Patient perspectives of high-quality care on the liver transplant waiting list: a qualitative study

Abstract

The prevalence of advanced liver disease and listing for liver transplantation is increasing. Prior assessments of quality of care neither incorporate nor emphasize the patient perspective on quality of care, which may impact clinical outcomes. Our aim was to identify patients’ perceptions on what constitutes high quality of care, comparing the findings to existing definitions, and to determine if a patient-derived tool assessing quality of care could facilitate efforts to improve healthcare. We conducted semi-structured interviews of patients waitlisted for liver transplantation, asking patients to describe the quality of their healthcare with a specific focus on how coordination, communication, office visits, hospitalizations, and cost affect their perceptions of the quality of their care. Data collection conducted concurrently with analysis determined emerging themes and saturation. Themes were mapped to an existing quality of care conceptual framework. Qualitative analysis revealed thematic saturation after 15 interviews, and to confirm and maximize the strength of the results an additional 15 interviews were analyzed. The 30 patients had a median age of 56 years (range 32–72) and included 15 (50%) men. While patients believed they received high quality of care and this was substantiated on current existing measures, qualitative analysis suggested that patient priorities emphasized 5 themes not currently assessed: 1) managing expectations; 2) providing education; 3) responding to patient needs; 4) executing the care plan efficiently; and 5) interdisciplinary communication and coordination of care.

Conclusion:

Transplant candidates perceived 5 themes that constitute quality of care, and existing quality of care measures do not assess these domains, suggesting a role for creating a patient-derived quality of care tool to improve healthcare and clinical outcomes.

Introduction:

The number of patients on the transplant waiting list continues to increase, with wide geographic variation in clinical outcomes and evidence of healthcare disparities. The total number of registrants added to the liver transplant waiting list in the US increased 6.6% in 2016, and from 2013–2016, the percentage of waitlisted patients receiving a transplant ranged geographically from 29% to 86%.⁽¹⁾ Waitlist mortality rates also varied substantially by region and were not inversely related to transplant rates, suggesting that factors other than organ availability may be influencing mortality.⁽¹⁾ There is evidence of gender, racial and socioeconomic disparity; women were less likely than men to be transplanted and waitlisted Blacks in comparison to Whites were more likely to die on the waiting list.⁽²⁾ Publically insured patients with cirrhosis had a 25% higher risk of post-transplant death than privately insured patients.⁽³⁾ These findings suggest patients on the transplant waiting list have different experiences and clinical outcomes, possibly due to varied quality of care provided and evolving healthcare disparities.

Prior frameworks assessing quality of care include those proposed by Donabedian⁽⁴⁾ and Campbell.⁽⁵⁾ Donabedian proposed that health outcomes are influenced by the structure and process of healthcare systems; structure refers to the way the healthcare system is organized and process refers to the interaction of patients with the healthcare system.⁽⁴⁾ In 2000, Campbell used this framework to conceptualize quality of care defined in terms of accessibility and effectiveness across these same two main components of care – structure and process – that results in outcomes assessed at the patient level (Supplementary Figure 1).⁽⁵⁾ In the Campbell framework, geography, affordability, and availability dimensions affect access (the ability of the patient to receive appropriate and necessary care), while clinical and inter-personal care dimensions (the social and psychological interaction between the patient and the provider) affect effectiveness (the delivery of necessary care results in the intended outcome).⁽⁵⁾

Prior attempts to assess quality of care have significant limitations. The Healthcare Effectiveness Data and Information Set (HEDIS) uses data gathered for billing purposes to assess quality of care, which limits depth and application of findings.^{(5, 6)} The Agency for Healthcare Research and Quality (AHRQ) annually administers the Consumer Assessment of Health Providers and Systems (CAHPS®), which focuses on consumer experiences with the healthcare system,⁽⁷⁾ but it is unknown if and how this represents patients’ viewpoints on what constitutes quality of care. Additionally, healthcare metrics have been proposed by physicians as being important when caring for patients with liver disease (Supplementary Table 1),⁽⁸⁾ but these do not incorporate the patient perspective. In cirrhosis populations specifically, research incorporating patient input appears limited to patient-reported outcomes (PROs) and generic and liver disease-specific health-related quality of life (HRQOL) instruments, which do not assess satisfaction with care, a major PRO domain proposed in a scoping review.^(9–12) This gap in the literature reflects the lack of research investigating the patient perception of quality of care.

