Original Research

More than 52,000 soldiers have been injured and 6,800 have been killed during the wars in Iraq and Afghanistan.¹ Blast injuries from improvised explosive devices (IEDs) account for 70% to 79% of combat-related injuries and deaths in these wars.² Advances in personal body armor, rapid and advanced surgical treatment, and the changing nature of combat in Iraq and Afghanistan have changed injury patterns and survival compared with prior military conflicts such as those in Vietnam and Korea.³

The most common combat-related injuries in the recent wars are extremity, facial, brain, and gastrointestinal injuries. Pelvic and genitourinary injuries are also common, accounting for about 8% of total injuries.² Pelvic and genitourinary injury can cause long-term disability from nerve injury (neurogenic bladder, neurogenic bowel, sexual dysfunction, urethral injury), as well as general loss of genital structures from blast injuries.

The usual care for bladder dysfunction from pelvic or genitourinary injury ranges from the use of chronic indwelling catheters to reconstructive surgery. However, there is no standard of care for long-term treatment of patients with pelvic or genitourinary injury who experience bladder dysfunction. Reconstructive surgery has the potential to improve quality of life (QOL) and eliminate chronic indwelling catheters, which are prone to cause infection and long-term kidney problems in patients with bladder dysfunction from traumatic injury. 

This case report evaluates the efficacy of reconstructive surgery for bladder dysfunction to improve independence and QOL and decrease complications associated with chronic indwelling urinary catheters. The authors hope to raise awareness regarding this option for patients with pelvic, spinal cord, or genitourinary injury who are young and face long-term disability from their injuries.

Case Presentation

A 22-year-old man presented to the George E. Wahlen VAMC Urology Clinic in Salt Lake City, Utah with a complicated history related to combat injuries. During combat operations 3 years earlier, he was injured by an IED blast while on foot patrol. His injuries included bilateral severe extremity injury, perineal and genital blast wounds, a bladder injury, pelvic fracture, colorectal injury, and extensive soft tissue loss. He underwent multiple abdominal explorations, left leg amputation below the knee, multiple skin grafts, soft tissue debridements, left-side orchiectomy, bladder repair, and diverting colostomy. He survived the injuries and was eventually discharged from active military service and returned home.

Upon presentation to the VAMC, the patient had a diverting colostomy, suprapubic bladder catheter, and bladder and bowel function consistent with cauda equina syndrome (pelvic nerve injury). Given the lack of rectal tone, fecal incontinence was likely with colostomy reversal. His bladder had low volume and poor compliance (elasticity). In addition, the patient had no volitional control of urination or defecation.

The patient previously performed intermittent self-catheterization but experienced total urinary incontinence (UI) between catheterizations, due to his bladder dynamics and a lack of urinary sphincter tone. A suprapubic bladder catheter was previously placed to control UI. However, the patient remained incontinent, and urinary leakage, need for diapers, and urinary tract infections (UTIs) negatively impacted QOL. The patient ambulated well and was physically active. His priority was to reduce incontinence and improve QOL.

Catheterizable Ileal Cecocystoplasty

The patient underwent cutaneous catheterizable ileal cecocystoplasty (CCIC) (Figure 1). In this surgery, a segment of the cecum and ascending colon with attached terminal ileum is used to increase the size of the bladder (augmentation cystoplasty) and create a channel for catheterization from the umbilicus. The cecum and colon are detubularized, and a large rectangular plate of large bowel is formed, which is then sewn to the bladder, expanding its volume. About 10 to 15 cm of the terminal ileum is tapered to the diameter of a pencil and brought through the base of the umbilicus, creating a small stoma for intermittent bladder catheterization. The ileocecal valve is tightened and serves as a continence mechanism to prevent urinary leakage through the small stoma in the umbilicus.⁴

A perineal urethral mesh sling was placed at the time of the patient’s surgery to bolster the deinnervated urinary sphincter and prevent urethral leakage. The goal of reconstructive surgery for this patient was to create a small bowel channel connecting the umbilicus and bladder that could be catheterized every 4 to 6 hours, increase bladder capacity, and increase sphincteric resistance to reduce urethral leakage through the penis. Because there can be damage from passing a catheter through mesh slings and the urethra over time, including stenosis or erosion of the sling, an alternative catheterizable channel was needed in this patient.

The patient recovered after the surgery and was able to self-catheterize without difficulty. However, the urethral mesh sling did not place enough pressure on the urethra to prevent leakage, and he had persistent incontinence from the penis. Three months after the original surgery the patient had exploration of the perineum, which revealed that the mesh sling was loose and exerting inadequate pressure on the urethra. It was likely the sling slipped postoperatively—a known complication of urethral slings. An artificial urinary sphincter (AUS) was placed around the urethra during the second surgery to address the patient’s UI.

A perineal and small-groin incision was used to place the AUS. The AUS was connected to a tissue expander port rather than to a conventional pump mechanism, to enable pressure adjustment within the sphincter to the lowest possible pressure to prevent incontinence (Figure 2). The modified AUS placement controlled his incontinence very well with minimal pressure within the system.

 

More than 1 year after the original surgery, the patient self-catheterizes about 4 to 5 times daily via the catheterizable channel using a single-use catheter. His bladder holds at least 500 mL. The patient does not have significant leakage from the channel or the penis. He is no longer dependent on a chronic indwelling catheter and is free of the problems associated with severe UI, including foul odor, UTIs, and social isolation.

Discussion

Patients with spinal cord or pelvic nerve injury often develop spastic bladders with low capacities. This is similar to muscle spasticity that may occur with a neurologic injury, below the level of the injury, such as in the lower extremities. The powerful uncontrolled bladder spasms and small bladder capacity most often lead to incontinence. Additionally, neurologic control of the urinary sphincter is affected, leading to either uncontrolled spasms or poor tone. Patients with these injuries have no volitional control of bladder functions and are forced to catheterize intermittently, use a condom-type catheter, or have a chronic indwelling catheter (a Foley catheter or suprapubic catheter).

Intermittent catheterization is the preferred management option for neurogenic bladder. When compared with chronic indwelling catheters, intermittent catheterization is associated with lower rates of UTI and upper tract abnormalities and with the loss of renal function.⁵ Unfortunately, patients do not often stay on intermittent catheterization. A recent study showed that up to 70% of patients with spinal cord injuries who used clean intermittent catheterization when discharged from acute rehabilitation discontinue use and are subsequently managed by chronic indwelling catheters.⁶ Although the reasons why intermittent catheterization is discontinued are unclear, patient dissatisfaction with catheterization, anatomic problems, such as urethral scarring, or continued leakage despite medical treatments, such as anticholinergic medicines, may be factors.

Uncontrolled leakage and UI significantly impacts QOL and may cause patients to choose chronic indwelling catheters over intermittent catheterization. Several treatments are available to control incontinence associated with intermittent catheterization. Anticholinergic medications and more recently onabotulinum toxin A may help improve bladder spasticity. In 2011, the FDA approved onabotulinum toxin A for transurethral bladder injections. It has been shown to increase functional bladder capacity and decrease spasticity.^7,8 Onabotulinum toxin A treatment will not enlarge a small, contracted bladder.

Onabotulinum toxin A treatment would not be ideal for the patient in this case study. His absolute bladder capacity was 200 mL, and onabotulinum toxin A treatment would not significantly improve capacity or make intermittent catheterization practical. Additionally, the patient had poor urinary sphincter function, and he would continue to leak regardless of improvements in the bladder spasticity or tone.

Augmentation enterocystoplasty is surgical enlargement of the bladder, using a piece of the bowel and is indicated in patients with low bladder volumes. With this procedure the native bladder becomes defunctionalized, and patients experience a dramatic improvement in bladder volumes and a reduction in bladder spasms and leakage. The use of the colon and terminal ileum for bladder augmentation, or CCIC, was first reported by Sarosdy in 2 patients in 1992.⁹ In 1996, King and colleagues demonstrated successful outcomes with CCIC in a cohort of 8 patients after 34 months of follow-up.¹⁰ Seven patients successfully used clean intermittent catheterization, and 1 patient chose an indwelling catheter because of progressive upper extremity weakness. No patients experienced worsened renal function or pyelonephritis suggestive of upper urinary tract deterioration. A single patient had mild stomal stenosis, which was successfully revised under local anesthesia.

In another study, Sutton and colleagues reported at 27 months an improvement of 276 mL in bladder capacity, no metabolic complications, and a 95% continence rate in a cohort of 23 patients with neurogenic bladder who underwent CCIC.⁴ Sutton and colleagues later reported outcomes for 34 patients with a median of 31 months follow-up.¹¹ The most common complications were recurrent UTIs (12%) and stomal stenosis (12%). Only 3 patients (9%) required surgical revisions for stomal stenosis.

Altered bowel function and metabolic abnormalities are a concern after bowel resection and reconstruction. However, a study has found no subjective change in bowel function following ileal resection of up to 60 cm for urinary diversion for bladder malignancy.¹² Rates of hyperchloremic hypokalemic metabolic acidosis are low, and most changes in electrolytes are subclinical.^13,14 Long-term vitamin B12 deficiency is seen with larger (> 50 cm) ileal resections but is rare with CCIC, given the small segment used for reconstruction.¹⁵ Overall, CCIC is shown to have excellent surgical outcomes in carefully selected patients with neurogenic bladder.

In addition to low bladder capacity, the case study patient also had intrinsic sphincteric deficiency (very low urinary sphincter tone), which is common with pelvic nerve injury but unusual with spinal cord injury. He initially received a suburethral mesh sling that supported and compressed the urethra and buttressed the natural urinary sphincter. However, patients can develop catheterization issues with a suburethral sling due to mechanical compression of the urethra and traversing the compressed area with a urinary catheter. Given the indication for augmentation cystoplasty in this patient, he additionally elected to undergo catheterization channel creation to avoid long-term issues of urethral catheterization through the urethra compressed by the sling.

Unfortunately, this patient had postoperative issues with his suburethral sling, and a modified AUS was inserted rather than a second sling. Normally, an AUS is attached to a pump mechanism in the scrotum. The pump allows the patient to cycle fluid from the sphincter cuff to a reservoir in the abdomen, removing compression on the urethra and allowing normal urination. Because this patient could not effectively urinate from the penis, the authors wanted to obstruct the urethra to prevent leakage without closing it permanently. The AUS was connected to a tissue expander port placed subcutaneously in the lower abdomen rather than to a pump mechanism. This modified approach used fewer mechanical parts compared with the pump mechanism, possibly reducing rates of mechanical failure. Additionally, a lower cuff pressure could be used to obstruct the urethra and prevent leakage, reducing the likelihood of urethral atrophy. Fewer mechanical parts and a lower cuff pressure could theoretically improve longevity of the AUS (Figure 3). This modified method of AUS placement has been described in patients with sphincteric deficiency and spinal cord injury.¹⁶

These 2 reconstructive surgeries freed the patient from indwelling catheter dependence and significantly improved his incontinence and QOL. Many patients with spinal cord injury or pelvic injury could benefit from similar reconstructive surgeries if conservative measures such as anticholinergic medications or onabotulinum toxin A treatments do not control incontinence.

Conclusion

Blast injuries in soldiers often cause pelvic and genitourinary injuries. These injuries can lead to chronic urinary problems and profound social and physical disability. These young veterans need innovative, individualized approaches to best manage their long-term urinary issues. Reconstructive surgery may improve QOL and decrease disability from bladder dysfunction for carefully selected patients. Clinicians caring for veterans with pelvic and genitourinary injury should strive to create a system where these options are available when they are appropriate.

More than 52,000 soldiers have been injured and 6,800 have been killed during the wars in Iraq and Afghanistan.¹ Blast injuries from improvised explosive devices (IEDs) account for 70% to 79% of combat-related injuries and deaths in these wars.² Advances in personal body armor, rapid and advanced surgical treatment, and the changing nature of combat in Iraq and Afghanistan have changed injury patterns and survival compared with prior military conflicts such as those in Vietnam and Korea.³

The most common combat-related injuries in the recent wars are extremity, facial, brain, and gastrointestinal injuries. Pelvic and genitourinary injuries are also common, accounting for about 8% of total injuries.² Pelvic and genitourinary injury can cause long-term disability from nerve injury (neurogenic bladder, neurogenic bowel, sexual dysfunction, urethral injury), as well as general loss of genital structures from blast injuries.

The usual care for bladder dysfunction from pelvic or genitourinary injury ranges from the use of chronic indwelling catheters to reconstructive surgery. However, there is no standard of care for long-term treatment of patients with pelvic or genitourinary injury who experience bladder dysfunction. Reconstructive surgery has the potential to improve quality of life (QOL) and eliminate chronic indwelling catheters, which are prone to cause infection and long-term kidney problems in patients with bladder dysfunction from traumatic injury. 

This case report evaluates the efficacy of reconstructive surgery for bladder dysfunction to improve independence and QOL and decrease complications associated with chronic indwelling urinary catheters. The authors hope to raise awareness regarding this option for patients with pelvic, spinal cord, or genitourinary injury who are young and face long-term disability from their injuries.

Case Presentation

A 22-year-old man presented to the George E. Wahlen VAMC Urology Clinic in Salt Lake City, Utah with a complicated history related to combat injuries. During combat operations 3 years earlier, he was injured by an IED blast while on foot patrol. His injuries included bilateral severe extremity injury, perineal and genital blast wounds, a bladder injury, pelvic fracture, colorectal injury, and extensive soft tissue loss. He underwent multiple abdominal explorations, left leg amputation below the knee, multiple skin grafts, soft tissue debridements, left-side orchiectomy, bladder repair, and diverting colostomy. He survived the injuries and was eventually discharged from active military service and returned home.

Upon presentation to the VAMC, the patient had a diverting colostomy, suprapubic bladder catheter, and bladder and bowel function consistent with cauda equina syndrome (pelvic nerve injury). Given the lack of rectal tone, fecal incontinence was likely with colostomy reversal. His bladder had low volume and poor compliance (elasticity). In addition, the patient had no volitional control of urination or defecation.

The patient previously performed intermittent self-catheterization but experienced total urinary incontinence (UI) between catheterizations, due to his bladder dynamics and a lack of urinary sphincter tone. A suprapubic bladder catheter was previously placed to control UI. However, the patient remained incontinent, and urinary leakage, need for diapers, and urinary tract infections (UTIs) negatively impacted QOL. The patient ambulated well and was physically active. His priority was to reduce incontinence and improve QOL.

Catheterizable Ileal Cecocystoplasty

The patient underwent cutaneous catheterizable ileal cecocystoplasty (CCIC) (Figure 1). In this surgery, a segment of the cecum and ascending colon with attached terminal ileum is used to increase the size of the bladder (augmentation cystoplasty) and create a channel for catheterization from the umbilicus. The cecum and colon are detubularized, and a large rectangular plate of large bowel is formed, which is then sewn to the bladder, expanding its volume. About 10 to 15 cm of the terminal ileum is tapered to the diameter of a pencil and brought through the base of the umbilicus, creating a small stoma for intermittent bladder catheterization. The ileocecal valve is tightened and serves as a continence mechanism to prevent urinary leakage through the small stoma in the umbilicus.⁴

A perineal urethral mesh sling was placed at the time of the patient’s surgery to bolster the deinnervated urinary sphincter and prevent urethral leakage. The goal of reconstructive surgery for this patient was to create a small bowel channel connecting the umbilicus and bladder that could be catheterized every 4 to 6 hours, increase bladder capacity, and increase sphincteric resistance to reduce urethral leakage through the penis. Because there can be damage from passing a catheter through mesh slings and the urethra over time, including stenosis or erosion of the sling, an alternative catheterizable channel was needed in this patient.

The patient recovered after the surgery and was able to self-catheterize without difficulty. However, the urethral mesh sling did not place enough pressure on the urethra to prevent leakage, and he had persistent incontinence from the penis. Three months after the original surgery the patient had exploration of the perineum, which revealed that the mesh sling was loose and exerting inadequate pressure on the urethra. It was likely the sling slipped postoperatively—a known complication of urethral slings. An artificial urinary sphincter (AUS) was placed around the urethra during the second surgery to address the patient’s UI.

A perineal and small-groin incision was used to place the AUS. The AUS was connected to a tissue expander port rather than to a conventional pump mechanism, to enable pressure adjustment within the sphincter to the lowest possible pressure to prevent incontinence (Figure 2). The modified AUS placement controlled his incontinence very well with minimal pressure within the system.

 

More than 1 year after the original surgery, the patient self-catheterizes about 4 to 5 times daily via the catheterizable channel using a single-use catheter. His bladder holds at least 500 mL. The patient does not have significant leakage from the channel or the penis. He is no longer dependent on a chronic indwelling catheter and is free of the problems associated with severe UI, including foul odor, UTIs, and social isolation.

Discussion

Patients with spinal cord or pelvic nerve injury often develop spastic bladders with low capacities. This is similar to muscle spasticity that may occur with a neurologic injury, below the level of the injury, such as in the lower extremities. The powerful uncontrolled bladder spasms and small bladder capacity most often lead to incontinence. Additionally, neurologic control of the urinary sphincter is affected, leading to either uncontrolled spasms or poor tone. Patients with these injuries have no volitional control of bladder functions and are forced to catheterize intermittently, use a condom-type catheter, or have a chronic indwelling catheter (a Foley catheter or suprapubic catheter).

Intermittent catheterization is the preferred management option for neurogenic bladder. When compared with chronic indwelling catheters, intermittent catheterization is associated with lower rates of UTI and upper tract abnormalities and with the loss of renal function.⁵ Unfortunately, patients do not often stay on intermittent catheterization. A recent study showed that up to 70% of patients with spinal cord injuries who used clean intermittent catheterization when discharged from acute rehabilitation discontinue use and are subsequently managed by chronic indwelling catheters.⁶ Although the reasons why intermittent catheterization is discontinued are unclear, patient dissatisfaction with catheterization, anatomic problems, such as urethral scarring, or continued leakage despite medical treatments, such as anticholinergic medicines, may be factors.

Uncontrolled leakage and UI significantly impacts QOL and may cause patients to choose chronic indwelling catheters over intermittent catheterization. Several treatments are available to control incontinence associated with intermittent catheterization. Anticholinergic medications and more recently onabotulinum toxin A may help improve bladder spasticity. In 2011, the FDA approved onabotulinum toxin A for transurethral bladder injections. It has been shown to increase functional bladder capacity and decrease spasticity.^7,8 Onabotulinum toxin A treatment will not enlarge a small, contracted bladder.

