Doctor of Nursing Practice (DNP) Project
Running head: DNP PRACTICE IMPROVEMENT PROJECT
Developing and Implementing a Protocol to Treat Comorbid Bipolar
and ADHD with Vyvanse (A Stimulant) in the Outpatient Setting
Jeffrey Day, RN, MSN, APRN, PMHNP-BC
NU 716: OL CEO 01
Evidence Based Practice II
University of Massachusetts-Boston
Fall 2016
Abstract
Problem Description: Proper screening and correct diagnosing is critical in distinguishing attention deficit hyperactivity disorder (ADHD) from the presence of bipolar disorder.
Available Knowledge: Some small studies of children and adolescents with comorbid ADHD and BPD have shown that treatment with a mood stabilizer and a psychostimulant can control both sets of psychiatric symptoms.
Rationale: This proposal is grounded in Hildegard Peplau’s Interpersonal Theory. Basically, the project seeks to help the patient reach health goals as the person’s needs develop through education, therapy, and supportive interpersonal processes.
Specific Aims: The purpose of this project is to demonstrate that using three assessment tools, the Vanderbilt Assessment Scale, the Patient Health Questionnaire-9 (PHQ-9), and the Young Mania Rating Scale (YMRS) can assist the provider in distinguishing whether a bipolar patient is truly experiencing ADHD symptoms or just an exacerbation of mood dysregulation and subsequently whether stimulant use is appropriate or not for a bipolar patient.
Methods: The project leader will need to identify who the staff are in this project and what specific role each one will play. The most critical intervention will include the prescribing of a stimulant and determining who will prescribe that stimulant. The project centers upon the development of a protocol that basically has nine steps involved in the intervention. If appropriate, Vyvanse 10 mg once daily, will be prescribed for 14 days and follow up appointments are given every 2 weeks.
Measures: The project will focus on patients that are specifically diagnosed with bipolar disorder exhibiting poor concentration, poor focus, and a poor attention span. One very important outcome is the prevention of treatment delay.
Analysis: 95% of the patients will take medications as prescribed as compared to the 50% national benchmark. 11% of people diagnosed with ADHD do not know about stimulant use for the treatment of ADHD. 95% of the patients will keep all outpatient appointments. Approximately 33% do not nationally. At least 65% of people report a reduction in the Vanderbilt Scale after 2 weeks of stimulant therapy. 45% of annual emergency room visits can be contributed to ADHD symptoms. 100% of patients will not present to an ER for ADHD symptoms.
Ethical Considerations: Almost every process improvement project that generate knowledge, including quality improvement projects, can create some risks to the participants and those risks need to be identified, examined and accounted for. This project proposal takes human rights and informed consent to the highest degree
Developing and Implementing a Protocol to Treat Comorbid Bipolar
and ADHD with Vyvanse (A Stimulant) in the Outpatient Setting
I. Problem Description
Comorbid attention-deficit/hyperactivity disorder (ADHD) is nearly universal in youths with bipolar disorder (BPD), and comorbid
mania has been noted in 16% of individuals with ADHD. 6 Proper screening and a correct diagnosis are critical in distinguishing
attention deficit hyperactivity disorder (ADHD) from bipolar disorder. Bipolar patients with co-comorbid ADHD perform worse on
tasks that require attention and a working memory than those with bipolar disorder alone. Patients with ADHD and a comorbid
bipolar disorder show a much higher emotional intensity than those with bipolar disorder alone. ADHD screening measures with
the Vanderbilt Assessment Scale and bipolar depression screening tools that use the PHQ-9, and bipolar mania screening tools that
use the Young Mania Rating Scale (YMRS) combined with adequate patient education, significantly facilitate discriminate between
the presence of ADHD and the presence of elevated bipolar symptoms and help the patient to make better informed decisions
regarding ultimate treatment with psychostimulants.