Patients are increasingly being diagnosed with liver disease and being placed on the liver transplant waitlist with varying experiences and outcomes concerning for underlying differences in the quality of care provided. Review of the Campbell framework, nationally used surveys, healthcare-derived metrics, and PRO domains suggests a need to incorporate the patient perspective into quality of care assessment. Therefore, we sought to assess in a diverse group of patients listed for liver transplantation patient defined determinants of quality of care. We conducted semi-structured interviews and qualitative analysis expanding upon the Campbell framework. We also captured currently proposed healthcare-quality metrics and HRQOL to contrast qualitative findings to existing measures. We hypothesized that patient defined quality of care would be different than currently used definitions and assessments, suggesting a role for creating a patient derived quality of care tool in order to provide high quality patient centered care.

Methods

Participant selection and study setting

Using i2b2 software, we identified all patients seen in the liver transplant clinic of an urban academic medical center between 1/2017–10/2017. We used diagnostic codes for cirrhosis in the International Classification of Diseases (ICD) – 9^th edition (571) or ICD-10^th edition (K74) (Supplementary Figure 2). Electronic medical records were reviewed to select English-speaking adults aged 18 to 80 years who were on the waiting list for liver transplantation. We used purposive sampling among eligible participants based on 3 characteristics (female gender, non-White race, and public insurance status) to obtain an equal sample of patients at high risk (having 2 of the 3 characteristics) and low risk (have one or less of the characteristics) for healthcare disparities.^(1–3) Potentially eligible participants were approached for enrollment and, if enrolled, underwent one-on-one semi-structured interviews over the phone or in person between 3/2018–8/2018. Our institutional review board approved our study (protocol #1710018603), and all participants provided written informed consent.

Data collection

Two authors (NTS, KF) conducted the semi-structured interviews using a topic guide with probes that allowed for expansion and exploration of topics to assure reliable and comprehensive qualitative data.⁽¹³⁾ Opening questions investigated the patients’ experience living with cirrhosis. Introductory questions explored their experiences with outpatient care for cirrhosis, handling of questions that arise at home, and access to the transplant team between clinic visits. Key questions were based on the Campbell framework, the CAHPS®, HEDIS indicators, and clinical experience, and asked patients to describe the quality of their cirrhosis care, specifically how coordination, communication, office visits, hospitalizations, and cost affect their quality of care.^(5–7) Ending questions asked the patients to offer their opinion on what else could be done to improve their care, eliciting both barriers and facilitators. All interviews were audio-recorded and transcribed. Transcriptions were uploaded into ATLAS.ti Software.

Physiologic and survey data were captured using the REDCap electronic data capture tool.(14) Data extracted from participants’ medical records included demographics; presence of liver complications (portal hypertension (ascites, varices, or Hepatic Encephalopathy (HE) or Hepatocellular Carcinoma (HCC)); Child-Turcotte-Pugh (CTP) score; Model for End-Stage Liver Disease (MELD) score reported as the laboratory value calculation and as the transplant listing score (inclusive of exception points, additional points added to the laboratory MELD score for certain disease processes); clinical outcomes; and, where applicable, outpatient clinician adherence to proposed healthcare quality metrics with the strongest level of evidence (Supplementary Table 1).⁽⁸⁾

Participants completed surveys rating their perception of the overall quality of their care delivered by the transplant hepatology team (0 being low quality and 10 being high quality), similar to how patients give overall experience ratings of their personal doctor, specialist, health care, and health insurance plan from 0 to 10 in the CAHPS® ratings.⁽⁷⁾ The survey additionally collected information on race, education level, current employment, activity level, social engagement and support, and household income. The survey also assessed HRQOL using two generic instruments, the RAND-36⁽¹⁰⁾ and the Patient Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 Global Health,⁽¹¹⁾ as well as a disease-specific instrument – the Chronic Liver Disease Questionnaire (CLDQ).⁽¹²⁾

Data analysis

The analysis was conducted and reported adhering to the consolidated criteria for reporting qualitative research.⁽¹⁵⁾ Each interview was independently reviewed by two authors (NTS and AW), with a prominent qualitative researcher (LR) serving as a third reviewer when needed to resolve disagreements. Two authors (NTS and AW) individually coded the data using open coding. Qualitative data analysis began after completion of the first interview. Concurrent data collection and analysis allowed determination of emerging themes and when a point of saturation was reached.⁽¹⁶⁾ Though data saturation occurred halfway through the analysis – no new themes emerged after analysis of the 15^th interview – an additional 15 interviews were conducted to confirm and maximize the strength of the results.⁽¹⁷⁾ Theory triangulation assessed the validity of the findings.