Onabotulinum toxin A treatment would not be ideal for the patient in this case study. His absolute bladder capacity was 200 mL, and onabotulinum toxin A treatment would not significantly improve capacity or make intermittent catheterization practical. Additionally, the patient had poor urinary sphincter function, and he would continue to leak regardless of improvements in the bladder spasticity or tone.

Augmentation enterocystoplasty is surgical enlargement of the bladder, using a piece of the bowel and is indicated in patients with low bladder volumes. With this procedure the native bladder becomes defunctionalized, and patients experience a dramatic improvement in bladder volumes and a reduction in bladder spasms and leakage. The use of the colon and terminal ileum for bladder augmentation, or CCIC, was first reported by Sarosdy in 2 patients in 1992.⁹ In 1996, King and colleagues demonstrated successful outcomes with CCIC in a cohort of 8 patients after 34 months of follow-up.¹⁰ Seven patients successfully used clean intermittent catheterization, and 1 patient chose an indwelling catheter because of progressive upper extremity weakness. No patients experienced worsened renal function or pyelonephritis suggestive of upper urinary tract deterioration. A single patient had mild stomal stenosis, which was successfully revised under local anesthesia.

In another study, Sutton and colleagues reported at 27 months an improvement of 276 mL in bladder capacity, no metabolic complications, and a 95% continence rate in a cohort of 23 patients with neurogenic bladder who underwent CCIC.⁴ Sutton and colleagues later reported outcomes for 34 patients with a median of 31 months follow-up.¹¹ The most common complications were recurrent UTIs (12%) and stomal stenosis (12%). Only 3 patients (9%) required surgical revisions for stomal stenosis.

Altered bowel function and metabolic abnormalities are a concern after bowel resection and reconstruction. However, a study has found no subjective change in bowel function following ileal resection of up to 60 cm for urinary diversion for bladder malignancy.¹² Rates of hyperchloremic hypokalemic metabolic acidosis are low, and most changes in electrolytes are subclinical.^13,14 Long-term vitamin B12 deficiency is seen with larger (> 50 cm) ileal resections but is rare with CCIC, given the small segment used for reconstruction.¹⁵ Overall, CCIC is shown to have excellent surgical outcomes in carefully selected patients with neurogenic bladder.

In addition to low bladder capacity, the case study patient also had intrinsic sphincteric deficiency (very low urinary sphincter tone), which is common with pelvic nerve injury but unusual with spinal cord injury. He initially received a suburethral mesh sling that supported and compressed the urethra and buttressed the natural urinary sphincter. However, patients can develop catheterization issues with a suburethral sling due to mechanical compression of the urethra and traversing the compressed area with a urinary catheter. Given the indication for augmentation cystoplasty in this patient, he additionally elected to undergo catheterization channel creation to avoid long-term issues of urethral catheterization through the urethra compressed by the sling.

Unfortunately, this patient had postoperative issues with his suburethral sling, and a modified AUS was inserted rather than a second sling. Normally, an AUS is attached to a pump mechanism in the scrotum. The pump allows the patient to cycle fluid from the sphincter cuff to a reservoir in the abdomen, removing compression on the urethra and allowing normal urination. Because this patient could not effectively urinate from the penis, the authors wanted to obstruct the urethra to prevent leakage without closing it permanently. The AUS was connected to a tissue expander port placed subcutaneously in the lower abdomen rather than to a pump mechanism. This modified approach used fewer mechanical parts compared with the pump mechanism, possibly reducing rates of mechanical failure. Additionally, a lower cuff pressure could be used to obstruct the urethra and prevent leakage, reducing the likelihood of urethral atrophy. Fewer mechanical parts and a lower cuff pressure could theoretically improve longevity of the AUS (Figure 3). This modified method of AUS placement has been described in patients with sphincteric deficiency and spinal cord injury.¹⁶

These 2 reconstructive surgeries freed the patient from indwelling catheter dependence and significantly improved his incontinence and QOL. Many patients with spinal cord injury or pelvic injury could benefit from similar reconstructive surgeries if conservative measures such as anticholinergic medications or onabotulinum toxin A treatments do not control incontinence.

Conclusion

Blast injuries in soldiers often cause pelvic and genitourinary injuries. These injuries can lead to chronic urinary problems and profound social and physical disability. These young veterans need innovative, individualized approaches to best manage their long-term urinary issues. Reconstructive surgery may improve QOL and decrease disability from bladder dysfunction for carefully selected patients. Clinicians caring for veterans with pelvic and genitourinary injury should strive to create a system where these options are available when they are appropriate.

More than 52,000 soldiers have been injured and 6,800 have been killed during the wars in Iraq and Afghanistan.¹ Blast injuries from improvised explosive devices (IEDs) account for 70% to 79% of combat-related injuries and deaths in these wars.² Advances in personal body armor, rapid and advanced surgical treatment, and the changing nature of combat in Iraq and Afghanistan have changed injury patterns and survival compared with prior military conflicts such as those in Vietnam and Korea.³

The most common combat-related injuries in the recent wars are extremity, facial, brain, and gastrointestinal injuries. Pelvic and genitourinary injuries are also common, accounting for about 8% of total injuries.² Pelvic and genitourinary injury can cause long-term disability from nerve injury (neurogenic bladder, neurogenic bowel, sexual dysfunction, urethral injury), as well as general loss of genital structures from blast injuries.

The usual care for bladder dysfunction from pelvic or genitourinary injury ranges from the use of chronic indwelling catheters to reconstructive surgery. However, there is no standard of care for long-term treatment of patients with pelvic or genitourinary injury who experience bladder dysfunction. Reconstructive surgery has the potential to improve quality of life (QOL) and eliminate chronic indwelling catheters, which are prone to cause infection and long-term kidney problems in patients with bladder dysfunction from traumatic injury. 

This case report evaluates the efficacy of reconstructive surgery for bladder dysfunction to improve independence and QOL and decrease complications associated with chronic indwelling urinary catheters. The authors hope to raise awareness regarding this option for patients with pelvic, spinal cord, or genitourinary injury who are young and face long-term disability from their injuries.

Case Presentation

A 22-year-old man presented to the George E. Wahlen VAMC Urology Clinic in Salt Lake City, Utah with a complicated history related to combat injuries. During combat operations 3 years earlier, he was injured by an IED blast while on foot patrol. His injuries included bilateral severe extremity injury, perineal and genital blast wounds, a bladder injury, pelvic fracture, colorectal injury, and extensive soft tissue loss. He underwent multiple abdominal explorations, left leg amputation below the knee, multiple skin grafts, soft tissue debridements, left-side orchiectomy, bladder repair, and diverting colostomy. He survived the injuries and was eventually discharged from active military service and returned home.

Upon presentation to the VAMC, the patient had a diverting colostomy, suprapubic bladder catheter, and bladder and bowel function consistent with cauda equina syndrome (pelvic nerve injury). Given the lack of rectal tone, fecal incontinence was likely with colostomy reversal. His bladder had low volume and poor compliance (elasticity). In addition, the patient had no volitional control of urination or defecation.

The patient previously performed intermittent self-catheterization but experienced total urinary incontinence (UI) between catheterizations, due to his bladder dynamics and a lack of urinary sphincter tone. A suprapubic bladder catheter was previously placed to control UI. However, the patient remained incontinent, and urinary leakage, need for diapers, and urinary tract infections (UTIs) negatively impacted QOL. The patient ambulated well and was physically active. His priority was to reduce incontinence and improve QOL.

Catheterizable Ileal Cecocystoplasty

The patient underwent cutaneous catheterizable ileal cecocystoplasty (CCIC) (Figure 1). In this surgery, a segment of the cecum and ascending colon with attached terminal ileum is used to increase the size of the bladder (augmentation cystoplasty) and create a channel for catheterization from the umbilicus. The cecum and colon are detubularized, and a large rectangular plate of large bowel is formed, which is then sewn to the bladder, expanding its volume. About 10 to 15 cm of the terminal ileum is tapered to the diameter of a pencil and brought through the base of the umbilicus, creating a small stoma for intermittent bladder catheterization. The ileocecal valve is tightened and serves as a continence mechanism to prevent urinary leakage through the small stoma in the umbilicus.⁴

A perineal urethral mesh sling was placed at the time of the patient’s surgery to bolster the deinnervated urinary sphincter and prevent urethral leakage. The goal of reconstructive surgery for this patient was to create a small bowel channel connecting the umbilicus and bladder that could be catheterized every 4 to 6 hours, increase bladder capacity, and increase sphincteric resistance to reduce urethral leakage through the penis. Because there can be damage from passing a catheter through mesh slings and the urethra over time, including stenosis or erosion of the sling, an alternative catheterizable channel was needed in this patient.

The patient recovered after the surgery and was able to self-catheterize without difficulty. However, the urethral mesh sling did not place enough pressure on the urethra to prevent leakage, and he had persistent incontinence from the penis. Three months after the original surgery the patient had exploration of the perineum, which revealed that the mesh sling was loose and exerting inadequate pressure on the urethra. It was likely the sling slipped postoperatively—a known complication of urethral slings. An artificial urinary sphincter (AUS) was placed around the urethra during the second surgery to address the patient’s UI.

A perineal and small-groin incision was used to place the AUS. The AUS was connected to a tissue expander port rather than to a conventional pump mechanism, to enable pressure adjustment within the sphincter to the lowest possible pressure to prevent incontinence (Figure 2). The modified AUS placement controlled his incontinence very well with minimal pressure within the system.

 

More than 1 year after the original surgery, the patient self-catheterizes about 4 to 5 times daily via the catheterizable channel using a single-use catheter. His bladder holds at least 500 mL. The patient does not have significant leakage from the channel or the penis. He is no longer dependent on a chronic indwelling catheter and is free of the problems associated with severe UI, including foul odor, UTIs, and social isolation.

Discussion

Patients with spinal cord or pelvic nerve injury often develop spastic bladders with low capacities. This is similar to muscle spasticity that may occur with a neurologic injury, below the level of the injury, such as in the lower extremities. The powerful uncontrolled bladder spasms and small bladder capacity most often lead to incontinence. Additionally, neurologic control of the urinary sphincter is affected, leading to either uncontrolled spasms or poor tone. Patients with these injuries have no volitional control of bladder functions and are forced to catheterize intermittently, use a condom-type catheter, or have a chronic indwelling catheter (a Foley catheter or suprapubic catheter).

Intermittent catheterization is the preferred management option for neurogenic bladder. When compared with chronic indwelling catheters, intermittent catheterization is associated with lower rates of UTI and upper tract abnormalities and with the loss of renal function.⁵ Unfortunately, patients do not often stay on intermittent catheterization. A recent study showed that up to 70% of patients with spinal cord injuries who used clean intermittent catheterization when discharged from acute rehabilitation discontinue use and are subsequently managed by chronic indwelling catheters.⁶ Although the reasons why intermittent catheterization is discontinued are unclear, patient dissatisfaction with catheterization, anatomic problems, such as urethral scarring, or continued leakage despite medical treatments, such as anticholinergic medicines, may be factors.

Uncontrolled leakage and UI significantly impacts QOL and may cause patients to choose chronic indwelling catheters over intermittent catheterization. Several treatments are available to control incontinence associated with intermittent catheterization. Anticholinergic medications and more recently onabotulinum toxin A may help improve bladder spasticity. In 2011, the FDA approved onabotulinum toxin A for transurethral bladder injections. It has been shown to increase functional bladder capacity and decrease spasticity.^7,8 Onabotulinum toxin A treatment will not enlarge a small, contracted bladder.

Onabotulinum toxin A treatment would not be ideal for the patient in this case study. His absolute bladder capacity was 200 mL, and onabotulinum toxin A treatment would not significantly improve capacity or make intermittent catheterization practical. Additionally, the patient had poor urinary sphincter function, and he would continue to leak regardless of improvements in the bladder spasticity or tone.

Augmentation enterocystoplasty is surgical enlargement of the bladder, using a piece of the bowel and is indicated in patients with low bladder volumes. With this procedure the native bladder becomes defunctionalized, and patients experience a dramatic improvement in bladder volumes and a reduction in bladder spasms and leakage. The use of the colon and terminal ileum for bladder augmentation, or CCIC, was first reported by Sarosdy in 2 patients in 1992.⁹ In 1996, King and colleagues demonstrated successful outcomes with CCIC in a cohort of 8 patients after 34 months of follow-up.¹⁰ Seven patients successfully used clean intermittent catheterization, and 1 patient chose an indwelling catheter because of progressive upper extremity weakness. No patients experienced worsened renal function or pyelonephritis suggestive of upper urinary tract deterioration. A single patient had mild stomal stenosis, which was successfully revised under local anesthesia.

In another study, Sutton and colleagues reported at 27 months an improvement of 276 mL in bladder capacity, no metabolic complications, and a 95% continence rate in a cohort of 23 patients with neurogenic bladder who underwent CCIC.⁴ Sutton and colleagues later reported outcomes for 34 patients with a median of 31 months follow-up.¹¹ The most common complications were recurrent UTIs (12%) and stomal stenosis (12%). Only 3 patients (9%) required surgical revisions for stomal stenosis.

Altered bowel function and metabolic abnormalities are a concern after bowel resection and reconstruction. However, a study has found no subjective change in bowel function following ileal resection of up to 60 cm for urinary diversion for bladder malignancy.¹² Rates of hyperchloremic hypokalemic metabolic acidosis are low, and most changes in electrolytes are subclinical.^13,14 Long-term vitamin B12 deficiency is seen with larger (> 50 cm) ileal resections but is rare with CCIC, given the small segment used for reconstruction.¹⁵ Overall, CCIC is shown to have excellent surgical outcomes in carefully selected patients with neurogenic bladder.

In addition to low bladder capacity, the case study patient also had intrinsic sphincteric deficiency (very low urinary sphincter tone), which is common with pelvic nerve injury but unusual with spinal cord injury. He initially received a suburethral mesh sling that supported and compressed the urethra and buttressed the natural urinary sphincter. However, patients can develop catheterization issues with a suburethral sling due to mechanical compression of the urethra and traversing the compressed area with a urinary catheter. Given the indication for augmentation cystoplasty in this patient, he additionally elected to undergo catheterization channel creation to avoid long-term issues of urethral catheterization through the urethra compressed by the sling.

Unfortunately, this patient had postoperative issues with his suburethral sling, and a modified AUS was inserted rather than a second sling. Normally, an AUS is attached to a pump mechanism in the scrotum. The pump allows the patient to cycle fluid from the sphincter cuff to a reservoir in the abdomen, removing compression on the urethra and allowing normal urination. Because this patient could not effectively urinate from the penis, the authors wanted to obstruct the urethra to prevent leakage without closing it permanently. The AUS was connected to a tissue expander port placed subcutaneously in the lower abdomen rather than to a pump mechanism. This modified approach used fewer mechanical parts compared with the pump mechanism, possibly reducing rates of mechanical failure. Additionally, a lower cuff pressure could be used to obstruct the urethra and prevent leakage, reducing the likelihood of urethral atrophy. Fewer mechanical parts and a lower cuff pressure could theoretically improve longevity of the AUS (Figure 3). This modified method of AUS placement has been described in patients with sphincteric deficiency and spinal cord injury.¹⁶

These 2 reconstructive surgeries freed the patient from indwelling catheter dependence and significantly improved his incontinence and QOL. Many patients with spinal cord injury or pelvic injury could benefit from similar reconstructive surgeries if conservative measures such as anticholinergic medications or onabotulinum toxin A treatments do not control incontinence.

Conclusion

Blast injuries in soldiers often cause pelvic and genitourinary injuries. These injuries can lead to chronic urinary problems and profound social and physical disability. These young veterans need innovative, individualized approaches to best manage their long-term urinary issues. Reconstructive surgery may improve QOL and decrease disability from bladder dysfunction for carefully selected patients. Clinicians caring for veterans with pelvic and genitourinary injury should strive to create a system where these options are available when they are appropriate.

Health care has become increasingly unaffordable in the U.S., yet it remains ineffective in preventing or effectively treating chronic diseases.^1,2 Given the increasing burden of chronic disease on the American health care system, there is an effort to shift the practice of medicine away from its reactive, disease-oriented approach to a more sustainable proactive model.^3-5

Personalized health care (PHC) is an approach to the practice of medicine where prediction, prevention, intense patient engagement, shared health care decision making, and coordination of care are essential to cost effectively facilitate better outcomes.^3,5-7 Greater collaboration between patient and clinician replaces the traditional clinician-dominated dialogue with more effective patient-clinician partnerships.^8,9 Patients’ knowledge, skills, and confidence to manage their health care have been linked to improved health outcomes, lower costs, and greater satisfaction with health care experiences.^10,11

Personalized health care has been proposed as a means to achieve better patient engagement as part of an aligned, proactive clinical approach. At the heart of PHC is personalized health planning, wherein the patient and clinician develop shared health-related goals and a plan to achieve them.³

The VHA, the largest integrated health care system in the country, is on the vanguard of incorporating tenets of PHC into its delivery model. In 2011, the Office of Patient Centered Care and Cultural Transformation (OPCC&CT) was founded to “oversee the VHA’s cultural transformation to patient-centered care.”¹² This undertaking represents “one of the most massive changes in the philosophy and process for health care delivery ever undertaken by an organized health care system.”¹³

The primary goal of the VHA’s strategic plan for 2013 to 2018 is to provide veterans personalized, proactive, patient-driven health care.¹⁴ The intention of this approach is to engage and inspire veterans to their highest possible level of health and well-being. A personalized approach requires a dynamic customization of care that is specifically relevant to the individual, based on factors such as medical conditions, genome, needs, values, and circumstances. In addition to being personalized, this approach must be proactive, and therefore, preventive and include strategies to strengthen the person’s innate capacity for enhancing health.

The third distinction of this new model health care is that it is patient-driven, rooted in and driven by that which matters most to people in their lives and aligns their health care with their day-to-day and long-term life goals.¹⁵ The latter may be the most critical of the 3 tenets, because a personalized, proactive approach that is not driven by an engaged and inspired individual will be unlikely to achieve adherence, let alone the highest level of health and well-being.

