Article Review

UROLOGIC NURSING / November-December 2019 / Volume 39 / Number 6 293

Rikka Burroughs, DNP, BA, ARNP, AGPCNP-C, CUNP, is a Nurse Practitioner, Physicians’ Clinic of Iowa, Cedar Rapids, IA and University of Iowa College of Nursing, Iowa City, IA.

Bone Health Assessment in Men On Androgen Deprivation Therapy For Prostate Cancer: A Nurse Practitioner-Led Quality Improvement Protocol Rikka Burroughs

P rostate cancer is the most common solid organ cancer and is the second leading cause of cancer

mortality for men in the United States (American Cancer Society [ACS], 2018; American Uro - logical Association [AUA], 2018). An d rogen dep rivation therapy (ADT) is a common ther- apy for locally advanced prostate cancer, and is the mainstay of treatment for metastatic and bio- chemically recurrent prostate cancer (Loblaw et al., 2007; National Comprehensive Cancer Network [NCCN], 2017). Al - though an effective treatment for prostate cancer, ADT causes accelerated loss of bone mass, leading to increased risk for frac- ture (Chahin, Gualamhusein, Breunis, & Alibhai, 2016; Damji, Bies, Alibhai, & Jones, 2015).

Approximately 1 in 2 men (44.8%) diagnosed with prostate cancer and on Medicare will receive ADT, many for 2 years or longer (Gilbert, Kuo, & Shahinian, 2011; Meng et al., 2002); the actu- al incidence of prostate cancer in the full U.S. population of men is unknown. ADT can cause mor- bidities that are often inadequate- ly addressed (NCCN, 2017). Two such sequelae are osteopenia and secondary osteoporosis (Chahin et al., 2016; NCCN, 2017). Substantial bone loss can occur within the first 6 months of ADT therapy (Datta & Schwartz, 2012). In fact, 1 in 10 men treated with ADT will sustain a new fracture

within 24 months of treatment initiation (Datta & Schwartz, 2012). About 6 in 10 men diag- nosed with prostate cancer are over age 65 years, and when screened, as many as half of these men are noted to have low bone mass prior to initiation of ADT (ACS, 2018; Panju et al., 2009). Therefore, ADT treatment places them at even further risk of frac- ture (Panju et al., 2009).

Significance of the Problem

Osteoporosis-related frac- tures are associated with in - creased morbidity and mortality (Walsh & Eastell, 2013). Low bone

© 2019 Society of Urologic Nurses and Associates

Burroughs, R. (2019). Bone health assessment in men on androgen deprivation therapy for prostate cancer: A nurse practitioner-led quality improvement protocol. Urologic Nursing, 39(6), 293-301 doi:10.7257/1053816X.2019. - 39.6.293

Androgen deprivation therapy (ADT) causes bone loss. Despite this, there is sub- stantial variability in clinical practice related to bone health prevention and treat- ment for men with prostate cancer receiving ADT. This quality improvement proj- ect facilitated consistency in providing evidence-based care for bone health in men with prostate cancer on ADT at a private urology clinic.

Key Words: Bone health, osteoporosis, Plan-Do-Study-Act, men’s health, bone density, nurse practitioner utilization.

SERIES/RESEARCH

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294 UROLOGIC NURSING / November-December 2019 / Volume 39 / Number 6

mass and fracture can cause increased anxiety and depres- sion, decreased self-esteem, de - creased socialization, increased isolation, strained relationships with social support persons, increased pain, overall higher health care costs, decreased sur- vival, and decreased quality of life for patients and their care- givers (Chahin et al., 2016; Damji et al., 2015; National Osteo - porosis Foundation [NOF], 2019; Turner et al., 2016a).

Men are often under-diag- nosed, under-educated, and under-treated for low bone mass (Chahin et al., 2016; Shahinian, Kuo, Freeman, & Goodwin, 2005). Men receiving ADT have a 50% increased risk of fracture; however, men receiving ADT are not routinely screened and treat- ed for osteopenia or osteoporosis (Chahin et. al, 2016; Damji et al., 2015; Shahinian et al., 2005). Bone health practices not con- forming to current guidelines for men on ADT are observed across the spectrum of care from pri-

mary care to urology and radia- tion and medical oncology (Alibhai et al., 2006; Al-Shamsi et al., 2012; Tanvetyanon, 2005).

