Disease and medication burden of medically complex adolescents seen in an interdisciplinary transitional care clinic

Abstract

PURPOSE:

Transitional care for adolescents with complex diseases, who are entering adulthood, is challenging. The purpose of this study is to quantify the disease and medication burden of this population, who are transitioning though an interdisciplinary specialty clinic.

METHODS:

This study is a retrospective observational study of all patients seen in a transitional care clinic between July 2012 and March 2015. The main outcomes assessed included disease state and medication burden. Descriptive statistics, along with the paired t-test and McNemar’s test, were used.

RESULTS:

The study cohort included 216 patients. The median patient age was 20.7 years, and the median number of clinic encounters was 6. Patients had at least 1 of 8 primary diagnoses. On average, patients took medications from 5 classes and used 3 dose forms. Among 163 patients who had medication reconciliation performed, the average number of medication classes increased by 0.44±1.53 (p = 0.0003). There was an average increase of 3.70%(SD±36.31%; p = 0.27) in the number of required medication lab assessments ordered for patients who had medication reconciliation performed.

CONCLUSION:

There is a high disease and medication burden among adolescent patients with complex disease states who are to transition to adult care.

Keywords

Complex care pharmacist polypharmacy transitions

Abbreviations

CCC

Comprehensive Care Clinic

ICD9

International classification of diseases, ninth revision

IQR

interquartile range

MTM

medication therapy management

SAS

statistical analysis system

1 Introduction

A formalized transition process for adolescents with complex diseases is an important process in the care of these patients. Health care transition is defined as the process of moving a child to an adult model of health care with or without a transfer to a new clinician [1]. The care of children with medical complexity often requires assessment and follow-up with one or more specialists creating a more difficult transition process. During childhood, the burden of patient care, including knowledge of the patient’s disease state(s) and therapy, is often placed on the patient’s parent(s) or guardian(s) [2]. As the patient nears adulthood, responsibility for their care often must be assumed by the patient themselves. Transferring care at this critical time to adult primary medicine and specialty providers, without a transitional care plan, has been found to be inadequate to cope with the healthcare needs of this patient population [3 –8].

Children with medical complexity not only have a high disease burden, but also a high medication burden as well [9 –11]. Medication adherence rates have been found to decline, during the transition from pediatric to adult care [11 –13]. In addition, necessary therapy may be interrupted for patients during the care transition [14, 15]. Families of children with medical complexity also find that their health care needs, regarding prescription medications, are not adequately met [16]. Other investigations have found that medication therapy knowledge to be low in patients who were transitioning to adult care [2, 17]. All of these elements present opportunities for involvement of additional health care providers, such as pharmacists, during the transitional care period for children with medical complexity.

To address the unique care challenges of children with medical complexity who are entering adulthood, Geisinger implemented an interdisciplinary transitional care clinic specifically focused on creating a higher level of care for these individuals. The Comprehensive Care Clinic (CCC) is an ambulatory clinic for adolescent patients with chronic and often complex pediatric disease states who are transitioning or have transitioned into adulthood. While enrolled in the CCC, patients are provided comprehensive care to address both their pediatric chronic diseases and the many additional chronic disease states that manifest in adulthood.

The CCC operates under the principles of a complex care clinic via a dedicated multidisciplinary team. This includes internal medicine-pediatrics trained physicians, a registered nurse case manager, and clinical pharmacist. Features of the CCC that are unique include: extended visits (up to 60 minutes), comprehensive assessment, medication reconciliation by a clinical pharmacist with focus on medication interactions and safety monitoring, development of a patient centric care plan including exacerbation plans, and self-management education and training. These interventions have been shown to reduce healthcare utilization through a total decrease in emergency department utilization, hospitalizations, and an increase in primary care access [19].

Geisinger’s CCC integrates a clinical pharmacist in the practice model to aid in safe and effective medication use in medically complex patients. The clinical pharmacist’s role is to perform comprehensive medication reviews for all patients enrolled in the CCC. The pharmacist also makes recommendations for consolidation, escalation, or de-escalation of drug therapies, identifies drug-drug interactions or therapeutic duplications, and monitors medications with narrow therapeutic indices. A collaborative practice agreement with the physician in the CCC allows the clinical pharmacist to order labs, renew medications, and assume management of certain chronic diseases including diabetes, chronic pain, and anticoagulation. The clinical pharmacist discusses every case with the physician to develop a comprehensive plan for medication prescribing, adjustment, and monitoring.