Survey data were reported as frequency distributions. PROMIS raw summed scores ranging from 2–10 were converted to T-scores, with 50 representing the mean and scores above and below representing better and worse disease states in comparison to the mean. The RAND-36 and CLDQ score on a scale of 0 to 100 and 1 to 7, respectively, with higher scores representing better quality of life.

Results

Sample construction

Of the 350 patients identified, 61 were adults on the liver transplant waiting list. Fifty-four of these were English speaking, had known demographic information and were eligible for recruitment. Of those eligible, 27/54 (50%) were at high risk for healthcare disparity, and half of the population interviewed, 15/30 (50%) were at high risk for healthcare disparity (Supplementary Figure 2).

Participant characteristics

Baseline characteristics are shown in Table 1. The median age was 56 years (range 32–72), 18/30 (60%) were White, 15/30 (50%) were women, 12/30 (40%) were publically insured, 13/30 (43%) were college educated, 12/30 (40%) were currently employed or retired, and 6/30 (20%) reported annual household income <$35,000. There was a median of 2 liver-related complications per patient (IQR 1–3). Median MELD scores by laboratory calculation and at transplant listing were 9 (IQR 7–14) and 12 (IQR 7–22), respectively. The median CTP score was 8 (IQR 6–10). Patients reported taking a median number of 7 daily prescription medications (IQR 4–10). Four of thirty patients (13%) were hospitalized over the past 90 days, and 16/30 (53%) were hospitalized over the past year. Median years between liver disease diagnosis and our interview, liver diagnosis and liver transplant listing, and time spent on the transplant waiting list was respectively 3 (IQR 2–9), 3 (IQR 1–7), and 1 (IQR 1–2). Assessment of PROs suggested worse quality of life compared to the general population in both physical and emotional domains, with lower summary component scores for fatigue, worry, role limitations due to physical health and social functioning (Table 1 and Supplementary Table 3).

Table 1:

Demographic and Clinical Characteristics of Interviewed Participants

Characteristic	N=30
Age, median (range) years	56 (32–72)
Men, N (%)	15 (50)
Race/ethnicity, N (%)
White	18 (60)
Black	5 (17)
Asian	2 (7)
Hispanic	2 (7)
Declined	3 (10)
Private Insurance, N (%)	18 (60)
College education, N (%)	13 (43)
Currently employed or retired, N (%)	12 (40)
Currently married or living with a life partner, N (%)	13 (43)
Currently sedentary, N (%)	6 (20)
Household income <$35,000, N (%)	6 (20)
Underlying liver disease, N (%)
Primary sclerosing cholangitis	9 (30)
Alcoholic liver disease	6 (20)
Autoimmune hepatitis	5 (17)
Non-alcoholic steatohepatitis	4 (13)
Hepatocellular carcinoma	3 (10)
Hepatitis C virus	1 (3)
Hepatitis B virus	1 (3)
Polycystic liver disease	1 (3)
Liver disease related complications and treatment, N (%)
Ascites	15 (50)
Diuretics
Both loop and potassium sparing diuretic	10 (67)
Varices	16 (53)
Non- selective beta-blocker regardless of bleeding	13 (81)
Experienced a variceal bleeding episode	8 (50)
Started on a non-selective beta-blocker	6 (75)
TIPS	6 (20)
Encephalopathy	20 (67)
Rifaximin	19 (86)
Lactulose	16 (67)
Hepatocellular carcinoma	6 (20)
Liver related complications per patient, median (IQR)	2 (1–3)
MELD-Na, median (IQR)
At which patient was listed for liver transplant	12 (7–22)
Based on laboratory calculation	9 (7–14)
Child-Turcotte-Pugh score, median (IQR)	8 (6–10)
Daily number of prescription medications consumed, median (IQR)	7 (4–10)
Hospitalization, N (%)
Past 90 days	4 (13)
Past year	16 (53)
Characteristics of liver disease in years, median (IQR)
Number of years since diagnosis	3 (2–9)
Number of years between diagnosis to liver transplant listing	3 (1–7)
Number of years spent on transplant waiting list	1 (1–2)
Health related quality of life
PROMIS Scale v1.2 – Global Health, mean (SD)
Physical	37 (4)
Mental	41 (4)
RAND 36-Item Short Form Survey, median (IQR)
General health	36 (16–56)
Chronic Liver Disease Questionnaire, median (IQR)
Summary score	5 (4–6)