The VHA is uniquely positioned to optimize health and well-being for veterans due in part to a systemwide emphasis on training providers to promote and support behavior change through approaches including health coaching and motivational interviewing. These synergistic approaches used widely by clinicians throughout the VHA are influenced by the transtheoretical model (ie, the stages of change theory), which considers patients holistically and helps them identify intrinsic motivation to improve their health behaviors.^16,17 The transformation occurring in the VHA is intended to shift the current disease-centric medical model to an approach that optimizes the health of veterans through patient-clinician engagement, health risk assessment (HRA), shared health goal creation, and a coordinated plan to attain them.^12,13

Personalized Health Planning

In recognition of the need to deliver care that emphasizes prevention and coordination, the patient-centered medical home, patient-aligned care teams (PACTs), and the chronic care model were developed. All of these embrace concepts of patient engagement, shared decision making, and team-based care. However, none of these approaches have outlined a clinical workflow that systematically and proactively operationalizes these concepts with the creation of a risk-based personalized care approach. Personalized health planning provides a clinical workflow that operationalizes all these features (Figure 1).

Of central importance is the creation of a personalized health plan (PHP), which the patient and clinician develop collaboratively. The plan serves to organize and coordinate care while engaging the patient in the process of care delivery and appropriate self-management of health.^3,5 This approach promotes personalized and proactive care that values the individual and fosters meaningful patient self-awareness and engagement through shared decision making.⁷

The personalized health planning process is composed of several key components (Figure 2).

It begins with a HRA and a comprehensive health evaluation whereby the clinician assesses the patient’s health through physical examination, family history, diagnostic testing, available biometric data, and tools to gauge the health status and health risks for the individual.⁴ In parallel, patients conduct a whole health self-assessment, which helps elucidate the importance of their health to their life’s purpose and to determine area(s) where they are motivated to make behavioral change. Based on the clinical assessment and the patient’s own health evaluation, the clinician prioritizes the health risks and identifies therapeutic goals needed to mitigate them.

With this information, the clinician develops a preliminary therapeutic plan to meet these goals and discusses this plan with the patient. The next component is the synthesis of the clinician’s goals and/or treatment plan with the priorities of the patient to establish shared clinician-patient goals. This is followed by the establishment of the PHP, which consists of the agreed upon shared clinician and patient goals, a therapeutic and wellness plan to meet them, metrics for tracking progress, consults and referrals, and a time frame for the patient to achieve the health goals.

Related: The Right Care at the Right Time and in the Right Place: The Role of Technology in the VHA

The final component is coordination of care and a formalized follow-up system in which the health care team monitors the patient’s progress and provides support by revisiting or updating the PHP at intervals determined by the provider, based on the level of monitoring required by the patient’s health status. This approach invites the patient to become an empowered member of the care team by creating a patient-clinician partnership and providing a model for delivering personalized, proactive, patient-driven care to individuals with a diverse range of needs.^4,5,18

 

Design and Implementation

This project qualified as exempt through the Duke University Institutional Review Board. The primary aim of this pilot was to examine the feasibility of implementing personalized health planning into primary care settings and to develop a workable process that is scalable and customizable to inpatient and outpatient clinics of varying sizes for different patient populations within the VHA. The pilot included 5 clinics in 2 geographic areas that were selected for their facility’s leadership support and desire to participate.

The VA Boston Healthcare System implemented personalized health planning at 3 primary care clinics: Jamaica Plain Primary Care, Jamaica Plain Women’s Health, and Quincy Primary Care. Three distinct PACTs participated in Boston, each composed of a medical doctor or doctor of osteopathy, a registered nurse (RN) or health technician, and a medical support assistant. The Sam Rayburn Memorial Veterans Center in Bonham, Texas, implemented personalized health planning at 2 clinics: the Hypertension Shared Medical Appointment and the Domiciliary Inpatient Primary Care. At Bonham, a medical doctor, pharmacist, RN, and an integrated mental health provider led the shared medical appointment (SMA) with guest presenters for individual appointments, depending on the topic covered. A RN and social worker implemented personalized health planning in the domiciliary.

After receiving training in the personalized health planning process, each of the clinics’ multidisciplinary PACTs incorporated their custom personalized health planning workflow into patient encounters. During the intake process of the clinic visit, the patient received a Personal Health Inventory (PHI) to determine health care priorities. The OPCC&CT developed the PHI as a whole-health self-assessment tool to help patients reflect on their health and lives, including core values, disparities between current and desired states, and preparedness to make behavioral changes to promote health.

The PHI assisted with framing this whole health approach to clinical care by expanding the definition of health to include more holistic elements of well-being, such as spirituality, personal relationships, emotional health, and personal development. A visual representation of the whole health domains termed The Circle of Health introduced this concept to the patient and assisted with goal setting (Figure 3).¹²

The PHI organized the patient’s input and was provided to the clinician to contribute to the development of the shared therapeutic goals and a final treatment plan. The PHP provided the tool to organize the goals, plans, and care following the visit and to connect the patient to additional resources within the VHA to support goal attainment through skill building and support. Each clinical site developed a mechanism to follow up with these patients either telephonically or with additional clinic appointments. The participating clinics implemented their customized version of personalized health planning for an average of 3 months.

Personalized health planning and accompanying tools were used primarily in routine ambulatory care visits. They were also used in the Bonham domiciliary clinic, which provides care for veterans with mental illnesses or addictive disorders who require additional structure and support. The purpose of the pilot was to determine whether personalized health planning could be used within this population. Given the small sample size and incompleteness of data collected, the Bonham domiciliary group was not included in the participating patient total. Across the other 4 clinics a total of 153 patients participated in the 3-month pilot study by establishing shared health goals and plans to meet them.

Results and Evaluation

Using a structured interview guide, a total of 6 small group interviews with participating clinicians were held (3 in Boston and 3 in Bonham, N = 18). Qualitative methods for research and evaluation were used to capture the depth of responses and to provide complex descriptions of the clinicians’ perspectives on the implementation of the personalized health planning process. Two researchers reviewed the transcripts to identify and code themes, and a third researcher reviewed the transcripts to confirm themes and resolve any discrepancies.

Analysis of the interview data revealed 9 core themes related to the feasibility, effectiveness, and future dissemination of personalized health planning. These themes, described below with exemplar data, include (a) patient engagement; (b) clinical assessment; (c) goal setting; (d) clinical workflow; (e) resources and support for veterans and clinicians; (f) Computerized Patient Record System (CPRS) integration; (g) patient-clinician relationship; (h) clinical outcomes; and (i) patient satisfaction.

The purpose of this study was to evaluate the feasibility of introducing personalized health planning within the workflows of the clinics that were participating. As a consequence of this, interviews were held with clinic staff rather than patients. However, the authors did obtain patient satisfaction data from 10 patients who received care from the hypertension SMA and responded to TruthPoint questions after their visit (Table).

Patient Engagement

A central tenant of personalized health planning is to engage patients in their health and health care. Findings revealed that clinicians at both sites perceived the PHP as an effective tool for integrating patients as robust members of the care team. Clinicians noted that by asking patients what was important to them, the patients felt more empowered to actively engage in the clinical encounter and to take responsibility for their health decisions. One pharmacist noted, “Patients are more empowered…when you change how you’re having your conversation with them that helps people start to recognize that they are an active participant [sic] and they can have an impact and can help with minimizing medicines or trying other things.”

Clinicians reported that including patients as active members in their care created a level of buy-in that motivated behavioral changes, because the patients identified behaviors they wanted to change vs the clinician telling them what they should or should not do. A nurse manager reported, “The key is that (the health goal) is coming from the patient…. Once it comes out of their mouth, they’re thinking about it and it’s not the clinician telling them what they should or shouldn’t do, but it’s helping them…identify something that’s important that will keep them into staying the way they want to, for the reasons that they want to.”

Clinical Assessment

The HRA tools are a vital part of the personalized health planning process, as they focus on preventive strategies that are most important for the patient.⁴ Clinicians reported using the PHI and additional HRA tools as part of the pilot program. The PHI is a self-assessment tool designed to identify psychosocial, behavioral, and environmental issues that can impact the patient’s care and health status. Most clinicians found that the PHI helped to solicit patients’ input on what was important to them and their health status while introducing the new approach to care. One nurse commented, “I found [PHI] very effective if I could actually sit down and review it with them to see what it was that was truly important to them and explain that this new approach is for a better understanding.”

Clinicians also found that the PHI helped focus the patient’s attention toward self-care areas that facilitated the shared goal setting process with the clinician. It moved the clinical encounter away from the chief health problems and toward identifying what is important to the patient and leveraging his or her intrinsic motivation to support health promotion via lifestyle modification.

Goal Setting

Shared goal setting is a critical component of personalized health planning. The clinician and patient must agree about realistic goals to improve the patient’s health. Clinicians reported that the goal setting stage was most successful when patients were invited to guide the process and offered the goals themselves; ie, when it was not just patient-centered but patient-driven.

“Setting a goal with a patient is pretty easy because people have an idea of what they should be doing and what they want to be doing,” one clinician reported. “They know their goal. So it’s a matter of just listening, really listening, and seeing what they want…. It’s not incongruous to get the medical goal and the patient goal to match.”

Patients were amenable to this collaborative approach to goal setting, and there was often commonality between the clinician’s goals and what was important to the patient. Occasionally, the patient set goals in seemingly unrelated areas that facilitated chronic disease management.

“One of our hypertensive patients wanted to work on things that are external that they felt are stressors that actually caused their blood pressure to be high,” a pharmacist recalled. “At the end of the day they wanted to control their environment better so that they could see if they could then be off of antihypertensives altogether. It appears that may be the case right now. That this individual has been able to accomplish that, which I thought was amazing, and since it’s still new, I’m still a little bit skeptical.... Is that possible? But if at the end of the day that is an outcome that we see from doing this, I think that’s wonderful.”

Clinicians reported that follow-up with the patient was a critical aspect of goal setting, because it improved accountability and helped track progress and health outcomes. However, due to the 3-month time limit of the pilot, there was insufficient time to get uniform data on the formalized follow-up systems developed by each clinic.

Clinical Workflow

Examining the feasibility of creating a process to incorporate personalized health planning into a busy primary care clinic was one of the major aims of this pilot. As such, issues of time, staff responsibilities, and use of the CPRS and other systems to facilitate the process were challenges that each clinic addressed in slightly different ways and with varying success. One method was to leverage the SMA for a group of patients with a common diagnosis to discuss their goals, provide accountability, and improve access to a medical team.

Another innovative approach was utilizing medical support administrators and health technicians to front-load some of the introductory information and patient education in the waiting room or during the intake process. Despite these efforts, some clinicians thought that the personalized health planning process might take longer than the traditional clinical encounter. One nurse manager commented, “I think it did affect the length of visits…it has made them a little bit longer.”

Resources and Support

The VHA has been undergoing a shift from an emphasis on tertiary care to include a greater focus on primary care. Part of this shift has been an investment in complementary and alternative medicine (CAM). The PHP helped clinicians explore what resources existed at their facility to support veterans in accomplishing their goals, including CAM. One nurse reported, “It made us look into other avenues that were actually available at the VHA that we didn’t even know we had…the acupuncture, the qigong, the voluntary services getting the veterans involved.”

Clinicians also identified the need for patient education in the concepts of whole health, personalized care, and patient involvement as necessary for moving the piloted approach forward. A nurse noted that “for [personalized health planning] to work well, [the patients] need more orientation and education upfront systemwide so that when they get into an appointment with us, we’re not starting at explaining the whole world view of partnership and doing things differently.”

Resources for clinicians were just as critical as resources for patients in facilitating the personalized health planning process. Specifically, most clinicians identified their own education and training in techniques to engage the patient in a meaningful way via motivational interviewing and health coaching complemented the personalized approach to care, particularly for shared goal setting,

CPRS Integration

The CPRS is an integrated, electronic patient record system that provides a single interface for clinicians to manage patient care as well as an efficient means for others to access and use patient information.¹⁹ The most commonly cited challenge in the pilot was the lack of available staff and time in the patient visit to complete the PHP while completing documentation requirements in CPRS.

One clinician stated, “For clinicians, the barriers…it’s time to get through the reminders and preventatives.” Clinicians reported that the process and the CPRS documentation were misaligned and lacked integration to coordinate care or support health planning. Moreover, clinicians reported that the data being collected did not support patient-centered care.

Patient-Clinician Relationship

A significant strength of personalized health planning was that it fostered a beneficial patient-clinician relationship that promoted greater depth of care. One clinician noted, “I think that it adds a more personalized dimension to the whole patient visit.” In addition to experiencing a deeper relationship with their patients, clinicians also expressed having higher levels of job satisfaction and relished the opportunity to connect with their patients in a more personal way.

 

Clinicians also reported that patients seemed more satisfied with the experience. One nurse commented, “They really respond to it very well when they figure out that you care about them as a whole… it’s not just about the disease process anymore.”

Clinical Outcomes

Clinicians reported a number of positive health outcomes during the pilot. One physician reported, “I have a patient, he had a follow-up today, a 29-year-old veteran, who was 260 pounds 5 months ago, and he’s 230 pounds today. He comes in monthly to see the nurse to let us know he’s doing it.”

The same physician also shared a similar transformation in a patient as a result of personalized health planning. “We had another one yesterday, 4 months ago his [hemoglobin] A_1c was 10.3%. It was 7.2% yesterday, and [his weight was] down 20 pounds.” In addition to positive clinical outcomes, patients made changes in areas of their health that they identified as important through the PHI, although these areas are not typically discussed in a clinical visit.

Patient Satisfaction

Although the overall goal of this pilot was to determine the feasibility of a clinical workflow embracing personalized health planning, data on patient satisfaction were collected from patients receiving care in the Hypertension Shared Medical Appointments Program at Bohnam. Ten patients were seen over the course of 5 visits. At each visit, they were asked to rate their satisfaction (Table).

Overall, patients were highly satisfied with their experience and the care they received: 91.7% reported exploring what they wanted for their health and setting shared goals; 100% reported that their providers truly listened to their needs and treated them with respect and dignity; and 97.2% reported that their experience was better than a traditional office visit. One participating physician noted that higher levels of patient and provider satisfaction are a product of this type of patient engagement. “I also think that looking at patient and provider satisfaction, the visits feel more meaningful, and there’s a better relationship built through this discussion,” he noted. These findings demonstrating increased satisfaction further suggest the benefits of personalized health planning approach.

Discussion

In 2012, the VHA National Leadership Council convened a Strategic Planning Summit to set goals and objectives to help the VHA be at the vanguard of a movement toward a more proactive health care delivery model. The first of 3 goals developed was to provide veterans personalized, proactive, patient-driven health care.¹³ It is becoming increasingly clear that truly affecting health and health outcomes requires motivated, engaged, and informed patients with a care delivery approach that provides ample opportunities for patient involvement and input in health care decision making.^10,11

The OPCC&CT has ongoing initiatives driving innovation, research, education, and deployment across the system to set the stage for personalized, proactive, patient-driven care.²⁰ Some of these innovations include clinician education in the concept of whole health; health coaching; group-based, peer-led approaches; and the expansion of CAM such as mind-body approaches, qi-gong, massage therapy, yoga, and acupuncture.²¹

The primary aim of the Whole Health in Primary Care Project was to determine the feasibility of using personalized health planning as the operational model to deliver personalized, proactive, patient-driven care. The decision was made to integrate personalized health planning into ongoing clinical operations rather than design clinical pilots de novo. This had the advantage of speed in starting the project but limited the ability to create an optimal workflow from scratch. Given the time and resources available for this study, it was not possible to obtain quantitative data particularly as it related to quantifying clinical outcomes.

Despite these limitations, early indications suggest that the personalized health planning process can serve as the operational clinical working model to enable personalized, proactive, patient-driven care in a variety of primary care settings. As noted by one nurse manager, preparing the personalized health plan made the initial visit “a bit longer.” However, after the first visit, monitoring health risk abatement and goal achievement is akin to what is currently done by reviewing problem lists. Thus, although the personalized health planning experience is just beginning, clinicians noted that it fostered a beneficial patient-clinician relationship. This deeper relationship between the patient and the clinician may be the most powerful signal that the process is worthwhile.

This pilot provided valuable information related to the implementation of a clinical workflow redesign, an initial step toward developing an optimized operational model of the PHP process. Additionally, although it is not yet possible to quantify the clinical impact of the personalized health planning, anecdotal evidence suggests its positive potential. Clinicians reported that patients were successful in managing a multitude of common chronic diseases, including weight loss, high blood pressure management, reduction of A_1c, and improved sleep habits.

These findings compare with studies using similar approaches that demonstrated their value in the treatment of congestive heart failure, cardiovascular disease risk, type 2 diabetes, and postpartum weight retention.^22-25 A growing body of evidence continues to affirm that a primary care model designed to deliver individualized care focused on improving health and an augmented patient-clinician relationship results in significant savings, primarily from reduced medical expenditures.²⁶

This pilot provided an important opportunity to learn how to improve the effectiveness of personalized health planning and how to scale it. The experiences in Boston and Bonham demonstrated that personalized health planning can be integrated into diverse primary care settings with PACTs. The authors suggest that the knowledge gained from this project should be incorporated into new pilots at various clinical settings to determine the usefulness of the PHP for clinical indications beyond primary care. Specialty care clinics, home-based primary care services, and telehealth programs would be potential clinical applications for such pilots.

New pilots should be designed de novo and be of sufficient length to gain quantitative data on patient activation and clinical outcomes. Furthermore, future studies of personalized health planning should obtain input from the patient using Likert scales, surveys, and focus groups to gauge and quantify patient satisfaction and outcomes with the approach. Since patient engagement and better understanding of patients’ holistic needs are central to development of the PHP, patients need to be educated about this new approach to care and their active role in it.

The choice of the tools, including the HRA instrument, materials for orienting patients to their more active role in their care, the PHI, the PHP template to document shared goals, and other avenues used to engage patients, require refinement to improve their clarity, effectiveness of conveying the intended information, and ease of use. These studies demonstrated the vital need to address the best means to engage patients in understanding the value of their health to them since the clinician visit is likely to be an opportune teaching moment. Initial observations suggested that patients respond with different degrees of enthusiasm when given the opportunity to be more engaged in their care. Future pilots should clarify whether these differences stem from (a) how the invitation is presented; (b) individual differences in personality and preferences; (c) perceived clinical needs; or (d) unfamiliarity with the collaborative personalized health planning process.

The alignment of personalized health planning with outcomes data in the CPRS is essential for widespread adoption. Importantly, incentives and performance metrics will need to be redesigned to support the intended outcomes of using personalized health planning in clinical care. To that end, further investigation into the potential for cost savings associated with personalized health planning use is warranted, especially given studies that suggest high levels of patient engagement result in lower health care utilization expenditures.²⁷

Additionally, wherever personalized health planning is initiated, employees across all levels of the system would benefit from training in patient engagement techniques and other means of attaining behavioral change. This would facilitate more effective use of time during the clinical visit and improve both the patient’s and the clinician’s satisfaction. Indeed, preliminary data indicate that this approach in a SMA setting is greatly valued by the patients.