The objective of this study was to explore the epidemiology of the patient population in the CCC by quantifying the disease and medication burden of the patients and the change over time while part of the CCC.

2 Methods

A retrospective observational study was conducted within the Geisinger CCC in Danville, Pennsylvania. Patients enrolled in the clinic receive care from various providers, depending on their needs. At a minimum, they are all seen by a physician Board Certified in internal medicine and pediatrics, and may also receive care from a clinical pharmacist, and a registered nurse case manager. The protocol was approved by the Geisinger Institutional Review Board. All patients whose first CCC encounter occurred between July 1, 2012 and March 31, 2015 were included. Data for these patients was collected from July 1, 2011 to March 31, 2016. Patients were excluded if they did not show up to their appointment despite medication reconciliation completed by the pharmacist.

All patient data were obtained from the electronic health record. The main outcomes assessed included disease state and medication burden. Primary diagnoses were identified using International Classification of Diseases, Ninth Revision (ICD-9) codes due to the time frame of the study. Additional disease states were identified through ICD-9 codes in the patient’s problem list and outpatient and inpatient encounters. A secondary outcome evaluated included medication-related laboratory monitoring. Outcomes were assessed at the time of patient enrollment in the CCC and again one year later. All data documented within a 90-day window of one year from the baseline CCC encounter was considered in evaluation of the one-year follow-up outcomes. Only patients who had medication reconciliation performed at both clinic enrollment and within the follow-up period were assessed for medication related laboratory monitoring. Performance of medication reconciliation was verified through documentation in the electronic health record. Medicine reconciliation is completed with the pharmacist with direct questioning of all medications in the medical record, review of medication lists with the patient and/or caregiver and use of other electronic medical record tolls including direct pull of medications from pharmacy databases.

Descriptive statistics were used to assess the patient population enrolled in the CCC as well as overall disease and medication burden. Changes in medication burden and laboratory monitoring from CCC enrollment to follow-up were compared using paired t-tests for continuous variables and McNemar’s test for categorical variables. All statistical analyses were performed using SAS version 9.4 (SAS Institute, Cary, NC). P-values less than 0.05 were considered statistically significant.

3 Results

The final study cohort included 216 patients seen in the CCC between July 1, 2012 and March 31, 2015. General demographic information for the study population, including disease and medication burden, are provided in Table 1. The median number of CCC encounters during the study period was 6 (IQR 3, 11). Among the study sample, 59 patients (27.3%) had over ten encounters in the CCC during the study period. The median number of days between the initial and first follow-up encounter was 119 (IQR 77, 197).

Table 1
Baseline Demographics, Disease and Medication Attributes of Study Population

Characteristic Patients (N = 216)

Median (IQR)

Age 20.7 (18.8, 23.2)

Number of medication classes 5 (2, 7)

Total medication dose forms 3 (2,4)

Number (%) of Patients

Male sex 130 (60.2)

Non-obese (BMI < 30 kg/m²) 161 (75.2)

Primary diagnosis

Autism 37 (17.1)

Cerebral palsy 16 (7.4)

Epilepsy 23 (10.6)

Genetic disorder 54 (25.0)

Intellectual disability 21 (9.7)

Psychiatric disorder 15 (6.9)

Spina bifida 20 (9.3)

Other 30 (13.9)

Secondary Diagnosis

GERD 74 (34.3)

Constipation 72 (33.3)

Epilepsy 56 (25.9)

Intellectual disability 105 (48.6)

Scoliosis 48 (22.2)

Obesity 40 (18.5)

Neurogenic bowel 7 (3.2)

Neurogenic bladder 15 (6.9)

Osteoporosis/Osteopenia 22 (10.2)

Cerebral palsy 58 (26.9)

Restrictive lung disease/asthma 60 (27.8)

Medication Classes

Anti-infectives 50 (23.1)

Antineoplastics 5 (2.3)

Biologics/Immunologics 9 (4.2)

Central Nervous System 173 (80.1)

Cardiovascular 47 (21.8)

Dermatological 72 (33.3)

Medication device 95 (44.0)

Endocrine/metabolic 69 (31.9)

Gastrointestinal 134 (62.0)

Genitourinary 34 (15.7)

Hematological 6 (2.8)

Nutrient/Nutritional 139 (64.4)