Choosing certain medications for these complex patients is sometimes difficult because psychostimulants could worsen mania
and mood stabilizers might not resolve ADHD symptoms such as poor concentration, poor focus, and poor attention span. There is
little information regarding combining psychostimulants with mood stabilizers or atypical antipsychotics. ADHD and bipolar
disorder (BPD) symptoms often overlap, and various clinicians disagree on which symptoms indicate coexisting ADHD versus
bipolar. Multiple daily mood swings and irritability commonly occur in both disorders, sometimes making it very difficult to
establish a differential diagnosis. Treating ADHD and bipolar together generally requires more than one medication. Thus, the use
of stimulants is becoming increasingly common.
II. Available Knowledge
The PICO question (Appendix A) does address a local and national problem that many outpatient psychiatric providers face
today. It does fit a national priority question and it does fit the framework for a performance improvement project. The surge of
ADHD diagnoses in the country coupled with the presence of bipolar has sparked an interest by the National Institute of Mental
Health as well as the HCH Clinician Network. Using proven assessment models is the cornerstone to determine the presence of
ADHD in a bipolar disorder. Behavioral health disorders account for as much as 69% of hospitalizations among many acutely ill
adults, many of whom have bipolar and a co-occurring mental health diagnosis such as ADHD. 10 The PICO question does identify
a problem question because it follows evidence based practice guidelines.
Some small studies of children and adolescents with comorbid ADHD and BPD have shown that treatment with a mood
stabilizer and a psychostimulant can control both sets of psychiatric symptoms. Stimulant use can safely reduce ADHD symptoms
without exacerbating tics or tremors in patients at risk. Many clinicians are faced with the question of what to treat first-the
ADHD or the bipolar disorder. Others must consider how to individualize combination therapy. There are many challenges that
come with comorbidity and dual treatment protocols. One study found that lithium plus a psychostimulant improved attention and
hyperactivity symptoms more effectively than either agent alone. 3 One retrospective analysis found that ADHD symptoms were
7.5 times more likely to improve if the mood was stabilized before rather than after ADHD treatment with stimulants. 2 For initial
treatment, many studies suggest prescribing a mood stabilizer first and then adding a stimulant once the mood is well sustained.
Medication side effects, potential interactions, compliance, adherence, and cost are all very important factors to consider when
implementing a protocol using stimulants in bipolar patients. If ADHD symptoms continue to present after the patient’s mood has
stabilized, then a trial period of psychostimulant therapy should be highly considered. Academic and social functioning will
generally improve once the stimulant has been initiated. Many times, a depressive or a mixed episode of mood dysregulation can
occur after the stimulant has been introduced. Some clinicians fear that psychostimulants will destabilize a stable patient’s mood.
One analysis of patients from the National Institute of Mental Health showed that extreme manic symptoms such as rapid and
pressured speech, grandiose delusions of identity, and tangential thought processes during stimulant therapy is highly unlikely and
even quite uncommon. 5
III. Rationale
This proposal is grounded in Hildegard Peplau’s Interpersonal Theory. Basically, the project seeks to help the patient reach health
goals as the person’s needs develop through education, therapy, and supportive interpersonal processes. A felt need is present by
the patient to control ADHD symptoms, and thus the psychiatric nurse practitioner will form a needed clinical relationship with the
patient. Peplau’s model fits this proposal as her theory is very popular with providers working with patients who have psychiatric
problems. 9 The need for a partnership between the patient, the provider, and the other staff involved in the project is very
substantial to this project’s success. A strong framework by which to process this project is crucial to help the staff and the patient
develop therapeutic interventions aimed at alleviating the patient’s symptoms. Vyvanse is the stimulant of choice for this protocol
because it has a long release which lessens the opportunity for abuse and misuse. It works consistently and has predictable release
patterns. Absorption is also not highly affected by meal intake.
IV. Specific Aims
The purpose of this project is to demonstrate that using three assessment tools, the Vanderbilt Assessment Scale, the Patient
Health Questionnaire-9 (PHQ-9), and the Young Mania Rating Scale (YMRS) can assist the provider in distinguishing whether a bipolar
patient is truly experiencing ADHD symptoms or just an exacerbation of mood dysregulation and subsequently whether stimulant
use is appropriate or not for a bipolar patient. The purpose of this report is to highlight and display the process of pulling it all
together and formulating a protocol to ultimately alleviate the patient’s symptoms and establish certain evidence-based guidelines in
treating this population with these two comorbid conditions. Creating a protocol to initiate and continue stimulant therapy will
ultimately identify those patients most at risk for decompensation and prevents potential harm to those patients whom stimulant
therapy might be contraindicated or not otherwise safe for prescribing.