Conclusions

The Whole Health in Primary Care Project was conducted to determine the feasibility of personalized health planning as the basis for primary care designed to facilitate personalized, proactive, patient-driven care. The pilot demonstrated that personalized health planning could be operational in VHA clinical settings and used to enhance patient-clinician engagement, establish shared health goals, and increase patient satisfaction. The personalized health planning process also provides a framework for the rational introduction of new capabilities to enhance prediction, clinical tracking, coordination of ancillary services, and clinical data collection. Future research should validate the efficacy of personalized health planning within both the VHA and health systems nationwide. Such research has the potential to refine this process so it becomes a key part of a personalized, proactive, patient-driven delivery approach. 

Acknowledgements
We gratefully acknowledge the assistance of Cindy Mitchell at Duke University Medical Center with the editing and preparation of this manuscript. We also gratefully acknowledge the participation of the providers and patients at VA Boston Healthcare System and Sam Rayburn Memorial Veterans Center. Funding for this project was provided by VA777-12-C-002 to the Pacific Institute for Research and Evaluation through subcontracts to Ralph Snyderman, MD, and to the Duke University School of Nursing (Simmons PI.)

Health care has become increasingly unaffordable in the U.S., yet it remains ineffective in preventing or effectively treating chronic diseases.^1,2 Given the increasing burden of chronic disease on the American health care system, there is an effort to shift the practice of medicine away from its reactive, disease-oriented approach to a more sustainable proactive model.^3-5

Personalized health care (PHC) is an approach to the practice of medicine where prediction, prevention, intense patient engagement, shared health care decision making, and coordination of care are essential to cost effectively facilitate better outcomes.^3,5-7 Greater collaboration between patient and clinician replaces the traditional clinician-dominated dialogue with more effective patient-clinician partnerships.^8,9 Patients’ knowledge, skills, and confidence to manage their health care have been linked to improved health outcomes, lower costs, and greater satisfaction with health care experiences.^10,11

Personalized health care has been proposed as a means to achieve better patient engagement as part of an aligned, proactive clinical approach. At the heart of PHC is personalized health planning, wherein the patient and clinician develop shared health-related goals and a plan to achieve them.³

The VHA, the largest integrated health care system in the country, is on the vanguard of incorporating tenets of PHC into its delivery model. In 2011, the Office of Patient Centered Care and Cultural Transformation (OPCC&CT) was founded to “oversee the VHA’s cultural transformation to patient-centered care.”¹² This undertaking represents “one of the most massive changes in the philosophy and process for health care delivery ever undertaken by an organized health care system.”¹³

The primary goal of the VHA’s strategic plan for 2013 to 2018 is to provide veterans personalized, proactive, patient-driven health care.¹⁴ The intention of this approach is to engage and inspire veterans to their highest possible level of health and well-being. A personalized approach requires a dynamic customization of care that is specifically relevant to the individual, based on factors such as medical conditions, genome, needs, values, and circumstances. In addition to being personalized, this approach must be proactive, and therefore, preventive and include strategies to strengthen the person’s innate capacity for enhancing health.

The third distinction of this new model health care is that it is patient-driven, rooted in and driven by that which matters most to people in their lives and aligns their health care with their day-to-day and long-term life goals.¹⁵ The latter may be the most critical of the 3 tenets, because a personalized, proactive approach that is not driven by an engaged and inspired individual will be unlikely to achieve adherence, let alone the highest level of health and well-being.

The VHA is uniquely positioned to optimize health and well-being for veterans due in part to a systemwide emphasis on training providers to promote and support behavior change through approaches including health coaching and motivational interviewing. These synergistic approaches used widely by clinicians throughout the VHA are influenced by the transtheoretical model (ie, the stages of change theory), which considers patients holistically and helps them identify intrinsic motivation to improve their health behaviors.^16,17 The transformation occurring in the VHA is intended to shift the current disease-centric medical model to an approach that optimizes the health of veterans through patient-clinician engagement, health risk assessment (HRA), shared health goal creation, and a coordinated plan to attain them.^12,13

Personalized Health Planning

In recognition of the need to deliver care that emphasizes prevention and coordination, the patient-centered medical home, patient-aligned care teams (PACTs), and the chronic care model were developed. All of these embrace concepts of patient engagement, shared decision making, and team-based care. However, none of these approaches have outlined a clinical workflow that systematically and proactively operationalizes these concepts with the creation of a risk-based personalized care approach. Personalized health planning provides a clinical workflow that operationalizes all these features (Figure 1).

Of central importance is the creation of a personalized health plan (PHP), which the patient and clinician develop collaboratively. The plan serves to organize and coordinate care while engaging the patient in the process of care delivery and appropriate self-management of health.^3,5 This approach promotes personalized and proactive care that values the individual and fosters meaningful patient self-awareness and engagement through shared decision making.⁷

The personalized health planning process is composed of several key components (Figure 2).

It begins with a HRA and a comprehensive health evaluation whereby the clinician assesses the patient’s health through physical examination, family history, diagnostic testing, available biometric data, and tools to gauge the health status and health risks for the individual.⁴ In parallel, patients conduct a whole health self-assessment, which helps elucidate the importance of their health to their life’s purpose and to determine area(s) where they are motivated to make behavioral change. Based on the clinical assessment and the patient’s own health evaluation, the clinician prioritizes the health risks and identifies therapeutic goals needed to mitigate them.

With this information, the clinician develops a preliminary therapeutic plan to meet these goals and discusses this plan with the patient. The next component is the synthesis of the clinician’s goals and/or treatment plan with the priorities of the patient to establish shared clinician-patient goals. This is followed by the establishment of the PHP, which consists of the agreed upon shared clinician and patient goals, a therapeutic and wellness plan to meet them, metrics for tracking progress, consults and referrals, and a time frame for the patient to achieve the health goals.

Related: The Right Care at the Right Time and in the Right Place: The Role of Technology in the VHA

The final component is coordination of care and a formalized follow-up system in which the health care team monitors the patient’s progress and provides support by revisiting or updating the PHP at intervals determined by the provider, based on the level of monitoring required by the patient’s health status. This approach invites the patient to become an empowered member of the care team by creating a patient-clinician partnership and providing a model for delivering personalized, proactive, patient-driven care to individuals with a diverse range of needs.^4,5,18

 

Design and Implementation

This project qualified as exempt through the Duke University Institutional Review Board. The primary aim of this pilot was to examine the feasibility of implementing personalized health planning into primary care settings and to develop a workable process that is scalable and customizable to inpatient and outpatient clinics of varying sizes for different patient populations within the VHA. The pilot included 5 clinics in 2 geographic areas that were selected for their facility’s leadership support and desire to participate.

The VA Boston Healthcare System implemented personalized health planning at 3 primary care clinics: Jamaica Plain Primary Care, Jamaica Plain Women’s Health, and Quincy Primary Care. Three distinct PACTs participated in Boston, each composed of a medical doctor or doctor of osteopathy, a registered nurse (RN) or health technician, and a medical support assistant. The Sam Rayburn Memorial Veterans Center in Bonham, Texas, implemented personalized health planning at 2 clinics: the Hypertension Shared Medical Appointment and the Domiciliary Inpatient Primary Care. At Bonham, a medical doctor, pharmacist, RN, and an integrated mental health provider led the shared medical appointment (SMA) with guest presenters for individual appointments, depending on the topic covered. A RN and social worker implemented personalized health planning in the domiciliary.

After receiving training in the personalized health planning process, each of the clinics’ multidisciplinary PACTs incorporated their custom personalized health planning workflow into patient encounters. During the intake process of the clinic visit, the patient received a Personal Health Inventory (PHI) to determine health care priorities. The OPCC&CT developed the PHI as a whole-health self-assessment tool to help patients reflect on their health and lives, including core values, disparities between current and desired states, and preparedness to make behavioral changes to promote health.

The PHI assisted with framing this whole health approach to clinical care by expanding the definition of health to include more holistic elements of well-being, such as spirituality, personal relationships, emotional health, and personal development. A visual representation of the whole health domains termed The Circle of Health introduced this concept to the patient and assisted with goal setting (Figure 3).¹²

The PHI organized the patient’s input and was provided to the clinician to contribute to the development of the shared therapeutic goals and a final treatment plan. The PHP provided the tool to organize the goals, plans, and care following the visit and to connect the patient to additional resources within the VHA to support goal attainment through skill building and support. Each clinical site developed a mechanism to follow up with these patients either telephonically or with additional clinic appointments. The participating clinics implemented their customized version of personalized health planning for an average of 3 months.

Personalized health planning and accompanying tools were used primarily in routine ambulatory care visits. They were also used in the Bonham domiciliary clinic, which provides care for veterans with mental illnesses or addictive disorders who require additional structure and support. The purpose of the pilot was to determine whether personalized health planning could be used within this population. Given the small sample size and incompleteness of data collected, the Bonham domiciliary group was not included in the participating patient total. Across the other 4 clinics a total of 153 patients participated in the 3-month pilot study by establishing shared health goals and plans to meet them.

Results and Evaluation

Using a structured interview guide, a total of 6 small group interviews with participating clinicians were held (3 in Boston and 3 in Bonham, N = 18). Qualitative methods for research and evaluation were used to capture the depth of responses and to provide complex descriptions of the clinicians’ perspectives on the implementation of the personalized health planning process. Two researchers reviewed the transcripts to identify and code themes, and a third researcher reviewed the transcripts to confirm themes and resolve any discrepancies.

Analysis of the interview data revealed 9 core themes related to the feasibility, effectiveness, and future dissemination of personalized health planning. These themes, described below with exemplar data, include (a) patient engagement; (b) clinical assessment; (c) goal setting; (d) clinical workflow; (e) resources and support for veterans and clinicians; (f) Computerized Patient Record System (CPRS) integration; (g) patient-clinician relationship; (h) clinical outcomes; and (i) patient satisfaction.

The purpose of this study was to evaluate the feasibility of introducing personalized health planning within the workflows of the clinics that were participating. As a consequence of this, interviews were held with clinic staff rather than patients. However, the authors did obtain patient satisfaction data from 10 patients who received care from the hypertension SMA and responded to TruthPoint questions after their visit (Table).

Patient Engagement

A central tenant of personalized health planning is to engage patients in their health and health care. Findings revealed that clinicians at both sites perceived the PHP as an effective tool for integrating patients as robust members of the care team. Clinicians noted that by asking patients what was important to them, the patients felt more empowered to actively engage in the clinical encounter and to take responsibility for their health decisions. One pharmacist noted, “Patients are more empowered…when you change how you’re having your conversation with them that helps people start to recognize that they are an active participant [sic] and they can have an impact and can help with minimizing medicines or trying other things.”

Clinicians reported that including patients as active members in their care created a level of buy-in that motivated behavioral changes, because the patients identified behaviors they wanted to change vs the clinician telling them what they should or should not do. A nurse manager reported, “The key is that (the health goal) is coming from the patient…. Once it comes out of their mouth, they’re thinking about it and it’s not the clinician telling them what they should or shouldn’t do, but it’s helping them…identify something that’s important that will keep them into staying the way they want to, for the reasons that they want to.”

Clinical Assessment

The HRA tools are a vital part of the personalized health planning process, as they focus on preventive strategies that are most important for the patient.⁴ Clinicians reported using the PHI and additional HRA tools as part of the pilot program. The PHI is a self-assessment tool designed to identify psychosocial, behavioral, and environmental issues that can impact the patient’s care and health status. Most clinicians found that the PHI helped to solicit patients’ input on what was important to them and their health status while introducing the new approach to care. One nurse commented, “I found [PHI] very effective if I could actually sit down and review it with them to see what it was that was truly important to them and explain that this new approach is for a better understanding.”

Clinicians also found that the PHI helped focus the patient’s attention toward self-care areas that facilitated the shared goal setting process with the clinician. It moved the clinical encounter away from the chief health problems and toward identifying what is important to the patient and leveraging his or her intrinsic motivation to support health promotion via lifestyle modification.

Goal Setting

Shared goal setting is a critical component of personalized health planning. The clinician and patient must agree about realistic goals to improve the patient’s health. Clinicians reported that the goal setting stage was most successful when patients were invited to guide the process and offered the goals themselves; ie, when it was not just patient-centered but patient-driven.

“Setting a goal with a patient is pretty easy because people have an idea of what they should be doing and what they want to be doing,” one clinician reported. “They know their goal. So it’s a matter of just listening, really listening, and seeing what they want…. It’s not incongruous to get the medical goal and the patient goal to match.”

Patients were amenable to this collaborative approach to goal setting, and there was often commonality between the clinician’s goals and what was important to the patient. Occasionally, the patient set goals in seemingly unrelated areas that facilitated chronic disease management.

“One of our hypertensive patients wanted to work on things that are external that they felt are stressors that actually caused their blood pressure to be high,” a pharmacist recalled. “At the end of the day they wanted to control their environment better so that they could see if they could then be off of antihypertensives altogether. It appears that may be the case right now. That this individual has been able to accomplish that, which I thought was amazing, and since it’s still new, I’m still a little bit skeptical.... Is that possible? But if at the end of the day that is an outcome that we see from doing this, I think that’s wonderful.”

Clinicians reported that follow-up with the patient was a critical aspect of goal setting, because it improved accountability and helped track progress and health outcomes. However, due to the 3-month time limit of the pilot, there was insufficient time to get uniform data on the formalized follow-up systems developed by each clinic.

Clinical Workflow

Examining the feasibility of creating a process to incorporate personalized health planning into a busy primary care clinic was one of the major aims of this pilot. As such, issues of time, staff responsibilities, and use of the CPRS and other systems to facilitate the process were challenges that each clinic addressed in slightly different ways and with varying success. One method was to leverage the SMA for a group of patients with a common diagnosis to discuss their goals, provide accountability, and improve access to a medical team.

Another innovative approach was utilizing medical support administrators and health technicians to front-load some of the introductory information and patient education in the waiting room or during the intake process. Despite these efforts, some clinicians thought that the personalized health planning process might take longer than the traditional clinical encounter. One nurse manager commented, “I think it did affect the length of visits…it has made them a little bit longer.”

Resources and Support

The VHA has been undergoing a shift from an emphasis on tertiary care to include a greater focus on primary care. Part of this shift has been an investment in complementary and alternative medicine (CAM). The PHP helped clinicians explore what resources existed at their facility to support veterans in accomplishing their goals, including CAM. One nurse reported, “It made us look into other avenues that were actually available at the VHA that we didn’t even know we had…the acupuncture, the qigong, the voluntary services getting the veterans involved.”

Clinicians also identified the need for patient education in the concepts of whole health, personalized care, and patient involvement as necessary for moving the piloted approach forward. A nurse noted that “for [personalized health planning] to work well, [the patients] need more orientation and education upfront systemwide so that when they get into an appointment with us, we’re not starting at explaining the whole world view of partnership and doing things differently.”

Resources for clinicians were just as critical as resources for patients in facilitating the personalized health planning process. Specifically, most clinicians identified their own education and training in techniques to engage the patient in a meaningful way via motivational interviewing and health coaching complemented the personalized approach to care, particularly for shared goal setting,

CPRS Integration

The CPRS is an integrated, electronic patient record system that provides a single interface for clinicians to manage patient care as well as an efficient means for others to access and use patient information.¹⁹ The most commonly cited challenge in the pilot was the lack of available staff and time in the patient visit to complete the PHP while completing documentation requirements in CPRS.

One clinician stated, “For clinicians, the barriers…it’s time to get through the reminders and preventatives.” Clinicians reported that the process and the CPRS documentation were misaligned and lacked integration to coordinate care or support health planning. Moreover, clinicians reported that the data being collected did not support patient-centered care.

Patient-Clinician Relationship

A significant strength of personalized health planning was that it fostered a beneficial patient-clinician relationship that promoted greater depth of care. One clinician noted, “I think that it adds a more personalized dimension to the whole patient visit.” In addition to experiencing a deeper relationship with their patients, clinicians also expressed having higher levels of job satisfaction and relished the opportunity to connect with their patients in a more personal way.

 

Clinicians also reported that patients seemed more satisfied with the experience. One nurse commented, “They really respond to it very well when they figure out that you care about them as a whole… it’s not just about the disease process anymore.”

Clinical Outcomes

Clinicians reported a number of positive health outcomes during the pilot. One physician reported, “I have a patient, he had a follow-up today, a 29-year-old veteran, who was 260 pounds 5 months ago, and he’s 230 pounds today. He comes in monthly to see the nurse to let us know he’s doing it.”

The same physician also shared a similar transformation in a patient as a result of personalized health planning. “We had another one yesterday, 4 months ago his [hemoglobin] A_1c was 10.3%. It was 7.2% yesterday, and [his weight was] down 20 pounds.” In addition to positive clinical outcomes, patients made changes in areas of their health that they identified as important through the PHI, although these areas are not typically discussed in a clinical visit.

Patient Satisfaction

Although the overall goal of this pilot was to determine the feasibility of a clinical workflow embracing personalized health planning, data on patient satisfaction were collected from patients receiving care in the Hypertension Shared Medical Appointments Program at Bohnam. Ten patients were seen over the course of 5 visits. At each visit, they were asked to rate their satisfaction (Table).

Overall, patients were highly satisfied with their experience and the care they received: 91.7% reported exploring what they wanted for their health and setting shared goals; 100% reported that their providers truly listened to their needs and treated them with respect and dignity; and 97.2% reported that their experience was better than a traditional office visit. One participating physician noted that higher levels of patient and provider satisfaction are a product of this type of patient engagement. “I also think that looking at patient and provider satisfaction, the visits feel more meaningful, and there’s a better relationship built through this discussion,” he noted. These findings demonstrating increased satisfaction further suggest the benefits of personalized health planning approach.

Discussion

In 2012, the VHA National Leadership Council convened a Strategic Planning Summit to set goals and objectives to help the VHA be at the vanguard of a movement toward a more proactive health care delivery model. The first of 3 goals developed was to provide veterans personalized, proactive, patient-driven health care.¹³ It is becoming increasingly clear that truly affecting health and health outcomes requires motivated, engaged, and informed patients with a care delivery approach that provides ample opportunities for patient involvement and input in health care decision making.^10,11

The OPCC&CT has ongoing initiatives driving innovation, research, education, and deployment across the system to set the stage for personalized, proactive, patient-driven care.²⁰ Some of these innovations include clinician education in the concept of whole health; health coaching; group-based, peer-led approaches; and the expansion of CAM such as mind-body approaches, qi-gong, massage therapy, yoga, and acupuncture.²¹

The primary aim of the Whole Health in Primary Care Project was to determine the feasibility of using personalized health planning as the operational model to deliver personalized, proactive, patient-driven care. The decision was made to integrate personalized health planning into ongoing clinical operations rather than design clinical pilots de novo. This had the advantage of speed in starting the project but limited the ability to create an optimal workflow from scratch. Given the time and resources available for this study, it was not possible to obtain quantitative data particularly as it related to quantifying clinical outcomes.