SD=standard deviation; TIPS=Transjugular intrahepatic portosystemic shunt; IQR=interquartile range

Quality of care assessment using existing measures

Quantitative analysis of quality of care provided suggested that patients were receiving high quality of care – the median rating for patient-reported quality of care was 9 out of 10 (IQR 8–10) and quality of care as assessed by currently used quality metrics ranged from 6/8 (75%) to 20/20 (100%) (Table 2). While quantitative analysis of quality of care suggested patients received high quality of care, qualitative findings suggested that patient priorities were not measured by exisiting metrics.

Table 2:

Quality of care findings using existing measures and single question assessment

Quality metric adherence*
TIPS	6/6 (100)
Ascites	10/10 (100)
Varices	6/8 (75)
Hepatic Encephalopathy	20/20 (100)
Hepatocellular carcinoma screening	24/24 (100)
Quality of care rating on a scale from 0 (low quality) to 10 (high quality), median (IQR)	9 (8–10)

TIPS=Transjugular intrahepatic portosystemic shunt;

^*Adherence to proposed quality metrics was assessed according to Supplementary Table 1.

Does this and perhaps QOL need its own section? If not change the header above to be more inclusive—one of your key points is that standard metrics don’t work, yet standard metrics not emphasized enough that readers will notice them. BB

Qualitative Results

Interview length ranged from 20 to 80 minutes and averaged 40 minutes. A total of 752 codes were generated independently and subsequently narrowed to 320 codes when combined. Using a consensus-based approach, these codes were grouped into 125 sub-categories and 15 categories, from which 3 comprehensive categories were created and 5 emerging themes were determined (Supplementary Table 2 and Supplementary Figure 3). Themes were mapped to the existing quality of care framework proposed by Campbell et al,⁽⁵⁾ with expansion of the existing framework (Figure 1).

Figure 1:

Expanded Theoretical Quality of Care Framework for Patients with Liver Disease Listed for Liver Transplantation.

The theoretical framework expands upon the Campbell conceptual framework (5), which was an extension of the components of care first proposed by Donabedian (4). Our themes interact with the previous Campbell dimensions (Geography, Affordability, Availability, Interpersonal Care, and Clinical Care), connecting these dimensions and emphasizing the overall interrelationships among Structure, Process, Effectiveness, and Accessibility that affect patient perceived quality of care.

Theme 1: Managing expectations.

The liver transplant process is complex and costly, and involves management of very sick patients among different providers. Participants described feeling overwhelmed when initiating the process.

“At first I was overwhelmed because there are the lots of things that are required and there are lot of doctors.”

Participants offered several perspectives on how to overcome these feelings. Many articulated the importance of establishing a plan. This enables setting shared expectations between the providers and the patients and was cited as an important aspect of quality. Patients liked checklists as a clear way to navigate the process, as demonstrated by the quote:

“Everything was laid out to date. So all we had to deal with was like a checklist and everything was in order. It was all laid out so if I had to change any appointment I could easily change them prior and plan accordingly.”

Completing tasks takes time, and slowdowns in the process or delays in communicating transplant consideration was viewed as poor quality of care:

“The other hospital wasted my time. They put me on a study. They never considered putting me on a transplant list and it was a waste of time, 2.5 years of my life. I could have been on the list already.”

Managing expectations extends to health insurance. Failure to address how health insurance changes would affect care was articulated; one participant related:

“They (transplant office) want to know if your coverage changes, so I do wonder how would my quality of care be. Do I get treated differently when I do not have insurance, I don’t know but I want to find out.”

Theme 2: Providing education.

Waitlisted patients reported that misinformation or lack of information about liver transplant process resulted in avoidable high anxiety. For example, patients described confusion about the relationship between MELD scores and access to liver transplantation. They wanted more information on how the limited availability of organs would affect the process. Patients expressed frustration that they did not understand the role of the MELD score until too late in the process:

“I was on the list a year and half ago, I was MELD 14. Within four months, I got two phone calls. Today, I am MELD 30 and I have not gotten one offer. I had better chances when my MELD score was lower. They are giving you information that really does not apply.”