Ophthalmic 17 (7.9)

Otic 8 (3.7)

Oxygen 14 (6.5)

Pulmonary 114 (52.8)

Characteristic	Patients (N = 216)
	Median (IQR)
Age	20.7 (18.8, 23.2)
Number of medication classes	5 (2, 7)
Total medication dose forms	3 (2,4)
	Number (%) of Patients
Male sex	130 (60.2)
Non-obese (BMI < 30 kg/m²)	161 (75.2)
Primary diagnosis
Autism	37 (17.1)
Cerebral palsy	16 (7.4)
Epilepsy	23 (10.6)
Genetic disorder	54 (25.0)
Intellectual disability	21 (9.7)
Psychiatric disorder	15 (6.9)
Spina bifida	20 (9.3)
Other	30 (13.9)
Secondary Diagnosis
GERD	74 (34.3)
Constipation	72 (33.3)
Epilepsy	56 (25.9)
Intellectual disability	105 (48.6)
Scoliosis	48 (22.2)
Obesity	40 (18.5)
Neurogenic bowel	7 (3.2)
Neurogenic bladder	15 (6.9)
Osteoporosis/Osteopenia	22 (10.2)
Cerebral palsy	58 (26.9)
Restrictive lung disease/asthma	60 (27.8)
Medication Classes
Anti-infectives	50 (23.1)
Antineoplastics	5 (2.3)
Biologics/Immunologics	9 (4.2)
Central Nervous System	173 (80.1)
Cardiovascular	47 (21.8)
Dermatological	72 (33.3)
Medication device	95 (44.0)
Endocrine/metabolic	69 (31.9)
Gastrointestinal	134 (62.0)
Genitourinary	34 (15.7)
Hematological	6 (2.8)
Nutrient/Nutritional	139 (64.4)
Ophthalmic	17 (7.9)
Otic	8 (3.7)
Oxygen	14 (6.5)
Pulmonary	114 (52.8)

BMI = body mass index; CCC = Complex Care Clinic; CNS = central nervous system; GERD = gastroesophageal reflux disease; ICR = interquartile range.

Among patients in the study cohort, 163 had a medication reconciliation performed one year after their initial CCC encounter. While the median number of medication classes remained the same at one year, the mean change in medication classes showed a significant increase (mean change of 0.44; 95%CI for mean: 0.20, 0.68; p = 0.0003). Table 2 shows the utilization of each medication class at baseline and after twelve months.

Table 2

Change in Medication Utilization by Class

Medication Class	Baseline (n = 163)	Twelve Month Follow-Up (n = 163)	P Value^a
	Number (%) of Patients
Anti-infectives	41 (25.2)	48 (29.4)	0.20
Antineoplastics	2 (1.2)	2 (1.2)	1.00
Biologics/Immunologics	8 (4.9)	8 (4.9)	1.00
Central Nervous System	133 (81.6)	145 (89.0)	0.01
Cardiovascular	32 (19.6)	40 (24.5)	0.03
Dermatological	59 (36.2)	79 (48.5)	<0.05
Medical device	78 (47.9)	76 (46.6)	0.53
Endocrine/metabolic	61 (37.4)	55 (33.7)	0.11
Gastrointestinal	107 (65.6)	119 (73.0)	0.01
Genitourinary	26 (16.0)	27 (16.6)	0.78
Hematological	5 (3.1)	6 (3.7)	0.65
Nutrient/Nutritional	110 (67.5)	125 (76.7)	<0.05
Ophthalmic	13 (8.0)	11 (6.7)	0.41
Otic	8 (4.9)	8 (4.9)	1.00
Oxygen	13 (8.0)	15 (9.2)	0.31
Pulmonary	88 (54.0)	92 (56.4)	0.37

CNS = central nervous system. ^aChanges in pre/post utilization were evaluated with a McNemar’s test for each medication individually. As patient could have been taking medications from multiple classes a McNemar’s test was used to evaluate pre-post utilization changes in each medication class separately.