Despite these limitations, early indications suggest that the personalized health planning process can serve as the operational clinical working model to enable personalized, proactive, patient-driven care in a variety of primary care settings. As noted by one nurse manager, preparing the personalized health plan made the initial visit “a bit longer.” However, after the first visit, monitoring health risk abatement and goal achievement is akin to what is currently done by reviewing problem lists. Thus, although the personalized health planning experience is just beginning, clinicians noted that it fostered a beneficial patient-clinician relationship. This deeper relationship between the patient and the clinician may be the most powerful signal that the process is worthwhile.

This pilot provided valuable information related to the implementation of a clinical workflow redesign, an initial step toward developing an optimized operational model of the PHP process. Additionally, although it is not yet possible to quantify the clinical impact of the personalized health planning, anecdotal evidence suggests its positive potential. Clinicians reported that patients were successful in managing a multitude of common chronic diseases, including weight loss, high blood pressure management, reduction of A_1c, and improved sleep habits.

These findings compare with studies using similar approaches that demonstrated their value in the treatment of congestive heart failure, cardiovascular disease risk, type 2 diabetes, and postpartum weight retention.^22-25 A growing body of evidence continues to affirm that a primary care model designed to deliver individualized care focused on improving health and an augmented patient-clinician relationship results in significant savings, primarily from reduced medical expenditures.²⁶

This pilot provided an important opportunity to learn how to improve the effectiveness of personalized health planning and how to scale it. The experiences in Boston and Bonham demonstrated that personalized health planning can be integrated into diverse primary care settings with PACTs. The authors suggest that the knowledge gained from this project should be incorporated into new pilots at various clinical settings to determine the usefulness of the PHP for clinical indications beyond primary care. Specialty care clinics, home-based primary care services, and telehealth programs would be potential clinical applications for such pilots.

New pilots should be designed de novo and be of sufficient length to gain quantitative data on patient activation and clinical outcomes. Furthermore, future studies of personalized health planning should obtain input from the patient using Likert scales, surveys, and focus groups to gauge and quantify patient satisfaction and outcomes with the approach. Since patient engagement and better understanding of patients’ holistic needs are central to development of the PHP, patients need to be educated about this new approach to care and their active role in it.

The choice of the tools, including the HRA instrument, materials for orienting patients to their more active role in their care, the PHI, the PHP template to document shared goals, and other avenues used to engage patients, require refinement to improve their clarity, effectiveness of conveying the intended information, and ease of use. These studies demonstrated the vital need to address the best means to engage patients in understanding the value of their health to them since the clinician visit is likely to be an opportune teaching moment. Initial observations suggested that patients respond with different degrees of enthusiasm when given the opportunity to be more engaged in their care. Future pilots should clarify whether these differences stem from (a) how the invitation is presented; (b) individual differences in personality and preferences; (c) perceived clinical needs; or (d) unfamiliarity with the collaborative personalized health planning process.

The alignment of personalized health planning with outcomes data in the CPRS is essential for widespread adoption. Importantly, incentives and performance metrics will need to be redesigned to support the intended outcomes of using personalized health planning in clinical care. To that end, further investigation into the potential for cost savings associated with personalized health planning use is warranted, especially given studies that suggest high levels of patient engagement result in lower health care utilization expenditures.²⁷

Additionally, wherever personalized health planning is initiated, employees across all levels of the system would benefit from training in patient engagement techniques and other means of attaining behavioral change. This would facilitate more effective use of time during the clinical visit and improve both the patient’s and the clinician’s satisfaction. Indeed, preliminary data indicate that this approach in a SMA setting is greatly valued by the patients.

Conclusions

The Whole Health in Primary Care Project was conducted to determine the feasibility of personalized health planning as the basis for primary care designed to facilitate personalized, proactive, patient-driven care. The pilot demonstrated that personalized health planning could be operational in VHA clinical settings and used to enhance patient-clinician engagement, establish shared health goals, and increase patient satisfaction. The personalized health planning process also provides a framework for the rational introduction of new capabilities to enhance prediction, clinical tracking, coordination of ancillary services, and clinical data collection. Future research should validate the efficacy of personalized health planning within both the VHA and health systems nationwide. Such research has the potential to refine this process so it becomes a key part of a personalized, proactive, patient-driven delivery approach. 

Acknowledgements
We gratefully acknowledge the assistance of Cindy Mitchell at Duke University Medical Center with the editing and preparation of this manuscript. We also gratefully acknowledge the participation of the providers and patients at VA Boston Healthcare System and Sam Rayburn Memorial Veterans Center. Funding for this project was provided by VA777-12-C-002 to the Pacific Institute for Research and Evaluation through subcontracts to Ralph Snyderman, MD, and to the Duke University School of Nursing (Simmons PI.)

Health care has become increasingly unaffordable in the U.S., yet it remains ineffective in preventing or effectively treating chronic diseases.^1,2 Given the increasing burden of chronic disease on the American health care system, there is an effort to shift the practice of medicine away from its reactive, disease-oriented approach to a more sustainable proactive model.^3-5

Personalized health care (PHC) is an approach to the practice of medicine where prediction, prevention, intense patient engagement, shared health care decision making, and coordination of care are essential to cost effectively facilitate better outcomes.^3,5-7 Greater collaboration between patient and clinician replaces the traditional clinician-dominated dialogue with more effective patient-clinician partnerships.^8,9 Patients’ knowledge, skills, and confidence to manage their health care have been linked to improved health outcomes, lower costs, and greater satisfaction with health care experiences.^10,11

Personalized health care has been proposed as a means to achieve better patient engagement as part of an aligned, proactive clinical approach. At the heart of PHC is personalized health planning, wherein the patient and clinician develop shared health-related goals and a plan to achieve them.³

The VHA, the largest integrated health care system in the country, is on the vanguard of incorporating tenets of PHC into its delivery model. In 2011, the Office of Patient Centered Care and Cultural Transformation (OPCC&CT) was founded to “oversee the VHA’s cultural transformation to patient-centered care.”¹² This undertaking represents “one of the most massive changes in the philosophy and process for health care delivery ever undertaken by an organized health care system.”¹³

The primary goal of the VHA’s strategic plan for 2013 to 2018 is to provide veterans personalized, proactive, patient-driven health care.¹⁴ The intention of this approach is to engage and inspire veterans to their highest possible level of health and well-being. A personalized approach requires a dynamic customization of care that is specifically relevant to the individual, based on factors such as medical conditions, genome, needs, values, and circumstances. In addition to being personalized, this approach must be proactive, and therefore, preventive and include strategies to strengthen the person’s innate capacity for enhancing health.

The third distinction of this new model health care is that it is patient-driven, rooted in and driven by that which matters most to people in their lives and aligns their health care with their day-to-day and long-term life goals.¹⁵ The latter may be the most critical of the 3 tenets, because a personalized, proactive approach that is not driven by an engaged and inspired individual will be unlikely to achieve adherence, let alone the highest level of health and well-being.

The VHA is uniquely positioned to optimize health and well-being for veterans due in part to a systemwide emphasis on training providers to promote and support behavior change through approaches including health coaching and motivational interviewing. These synergistic approaches used widely by clinicians throughout the VHA are influenced by the transtheoretical model (ie, the stages of change theory), which considers patients holistically and helps them identify intrinsic motivation to improve their health behaviors.^16,17 The transformation occurring in the VHA is intended to shift the current disease-centric medical model to an approach that optimizes the health of veterans through patient-clinician engagement, health risk assessment (HRA), shared health goal creation, and a coordinated plan to attain them.^12,13

Personalized Health Planning

In recognition of the need to deliver care that emphasizes prevention and coordination, the patient-centered medical home, patient-aligned care teams (PACTs), and the chronic care model were developed. All of these embrace concepts of patient engagement, shared decision making, and team-based care. However, none of these approaches have outlined a clinical workflow that systematically and proactively operationalizes these concepts with the creation of a risk-based personalized care approach. Personalized health planning provides a clinical workflow that operationalizes all these features (Figure 1).

Of central importance is the creation of a personalized health plan (PHP), which the patient and clinician develop collaboratively. The plan serves to organize and coordinate care while engaging the patient in the process of care delivery and appropriate self-management of health.^3,5 This approach promotes personalized and proactive care that values the individual and fosters meaningful patient self-awareness and engagement through shared decision making.⁷

The personalized health planning process is composed of several key components (Figure 2).

It begins with a HRA and a comprehensive health evaluation whereby the clinician assesses the patient’s health through physical examination, family history, diagnostic testing, available biometric data, and tools to gauge the health status and health risks for the individual.⁴ In parallel, patients conduct a whole health self-assessment, which helps elucidate the importance of their health to their life’s purpose and to determine area(s) where they are motivated to make behavioral change. Based on the clinical assessment and the patient’s own health evaluation, the clinician prioritizes the health risks and identifies therapeutic goals needed to mitigate them.

With this information, the clinician develops a preliminary therapeutic plan to meet these goals and discusses this plan with the patient. The next component is the synthesis of the clinician’s goals and/or treatment plan with the priorities of the patient to establish shared clinician-patient goals. This is followed by the establishment of the PHP, which consists of the agreed upon shared clinician and patient goals, a therapeutic and wellness plan to meet them, metrics for tracking progress, consults and referrals, and a time frame for the patient to achieve the health goals.

Related: The Right Care at the Right Time and in the Right Place: The Role of Technology in the VHA

The final component is coordination of care and a formalized follow-up system in which the health care team monitors the patient’s progress and provides support by revisiting or updating the PHP at intervals determined by the provider, based on the level of monitoring required by the patient’s health status. This approach invites the patient to become an empowered member of the care team by creating a patient-clinician partnership and providing a model for delivering personalized, proactive, patient-driven care to individuals with a diverse range of needs.^4,5,18

 

Design and Implementation

This project qualified as exempt through the Duke University Institutional Review Board. The primary aim of this pilot was to examine the feasibility of implementing personalized health planning into primary care settings and to develop a workable process that is scalable and customizable to inpatient and outpatient clinics of varying sizes for different patient populations within the VHA. The pilot included 5 clinics in 2 geographic areas that were selected for their facility’s leadership support and desire to participate.

The VA Boston Healthcare System implemented personalized health planning at 3 primary care clinics: Jamaica Plain Primary Care, Jamaica Plain Women’s Health, and Quincy Primary Care. Three distinct PACTs participated in Boston, each composed of a medical doctor or doctor of osteopathy, a registered nurse (RN) or health technician, and a medical support assistant. The Sam Rayburn Memorial Veterans Center in Bonham, Texas, implemented personalized health planning at 2 clinics: the Hypertension Shared Medical Appointment and the Domiciliary Inpatient Primary Care. At Bonham, a medical doctor, pharmacist, RN, and an integrated mental health provider led the shared medical appointment (SMA) with guest presenters for individual appointments, depending on the topic covered. A RN and social worker implemented personalized health planning in the domiciliary.

After receiving training in the personalized health planning process, each of the clinics’ multidisciplinary PACTs incorporated their custom personalized health planning workflow into patient encounters. During the intake process of the clinic visit, the patient received a Personal Health Inventory (PHI) to determine health care priorities. The OPCC&CT developed the PHI as a whole-health self-assessment tool to help patients reflect on their health and lives, including core values, disparities between current and desired states, and preparedness to make behavioral changes to promote health.

The PHI assisted with framing this whole health approach to clinical care by expanding the definition of health to include more holistic elements of well-being, such as spirituality, personal relationships, emotional health, and personal development. A visual representation of the whole health domains termed The Circle of Health introduced this concept to the patient and assisted with goal setting (Figure 3).¹²

The PHI organized the patient’s input and was provided to the clinician to contribute to the development of the shared therapeutic goals and a final treatment plan. The PHP provided the tool to organize the goals, plans, and care following the visit and to connect the patient to additional resources within the VHA to support goal attainment through skill building and support. Each clinical site developed a mechanism to follow up with these patients either telephonically or with additional clinic appointments. The participating clinics implemented their customized version of personalized health planning for an average of 3 months.

Personalized health planning and accompanying tools were used primarily in routine ambulatory care visits. They were also used in the Bonham domiciliary clinic, which provides care for veterans with mental illnesses or addictive disorders who require additional structure and support. The purpose of the pilot was to determine whether personalized health planning could be used within this population. Given the small sample size and incompleteness of data collected, the Bonham domiciliary group was not included in the participating patient total. Across the other 4 clinics a total of 153 patients participated in the 3-month pilot study by establishing shared health goals and plans to meet them.

Results and Evaluation

Using a structured interview guide, a total of 6 small group interviews with participating clinicians were held (3 in Boston and 3 in Bonham, N = 18). Qualitative methods for research and evaluation were used to capture the depth of responses and to provide complex descriptions of the clinicians’ perspectives on the implementation of the personalized health planning process. Two researchers reviewed the transcripts to identify and code themes, and a third researcher reviewed the transcripts to confirm themes and resolve any discrepancies.

Analysis of the interview data revealed 9 core themes related to the feasibility, effectiveness, and future dissemination of personalized health planning. These themes, described below with exemplar data, include (a) patient engagement; (b) clinical assessment; (c) goal setting; (d) clinical workflow; (e) resources and support for veterans and clinicians; (f) Computerized Patient Record System (CPRS) integration; (g) patient-clinician relationship; (h) clinical outcomes; and (i) patient satisfaction.

The purpose of this study was to evaluate the feasibility of introducing personalized health planning within the workflows of the clinics that were participating. As a consequence of this, interviews were held with clinic staff rather than patients. However, the authors did obtain patient satisfaction data from 10 patients who received care from the hypertension SMA and responded to TruthPoint questions after their visit (Table).

Patient Engagement

A central tenant of personalized health planning is to engage patients in their health and health care. Findings revealed that clinicians at both sites perceived the PHP as an effective tool for integrating patients as robust members of the care team. Clinicians noted that by asking patients what was important to them, the patients felt more empowered to actively engage in the clinical encounter and to take responsibility for their health decisions. One pharmacist noted, “Patients are more empowered…when you change how you’re having your conversation with them that helps people start to recognize that they are an active participant [sic] and they can have an impact and can help with minimizing medicines or trying other things.”

Clinicians reported that including patients as active members in their care created a level of buy-in that motivated behavioral changes, because the patients identified behaviors they wanted to change vs the clinician telling them what they should or should not do. A nurse manager reported, “The key is that (the health goal) is coming from the patient…. Once it comes out of their mouth, they’re thinking about it and it’s not the clinician telling them what they should or shouldn’t do, but it’s helping them…identify something that’s important that will keep them into staying the way they want to, for the reasons that they want to.”

Clinical Assessment

The HRA tools are a vital part of the personalized health planning process, as they focus on preventive strategies that are most important for the patient.⁴ Clinicians reported using the PHI and additional HRA tools as part of the pilot program. The PHI is a self-assessment tool designed to identify psychosocial, behavioral, and environmental issues that can impact the patient’s care and health status. Most clinicians found that the PHI helped to solicit patients’ input on what was important to them and their health status while introducing the new approach to care. One nurse commented, “I found [PHI] very effective if I could actually sit down and review it with them to see what it was that was truly important to them and explain that this new approach is for a better understanding.”

Clinicians also found that the PHI helped focus the patient’s attention toward self-care areas that facilitated the shared goal setting process with the clinician. It moved the clinical encounter away from the chief health problems and toward identifying what is important to the patient and leveraging his or her intrinsic motivation to support health promotion via lifestyle modification.

Goal Setting

Shared goal setting is a critical component of personalized health planning. The clinician and patient must agree about realistic goals to improve the patient’s health. Clinicians reported that the goal setting stage was most successful when patients were invited to guide the process and offered the goals themselves; ie, when it was not just patient-centered but patient-driven.

“Setting a goal with a patient is pretty easy because people have an idea of what they should be doing and what they want to be doing,” one clinician reported. “They know their goal. So it’s a matter of just listening, really listening, and seeing what they want…. It’s not incongruous to get the medical goal and the patient goal to match.”

Patients were amenable to this collaborative approach to goal setting, and there was often commonality between the clinician’s goals and what was important to the patient. Occasionally, the patient set goals in seemingly unrelated areas that facilitated chronic disease management.

“One of our hypertensive patients wanted to work on things that are external that they felt are stressors that actually caused their blood pressure to be high,” a pharmacist recalled. “At the end of the day they wanted to control their environment better so that they could see if they could then be off of antihypertensives altogether. It appears that may be the case right now. That this individual has been able to accomplish that, which I thought was amazing, and since it’s still new, I’m still a little bit skeptical.... Is that possible? But if at the end of the day that is an outcome that we see from doing this, I think that’s wonderful.”

Clinicians reported that follow-up with the patient was a critical aspect of goal setting, because it improved accountability and helped track progress and health outcomes. However, due to the 3-month time limit of the pilot, there was insufficient time to get uniform data on the formalized follow-up systems developed by each clinic.

Clinical Workflow

Examining the feasibility of creating a process to incorporate personalized health planning into a busy primary care clinic was one of the major aims of this pilot. As such, issues of time, staff responsibilities, and use of the CPRS and other systems to facilitate the process were challenges that each clinic addressed in slightly different ways and with varying success. One method was to leverage the SMA for a group of patients with a common diagnosis to discuss their goals, provide accountability, and improve access to a medical team.

Another innovative approach was utilizing medical support administrators and health technicians to front-load some of the introductory information and patient education in the waiting room or during the intake process. Despite these efforts, some clinicians thought that the personalized health planning process might take longer than the traditional clinical encounter. One nurse manager commented, “I think it did affect the length of visits…it has made them a little bit longer.”

Resources and Support

The VHA has been undergoing a shift from an emphasis on tertiary care to include a greater focus on primary care. Part of this shift has been an investment in complementary and alternative medicine (CAM). The PHP helped clinicians explore what resources existed at their facility to support veterans in accomplishing their goals, including CAM. One nurse reported, “It made us look into other avenues that were actually available at the VHA that we didn’t even know we had…the acupuncture, the qigong, the voluntary services getting the veterans involved.”