The NCCN (2017) guideline for prostate cancer recommends use of supplemental calcium and vitamin D for all men on ADT. The NCCN (2017) also recom- mends obtaining a baseline dual- energy X-ray absorptiometry (DXA) to measure bone mineral density (BMD) in men with increased risk for fracture prior to or within 90 days of initiation of ADT. DXA is a radiologic test that quantifies BMD, a determin- ing factor of bone strength (Lewiecki et al., 2016). The NCCN (2017) also recommends additional treatment if DXA shows high fracture risk using a fracture risk tool, such as the Fracture Risk Assessment Tool (FRAX). FRAX is completed by the health care provider and assesses select risk factors, such as glucocorticoid and smoking history, personal and familial fracture history, alcohol use, and

height and weight (Kanis et al., 2011; University of Sheffield, n.d.). FRAX determines a 10-year probability of fracture of the hip or other major fracture, such as wrist, shoulder, or spine that is responsive to treatment (Kanis et al., 2011; University of Sheffield, n.d.).

Despite NCCN guideline rec- ommendations, there is substan- tial variability in provider prac- tice, knowledge, prevention, and treatment of low bone density for men on ADT (Al-Shamsi et al., 2012; Damji et al., 2015; NCCN, 2017; Panju, et al., 2009; Pradhan et al., 2012; Tanvetyanon, 2004). Risks of fracture within this pop- ulation, coupled with co-mor- bidities and lifestyle choices, fur- ther place this population at risk (Chahin et al., 2016). Damji and colleagues (2015) found that only about 32% of the 83 urologists and 73 radiation oncologists they surveyed tested BMD routinely (≥ 80% of patients) prior to start- ing ADT. Low self-reported com- petency levels regarding calcium

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Research Summary Introduction

Androgen deprivation therapy (ADT) is a common ther- apy for locally advanced prostate cancer, as well as for bio- chemically recurrent and metastatic prostate cancer. An effective treatment for men with prostate cancer, ADT can cause morbidities which are often not fully or adequately addressed in urology.

Purpose The purpose of this quality improvement (QI) project

was to facilitate consistency in providing evidence-based care related to bone health screening, education, and treat- ment for men with prostate cancer on ADT by decreasing barriers to assessment and creating a pathway from urolo- gists to the nurse practitioner who also specializes in bone health and prostate cancer.

Methods An office-based protocol for an internal referral process

was developed to facilitate transition from urologist to nurse practitioner in a urology clinic. The protocol included the referral order, lab order, and appropriate time interval, and was implemented upon the initiation of ADT. A survey assessed urologist knowledge and perceived treatment bar- riers prior to and after education and implementation of the protocol.

Results The number of patients seen by the nurse practitioner

within 90 days of ADT treatment initiation increased from 36% (Q4 2017) to 53% (Q4 2018) (p > 0.05). The proportion of patients who completed the lab set after implementation of the referral process increased from 16% (Q4 2017) to 73% (Q4 2018) (p < 0.01). The urologist survey demonstrat- ed an increase in urologist perception of the importance of bone health assessment, overall knowledge of bone health for men on ADT, and a reduction in barriers to bone health care.

Conclusion Implementation of a protocolized internal referral

process facilitated consistency in providing timely, evidence- based care related to bone health for men with prostate can- cer on ADT. This QI project enhanced urologist knowledge of bone health in men on ADT and reduced barriers to bone health care.

Level of Evidence: V-B Source: Johns Hopkins Hospital/Johns Hopkins University, 2016.

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(64%) and vitamin D supplemen- tation (62%), providing educa- tion regarding healthy bone behaviors (40.5%), and managing osteopenia and osteoporosis (41.2%) among survey partici- pants were also found (Damji et al., 2015). Furthermore, less than 20% of survey participants received at least some type of specialized training and educa- tion regarding bone health risk and measurement (Damji et al., 2015).