V. Methods
Context
The situation that the protocol calls for is identifying patients with bipolar who have comorbid ADHD symptoms and poor
symptom management where the individual nurse practitioner prescribes the stimulant but also looks at the patient wishes and
the provider needs. The patients’ needs and wishes are priority. Symptom exacerbation, patient desires, provider time, and both
patient and leader educational needs are top priorities.
The protocol has certain investments. If the staff, consisting of one psychiatric nurse practitioner, one Chief Executive Officer
(CEO), one Administrative Assistant, and one psychotherapist, are present and willing then there must be a determination if there
is enough time to do the visits. The visits will last approximately 20-30 minutes long. The visits will be reimbursable to the patient’s
managed care insurance company. Data will be collected and documented from each site visit. Having enough space is important
to carry out the protocol. Student energy must be taken into consideration. There must be administrative and referral buy-in. The
psychiatric nurse practitioner will be the only prescriber.
Once all of this is in place, then the development of the protocol and processing where the patients will get seen occur. Patients
will be identified and the administrative assistant will have them come in. Screenings using the assessment scales are administered
by the NP. Administrative staff will reach out to everyone with dual bipolar and ADHD diagnoses. Patient education will be delivered
by the NP. Reinforcement centering upon rolling with resistance will be emphasized with the patients. Then the medication,
Vyvanse 10 mg, will be prescribed. Eligible patients will get seen and assessed. Target number of participants will be 20 patients.
Eligible patients will get started on Vyvanse the first day of the visit who score high on the three assessment scales. The medication
will be prescribed that day. A transitional care plan will be enacted at the first visit where the patient will be linked to counseling
services.
Short-term results within the first month will look at whether the patient took the prescribed medication. Follow-up care is every
two weeks. Medication adherence goals will be set at least 85% of the time the patient will take the medication as prescribed.
Symptom reduction is a short-term goal aimed at after the patient has been screened and seen twice. Symptom-awareness is also
an important goal in this protocol. Collaboration with the primary care physician and the psychotherapist is an important goal in
the first month. Medium-term goals during month two and three include medication adherence at least 95% of the time. This is
also a time when community partnerships are established. Enhanced coping skills are encouraged with the patients during this
time and support from the clinic staff is elevated. The ultimate impact and the whole reason this project was developed happens
during month four and after the patient has left the project timeframe. Less hospitalizations is a target long-term goal. The patient
will receive continued therapeutic support and hopefully there will be optimization of symptom management. Scores on all the
assessment tools will be at least 25% better by week 2 and at least 50% better by week 4.
There are some contextual elements considered important at the onset of introducing the interventions. The project leader will
need to identify who the staff are in this project and what specific role each one will play. That person also will identify exactly what
the intervention is. The most critical intervention will include the prescribing of a stimulant and determining who will prescribe that
stimulant. Time considerations must also be examined. A definitive schedule will help to determine what days the intervention will
be carried out and what days are set aside for administrative tasks such as data collection and patient follow up. Determining
whether the visit is reimbursable is also critical to examine and plan for. Determining whether there will be data collected from the
site is critical to this project to be successful. The data should be easily reported, and the project should be easily reproduced by
other researchers.
Ensuring that there is enough space at the clinical site to carry out the intervention and follow through with the project is
important. It is also a good idea to calculate for the researchers’ energy and inputs prior to introducing the intervention. Planning
for administrative buy-in is important for this kind of project. Getting the Chief Executive Officer (CEO) on board for the project will
take strategic planning and some public relations efforts. Determining exactly what the visit will look like helps set the stage for
implementing the interventions. Exclusion and inclusion criteria must be determined first before recruiting any patient in the
project. Screenings using evidence based tools such as the PHQ-9, the Vanderbilt Scale, and the Young Mania Rating Scale are
integral to initiating the intervention. As far as the intervention itself, a determination must be made as to how and what to
prescribe and sound rationale must follow this.