One participant shared that misunderstanding of the MELD score resulted in turning down a transplant opportunity.

“My MELD score was only 12, and I get a call from the surgeon saying he has a liver I want, a liver. It didn’t enter my head that they would give me a liver with a MELD score that low, I thought everybody else would go ahead of me. So I turned it down.”

Inadequate knowledge was also cited about “extended criteria donation” organs, which may require additional treatments (e.g., hepatitis B or C) or increase risk for post-transplant complications (e.g. cardiac death donation, older-aged donor). Accepting these organs increases the number of organs available for transplantation but patients must understand their risks and benefits. Though one participant consented to accept an extended criteria organ, when offered, the participant expressed frustration about feeling unprepared to make the decision. Part of the frustration stemmed from the lack of the information needed when having to make a quick decision:

“I agreed to accept extended criteria organs. I kind of felt that they got me to understand what I was doing until I got the call from the surgeon about an organ, the donor had Hep B and I felt completely unprepared to make a judgment. When they were giving me a call asking, “if you want to come in,” it didn’t give me adequate time to think about it. Information could be made available on the website.”

Theme 3: Responding to patient needs.

Patients expressed high regard for responsive providers who delivered personalized, respectful care that minimized exposure to system inefficiencies. Whether at clinic visits or during hospitalizations, provider responsiveness was cited as being inconsistent, which participants considered substandard care.

“For ***(transplant hepatologist) it (response to phone question) is like in certain minutes, and for other doctors, a lot of time I do not get answer.”

“They wouldn’t give me answers, I couldn’t get a hold of anyone. They were very rude.”

“Even if they don’t have a definitive answer, they could just tell me what they are suspecting and that they are waiting on this blood thing or whatever.”

“I think one important thing: I always knew what was happening and what I was there for and how long of a time I will be there.”

Even with optimized provider level responsiveness, process inefficiencies impair delivery of care. One participant stated:

“It is very hard to get a hold of people on the telephone. Once I am through, they are great. When you call the standard number, none of them (of the options) involve talking to somebody. It is all an answering machine.”

Responses that minimize patient interaction with structural inefficiencies were felt to be an important aspect of high-quality care.

“When they call back they know what I need. So if they get my voicemail they just leave a message, but I have got the answers. Much easier. I don’t have time to be chasing people around.”

Responding to patient needs included visit frequency. Some participants questioned the utility of quarterly outpatient visits, whereas others found regular visits to be useful for monitoring progress, managing expectations, asking questions, and keeping everyone up to date.

“I feel good about it (quarterly office visits). They keep everything in place. They will tell me what is now. What will happen in the future. What to look out for, you know, like this MRI, and what should be the next step.”

“I think that to see them regularly is very important because you got to get those questions answered.”

“Office visits keeps them abreast of what is going on with me for 3 months. I come every 3 months and things change in 3 months,”

Other patients found regular visits to be unhelpful or overly focused on laboratory values rather than actually helping the patient:

“There is no care, they (transplant hepatologist) are not doing anything to make me comfortable. They are not doing anything to make my situation any better. He (transplant hepatologist) is monitoring my results. You are just following the need of the doctors.”

Others found such monitoring psychologically stressful, emphasizing their illness more than they would like, such that one participant continued with laboratory testing but no longer came in for follow-up:

“I don’t care I don’t want to come a thousand times to see 1000 different people. Every 3 months my blood is drawn to make sure everything is okay. If there is an issue they can discuss it with me. I don’t really want to feel more sick or disgraced than what I am.”

Failing to take patient concerns seriously was viewed as poor quality of care:

“She (the nurse) just like did not take me serious. Like she put me in an emergency room and I was basically in tears, literally crying and asking somebody to help because I was like really passing a lot of blood. The most terrible experience I have ever had.”

Additionally, participants wanted each provider to offer their medical opinion.

“I would go and I would ask her (primary care provider) opinion. I would say, this doctor says this and this one says that, what do you think, and she said what they said. While I wanted her opinion, I was asking for her opinion and she didn’t give me. She said go to the specialists instead of looking at the information and giving me an honest view.”

Theme 4: Executing the care plan efficiently.

Executing the care plan in a way that minimized system inefficiencies experienced by patients was viewed as high quality care. This included completion of paperwork prior to arrival for scheduled laboratory or diagnostic procedures.