Clinicians also identified the need for patient education in the concepts of whole health, personalized care, and patient involvement as necessary for moving the piloted approach forward. A nurse noted that “for [personalized health planning] to work well, [the patients] need more orientation and education upfront systemwide so that when they get into an appointment with us, we’re not starting at explaining the whole world view of partnership and doing things differently.”

Resources for clinicians were just as critical as resources for patients in facilitating the personalized health planning process. Specifically, most clinicians identified their own education and training in techniques to engage the patient in a meaningful way via motivational interviewing and health coaching complemented the personalized approach to care, particularly for shared goal setting,

CPRS Integration

The CPRS is an integrated, electronic patient record system that provides a single interface for clinicians to manage patient care as well as an efficient means for others to access and use patient information.¹⁹ The most commonly cited challenge in the pilot was the lack of available staff and time in the patient visit to complete the PHP while completing documentation requirements in CPRS.

One clinician stated, “For clinicians, the barriers…it’s time to get through the reminders and preventatives.” Clinicians reported that the process and the CPRS documentation were misaligned and lacked integration to coordinate care or support health planning. Moreover, clinicians reported that the data being collected did not support patient-centered care.

Patient-Clinician Relationship

A significant strength of personalized health planning was that it fostered a beneficial patient-clinician relationship that promoted greater depth of care. One clinician noted, “I think that it adds a more personalized dimension to the whole patient visit.” In addition to experiencing a deeper relationship with their patients, clinicians also expressed having higher levels of job satisfaction and relished the opportunity to connect with their patients in a more personal way.

 

Clinicians also reported that patients seemed more satisfied with the experience. One nurse commented, “They really respond to it very well when they figure out that you care about them as a whole… it’s not just about the disease process anymore.”

Clinical Outcomes

Clinicians reported a number of positive health outcomes during the pilot. One physician reported, “I have a patient, he had a follow-up today, a 29-year-old veteran, who was 260 pounds 5 months ago, and he’s 230 pounds today. He comes in monthly to see the nurse to let us know he’s doing it.”

The same physician also shared a similar transformation in a patient as a result of personalized health planning. “We had another one yesterday, 4 months ago his [hemoglobin] A_1c was 10.3%. It was 7.2% yesterday, and [his weight was] down 20 pounds.” In addition to positive clinical outcomes, patients made changes in areas of their health that they identified as important through the PHI, although these areas are not typically discussed in a clinical visit.

Patient Satisfaction

Although the overall goal of this pilot was to determine the feasibility of a clinical workflow embracing personalized health planning, data on patient satisfaction were collected from patients receiving care in the Hypertension Shared Medical Appointments Program at Bohnam. Ten patients were seen over the course of 5 visits. At each visit, they were asked to rate their satisfaction (Table).

Overall, patients were highly satisfied with their experience and the care they received: 91.7% reported exploring what they wanted for their health and setting shared goals; 100% reported that their providers truly listened to their needs and treated them with respect and dignity; and 97.2% reported that their experience was better than a traditional office visit. One participating physician noted that higher levels of patient and provider satisfaction are a product of this type of patient engagement. “I also think that looking at patient and provider satisfaction, the visits feel more meaningful, and there’s a better relationship built through this discussion,” he noted. These findings demonstrating increased satisfaction further suggest the benefits of personalized health planning approach.

Discussion

In 2012, the VHA National Leadership Council convened a Strategic Planning Summit to set goals and objectives to help the VHA be at the vanguard of a movement toward a more proactive health care delivery model. The first of 3 goals developed was to provide veterans personalized, proactive, patient-driven health care.¹³ It is becoming increasingly clear that truly affecting health and health outcomes requires motivated, engaged, and informed patients with a care delivery approach that provides ample opportunities for patient involvement and input in health care decision making.^10,11

The OPCC&CT has ongoing initiatives driving innovation, research, education, and deployment across the system to set the stage for personalized, proactive, patient-driven care.²⁰ Some of these innovations include clinician education in the concept of whole health; health coaching; group-based, peer-led approaches; and the expansion of CAM such as mind-body approaches, qi-gong, massage therapy, yoga, and acupuncture.²¹

The primary aim of the Whole Health in Primary Care Project was to determine the feasibility of using personalized health planning as the operational model to deliver personalized, proactive, patient-driven care. The decision was made to integrate personalized health planning into ongoing clinical operations rather than design clinical pilots de novo. This had the advantage of speed in starting the project but limited the ability to create an optimal workflow from scratch. Given the time and resources available for this study, it was not possible to obtain quantitative data particularly as it related to quantifying clinical outcomes.

Despite these limitations, early indications suggest that the personalized health planning process can serve as the operational clinical working model to enable personalized, proactive, patient-driven care in a variety of primary care settings. As noted by one nurse manager, preparing the personalized health plan made the initial visit “a bit longer.” However, after the first visit, monitoring health risk abatement and goal achievement is akin to what is currently done by reviewing problem lists. Thus, although the personalized health planning experience is just beginning, clinicians noted that it fostered a beneficial patient-clinician relationship. This deeper relationship between the patient and the clinician may be the most powerful signal that the process is worthwhile.

This pilot provided valuable information related to the implementation of a clinical workflow redesign, an initial step toward developing an optimized operational model of the PHP process. Additionally, although it is not yet possible to quantify the clinical impact of the personalized health planning, anecdotal evidence suggests its positive potential. Clinicians reported that patients were successful in managing a multitude of common chronic diseases, including weight loss, high blood pressure management, reduction of A_1c, and improved sleep habits.

These findings compare with studies using similar approaches that demonstrated their value in the treatment of congestive heart failure, cardiovascular disease risk, type 2 diabetes, and postpartum weight retention.^22-25 A growing body of evidence continues to affirm that a primary care model designed to deliver individualized care focused on improving health and an augmented patient-clinician relationship results in significant savings, primarily from reduced medical expenditures.²⁶

This pilot provided an important opportunity to learn how to improve the effectiveness of personalized health planning and how to scale it. The experiences in Boston and Bonham demonstrated that personalized health planning can be integrated into diverse primary care settings with PACTs. The authors suggest that the knowledge gained from this project should be incorporated into new pilots at various clinical settings to determine the usefulness of the PHP for clinical indications beyond primary care. Specialty care clinics, home-based primary care services, and telehealth programs would be potential clinical applications for such pilots.

New pilots should be designed de novo and be of sufficient length to gain quantitative data on patient activation and clinical outcomes. Furthermore, future studies of personalized health planning should obtain input from the patient using Likert scales, surveys, and focus groups to gauge and quantify patient satisfaction and outcomes with the approach. Since patient engagement and better understanding of patients’ holistic needs are central to development of the PHP, patients need to be educated about this new approach to care and their active role in it.

The choice of the tools, including the HRA instrument, materials for orienting patients to their more active role in their care, the PHI, the PHP template to document shared goals, and other avenues used to engage patients, require refinement to improve their clarity, effectiveness of conveying the intended information, and ease of use. These studies demonstrated the vital need to address the best means to engage patients in understanding the value of their health to them since the clinician visit is likely to be an opportune teaching moment. Initial observations suggested that patients respond with different degrees of enthusiasm when given the opportunity to be more engaged in their care. Future pilots should clarify whether these differences stem from (a) how the invitation is presented; (b) individual differences in personality and preferences; (c) perceived clinical needs; or (d) unfamiliarity with the collaborative personalized health planning process.

The alignment of personalized health planning with outcomes data in the CPRS is essential for widespread adoption. Importantly, incentives and performance metrics will need to be redesigned to support the intended outcomes of using personalized health planning in clinical care. To that end, further investigation into the potential for cost savings associated with personalized health planning use is warranted, especially given studies that suggest high levels of patient engagement result in lower health care utilization expenditures.²⁷

Additionally, wherever personalized health planning is initiated, employees across all levels of the system would benefit from training in patient engagement techniques and other means of attaining behavioral change. This would facilitate more effective use of time during the clinical visit and improve both the patient’s and the clinician’s satisfaction. Indeed, preliminary data indicate that this approach in a SMA setting is greatly valued by the patients.

Conclusions

The Whole Health in Primary Care Project was conducted to determine the feasibility of personalized health planning as the basis for primary care designed to facilitate personalized, proactive, patient-driven care. The pilot demonstrated that personalized health planning could be operational in VHA clinical settings and used to enhance patient-clinician engagement, establish shared health goals, and increase patient satisfaction. The personalized health planning process also provides a framework for the rational introduction of new capabilities to enhance prediction, clinical tracking, coordination of ancillary services, and clinical data collection. Future research should validate the efficacy of personalized health planning within both the VHA and health systems nationwide. Such research has the potential to refine this process so it becomes a key part of a personalized, proactive, patient-driven delivery approach. 

Acknowledgements
We gratefully acknowledge the assistance of Cindy Mitchell at Duke University Medical Center with the editing and preparation of this manuscript. We also gratefully acknowledge the participation of the providers and patients at VA Boston Healthcare System and Sam Rayburn Memorial Veterans Center. Funding for this project was provided by VA777-12-C-002 to the Pacific Institute for Research and Evaluation through subcontracts to Ralph Snyderman, MD, and to the Duke University School of Nursing (Simmons PI.)

Gout is an extremely painful arthritis initiated by innate immune responses to monosodium urate crystals that accumulate in affected joints and surrounding tissues. As a result, gout is characterized by painful arthritis flares followed by intervening periods of disease quiescence. Over time, gout can lead to chronic pain, disability, and tophi. Nearly 10% of those aged > 65 years report having gout. The overall prevalence in the U.S. population approaches 4%.¹

Gout treatment has 2 overarching goals: alleviating the pain and inflammation caused by acute gout attacks and long-term management that is focused on lowering serum urate (sUA) levels to reduce the risk of future attacks. Alleviating the pain and inflammation of an acute attack is often complicated by patient characteristics, namely, other chronic health conditions that frequently accompany gout, such as diabetes mellitus (DM), chronic kidney disease (CKD), hypertension, and cardiovascular disease (CVD).

Patients with gout tend to be older and have multiple comorbidities that require the use of many medications.² Because the VA patient population tends to be older, acute gout and attendant complications of treatment are an important consideration for VA health care providers (HCPs).

Recently, the American College of Rheumatology (ACR) released management recommendations for gout, including those for the treatment of acute gout.³ The ACR recommends 3 first-line therapies, but limited guidance is provided for deciding among therapies. This article briefly reviews the relevant ACR recommendations and details important comorbidity and concomitant medication considerations in the treatment of acute gout.

Acute Gout Characteristics

Acute gout attacks are characterized by a rapid onset and escalation with joint pain typically peaking within 24 hours of attack onset. An acute attack often begins to remit after 5 to 12 days without intervention, but complete resolution may take longer in some patients.⁴ In one study, at 24 hours after attack onset, 16% of patients on placebo had > 50% reduction in pain compared with 70% that had no recovery at all.⁵ By 48 hours, one-third of patients on placebo achieved a 50% reduction in pain.⁶

Acute gout attacks are most commonly monoarticular, although 10% to 40% can involve ≥ 2 joints.⁷ The first metatarsophalangeal (MTP) joint is the initial site of involvement in about 50% of cases and is eventually observed in the majority of patients with gout (Figure 1).⁷ Other commonly affected joints include the midfoot, ankle, knee, wrist, elbow, and fingers. Most patients still reach peak pain within 24 hours with pain remitting predictably over 1 to 2 weeks. Chronic or variable intensity pain is more common among those with long-standing disease, polyarticular gout, or tophi.

Treatment Recommendations

Therapy for acute gout attacks aims to reduce pain and promote a full, early resolution. The ACR recommends pharmacologic therapy as first-line treatment with adjunctive topical ice and rest as needed.³ Typically, monotherapy is appropriate if the individual is experiencing mild-to-moderate pain affecting ≤ 2 joints of any size. Severe pain or attacks affecting multiple joints may benefit from initial combination therapy. Three first-line therapies are available: nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors, colchicine, or systemic glucocorticoids (Figure 2).

Few studies compare the efficacy of first-line therapeutic categories. There are no clinical trials directly comparing colchicine with NSAIDs or colchicine with glucocorticoids. No difference in mean reduction of pain and no differences in adverse events (AEs) were shown in a trial that compared glucocorticoids with NSAIDs.⁸ Thus, without further study, treatment choices made by HCPs are often guided by factors other than the existence of robust evidence.

Treatment with NSAIDs or COX-2 inhibitors should be initiated at the approved dose and continued until the gout attack has completely resolved. In one study, 73% of patients had pain reduction of ≥ 50% when taking NSAIDs relative to only 27% of patients on placebo.⁸ All available NSAIDs are considered effective, but only 3 NSAIDs are specifically approved for treatment of acute gout (naproxen, indomethacin, and sulindac). There is no evidence supporting one NSAID as being more effective than another; evidence fails to show a meaningful difference.⁸ Limited evidence indicates that selective COX-2 inhibitors, including celexocib, have similar efficacy as nonselective NSAIDs but may have fewer AEs, driven in part by fewer gastrointestinal (GI) events (6% vs 16% for GI events).⁸

Colchicine has long been used as prophylaxis for acute gout attacks and has been endorsed for the treatment of acute attacks. Recent evidence suggests that colchicine initially dosed at 1.2 mg followed by a single 0.6-mg dose 1 hour later is as effective with fewer AEs compared with a traditional regimen of 1.2 mg followed by 0.6 mg every hour for up to 6 hours.⁵ About 40% of patients have 50% pain reduction within 24 hours and a 40% absolute risk reduction in AEs on this low-dose regimen. The efficacy of colchicine relative to other therapies is poorly defined, especially for patients presenting longer after attack onset. The ACR guidelines recommend colchicine only if treatment is initiated within 36 hours of attack onset, but this is based solely on expert consensus. Likewise, the above trial for low-dose colchicine did not provide information about dosing beyond the first 6 hours, leaving little guidance for follow-up treatment of residual pain beyond the 32 hours reported.⁵ Traditionally, one 0.6-mg dose is provided every 12 to 24 hours.³

 

Systemic glucocorticoids are also commonly used in treating acute gout.⁹ There was a small pain reduction benefit for prednisolone, but the difference was not clinically significant in one clinical trial comparing oral prednisolone 30 mg daily for 5 days vs a combination of indomethacin for 5 days and an initial intramuscular injection of diclofenac 75 mg.¹⁰ The prednisolone group also had fewer patients with AEs, including abdominal pain (0% vs 30%) and GI bleeding (0% vs 11%). The lower incidence of short-term AEs may be a primary benefit of systemic glucocorticoids.¹¹

Intra-articular glucocorticoids are not suggested first-line therapies but are commonly used by rheumatologists.⁹ In an uncontrolled study conducted by Fernández and colleagues, intra-articular glucocorticoid injections helped to quickly resolve 20 out of 20 crystal-proven gout attacks.¹² However, no randomized controlled trials have examined this approach. Although seemingly efficacious, other considerations are important for this modality. Intra-articular glucocorticoids may not be preferred for polyarticular attacks or attacks in difficult-to-aspirate joints. Additionally, intra-articular glucocorticoids have been anecdotally associated with rebound attacks (ie, attacks that occur shortly after resolution without other interventions). However, the Fernández study had no such attacks occur among participants.¹² Finally, septic arthritis must be ruled out as in any case of acute onset monoarticular arthritis.

Biologic agents targeting interleukin-1(IL-1) are not currently approved for gout, although there is burgeoning data suggesting that this strategy may have substantial merit.¹³ Additionally, there is limited evidence that adrenocorticotropic hormone (ACTH) may provide rapid pain relief when other available therapies are ineffective or contraindicated. However, ACTH studies have not provided robust trial designs, and drug costs remain substantial, thus limiting the widespread use of ACTH in acute gout.^14,15 Anti-IL-1 agents and ACTH may both be considered as second-line options if first-line therapies are contraindicated or fail. Careful consideration should be given to AE profiles, patient preferences, and cost.

Comorbidities

Acute gout care, especially in the context of comorbidities, has been identified as a critical treatment concern by an international panel of rheumatologists as part of the 3e (Evidence, Expertise, Exchange) Initiative.¹⁶ However, regular clinical trial exclusion criteria have limited data necessary to guide treatment when comorbidities are present. Therefore, studies of acute gout treatment in the context of disease comorbidity represents a major unmet need in understanding and optimizing gout care.

Chronic Kidney Disease

Chronic kidney disease is common in gout; 20% of patients with gout have an estimated glomerular filtration rate (eGFR) of < 30 mL/min.² Thus, CKD is an important consideration when deciding the best treatment for acute gout. The ACR recommendations do not provide specific guidance on NSAID use in CKD but suggest the potential option of tapering the dose as pain begins to resolve. There is mixed evidence that NSAIDs accelerate CKD progression with the best evidence for high-dose NSAID use.¹⁷ When prescribing the concomitant use of NSAIDs with other medications affecting kidney function, HCPs should consider CKD.

For colchicine, current labeling and evidence indicate that no dose adjustments are needed for stage 3 or better CKD (eGFR ≥ 60 mL/min) even among the elderly.^18,19 Although labeling indicates that a single unadjusted dose (0.6 mg) can be given once every 2 weeks for those with severe CKD (eGFR < 30 mL/min) or for those who are on dialysis, alternative therapies should be considered, as AEs increase with decreasing renal function.¹⁹ Colchicine should not be used in those with eGFR < 10 mL/min.²⁰ All patients who have CKD and are treated with colchicine should be informed of the AEs and closely observed for signs of toxicity, including blood dyscrasias, neuromyopathy, emesis, or diarrhea.

Considering the potential complications for NSAIDs and colchicine, patients with CKD may be good candidates for glucocorticoid therapy, administered either systemically or as an intra-articular injection. Alternatively, second-line agents such as ACTH or IL-1 inhibition may be considered in such patients.

Hypertension

Hypertension is one of the most common comorbidities among patients with gout. It is important for HCP consideration when deciding treatment. Poorly controlled hypertension is a contraindication for both NSAIDs and systemic glucocorticoids. Patients with hypertension in the absence of significant renal impairment may be good candidates for colchicine.

Diabetes and Hyperlipidemia

Glucocorticoids should be avoided if possible in the setting of inadequately controlled type 2 DM (T2DM) or hyperlipidemia. Glucocorticoids exacerbate insulin resistance and stimulate glucose secretion from the liver. This can create substantial and sometimes dangerous fluctuations in circulating glucose concentrations. Additionally, glucocorticoids may increase serum triglycerides and low-density lipoprotein levels. Thus, patients with T2DM or hyperlipidemia may be good candidates for alternative treatments, such as colchicine or NSAIDs.