Program Innovation and Intervention
The project centers upon the development of a protocol that basically has nine steps involved in the intervention. An
administrative assistant will pull data from the electronic medical record called Therapy Notes to determine twenty patients who
have a comorbid and concurrent diagnoses of Bipolar (ICD-10 Code F31.10) and Attention Deficit Hyperactivity Disorder (ICD-10 Code
F90.9). The administrative assistant will call these patients to get consent for inclusion in the project. A time will be scheduled on
either a Saturday or a Sunday at the clinic of their choosing. The patient will arrive for the visit at their scheduled time. A PHQ-9
(Appendix B), a Vanderbilt Scale (Appendix C), and a Young Mania Rating Scale (Appendix D) will be distributed to the patient at their
set appointment to be filled out. The provider will review the scales and review pertinent history to determine whether stimulants are
appropriate. If appropriate, a stimulant, particularly Vyvanse 10 mg by mouth once in the morning, will be prescribed for 14 days and
a follow up appointment will be given for 2 weeks. Education will be given over side effects, benefits, and potential for abuse. A follow
up appointment is always given and the two scales will always be reassessed every two weeks to determine if the intervention is
effective in treating the ADHD symptoms.
Specifics of the Team
The team will be comprised of a provider (the Psychiatric Nurse Practitioner), an Administrative Assistant, the Chief Executive
Officer (CEO), a coding and billing specialist, and a mental health psychotherapist implemented at the referral stage and for future
follow up. The Administrative Assistant will be the orchestrator who calls the patients for inclusion in the project and sets the
appointment times as well as follow up visits. The CEO will ensure there is enough space and time to carry out the interventions. The
billing and coding specialist will make sure the visit gets reimbursed. The mental health therapist will be instrumental in providing
ongoing support and encouragement. The provider will prescribe the medications.
Evaluation of the Program Innovation and Intervention
The effectiveness of the intervention will be evaluated by utilizing a patient survey satisfaction tool (Figure 1), a staff satisfaction
tool (Figure 2), and an Excel Comparison Spreadsheet (Figure 3). Development of a satisfaction tool will consist of fifteen questions
that will address the overall effectiveness of the project on the quality of life of the patients and staff involved. This will be distributed
at two points in the project implementation-one at two weeks and one at four weeks. Data will be compiled from the surveys and
analyzed to determine if the intervention made a difference and controlled the patient's’ symptoms to their satisfaction level.
Assessing the Impact of the Program/Innovation/Intervention
It is very helpful to look at the Logic Model Table (Appendix E) when determining just how much of an impact the intervention has
on the lives of the patients. The ultimate impact is symptom relief by the patient. ADHD and bipolar symptoms have many
commonalities, and an unstable vigilance might be a common pathophysiology. Psychostimulants might even ameliorate both ADHD
and mania. 7 Less hospitalizations for mania or ADHD exacerbations is a measure used to determine whether the intervention was
effective or not. Ultimately a change in behavior is what is desired with the intervention. Enhanced coping skills and better education
are ultimate goals of the intervention that will prove its effectiveness and need.
Observed Outcomes in Relation to the Program/Innovation/Intervention
Twenty patients will be screened and included as part of the intervention protocol. Ten patients will not receive stimulants but will
receive other forms of treatment such as a non-stimulant for the treatment of ADHD, psychotherapy, or no treatment at all. A
comparison will be made between the two groups to determine if the resulting behaviors and symptom relief is directly related to the
intervention.
VI. Measures
Processes and Outcomes
The External Mapping Tool: Values by Design Microsystem Map (Appendix F) shows that the project will be implemented in an
outpatient psychiatric setting. The project will focus on patients that are specifically diagnosed with bipolar disorder exhibiting poor
concentration, poor focus, and a poor attention span. The processes demonstrated by the mapping tool show that these patients will
have close monitoring of vital signs during the intervention phase and a thorough medical review will be completed. Substance abuse
counseling is also an integral part of the intervention. Cognitive behavioral therapy (CBT) will be offered through a referral to the
primary care therapist. Basic assessments are initiated at first visit using the PHQ-9, the Vanderbilt Scale, and the Young Mania Rating
Scale. Helping these patients understand their treatment choices and helping educate those who are considering stimulant use is the
backbone of this project and the intervention.