“I think the coordination was good. Every time I went there they had all of the paperwork ready and the blood work orders ready.”

“Whenever I have gone down for an x-ray or MRI you know, not of lot of waiting around.”

Inefficiencies in carrying out plans formed at a clinic encounter represented poor quality of care. For example, a delay in processing an insurance authorization resulted in significant emotional stress and eventual hospitalization of one participant:

“They discharged me on Monday. I went to him (transplant hepatologist) on Tuesday and he wanted a CT scan. So I was there on Tuesday and I am waiting for this authorization. Of course I did not get it by Friday. On Saturday, I felt so awful and my daughter gets so concerned and I was scared. And so, we went to the hospital and then I got an appointment for CT scan on Tuesday.”

Poor follow through was cited as poor quality of care. One patient described traveling to a clinic visit and then being informed the visit was canceled, inconveniencing the patient and causing financial burden. Failure to accommodate the patient was viewed as poor quality of care:

“It takes me an hour on the train and then I take either Uber or taxi to come to the hospital. It is a good journey to not be seen. That cost is way over $100 and then I am sitting in your office and you are telling me that we just rescheduled your appointment.”

Theme 5: interdisciplinary communication and coordination of care.

Patients on the liver transplant waiting list receive multidisciplinary care across healthcare settings within a system as well as across healthcare systems. Patients emphasized the importance of different care providers remaining up-to-date and coordinating their care.

“The hardest part for me was the ascites and how quickly they took care of that! I had so much fluid and I went over to see (the interventional radiologist). In about five days I was in surgery (TIPS procedure).”

To achieve this, participants expected excellent communication among multidisciplinary providers.

“Everybody should know what the other one is doing and how it is going to affect the other doctor, that is all.”

“He (transplant hepatologist) worked a lot with my primary care doctor. They kept him well informed.”

“To improve care, the communication between my primary doctor and all the liver doctors would be really really good because she has no idea of what I really go through. Sometimes duplicate testing is done, in terms of blood test or anything.”

Poor interdisciplinary coordination placed the burden of communicating between providers of different disciplines on the patient, which was disliked, difficult, and time consuming.

“I have to chase them, I have to tell them what is wrong and I have to say what I am going to do next.”

“Too much time was spent on me explaining things that the doctor should have already known and my visit was shortened because of that. Less time should have been spent on me having to tell the doctor the fact. The doctor should already be aware of the fact”

Participants related particular challenges with inter-hospital system care coordination. They wanted easy online access across all doctors and health systems:

“I do not think he (transplant hepatologist) has access to my records electronically. That would have helped if he could just go online and get every bit of information at the hospital or the office. That would be very helpful.”

Further supporting this, indirect delivery of information through online portals was valued by participants as an effective strategy to combat process inefficiencies, providing ready access to test results while empowering patients with the ability to follow their disease over time.

“It (the portal) gives me all the information that I need. I print tests and anything else that I have done.”

Another aspect related to transitions of care and multidisciplinary communication. Participants reported this was sometimes but not always optimal:

“You leave a message with the answering service and then the doctor will quickly call you back and then he will send the ambulance to my house to take me all the way to Cornell and then I do not wait. I am always seen quickly because the doctor already spoke to staff or the emergency or whatever.”

“Different department is giving different drugs, not knowing what disease you have. They were giving me a bunch of drugs and I said, “Please get this approved with the liver people before you give me any drugs.” Eventually, they finally did get the drugs approved.”

Mapping themes to Campbell’s conceptual framework

The themes that emerged from these interviews mapped to and expanded upon Campbell’s conceptual framework (Figure 1).⁽⁵⁾ Grey arrows pointing from dimensions toward our themes emphasize how dimensions affect our themes (Figure 1). Black arrows point away from the themes to represent the dimension, Clinical Care, affected by our themes (Figure 1). The themes that emerged from our study suggest that Structure, Process, Accessibility, and Effectiveness are more interrelated, emphasized by placing our themes in the middle of the figure. Our themes address issues important to providing quality care to medically complex patients that require multidisciplinary care, of which some were previously not accounted for in the Campbell framework – “Managing Expectations,” “Executing the Care Plan Efficiently” and “Interdisciplinary Communication and Coordination.”