Reasons for low rates of bone health screening include pro - viders’ lack of understanding of bone health, poor clarity of guidelines, and insufficient knowledge of potential conse- quences of low bone density (Damji et al., 2015). Jain, Bilori, Gupta, Spanos, and Singh (2016) identified additional reasons for low screening rates, including low priority for providers to screen for low bone density and that the electronic medical record (EMR) lacks reminders to support clinical decision-mak- ing. Pradhan and colleagues (2012) noted the unavailability of the DXA scan within the practice area as a contributing factor for lack of screening. Provider time constraints, discomfort with pa - tient counseling regarding low bone density, and risk of overbur- dening the patient with informa- tion are other reasons cited for not following the guidelines (Jain et al., 2016; Turner et al., 2016b).

Literature Review

A literature search was con- ducted to examine the evidence on improving bone health prac- tice in the care of men treated with ADT for prostate cancer. PubMed and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) data- bases were reviewed. Key search terms included implementation, protocol, osteoporosis, prostate cancer, nurse practitioner, health care costs, and fracture (Pub - Med); and prostatic neoplasms,

androgen deprivation, urologic nursing, urology, osteoporosis, calcium, and vitamin D (CINAHL). Inclusion criteria included vitamin D and calcium supplementation in men with low bone mass, men treated with ADT for prostate cancer, and provider knowledge of treatment guidelines for men with low bone mass. Exclusion criteria included articles specific to women and children, comple- mentary and alternative medi- cine and non-FDA approved sup- plements, and articles focused specifically on skeletal-related events in metastatic prostate can- cer.

Only English language arti- cles from peer-reviewed journals limited to the last 5 years were considered because NCCN guide- lines for men on ADT changed significantly within that time frame. Articles with data from outside the United States were accepted due to the paucity of information available on similar projects. Ultimately, the total number of relevant articles using these search strategies was 29. All 29 articles were then reviewed.

Adherence to guidelines and patient outcomes can improve by implementation of a screening protocol (Hall, Shrader, & Ragucci, 2009; Turner et al., 2016b). Hall and colleagues (2009) conducted a pharmacist- led osteoporosis clinic in a fami- ly medicine practice. A protocol was designed based upon evi- dence-based practice guidelines that included patient education, screening, prevention, and treat- ment of osteoporosis (Hall et al., 2009). Turner and colleagues (2016b) established a nurse prac- titioner-led bone health clinic for men with prostate cancer. A care pathway was developed that included a referral from the oncologist to the nurse practi- tioner who orders labs and imag- ing, refers to maxillofacial sur- geons for dental evaluation, and provides education and counsel-

ing to patients and their families (Turner et al., 2016b). Bone health management is then coor- dinated with the prostate cancer follow-up visit (Turner et al., 2016b). Turner and colleagues (2016b) also attempted to main- tain the patient’s optimal quality of life and prevent or delay skele- tal-related events. Both studies ameliorated the gap in provider and patient knowledge and lack of guideline adherence as related to low bone health, while de - creasing the workload of the physician provider.

Purpose

The purpose of this quality improvement (QI) project was to facilitate consistency in provid- ing evidence-based care related to bone health screening, educa- tion, and treatment for men with prostate cancer on ADT. Spec - ifically, this project aimed to enhance urologist knowledge of bone health in men on ADT, cre- ate a protocol for bone health referral, increase timely referrals from the urologist to the nurse practitioner (who also special- ized in bone health), and obtain appropriate lab studies prior to the referral to prevent treatment delays.

Method

The Institutional Review Board at the University of Iowa deemed this project as not human subject research.

Setting This QI project was imple-

mented in a private, physician- owned urology clinic in Iowa that specializes in disorders of the genitourinary system, includ- ing prostate cancer. There were 6 physicians and 1 nurse practi- tioner in the clinic, all of whom treated patients with prostate cancer at varying stages of the disease. Prior to the start of this project, no established evidence- based protocols were in place for

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bone health monitoring and treatment in patients on ADT, such as calcium and vitamin D supplementation, baseline DXA scans, patient education regard- ing bone health, or bone strength- ening medications.

QI Methodology T h e P l a n - D o - S t u d y - A c t

(PDSA) method for quality improvement was chosen for this project (Langley, 1996). The model is relevant because it uses a systematic, data-guided me - thod to process improvement. It also reduces waste and efforts.