 

Cardiovascular Disease

Cardiovascular disease risk has been shown to increase with the use of COX-2 inhibitors. This risk may be present for all NSAIDs. Current FDA labeling suggests limiting NSAID and COX-2 inhibitor use in patients with a history of myocardial infarction (MI), congestive heart failure, or stroke. Given the potential impact on cardiovascular risk factors, including hypertension, T2DM, and hyperlipidemia, glucocorticoids may not be ideal for patients with known CVD or those at high risk.

Recent evidence has shown that colchicine use is associated with a lower risk of MI among patients with gout.²¹ These results, in addition to a proposed dual role of IL-1 in both gout and CVD, suggest that either colchicine or IL-1 inhibitors may be rational agents in the treatment of acute gout in the context of CVD.²²

Hepatic Impairment and GI Bleeding

Patients with cirrhosis should avoid NSAID use due to the potential increased bleeding risk from underlying coagulopathy. Additionally, colchicine clearance may be reduced in patients with severe liver impairment, mandating close surveillance when this agent is used. If hepatic impairment is mild to moderate, judicious use of any of the first-line therapies may be appropriate.

Patients with GI bleeding or a history of peptic ulcer disease should avoid NSAID use because of increased bleeding risk. If an NSAID is used, proton pump inhibitors decrease the risk of NSAID-associated mucosal damage.

Drug Interactions

Colchicine is metabolized by the cytochrome P450 3A4 enzyme (CYP3A4) and is a substrate for P-glycoprotein (P-gp). Therefore, concomitant use of colchicine with potent inhibitors of CYP3A4 or P-gp should be avoided when possible. These agents include macrolide antibiotics (clarithromyocin), calcium channel blockers (verapamil and diltiazem), and cyclosporine (commonly used in transplant patients who are at high risk for gout). New evidence-based dosing recommendations indicate that no dose reduction is required with azithromyocin.²³

Nonsteroidal anti-inflammatory drugs are contraindicated with the concomitant use of angiotensin-converting enzyme (ACE) inhibitors and/or diuretics. Prostaglandin production is decreased while using NSAIDs, resulting in increased constriction of afferent renal arterioles and decreased glomerular filtration pressure. This physiologic effect of NSAIDs can be exacerbated when used in combination with ACE inhibitors or diuretics, both of which can also reduce glomerular filtration pressures. Combination therapy with either ACE inhibitors or diuretics increases the risk for NSAID-mediated acute kidney injury. Additionally, NSAID use should be avoided in patients taking anticoagulants such as warfarin or heparin due to increased bleeding risk.

Diagnosis

Diagnosis is a key component of proper treatment of acute gout. A gout diagnosis is usually made based on clinical signs and symptoms, including sudden onset of pain that peaks within 24 hours, past history of acute self-limited attacks of arthritis, first MTP involvement, and an elevated sUA. However, not all these factors must be present. In a study conducted by Janssens and colleagues, these factors plus additional demographics had a sensitivity of 90% and specificity of 65% when compared with crystal diagnosis.²⁴ However, a normal sUA level does not exclude gout as a diagnosis due to the uricosuric effect of the inflammatory process.²⁵ In fact, one observational cohort recorded an average sUA decrease from baseline of 2 mg/dL during an acute gout attack.²⁶

Alternative diagnoses, including septic arthritis, should be considered, particularly in the context of treatment failure (< 50% reduction in pain) within the first 24 to 48 hours. A definitive diagnosis is made by identifying negatively birefringent crystals in the synovial fluid of the affected joint (using polarized microscopy) with negative cultures. In the absence of crystal confirmation, there is an emerging role for imaging in gout diagnosis, including the use of ultrasound and dual-energy computed tomography.²⁷

Long-term Treatment Considerations

During treatment for acute gout attacks, urate-lowering therapy that was initiated before the attack should not be discontinued.²⁸ There is no evidence to suggest that current urate lowering has any AEs during attacks. However, removing treatment may increase sUA levels, precipitating attacks in other joints by “destabilizing” crystals still present. Current recommendations also state that urate-lowering therapy may be started during an attack despite traditionally being deferred until the attack has resolved.²⁸ In a randomized trial comparing a group starting allopurinol 300 mg during an attack vs a placebo group (with all patients receiving anti-inflammatory treatment for the acute attack), there was no difference in pain outcomes.²⁹ Regardless of the chosen timing, lowering and maintaining sUA ≤ 6.0 mg/dL is the primary method for minimizing long-term risk of gout attacks.²⁸

Health care providers should discuss with patients the likely need for indefinite urate-lowering therapy while noting that attacks related to therapy initiation are relatively common.³⁰ Current guidelines recommend starting urate-lowering therapy in low doses (≤ 100 mg/d for allopurinol) and titrating to achieve and maintain the target sUA level. Along with the judicious use of anti-inflammatory prophylaxis, this may minimize attacks related to therapy initiation.^3,28 By lowering and maintaining sUA below the target level, monosodium urate crystals will dissolve, thereby eliminating the major inciting factor of acute attacks.

Other day-to-day triggers such as alcohol, meat or seafood consumption, and dehydration exist for some patients with gout. Patients should be informed of these inciting factors, as they could potentially be avoided, reducing the risk of future gout attacks. It is important to recognize, however, that dietary or behavioral interventions have generally yielded only modest sUA reductions. For the majority of patients, therefore, reduction and maintenance of sUA ≤ 6.0 mg/dL requires pharmacologic intervention.

Conclusions

Gout attacks should be treated immediately with pharmacologic treatment when contraindications are absent. First-line treatment options include NSAIDs, colchicine, and systemic glucocorticoids. Use of these modalities can be complicated because of comorbidity and concomitant medication use that is prevalent among patients with gout. Comorbidities commonly limiting treatment choice include hypertension (NSAIDs, glucocorticoids), CKD (NSAIDS, colchicine), CVD (NSAIDs, COX-2 inhibitors, glucocorticoids), T2DM (glucocorticoids), and liver disease (NSAIDs, colchicine). Careful consideration must be given to these comorbidities and contraindications as well as patient preferences.

Gout is an extremely painful arthritis initiated by innate immune responses to monosodium urate crystals that accumulate in affected joints and surrounding tissues. As a result, gout is characterized by painful arthritis flares followed by intervening periods of disease quiescence. Over time, gout can lead to chronic pain, disability, and tophi. Nearly 10% of those aged > 65 years report having gout. The overall prevalence in the U.S. population approaches 4%.¹

Gout treatment has 2 overarching goals: alleviating the pain and inflammation caused by acute gout attacks and long-term management that is focused on lowering serum urate (sUA) levels to reduce the risk of future attacks. Alleviating the pain and inflammation of an acute attack is often complicated by patient characteristics, namely, other chronic health conditions that frequently accompany gout, such as diabetes mellitus (DM), chronic kidney disease (CKD), hypertension, and cardiovascular disease (CVD).

Patients with gout tend to be older and have multiple comorbidities that require the use of many medications.² Because the VA patient population tends to be older, acute gout and attendant complications of treatment are an important consideration for VA health care providers (HCPs).

Recently, the American College of Rheumatology (ACR) released management recommendations for gout, including those for the treatment of acute gout.³ The ACR recommends 3 first-line therapies, but limited guidance is provided for deciding among therapies. This article briefly reviews the relevant ACR recommendations and details important comorbidity and concomitant medication considerations in the treatment of acute gout.

Acute Gout Characteristics

Acute gout attacks are characterized by a rapid onset and escalation with joint pain typically peaking within 24 hours of attack onset. An acute attack often begins to remit after 5 to 12 days without intervention, but complete resolution may take longer in some patients.⁴ In one study, at 24 hours after attack onset, 16% of patients on placebo had > 50% reduction in pain compared with 70% that had no recovery at all.⁵ By 48 hours, one-third of patients on placebo achieved a 50% reduction in pain.⁶

Acute gout attacks are most commonly monoarticular, although 10% to 40% can involve ≥ 2 joints.⁷ The first metatarsophalangeal (MTP) joint is the initial site of involvement in about 50% of cases and is eventually observed in the majority of patients with gout (Figure 1).⁷ Other commonly affected joints include the midfoot, ankle, knee, wrist, elbow, and fingers. Most patients still reach peak pain within 24 hours with pain remitting predictably over 1 to 2 weeks. Chronic or variable intensity pain is more common among those with long-standing disease, polyarticular gout, or tophi.

Treatment Recommendations

Therapy for acute gout attacks aims to reduce pain and promote a full, early resolution. The ACR recommends pharmacologic therapy as first-line treatment with adjunctive topical ice and rest as needed.³ Typically, monotherapy is appropriate if the individual is experiencing mild-to-moderate pain affecting ≤ 2 joints of any size. Severe pain or attacks affecting multiple joints may benefit from initial combination therapy. Three first-line therapies are available: nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors, colchicine, or systemic glucocorticoids (Figure 2).

Few studies compare the efficacy of first-line therapeutic categories. There are no clinical trials directly comparing colchicine with NSAIDs or colchicine with glucocorticoids. No difference in mean reduction of pain and no differences in adverse events (AEs) were shown in a trial that compared glucocorticoids with NSAIDs.⁸ Thus, without further study, treatment choices made by HCPs are often guided by factors other than the existence of robust evidence.

Treatment with NSAIDs or COX-2 inhibitors should be initiated at the approved dose and continued until the gout attack has completely resolved. In one study, 73% of patients had pain reduction of ≥ 50% when taking NSAIDs relative to only 27% of patients on placebo.⁸ All available NSAIDs are considered effective, but only 3 NSAIDs are specifically approved for treatment of acute gout (naproxen, indomethacin, and sulindac). There is no evidence supporting one NSAID as being more effective than another; evidence fails to show a meaningful difference.⁸ Limited evidence indicates that selective COX-2 inhibitors, including celexocib, have similar efficacy as nonselective NSAIDs but may have fewer AEs, driven in part by fewer gastrointestinal (GI) events (6% vs 16% for GI events).⁸

Colchicine has long been used as prophylaxis for acute gout attacks and has been endorsed for the treatment of acute attacks. Recent evidence suggests that colchicine initially dosed at 1.2 mg followed by a single 0.6-mg dose 1 hour later is as effective with fewer AEs compared with a traditional regimen of 1.2 mg followed by 0.6 mg every hour for up to 6 hours.⁵ About 40% of patients have 50% pain reduction within 24 hours and a 40% absolute risk reduction in AEs on this low-dose regimen. The efficacy of colchicine relative to other therapies is poorly defined, especially for patients presenting longer after attack onset. The ACR guidelines recommend colchicine only if treatment is initiated within 36 hours of attack onset, but this is based solely on expert consensus. Likewise, the above trial for low-dose colchicine did not provide information about dosing beyond the first 6 hours, leaving little guidance for follow-up treatment of residual pain beyond the 32 hours reported.⁵ Traditionally, one 0.6-mg dose is provided every 12 to 24 hours.³

 

Systemic glucocorticoids are also commonly used in treating acute gout.⁹ There was a small pain reduction benefit for prednisolone, but the difference was not clinically significant in one clinical trial comparing oral prednisolone 30 mg daily for 5 days vs a combination of indomethacin for 5 days and an initial intramuscular injection of diclofenac 75 mg.¹⁰ The prednisolone group also had fewer patients with AEs, including abdominal pain (0% vs 30%) and GI bleeding (0% vs 11%). The lower incidence of short-term AEs may be a primary benefit of systemic glucocorticoids.¹¹

Intra-articular glucocorticoids are not suggested first-line therapies but are commonly used by rheumatologists.⁹ In an uncontrolled study conducted by Fernández and colleagues, intra-articular glucocorticoid injections helped to quickly resolve 20 out of 20 crystal-proven gout attacks.¹² However, no randomized controlled trials have examined this approach. Although seemingly efficacious, other considerations are important for this modality. Intra-articular glucocorticoids may not be preferred for polyarticular attacks or attacks in difficult-to-aspirate joints. Additionally, intra-articular glucocorticoids have been anecdotally associated with rebound attacks (ie, attacks that occur shortly after resolution without other interventions). However, the Fernández study had no such attacks occur among participants.¹² Finally, septic arthritis must be ruled out as in any case of acute onset monoarticular arthritis.

Biologic agents targeting interleukin-1(IL-1) are not currently approved for gout, although there is burgeoning data suggesting that this strategy may have substantial merit.¹³ Additionally, there is limited evidence that adrenocorticotropic hormone (ACTH) may provide rapid pain relief when other available therapies are ineffective or contraindicated. However, ACTH studies have not provided robust trial designs, and drug costs remain substantial, thus limiting the widespread use of ACTH in acute gout.^14,15 Anti-IL-1 agents and ACTH may both be considered as second-line options if first-line therapies are contraindicated or fail. Careful consideration should be given to AE profiles, patient preferences, and cost.

Comorbidities

Acute gout care, especially in the context of comorbidities, has been identified as a critical treatment concern by an international panel of rheumatologists as part of the 3e (Evidence, Expertise, Exchange) Initiative.¹⁶ However, regular clinical trial exclusion criteria have limited data necessary to guide treatment when comorbidities are present. Therefore, studies of acute gout treatment in the context of disease comorbidity represents a major unmet need in understanding and optimizing gout care.

Chronic Kidney Disease

Chronic kidney disease is common in gout; 20% of patients with gout have an estimated glomerular filtration rate (eGFR) of < 30 mL/min.² Thus, CKD is an important consideration when deciding the best treatment for acute gout. The ACR recommendations do not provide specific guidance on NSAID use in CKD but suggest the potential option of tapering the dose as pain begins to resolve. There is mixed evidence that NSAIDs accelerate CKD progression with the best evidence for high-dose NSAID use.¹⁷ When prescribing the concomitant use of NSAIDs with other medications affecting kidney function, HCPs should consider CKD.

For colchicine, current labeling and evidence indicate that no dose adjustments are needed for stage 3 or better CKD (eGFR ≥ 60 mL/min) even among the elderly.^18,19 Although labeling indicates that a single unadjusted dose (0.6 mg) can be given once every 2 weeks for those with severe CKD (eGFR < 30 mL/min) or for those who are on dialysis, alternative therapies should be considered, as AEs increase with decreasing renal function.¹⁹ Colchicine should not be used in those with eGFR < 10 mL/min.²⁰ All patients who have CKD and are treated with colchicine should be informed of the AEs and closely observed for signs of toxicity, including blood dyscrasias, neuromyopathy, emesis, or diarrhea.

Considering the potential complications for NSAIDs and colchicine, patients with CKD may be good candidates for glucocorticoid therapy, administered either systemically or as an intra-articular injection. Alternatively, second-line agents such as ACTH or IL-1 inhibition may be considered in such patients.

Hypertension

Hypertension is one of the most common comorbidities among patients with gout. It is important for HCP consideration when deciding treatment. Poorly controlled hypertension is a contraindication for both NSAIDs and systemic glucocorticoids. Patients with hypertension in the absence of significant renal impairment may be good candidates for colchicine.

Diabetes and Hyperlipidemia

Glucocorticoids should be avoided if possible in the setting of inadequately controlled type 2 DM (T2DM) or hyperlipidemia. Glucocorticoids exacerbate insulin resistance and stimulate glucose secretion from the liver. This can create substantial and sometimes dangerous fluctuations in circulating glucose concentrations. Additionally, glucocorticoids may increase serum triglycerides and low-density lipoprotein levels. Thus, patients with T2DM or hyperlipidemia may be good candidates for alternative treatments, such as colchicine or NSAIDs.

 

Cardiovascular Disease

Cardiovascular disease risk has been shown to increase with the use of COX-2 inhibitors. This risk may be present for all NSAIDs. Current FDA labeling suggests limiting NSAID and COX-2 inhibitor use in patients with a history of myocardial infarction (MI), congestive heart failure, or stroke. Given the potential impact on cardiovascular risk factors, including hypertension, T2DM, and hyperlipidemia, glucocorticoids may not be ideal for patients with known CVD or those at high risk.

Recent evidence has shown that colchicine use is associated with a lower risk of MI among patients with gout.²¹ These results, in addition to a proposed dual role of IL-1 in both gout and CVD, suggest that either colchicine or IL-1 inhibitors may be rational agents in the treatment of acute gout in the context of CVD.²²

Hepatic Impairment and GI Bleeding

Patients with cirrhosis should avoid NSAID use due to the potential increased bleeding risk from underlying coagulopathy. Additionally, colchicine clearance may be reduced in patients with severe liver impairment, mandating close surveillance when this agent is used. If hepatic impairment is mild to moderate, judicious use of any of the first-line therapies may be appropriate.

Patients with GI bleeding or a history of peptic ulcer disease should avoid NSAID use because of increased bleeding risk. If an NSAID is used, proton pump inhibitors decrease the risk of NSAID-associated mucosal damage.

Drug Interactions

Colchicine is metabolized by the cytochrome P450 3A4 enzyme (CYP3A4) and is a substrate for P-glycoprotein (P-gp). Therefore, concomitant use of colchicine with potent inhibitors of CYP3A4 or P-gp should be avoided when possible. These agents include macrolide antibiotics (clarithromyocin), calcium channel blockers (verapamil and diltiazem), and cyclosporine (commonly used in transplant patients who are at high risk for gout). New evidence-based dosing recommendations indicate that no dose reduction is required with azithromyocin.²³

Nonsteroidal anti-inflammatory drugs are contraindicated with the concomitant use of angiotensin-converting enzyme (ACE) inhibitors and/or diuretics. Prostaglandin production is decreased while using NSAIDs, resulting in increased constriction of afferent renal arterioles and decreased glomerular filtration pressure. This physiologic effect of NSAIDs can be exacerbated when used in combination with ACE inhibitors or diuretics, both of which can also reduce glomerular filtration pressures. Combination therapy with either ACE inhibitors or diuretics increases the risk for NSAID-mediated acute kidney injury. Additionally, NSAID use should be avoided in patients taking anticoagulants such as warfarin or heparin due to increased bleeding risk.