Comparisons of our framework to existing quality of care assessments

Our five themes highlight issues important to patients when defining quality of care that are not captured by existing quality of care assessments (Table 3). The CAHPS® focus on user experience with the healthcare system, broken into composite scores and ratings, assesses parts of our themes as indicated in Table 3 by ‘+’ marks, though no theme was assessed entirely.⁽⁷⁾ The HEDIS, proposed liver disease quality measures, and the CLDQ all fail to assess any of the presented themes, suggested by the “x” marks in Table 3.^{(6, 8, 12)} Proposed PRO domains do not relate to the themes; while overall Satisfaction with Care is affected by the proposed 5 themes, the domain itself does not assess the five themes.⁽⁹⁾ Thus, themes found to be important to patients when defining quality of care do not appear to be captured by existing quality of care assessments.

Table 3:

Published Tools or Domains Assessing Quality of Care, Healthcare Derived Quality Metrics, Patient Reported Outcomes, or Liver Disease Specific Quality of Life Fail to Adequately Assess the Qualitative Themes

Assessment Tool or Published Domains of Interest	Theme*
	1	2	3	4	5
CAHPS® (7)
Composites
Getting Needed Care	×	×	×	+	×
Getting Care Quickly	×	×	+	×	×
How Well Doctors Communicate	×	×	×	×	×
Health Plan Information and Customer Service	×	×	×	×	×
Ratings
Rating of Personal Doctor	×	×	×	×	×
Rating of Specialist	×	×	×	×	×
Rating of Health Care	×	×	×	×	×
Rating of Health Plan	×	×	×	×	×
HEDIS (6)
Effectiveness of Care	×	×	×	×	×
Access/Availability of Care	×	×	×	×	×
Utilization	×	×	×	×	×
Risk Adjusted Utilization	×	×	×	×	×
Measures Collected using Electronic Clinical Data Systems	×	×	×	×	×
Healthcare Liver Disease Quality Metrics (8)
Use of TIPS	×	×	×	×	×
Management of Varices	×	×	×	×	×
Management of Ascites	×	×	×	×	×
Management of Hepatic Encephalopathy	×	×	×	×	×
Hepatocellular Carcinoma Screening	×	×	×	×	×
Domains of Patient Reported Outcomes (9)
Physical Symptoms	×	×	×	×	×
Physical Function	×	×	×	×	×
Mental Health	×	×	×	×	×
General Function	×	×	×	×	×
Cognition	×	×	×	×	×
Social Life	×	×	×	×	×
Satisfaction with Care	×	×	×	×	×
Chronic Liver Disease Questionnaire (CLDQ) (12)
Abdominal Symptoms	×	×	×	×	×
Fatigue	×	×	×	×	×
Systemic Symptoms	×	×	×	×	×
Activity	×	×	×	×	×
Emotional Function	×	×	×	×	×
Worry	×	×	×	×	×

CAHPS®=Consumer Assessment of Health Providers and Systems; HEDIS=Healthcare Effectiveness Data and Information Set; TIPS=Transjugular intrahepatic portosystemic shunt;

^*A ‘+’ and ‘x’ respectively represent the tool or domain assesses or fails to assess the theme.

Discussion

Increasingly, patients are listed for liver transplantation, and though evidence suggests varied patient experiences concerning for differences in quality of care provided,^(1–3) patient perspectives on quality of care have not been reported. Using qualitative methods we address this gap, identifying 5 themes that are important to patients when assessing quality of care that are not currently represented in existing quality of care measures (Table 3) and expand upon a previous quality of care framework (Figure 1). These findings suggest the limitations of current assessment of quality of care and overall assessment of quality of care via rating; while our patient population appeared to be receiving evidence based care (a current quality metric in this population, Supplementary Table 1) and rated the overall quality of their care as high, qualitative analysis contradicts these findings, suggesting areas of interest to patients that are going unrecognized. While two of the themes map to an existing quality of care framework,⁽⁵⁾ the other three themes more specific to patients requiring multidisciplinary care were not previously represented. This suggests that a patient-derived quality of care instrument may be helpful in improving delivery of high quality healthcare and clinical outcomes.