One very important outcome is the prevention of treatment delay. Bipolar disorder and ADHD have overlapping clinical symptoms,
thus differentiating these symptoms is an important task of the clinician aided by the assessment tools. Both disorders present with
impulsivity, physical over-activity, mood reactivity, and so on. The clinical situation is often compounded by the fact that both
disorders start early in life and are often confused with one another. 1
Ongoing Assessment
Ongoing assessment of the contextual elements that contribute to the success, efficiency, and cost of the project depends on
input from the team members and the data collected from the interventions. This project depends highly on the subjective data
obtained from the patients in regards to the alleviation of symptoms once the intervention has been initiated. Through The Eyes of
the Patient Table (Appendix G) looks at ongoing assessment by displaying the positives, negatives, surprises, frustrations, confusions,
and gratuities of the project and the intervention. Learning about the use of stimulants and the degree of ADHD the patient has is an
ongoing process throughout the project. Exploring treatment alternatives is important for ongoing care. A Measures Table (Appendix
H) shows expected outcomes and the analyses that accompanies these. It is important to also validate the patients who might think
that ADHD cannot exist in the face of a bipolar disorder. It is important to give support and check in with the patients whom
stimulants would have been a nice treatment choice for but unfortunately under no circumstance they were not appropriate for.
Closely working with the outpatient therapist is paramount in assessing those patients coming to terms with the fact that a dual
diagnosis exists. Comparing medications and ultimately choosing which drug is appropriate helps the patient explore such things as
side effects, alternative treatment options, and informed decisions should Vyvanse not be an option.
Completeness and Accuracy of Data
Accuracy of data using the Vanderbilt Scale, the PHQ-9 scale, and the Young Mania Rating Scale is important. The provider will
review each document at each visit to ensure that the tool has been completed in its entirety and the patient understands how to fill
it out. These are collected and scored at each visit and data derived from the scores to determine the effectiveness of the
intervention. The Vanderbilt Scale will carry the most weight because it is the tool specifically looking at a reduction in the ADHD
symptoms.
VII. Analysis
95% of the patients will take medications as prescribed as compared to the 50% national benchmark. 11% of people diagnosed
with ADHD do not know about stimulant use for the treatment of ADHD. 95% of the patients will keep all outpatient appointments.
Approximately 33% do not nationally. At least 65% of people report a reduction in the Vanderbilt Scale after 2 weeks of stimulant
therapy. 45% of annual emergency room visits can be contributed to ADHD symptoms. 100% of patients will not present to an ER for
ADHD symptoms. Patient will take 90% of the medications that are prescribed. Approximately 50% of patients do not take their
medications as prescribed. A pill count will be performed to check benchmark data. Patients will report reading 85% of educational
material provided to them over bipolar disorder and stimulant use and 5% of patients will report knowing about stimulants. A 5
question quiz can be given at end of 4-week treatment
Financial, human, and material resources are accounted for and inputs as well as outputs are considered critical to the project
success. Systematic collection of data is ultimately the foundation of the project. Changes in patient health resulting from the
intervention are relevant to the achievement of the outcomes. A results chain is formulated to look at casual sequences for the
intervention. Moving from principles to practice and tackling gaps in patient care are two important outputs the intervention highly
promote. Making sure that follow up evaluations are done in a systematic and meaningful way is very relevant to the success of this
project. Ethical considerations and patient confidentiality are two important issues to always be considered.
Using appropriate methodology to carry out the intervention is also very important.
What it is like for the patient to be a part of the clinic where this project is carried out is very systematic and meaningful. The
patient has a lot of flexibility in scheduling a time on a weekend day as these are the only days the provider is in office. Visits last
approximately twenty to thirty minutes and during this time an evaluation and assessment is performed. At the end of the session, a
diagnosis is determined and a prescription is given to those individuals who screen in for the project. Patient education is delivered
using motivational interviewing which is just a piece of the project and support is on-going throughout the entire process. The
Summary Evidence Table (Appendix I) describes the available literature on the intervention and shows that more research is needed
on this topic.