Table 4

Change in # of Required Labs from Baseline to 12 Month Follow-up

	N (%)
Increased (ranged from 1 to 10)	69 (42.3%)
Decreased (ranged from 1 to 6)	24 (14.7%)
No Change	70 (42.9%)

Table 5

Change in # of Required Labs from Baseline to 12 Month Follow-up

	N (%)
Increased
1	29 (17.8%)
2	9 (5.5%)
3	18 (11.0%)
4	4 (2.5%)
5	5 (3.1%)
6	2 (1.2%)
8	1 (0.6%)
10	1 (0.6%)
No Change
0	70 (42.9%)
Decreased
–1	10 (6.1%)
–2	7 (4.3%)
–3	2 (1.2%)
–4	3 (1.8%)
–5	1 (0.6%)
–6	1(0.6%)

Within the entire study population patients were on a median number of 2 medications (IQR 0, 4) that required regular laboratory monitoring upon enrollment in the CCC. A total of 159 (73.6%) patients were on at least one medication that required laboratory monitoring. The median number of required medication-related laboratory assessments within the study cohort was four (IQR 0, 6). Changes in medication-related laboratory monitoring for patients who had medication reconciliation performed at clinic enrollment and during the follow-up period are provided in Tables 3 through 5.

Table 3

Changes in Medication-Related Laboratory Monitoring

Laboratory Monitoring	Baseline (n = 163)	Twelve Month Follow-up (n = 163)	P-Value^b
Number of required labs, median (IQR)	4 (0, 7)	5 (2, 8)
Change in number of required labs, mean (95%CI for mean)	0.73 (0.40, 1.06)		<0.01
Percent of required labs ordered, median (IQR)^a	62.0 (20.0, 80.0)	66.7 (33.3, 85.7)
Change in percent of required labs ordered, mean (95%CI for mean)^a	3.70 (–2.92, 10.32)		0.27

IQR = interquartile range; CI = confidence interval. ^aBased on an N of 118 patients with at least one laboratory assessment needed at both baseline and follow-up. ^bChanges in pre/post utilization were evaluated with paired t-tests.

4 Discussion

Overall, disease and medication burden were high in an ambulatory clinic that specializes in the care of adolescents with complex pediatric diseases who have transitioned into adulthood. Patients included in the study sample had a variety of primary and secondary diagnoses, and the majority had at least one half-dozen CCC encounters within a twelve-month period following their initial encounter. Time between the initial and first CCC follow-up encounter was also short, with about half occurring in under four months. Some patients however did have greater than twelve months between visits.

Regarding medication burden, half of the patients were on medications from at least five medication classes, composed of a median of three different dose forms. This medication burden is similar to that seen by Cohen and colleagues, who demonstrated children using high spending medications may be on six or more drug classes [18]. This study highlights the high polypharmacy burden for patients with complex medical illness and the need for continued medication monitoring and evaluation of polypharmacy burden.

Overall, the medication burden also increased during the study period, with a higher percentage of patients being prescribed medications from most classes at the twelve-month follow-up period. There was a particularly high burden of central nervous system, gastrointestinal and nutritional agents, with a significantly higher percentage of patients being prescribed medications from these classes after enrollment in the CCC. Significantly more patients were also prescribed cardiovascular and dermatological agents. There are several potential explanations for the increase in medication burden including, but not limited to, a comprehensive medical assessment revealed poorly controlled disease states requiring new medications or escalation of therapy, a more in-depth medication reconciliation improved the accuracy of the patient’s medication list, and patients were prescribed additional medications to serve as rescue kits for disease exacerbations. A previous study of this population showed a total increase in prescription drug use that was not statistically significant overall for Medicaid patients within the CCC [19].

As expected with such a high medication burden, patients within the study cohort also required several laboratory assessments related to medication use. The number of medication-related laboratory assessments increased significantly within the first year of enrollment in the CCC. This is likely attributed to the increase in medication burden and an improved level of monitoring opportunity identification. It may also be due to the added involvement of a clinical pharmacist, in the care of these patients after enrollment in the CCC. The clinical pharmacist reviews each medication list with the physician at the time of visit, as well as what laboratory monitoring is required in real time. The percentage of laboratory assessments related to medication use also increased after clinic enrollment, but the change in the percentage ordered was not significant.

This is perhaps the first study to review disease and medication burden in a diverse population of patients with complex pediatric disease states who have transitioned into adulthood through a specialized transitional care clinic. Previous studies of pediatric transitional care services have included patients with specific disease states such as diabetes [20], heart disease [21] and kidney disease [22]. One previous study included patients with at least one of three disease states, but utilized a technology intervention to facilitate independent care transition into adulthood, instead of a traditional clinic-based intervention [23]. Another study investigated a comprehensive transitional care program, but focused on adolescents requiring long-term anticoagulation for various disease conditions [24].