The themes shift emphasis away from the compartmentalized Campbell and Donabedian frameworks,^(4,5) refocusing attention on the interrelationship of these compartments (Structure, Process, Accessibility, and Effectiveness) and dimensions (Geography, Availability, Affordability, Interpersonal Care, and Clinical Care) (Figure 1). Shifting focus highlights the evolving healthcare system and the challenges our healthcare system faces as more specialized medical professionals⁽¹⁸⁾ care for more medically complex patients.⁽¹⁹⁾

While our themes were derived from a pre-transplant population, components have applicability to other healthcare populations. Themes 1 and 2 have previously been associated with high quality healthcare in general patient populations.⁽²⁰⁾ Recognizing the individual needs of patients (theme 3) has long been advocated for in the healthcare sector.⁽²¹⁾ The need to complete paperwork and obtain approvals from health insurance companies (theme 4), appears to be a growing problem that is not unique to patients awaiting liver transplantation.⁽²²⁾ Lastly, the worse outcomes in fragmented care (theme 5) have been observed across disease populations.⁽²³⁾ While our five themes derived from liver transplant candidates, the themes may have broader clinical applicability, particularly for patients requiring complex multidisciplinary care, e.g. hepatobiliary malignancy.

Our expanded framework is supported by other published quality of care and access to care frameworks and aims in the literature. A prior report in the Iranian healthcare setting proposed a conceptual framework of quality of healthcare, reporting intangible influences (empathy, efficiency, effectiveness, efficacy) and a single tangible influence (environment), all of which are represented in our themes (Figure 1).⁽²⁴⁾ Themes identified in our study are represented in the framework for access to healthcare presented by Aday and Andersen, which includes consumer satisfaction that is shaped by convenience, costs, coordination, courtesy, information, and patient judgment of quality of care delivered.⁽²⁵⁾ Additionally, our themes are represented in the six specific aims previously proposed within the Institute of Medicine on how to improve delivery of care – Effective, Patient-centered, Timely, Efficient, Safe and Equitable care.⁽²⁶⁾ The representation of our themes in previously published quality of care work further highlight the importance of incorporating patient perspectives into our current assessment of quality care.

Not only does the generalizability and the representation within previously published quality of care frameworks and aims support the importance of our patient-derived themes, but also shifts in reimbursement practices emphasize the necessity of comprehensively defining delivery of quality care. The merit-based incentive payment system (MIPS) bases reimbursement on a score, 50% of which centers on quality of care.⁽²⁷⁾ Other programs put forth by the Centers for Medicaid and Medicare services (CMS) further emphasize the importance of defining quality from the patient perspective, as work moves towards creating the quality of patient care star ratings methodology.⁽²⁸⁾

Strengths and Limitations

Strengths of our study include the rigorous qualitative methods used to conduct the study. We expanded upon an existing conceptual framework to develop a more relevant, clinically applicable quality of care framework. The fact that all patients attended a single academic institution could impact the generalizability of the findings; however, the purpose of a qualitative study is to generate hypotheses rather than to produce definite generalizable findings. While the interviews were restricted to a pre-transplant population, the themes reached appear to have broader applicability in diseases requiring multi-disciplinary care. While surveying a larger sample of patients could be done to confirm the generalizability of these findings, the data saturation and the overwhelming discrepancies in patients’ definitions of what constitutes quality of care with what is currently being assessed suggest that future work exploring assessment of the 5 themes and impact on clinical outcomes is necessary.

Conclusion

In healthcare, assessment of the quality of care delivered is a high priority, but it is unknown how patients define quality of care and if this is being captured. This study identified 5 themes that patients on the transplant waiting list perceive to constitute quality of care, all of which are not adequately represented in existing quality of care tools. This suggests that creation of a patient-derived quality of care tool could improve the quality of care provided to patients and overall clinical outcomes.

Glossary

List of abbreviations:

HEDIS

Healthcare Effectiveness Data and Information Set

AHRQ

Agency for Healthcare Research and Quality

CAHPS®

Consumer Assessment of Health Providers and Systems

PROs

Patient-reported outcomes

HRQOL

Health-related quality of life

ICD

International Classification of Diseases – 9^th edition

HE

Hepatic encephalopathy

HCC

Hepatocellular carcinoma

TIPS

Transjugular intrahepatic portosystemic shunt

CTP

Child-Turcotte-Pugh

MELD

Model for End-Stage Liver Disease

PROMIS

Patient Reported Outcomes Measurement Information System

CLDQ

Chronic Liver Disease Questionnaire

MIPS

Merit-based incentive payment system

CMS

Centers for Medicaid and Medicare services