VIII. Ethical Considerations
Many people assume that quality improvement projects pose no ethical dilemmas to the participants involved or that there are no
ethical issues related to the participant's’ rights. However, any and all projects that generate knowledge, including quality
improvement projects, can create some risks to the participants and those risks need to be identified, examined and accounted for.
4 This project proposal takes human rights and informed consent to the highest degree. What is good and right for human beings is
the cornerstone of the project. Potential conflicts of interest are identified and accounted for. The project appears to have no conflict
of interest. All patients involved in the project will have been fully informed of risks versus benefits of using stimulants for the
treatment of their symptoms. The patients will also know the risks versus the benefits of choosing no treatment at all.
Activities will be enacted to address scientific validity, fair participant selection, favorable risk-benefit ratio, respect for participants,
and independent reviews. An outside advisory panel, constructed and consulted by administration, will be included in the pre-
intervention activities. Many times, the determination of whether an activity is performance improvement governed by an
Institutional Review Board (IRB) and local policy or research governed by federal regulations and requiring IRB review and approval
can be very complex. 8 This project is not a research endeavor and thus does not need an IRB approval. Participant respect,
confidentiality, partnership, team-building, and constructive criticism are very much included in the development of this project.
Wishes of the participants will be carried out first and foremost before any intervention is initiated. Patient education and return
demonstration are also accounted for during the development of the project.
References
1. Biederman, J., Faraone, S., Petty, C., Martelon, M., Woodworth, Y., & Wozniak, J. (2013). Further evidence that pediatric-onset bipolar disorder comorbid with ADHD represents a distinct subtype: results from a large controlled family study. Journal of Psychiatric Research, 47(1): 15-22. DOI: http://dx.doi.org/10.1016/j.jpsychires.2012.08.002
2. Biederman J, Mick E, Prince J, et al. (1999) Systematic chart review of the pharmacological treatment of comorbid attention deficit hyperactivity disorder in youth with bipolar disorder. Journal of Child Adolescent Psychopharmacology, 9(4): 247-56.
3. Carlson GA, Rapport MD, Kelly KL, Pataki CS. (1992) The effects of methylphenidate and lithium on attention and activity level. Journal of American Academy Child Adolescent Psychiatry, 31(2): 262-270.
4. Flaming, D., Barrett-Smith, L., Brown, N., & Corcoran, J. (2009) “Ethics? But it’s only quality improvement. Healthcare Quality, 12(2): 50-55.
5. Galanter CA, Carlson GA, Jensen PS, et al. (2003). Response to methylphenidate in children with attention deficit hyperactivity disorder and manic symptoms in the multimodal treatment study of children with attention deficit hyperactivity disorder
titration trial. Journal of Child Adolescent Psychopharmacology, 13(2): 123-36.
6. Goodwin, G., Haddad, P./, Ferrier, I., Aronson, J., Barnes, T.,…….Young, A. (2016). Evidenced-based guidelines for treating bipolar disorder: revised third edition recommendations from the British Association for Psychopharmacology. Journal of
Psychopharmacology, 30(6): 495-553. doi:10.1177/0269881116636545.
7. Hegerl, U., & Hensch, T. (2014). The vigilance regulation model of affective disorders and ADHD. Neuroscience & Biobehavioral
Reviews, 44(1): 45-47. DOI: http://dx.doi.org/10.1016/j.neubiorev.2012.10.008.
8. Platteborze, L., Young-McCaughan, S., King-Letzkus, McClinton, A., Halliday, A., & Jefferson, T. (2010). Performance
improvement/research advisory panel: a model for determining whether a project is a performance or quality improvement
activity or research. Military Medicine, 175(4): 289-291.
9. Ramesh, C. (2013) Application of Peplau’s Interpersonal Theory in Nursing Practice. Indian Journal of Surgical Nursing, 2(1): 13-17.
10. Which Is It: ADHD, Bipolar Disorder, or PTSD? A Publication of the HCH Clinicians’ Network. Taken from website:
https://www.nhchc.org. Retrieved September 28, 2016.