Interventions The interventions focused on

three objectives: 1) increase time- ly referrals (within 90 days of ADT initiation) to the nurse prac- titioner through an internal refer- ral process, 2) increase the rate of completion of an appropriate lab set (i.e., prostate-specific antigen [PSA], total testosterone, calci- um, and vitamin D) prior to the visit with the nurse practitioner by implementing electronic standing orders, and 3) improve

the urologists’ knowledge of bone health management inter- ventions to decrease barriers to these interventions.

Performance Improvement Process

An internal referral process was created within the urology clinic to facilitate the transition of care from the urologist to the nurse practitioner, who also spe- cialized in bone health (see Figure 1). Group and one-on-one educa- tion and training sessions were provided by the nurse prac - titioner/project leader to the 6 urologists, 6 nurses, 1 medical assistant, and 9 office staff regard- ing bone health. This included the importance of obtaining the appropriate lab set and referring the patient to the nurse practition- er within 90 days of initiation of ADT. Written materials were also provided. Although the RNs, MA, and office staff had no active role in this project, they were made aware of the protocol and why it was important to allow them to address questions from patients. The project protocol was de signed

solely to facilitate referral from MD to the nurse practitioner.

An electronic order set for MDs was created, which includ- ed a referral to the nurse practi- tioner in the appropriate time interval and necessary labs. The scheduled appointment with the nurse practitioner coincided with the next ADT injection. Due to technological issues within a new EMR, the order set did not work properly through the entirety of the project. Therefore, laminated reminder cards were placed at each work station with the protocol information.

An electronic survey guided by the current literature was developed to assess urologists’ knowledge of bone health and perceived treatment barriers. Identified barriers included cost of assessment tests and treat- ments, unclear benefit to bone health assessment and treatment, patient’s lack of insurance, urolo- gist time constraints, urologist lack of knowledge of bone health, and clarity of the guidelines. The survey was administered prior to education and implementation of

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Figure 1. Flow Chart for Patients Referred for Bone Health

Patient started on ADT

Patient referred to NP

First appointment

with NP

• Referral to NP with 90 days of initiation of ADT • Order PSA, total testosterone, calcium, and vitamin D

• Discuss rationale for ADT treatment • Discuss potential side effects of ADT • Discuss risks and obtain consent for bone health

treatment • Rx calcium and vitamin D supplements, if needed • Baseline serum total testosterone, calcium, and

vitamin D, if not already completed • Assess patient understanding • Provide patient literature • Provide NP contact information • Order additional labs or imaging as needed

Notes: ADT = androgen deprivation therapy, NP = nurse practitioner, PSA = prostate-specific antigen.

UROLOGIC NURSING / November-December 2019 / Volume 39 / Number 6 297

the order set, and after comple- tion of the QI project.

Data were manually extract- ed from the EMR by the nurse practitioner. Because a new and different EMR was introduced between the pre-implementation and post-implementation time frames, data were collected from two unique and separate EMR systems. Data collected from the EMRs were identical and includ- ed new referrals, date of first ADT injection, date seen by the nurse practitioner, if the patient was seen within 90 days of ADT initiation or beyond, labs ob - tained prior to the first appoint- ment with the nurse practitioner, if the patient was a repeat refer- ral, and from whom they were referred.

Analysis It was not possible to collect

data on the number of patients with prostate cancer on ADT who were not referred to the nurse practitioner; thus the num- ber of patients seen by the nurse practitioner within 90 days of initial ADT treatment was used as a proxy.

Statistical analyses were con- ducted to compare the propor- tions of patients referred and completion of the lab set ordered before and after the interven- tions. Using Fisher’s exact test and 95% confidence intervals, a plausible range of values was determined. Confidence inter- vals are a substitute for applying interventions to the entire popu- lation of all urologists who treat- ed patients on ADT. The differ- ence among the entire popula- tion then would plausibly fall within this range.

Fisher’s exact test is appro- priate for smaller counts. While the Fisher’s exact test does not calculate variability, other meth- ods were used to measure the variability. The uncertainty of the sample proportions was quanti- fied by using 95% confidence intervals.

Due to the small sample size of urologists (n = 6), no formal test on the differences in survey responses was conducted. In - ferential methods could not be completed; therefore, no calcula- tion of the variability in respons- es was done.