Providing comprehensive health care to adolescents with complex disease states who are transitioning into adulthood is complex and challenging. The best model of transitional care that produces the best outcomes for this patient population is difficult to determine. In addition, various factors, such as age, gender, and ecological factors, have been shown to affect successful transition of these patients to adult health care services [11 , 25]. There is a paucity of data regarding clinical outcomes for this population, and what works for one disease state may not work for others. One institution successfully implemented a transition program for adolescent patients with Type I diabetes mellitus without detrimental effects on outcomes [20]. Mackie and colleagues reported an improvement in self-management and knowledge for patients with congenital heart disease who attended an individual educational session [21]. A small trial of 19 patients who received comprehensive adolescent transitional care for chronic vitamin K antagonist anticoagulation showed high success in maintaining time-in-therapeutic-range for the INR, as well as other therapeutic outcomes assessed [24]. Another small single-center trial showed a decrease in rejection rates for adolescents with a recent kidney transplant who were enrolled in a comprehensive transitional care program [26]. In a cohort of 81 adolescents with chronic diseases, Huang and colleagues demonstrated that a web-based and text-delivered disease management and skill-based intervention improved patient disease management tasks, health-related self- efficacy, and patient-initiated communications [23].

While Geisinger’s CCC incorporates the involvement of a pharmacist, little evidence exists regarding the involvement of pharmacists in the care of such a unique patient population. The clinical pharmacist in the CCC was integral in assessing accurate medication reconciliation, education of patients and their families about medications and possible interactions, and provided routine phone monitoring when medication changes were made. The increase in health literacy, by the patient and family, appeared to have a subjective improvement in medication compliance, when evaluating disease screening scores (HgbA1c) or drug levels. One report of pharmacists providing medication therapy management services (MTM) to medically complex children in a medical home model reported over 110 medication related problems identified within a 15 month period [9]. Another study found that among the patients identified in a pediatric behavioral health center who would qualify for MTM services, more than half had incomplete medication regimens [29]. While conducted in children with special health care needs, a pilot study found an overall decrease in hospital admissions and 30-day readmission, and a 40%decline in days of hospitalization with pharmacist-led care coordination [30].

Because of the unique knowledge and skills pharmacists bring to patient care, their involvement in the care of medically complex children and adolescents has been advocated. The authors of one study that found an unmet need regarding prescription medications and care coordination among children with medical complexity concluded that pharmacists could bring a perspective and expertise that is usually not present [16]. Another mixed methods study involving pharmacists and other health care providers, who care for pediatric patients with juvenile arthritis, identified specific enhancements to pharmacy services within the British Health System for pediatric patients with complex disorders [30]. Finally, others have identified the Patient Protection and Affordable Care Act in the United States as a potential opportunity for pharmacists to engage in the care of pediatric patients, especially those with medical complexity, through the patient-centered medical home and accountable care organization models [32].

There are obvious limitations to this study. As a single center study, the population observed in this study may be dissimilar to that enrolled in a clinic comparable to that of the CCC. Also, this was a retrospective study, which did not allow us to determine the impact of clinical judgement and decision making on patient outcomes. Additionally, due to the limited observation time of study subjects, data was limited that allowed assessment of being enrolled in the CCC on outcomes beyond medication evaluation. Longer observation may have shown different results on the impact of medication reconciliation. The data that was gathered also could not determine the influence of individual providers within this interdisciplinary clinic. For instance, the data collected did not include which provider performed medication reconciliation for patients in the CCC. Understanding the impact of individual providers in such a unique clinic could influence change that could further affect patient care.

5 Conclusion

A high degree of disease and medication burden was found in a population of adolescents with complex disease states who had transitioned to adult care within an interdisciplinary specialty clinic. The transitional process to adult care for pediatric patients with medical complexity is an important and challenging process. Considering the high degree of medication burden found in this study, further investigation of a clinical pharmacist role within the transitional and complex care clinics is needed. This review will determine if the integration of a clinical pharmacist will improve the accuracy of medication reconciliation, lab monitoring, and medication compliance.

Footnotes

Acknowledgments

The study was approved by Geisinger Institution Review Board and internal funding paid for biostatics core time and effort.

Conflict of interest

The authors have no conflict of interest to report.

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