in designing and implementing strategies that target lifestyle modification, however, we are limited by our data sources to test associations with longer term outcomes associated with AF ablation procedure success. This, in part, is due to the nature of the cardiac ablation procedure. The presence of atrial arrhythmias in the early post-ablation period is common because of ablation-related inflammation and healing and atrial arrhythmias during this period are not seen as a true recurrence [33]. In fact, atrial arrhythmias during this early post-ablation period are not associated with worse long-term outcomes or arrhythmia recurrence [33]. Ablation procedure success is best measured up to at least 1 year, but because our data is limited to the first 6 months post-ablation, we are constrained at linking intervention results with longer-term AF ablation procedure success.

Implications

With increasing provider burnout [34] and healthcare systems pressured to focus on reducing costs, identifying novel models of care and methods to deliver quality, complex care in efficient and effective ways is imperative. Our project demonstrated that AF patients were highly motivated to manage their own care, and that SMAs may be a method to enhance knowledge of the disease process while providing high quality care that does not impact patient reported outcome measures.