Results

Prior to the project concep- tion, 28 patients were referred for bone health to the nurse practi- tioner between October 1 and December 31 (Q4) in 2016. All patients referred during this time were new to the nurse practition- er. One (3.5%) was referred with- in 90 days of ADT initiation, and none (0%) had the appropriate lab set completed.

In Q4 of 2017 prior to project implementation, a total of 69 patients were referred for bone health, of which 25 (36.2%) were new to the nurse practitioner. Of these 25 new patients, 9 (36%) were referred within 90 days of starting ADT and (16%) had the lab set completed.

In Q4 of 2018, after project implementation, a total of 76 were referred for bone health. Of these, 15 (19.7%) were new to the nurse practitioner. Of these new patients, 8 (53.3%) were referred within 90 days of start- ing ADT, with 11 (73.3%) having the labs completed. The other 7 (46.7%) new patients started ADT more than 90 days prior, and all (100%) had the appropri- ate lab set completed. Of note, all

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Figure 2. Proportion of Complete vs. Incomplete Lab Sets

among New Patient by Year

1.00

0.75

0.50

0.25

0.00

P e rc

e n

t

Proportion of ‘Yes’: 4/25

Oct-Dec 2017 Oct-Dec 2018

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Complete Labs Yes No

Note: ADT = androgen deprivation therapy.

298 UROLOGIC NURSING / November-December 2019 / Volume 39 / Number 6

patients referred in 2017 were re- referred (if not deceased) for fol- low up in 2018.

There was a significant increase in the number of referred patients who completed the lab set after the referral process was implemented. The percentage increased from 16% in Q4 2017 to 73% in Q4 2018 (95% confidence interval, 2.459, 92.936, p < 0.01) (see Figure 2).

While not statistically signif- icant, the percentage of patients seen by the nurse practitioner within 90 days of initial treat- ment increased from 36% (Q4 2017) to 53% (Q4 2018) (95% confidence interval, 0.458, 9.073, p > 0.05) (see Figure 3).

The urologist survey was administered prior to education and project implementation, and again after project completion. Results demonstrated an increase in urologists’ perception of the importance of bone health assessment in men on ADT and overall knowledge of bone health. A better understanding of the NCCN guidelines and modifi- able risk factors associated with low bone mass was observed. Responses also indicated a decrease in barriers to bone health evaluation and referral to the nurse practitioner, including ease of referral and minimal time constraints. The survey revealed a concern for insurance coverage and cost of treatment remained. A distribution of pre- and post- intervention survey responses is displayed in Figure 4.

Discussion

The QI project facilitated consistency in providing evi- dence-based care related to bone health screening, education, and treatment for men with prostate cancer on ADT at the urology clinic. Specifically, this project enhanced the urologists’ knowl- edge of bone health in men on ADT, created a pathway for bone health referral, increased timely referrals to the nurse practitioner

who specializes in bone health, and increased the number of patients who had the appropriate lab set completed prior to being seen by the nurse practitioner for bone health.

Prior to the project QI proto- col, there was no standardized method of assessing patients for bone health within this urology clinic. Therefore, improvements in lab set completion, patient referrals, urologist-perceived im - p o r t ance of bone health, and reduction in barriers to assess- ment and treatment may be attributable to interventions of this project.

Implementation of the proto- col did not increase the burden on urologists, nurses, or office staff. The electronic order set required development by the Information Technology (IT) department; however, the elec-

tronic order set was not function- al for the first six weeks of the project. This order set proved to be a non-vital component of the protocol because urologists still improved their referrals and lab orders by using laminated cards.

Resources and costs associat- ed with this QI project were min- imal, including IT costs to devel- op the order set. The overall costs of the project included printing costs for the educational materi- als and laminating costs for the reminder cards. The nurse practi- tioner served as project leader and performed all educational duties for staff, nurses, and urol- ogists outside of designated patient care time. The urology clinic incurred the cost of staff, nurse, and physician wages dur- ing the education and implemen- tation of the project.

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Figure 3. Proportion of New Patients Seen within 90 Days

of

1.00

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0.50

0.25

0.00

P e rc

e n

t

Proportion of ‘Yes’: 9/25

Oct-Dec 2017 Oct-Dec 2018

Proportion of ‘Yes’: 8/15

Year

Complete Labs Yes No

Note: ADT = androgen deprivation therapy.