Diagnosis

Diagnosis is a key component of proper treatment of acute gout. A gout diagnosis is usually made based on clinical signs and symptoms, including sudden onset of pain that peaks within 24 hours, past history of acute self-limited attacks of arthritis, first MTP involvement, and an elevated sUA. However, not all these factors must be present. In a study conducted by Janssens and colleagues, these factors plus additional demographics had a sensitivity of 90% and specificity of 65% when compared with crystal diagnosis.²⁴ However, a normal sUA level does not exclude gout as a diagnosis due to the uricosuric effect of the inflammatory process.²⁵ In fact, one observational cohort recorded an average sUA decrease from baseline of 2 mg/dL during an acute gout attack.²⁶

Alternative diagnoses, including septic arthritis, should be considered, particularly in the context of treatment failure (< 50% reduction in pain) within the first 24 to 48 hours. A definitive diagnosis is made by identifying negatively birefringent crystals in the synovial fluid of the affected joint (using polarized microscopy) with negative cultures. In the absence of crystal confirmation, there is an emerging role for imaging in gout diagnosis, including the use of ultrasound and dual-energy computed tomography.²⁷

Long-term Treatment Considerations

During treatment for acute gout attacks, urate-lowering therapy that was initiated before the attack should not be discontinued.²⁸ There is no evidence to suggest that current urate lowering has any AEs during attacks. However, removing treatment may increase sUA levels, precipitating attacks in other joints by “destabilizing” crystals still present. Current recommendations also state that urate-lowering therapy may be started during an attack despite traditionally being deferred until the attack has resolved.²⁸ In a randomized trial comparing a group starting allopurinol 300 mg during an attack vs a placebo group (with all patients receiving anti-inflammatory treatment for the acute attack), there was no difference in pain outcomes.²⁹ Regardless of the chosen timing, lowering and maintaining sUA ≤ 6.0 mg/dL is the primary method for minimizing long-term risk of gout attacks.²⁸

Health care providers should discuss with patients the likely need for indefinite urate-lowering therapy while noting that attacks related to therapy initiation are relatively common.³⁰ Current guidelines recommend starting urate-lowering therapy in low doses (≤ 100 mg/d for allopurinol) and titrating to achieve and maintain the target sUA level. Along with the judicious use of anti-inflammatory prophylaxis, this may minimize attacks related to therapy initiation.^3,28 By lowering and maintaining sUA below the target level, monosodium urate crystals will dissolve, thereby eliminating the major inciting factor of acute attacks.

Other day-to-day triggers such as alcohol, meat or seafood consumption, and dehydration exist for some patients with gout. Patients should be informed of these inciting factors, as they could potentially be avoided, reducing the risk of future gout attacks. It is important to recognize, however, that dietary or behavioral interventions have generally yielded only modest sUA reductions. For the majority of patients, therefore, reduction and maintenance of sUA ≤ 6.0 mg/dL requires pharmacologic intervention.

Conclusions

Gout attacks should be treated immediately with pharmacologic treatment when contraindications are absent. First-line treatment options include NSAIDs, colchicine, and systemic glucocorticoids. Use of these modalities can be complicated because of comorbidity and concomitant medication use that is prevalent among patients with gout. Comorbidities commonly limiting treatment choice include hypertension (NSAIDs, glucocorticoids), CKD (NSAIDS, colchicine), CVD (NSAIDs, COX-2 inhibitors, glucocorticoids), T2DM (glucocorticoids), and liver disease (NSAIDs, colchicine). Careful consideration must be given to these comorbidities and contraindications as well as patient preferences.

Gout is an extremely painful arthritis initiated by innate immune responses to monosodium urate crystals that accumulate in affected joints and surrounding tissues. As a result, gout is characterized by painful arthritis flares followed by intervening periods of disease quiescence. Over time, gout can lead to chronic pain, disability, and tophi. Nearly 10% of those aged > 65 years report having gout. The overall prevalence in the U.S. population approaches 4%.¹

Gout treatment has 2 overarching goals: alleviating the pain and inflammation caused by acute gout attacks and long-term management that is focused on lowering serum urate (sUA) levels to reduce the risk of future attacks. Alleviating the pain and inflammation of an acute attack is often complicated by patient characteristics, namely, other chronic health conditions that frequently accompany gout, such as diabetes mellitus (DM), chronic kidney disease (CKD), hypertension, and cardiovascular disease (CVD).

Patients with gout tend to be older and have multiple comorbidities that require the use of many medications.² Because the VA patient population tends to be older, acute gout and attendant complications of treatment are an important consideration for VA health care providers (HCPs).

Recently, the American College of Rheumatology (ACR) released management recommendations for gout, including those for the treatment of acute gout.³ The ACR recommends 3 first-line therapies, but limited guidance is provided for deciding among therapies. This article briefly reviews the relevant ACR recommendations and details important comorbidity and concomitant medication considerations in the treatment of acute gout.

Acute Gout Characteristics

Acute gout attacks are characterized by a rapid onset and escalation with joint pain typically peaking within 24 hours of attack onset. An acute attack often begins to remit after 5 to 12 days without intervention, but complete resolution may take longer in some patients.⁴ In one study, at 24 hours after attack onset, 16% of patients on placebo had > 50% reduction in pain compared with 70% that had no recovery at all.⁵ By 48 hours, one-third of patients on placebo achieved a 50% reduction in pain.⁶

Acute gout attacks are most commonly monoarticular, although 10% to 40% can involve ≥ 2 joints.⁷ The first metatarsophalangeal (MTP) joint is the initial site of involvement in about 50% of cases and is eventually observed in the majority of patients with gout (Figure 1).⁷ Other commonly affected joints include the midfoot, ankle, knee, wrist, elbow, and fingers. Most patients still reach peak pain within 24 hours with pain remitting predictably over 1 to 2 weeks. Chronic or variable intensity pain is more common among those with long-standing disease, polyarticular gout, or tophi.

Treatment Recommendations

Therapy for acute gout attacks aims to reduce pain and promote a full, early resolution. The ACR recommends pharmacologic therapy as first-line treatment with adjunctive topical ice and rest as needed.³ Typically, monotherapy is appropriate if the individual is experiencing mild-to-moderate pain affecting ≤ 2 joints of any size. Severe pain or attacks affecting multiple joints may benefit from initial combination therapy. Three first-line therapies are available: nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors, colchicine, or systemic glucocorticoids (Figure 2).

Few studies compare the efficacy of first-line therapeutic categories. There are no clinical trials directly comparing colchicine with NSAIDs or colchicine with glucocorticoids. No difference in mean reduction of pain and no differences in adverse events (AEs) were shown in a trial that compared glucocorticoids with NSAIDs.⁸ Thus, without further study, treatment choices made by HCPs are often guided by factors other than the existence of robust evidence.

Treatment with NSAIDs or COX-2 inhibitors should be initiated at the approved dose and continued until the gout attack has completely resolved. In one study, 73% of patients had pain reduction of ≥ 50% when taking NSAIDs relative to only 27% of patients on placebo.⁸ All available NSAIDs are considered effective, but only 3 NSAIDs are specifically approved for treatment of acute gout (naproxen, indomethacin, and sulindac). There is no evidence supporting one NSAID as being more effective than another; evidence fails to show a meaningful difference.⁸ Limited evidence indicates that selective COX-2 inhibitors, including celexocib, have similar efficacy as nonselective NSAIDs but may have fewer AEs, driven in part by fewer gastrointestinal (GI) events (6% vs 16% for GI events).⁸

Colchicine has long been used as prophylaxis for acute gout attacks and has been endorsed for the treatment of acute attacks. Recent evidence suggests that colchicine initially dosed at 1.2 mg followed by a single 0.6-mg dose 1 hour later is as effective with fewer AEs compared with a traditional regimen of 1.2 mg followed by 0.6 mg every hour for up to 6 hours.⁵ About 40% of patients have 50% pain reduction within 24 hours and a 40% absolute risk reduction in AEs on this low-dose regimen. The efficacy of colchicine relative to other therapies is poorly defined, especially for patients presenting longer after attack onset. The ACR guidelines recommend colchicine only if treatment is initiated within 36 hours of attack onset, but this is based solely on expert consensus. Likewise, the above trial for low-dose colchicine did not provide information about dosing beyond the first 6 hours, leaving little guidance for follow-up treatment of residual pain beyond the 32 hours reported.⁵ Traditionally, one 0.6-mg dose is provided every 12 to 24 hours.³

 

Systemic glucocorticoids are also commonly used in treating acute gout.⁹ There was a small pain reduction benefit for prednisolone, but the difference was not clinically significant in one clinical trial comparing oral prednisolone 30 mg daily for 5 days vs a combination of indomethacin for 5 days and an initial intramuscular injection of diclofenac 75 mg.¹⁰ The prednisolone group also had fewer patients with AEs, including abdominal pain (0% vs 30%) and GI bleeding (0% vs 11%). The lower incidence of short-term AEs may be a primary benefit of systemic glucocorticoids.¹¹

Intra-articular glucocorticoids are not suggested first-line therapies but are commonly used by rheumatologists.⁹ In an uncontrolled study conducted by Fernández and colleagues, intra-articular glucocorticoid injections helped to quickly resolve 20 out of 20 crystal-proven gout attacks.¹² However, no randomized controlled trials have examined this approach. Although seemingly efficacious, other considerations are important for this modality. Intra-articular glucocorticoids may not be preferred for polyarticular attacks or attacks in difficult-to-aspirate joints. Additionally, intra-articular glucocorticoids have been anecdotally associated with rebound attacks (ie, attacks that occur shortly after resolution without other interventions). However, the Fernández study had no such attacks occur among participants.¹² Finally, septic arthritis must be ruled out as in any case of acute onset monoarticular arthritis.

Biologic agents targeting interleukin-1(IL-1) are not currently approved for gout, although there is burgeoning data suggesting that this strategy may have substantial merit.¹³ Additionally, there is limited evidence that adrenocorticotropic hormone (ACTH) may provide rapid pain relief when other available therapies are ineffective or contraindicated. However, ACTH studies have not provided robust trial designs, and drug costs remain substantial, thus limiting the widespread use of ACTH in acute gout.^14,15 Anti-IL-1 agents and ACTH may both be considered as second-line options if first-line therapies are contraindicated or fail. Careful consideration should be given to AE profiles, patient preferences, and cost.

Comorbidities

Acute gout care, especially in the context of comorbidities, has been identified as a critical treatment concern by an international panel of rheumatologists as part of the 3e (Evidence, Expertise, Exchange) Initiative.¹⁶ However, regular clinical trial exclusion criteria have limited data necessary to guide treatment when comorbidities are present. Therefore, studies of acute gout treatment in the context of disease comorbidity represents a major unmet need in understanding and optimizing gout care.

Chronic Kidney Disease

Chronic kidney disease is common in gout; 20% of patients with gout have an estimated glomerular filtration rate (eGFR) of < 30 mL/min.² Thus, CKD is an important consideration when deciding the best treatment for acute gout. The ACR recommendations do not provide specific guidance on NSAID use in CKD but suggest the potential option of tapering the dose as pain begins to resolve. There is mixed evidence that NSAIDs accelerate CKD progression with the best evidence for high-dose NSAID use.¹⁷ When prescribing the concomitant use of NSAIDs with other medications affecting kidney function, HCPs should consider CKD.

For colchicine, current labeling and evidence indicate that no dose adjustments are needed for stage 3 or better CKD (eGFR ≥ 60 mL/min) even among the elderly.^18,19 Although labeling indicates that a single unadjusted dose (0.6 mg) can be given once every 2 weeks for those with severe CKD (eGFR < 30 mL/min) or for those who are on dialysis, alternative therapies should be considered, as AEs increase with decreasing renal function.¹⁹ Colchicine should not be used in those with eGFR < 10 mL/min.²⁰ All patients who have CKD and are treated with colchicine should be informed of the AEs and closely observed for signs of toxicity, including blood dyscrasias, neuromyopathy, emesis, or diarrhea.

Considering the potential complications for NSAIDs and colchicine, patients with CKD may be good candidates for glucocorticoid therapy, administered either systemically or as an intra-articular injection. Alternatively, second-line agents such as ACTH or IL-1 inhibition may be considered in such patients.

Hypertension

Hypertension is one of the most common comorbidities among patients with gout. It is important for HCP consideration when deciding treatment. Poorly controlled hypertension is a contraindication for both NSAIDs and systemic glucocorticoids. Patients with hypertension in the absence of significant renal impairment may be good candidates for colchicine.

Diabetes and Hyperlipidemia

Glucocorticoids should be avoided if possible in the setting of inadequately controlled type 2 DM (T2DM) or hyperlipidemia. Glucocorticoids exacerbate insulin resistance and stimulate glucose secretion from the liver. This can create substantial and sometimes dangerous fluctuations in circulating glucose concentrations. Additionally, glucocorticoids may increase serum triglycerides and low-density lipoprotein levels. Thus, patients with T2DM or hyperlipidemia may be good candidates for alternative treatments, such as colchicine or NSAIDs.

 

Cardiovascular Disease

Cardiovascular disease risk has been shown to increase with the use of COX-2 inhibitors. This risk may be present for all NSAIDs. Current FDA labeling suggests limiting NSAID and COX-2 inhibitor use in patients with a history of myocardial infarction (MI), congestive heart failure, or stroke. Given the potential impact on cardiovascular risk factors, including hypertension, T2DM, and hyperlipidemia, glucocorticoids may not be ideal for patients with known CVD or those at high risk.

Recent evidence has shown that colchicine use is associated with a lower risk of MI among patients with gout.²¹ These results, in addition to a proposed dual role of IL-1 in both gout and CVD, suggest that either colchicine or IL-1 inhibitors may be rational agents in the treatment of acute gout in the context of CVD.²²

Hepatic Impairment and GI Bleeding

Patients with cirrhosis should avoid NSAID use due to the potential increased bleeding risk from underlying coagulopathy. Additionally, colchicine clearance may be reduced in patients with severe liver impairment, mandating close surveillance when this agent is used. If hepatic impairment is mild to moderate, judicious use of any of the first-line therapies may be appropriate.

Patients with GI bleeding or a history of peptic ulcer disease should avoid NSAID use because of increased bleeding risk. If an NSAID is used, proton pump inhibitors decrease the risk of NSAID-associated mucosal damage.

Drug Interactions

Colchicine is metabolized by the cytochrome P450 3A4 enzyme (CYP3A4) and is a substrate for P-glycoprotein (P-gp). Therefore, concomitant use of colchicine with potent inhibitors of CYP3A4 or P-gp should be avoided when possible. These agents include macrolide antibiotics (clarithromyocin), calcium channel blockers (verapamil and diltiazem), and cyclosporine (commonly used in transplant patients who are at high risk for gout). New evidence-based dosing recommendations indicate that no dose reduction is required with azithromyocin.²³

Nonsteroidal anti-inflammatory drugs are contraindicated with the concomitant use of angiotensin-converting enzyme (ACE) inhibitors and/or diuretics. Prostaglandin production is decreased while using NSAIDs, resulting in increased constriction of afferent renal arterioles and decreased glomerular filtration pressure. This physiologic effect of NSAIDs can be exacerbated when used in combination with ACE inhibitors or diuretics, both of which can also reduce glomerular filtration pressures. Combination therapy with either ACE inhibitors or diuretics increases the risk for NSAID-mediated acute kidney injury. Additionally, NSAID use should be avoided in patients taking anticoagulants such as warfarin or heparin due to increased bleeding risk.

Diagnosis

Diagnosis is a key component of proper treatment of acute gout. A gout diagnosis is usually made based on clinical signs and symptoms, including sudden onset of pain that peaks within 24 hours, past history of acute self-limited attacks of arthritis, first MTP involvement, and an elevated sUA. However, not all these factors must be present. In a study conducted by Janssens and colleagues, these factors plus additional demographics had a sensitivity of 90% and specificity of 65% when compared with crystal diagnosis.²⁴ However, a normal sUA level does not exclude gout as a diagnosis due to the uricosuric effect of the inflammatory process.²⁵ In fact, one observational cohort recorded an average sUA decrease from baseline of 2 mg/dL during an acute gout attack.²⁶

Alternative diagnoses, including septic arthritis, should be considered, particularly in the context of treatment failure (< 50% reduction in pain) within the first 24 to 48 hours. A definitive diagnosis is made by identifying negatively birefringent crystals in the synovial fluid of the affected joint (using polarized microscopy) with negative cultures. In the absence of crystal confirmation, there is an emerging role for imaging in gout diagnosis, including the use of ultrasound and dual-energy computed tomography.²⁷

Long-term Treatment Considerations

During treatment for acute gout attacks, urate-lowering therapy that was initiated before the attack should not be discontinued.²⁸ There is no evidence to suggest that current urate lowering has any AEs during attacks. However, removing treatment may increase sUA levels, precipitating attacks in other joints by “destabilizing” crystals still present. Current recommendations also state that urate-lowering therapy may be started during an attack despite traditionally being deferred until the attack has resolved.²⁸ In a randomized trial comparing a group starting allopurinol 300 mg during an attack vs a placebo group (with all patients receiving anti-inflammatory treatment for the acute attack), there was no difference in pain outcomes.²⁹ Regardless of the chosen timing, lowering and maintaining sUA ≤ 6.0 mg/dL is the primary method for minimizing long-term risk of gout attacks.²⁸

Health care providers should discuss with patients the likely need for indefinite urate-lowering therapy while noting that attacks related to therapy initiation are relatively common.³⁰ Current guidelines recommend starting urate-lowering therapy in low doses (≤ 100 mg/d for allopurinol) and titrating to achieve and maintain the target sUA level. Along with the judicious use of anti-inflammatory prophylaxis, this may minimize attacks related to therapy initiation.^3,28 By lowering and maintaining sUA below the target level, monosodium urate crystals will dissolve, thereby eliminating the major inciting factor of acute attacks.

Other day-to-day triggers such as alcohol, meat or seafood consumption, and dehydration exist for some patients with gout. Patients should be informed of these inciting factors, as they could potentially be avoided, reducing the risk of future gout attacks. It is important to recognize, however, that dietary or behavioral interventions have generally yielded only modest sUA reductions. For the majority of patients, therefore, reduction and maintenance of sUA ≤ 6.0 mg/dL requires pharmacologic intervention.

Conclusions

Gout attacks should be treated immediately with pharmacologic treatment when contraindications are absent. First-line treatment options include NSAIDs, colchicine, and systemic glucocorticoids. Use of these modalities can be complicated because of comorbidity and concomitant medication use that is prevalent among patients with gout. Comorbidities commonly limiting treatment choice include hypertension (NSAIDs, glucocorticoids), CKD (NSAIDS, colchicine), CVD (NSAIDs, COX-2 inhibitors, glucocorticoids), T2DM (glucocorticoids), and liver disease (NSAIDs, colchicine). Careful consideration must be given to these comorbidities and contraindications as well as patient preferences.