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300 UROLOGIC NURSING / November-December 2019 / Volume 39 / Number 6

There were no measured rev- enue increases by implementa- tion of the protocol. However, revenue was likely generated by the increase in services provided by implementation of the proto- col. Anecdotally, the coding auditors reported billing codes for patients seen by the nurse practitioner increased during Q4 2018 due to the augmented level of complexity and/or time spent with the patient.

No observed opportunity costs were associated with this project. However, there could have been an unintentional decrease in patient referrals to the nurse practitioner for other urology conditions. For instance, urologists were aware of the new protocol, and therefore, may not have sent other non-ADT urology patients as normally would be referred due to concern for over- burden after establishing the new pattern for ADT management. The urology nurse practitioner in this clinic was salaried with RVU-based bonuses semi-annu- ally. Patient appointment times were scheduled as 40 minutes, similar to new patients, as com- pared to 20 minutes for other established patients. Patients were scheduled in either two 20- minute recheck appointment slots or a new patient slot. Therefore, the nurse practitioner frequently saw fewer new patients than was templated in the schedule. This urology clinic has dedicated urology coders who review each encounter for each provider; therefore, their workload did not increase.

Strengths of this QI project include universal acceptance and support by urologists of the clinic. A group consensus on the importance of bone health, as well as who would assess and treat these patients, was essential for success. Consistency in bone health practice was lacking in urologic and oncologic practices within this clinic. This QI proto- col addressed many of the most common causes of nonadherence

to guideline recommendations by decreasing barriers to assess- ment and treatment, improving knowledge of bone health and clarity of the guidelines, and reducing time constraints.

An unexpected finding was that urologists started referring all patients on ADT for greater than 12 months regardless of when they received their first ADT injection. Although this was outside of the original proj- ect objectives, it followed the NCCN (2017) guidelines for bone health in men on ADT.

Limitations The greatest limitation of this

QI project was the inability of the EMR systems to mine data elec- tronically. This prevented analy- sis of the proportion of patients who were referred versus those who were not referred. The change to a new EMR late in proj- ect development also created limitations, including failure of a functional order set throughout the entirety of the project. Another challenge was inherent in one objective; patient referrals were determined by incidence of advancing prostate cancer that required ADT, not by physician knowledge or decrease in barri- ers. Those started on ADT could not be controlled nor predicted. A final limitation is the sample size of urologists surveyed.

Conclusions

Creation and implementa- tion of a streamlined referral pro- tocol improved collaboration between the nurse practitioner and urologists. It improved ad - herence to the NCCN guidelines by establishing a protocol for evi-

dence-based assessment of bone loss in all patients. The protocol led to earlier treatment for bone loss in select patients and poten- tially decreased adverse effects of ADT. Lastly, urologists reported a decrease in barriers to bone health assessment and treatment.

The sustainability of the bone health assessment protocol was demonstrated by the request of urologists to continue with the referral process, but with some changes. Therefore, a new proto- col was developed, which will continue to include the nurse practitioner’s evaluation of new patients starting on ADT, but also any patients on ADT greater than 12 months who have not yet had bone health evaluation.

The bone health assessment protocol could feasibly be adapt- ed to other urology clinics in a wide variety of institutions that care for men with prostate cancer on ADT. Such institutions include private physician or hos- pital-owned clinics, public and private teaching hospitals and clinics, multispecialty institu- tions, and rural outreach hospi- tals across geographic areas. The bone health champion could be a single or group of nurse practi- tioners that are trained in bone health assessment and manage- ment. Ideally, the champion would also be proficient in prostate cancer management. The protocol could then be seam- lessly incorporated into the prostate cancer clinic and elimi- nate extra visits for the patient.

Urologist knowledge of bone loss related to ADT increased after implementation of educa- tion and the referral process. Bone health can be added into a prostate cancer treatment algo-

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Creation and implementation of a streamlined referral protocol improved collaboration

between the nurse practitioner and urologists.

UROLOGIC NURSING / November-December 2019 / Volume 39 / Number 6 301

rithm with little financial cost to the clinic. This program allowed the nurse practitioner to serve as the bone health champion in the urology clinic and did not increase the workload to urolo- gists.

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