Symptom Assessment in CKD Patients

Fredric O. Finkelstein Yale University

What’s more important for these patients: phosphorus level or depression management? Van Gogh 1888

Picasso 1939

Our Challenge • Incorporate PRO measures into routine patient care and recognize these measures as important elements in standard care assessments • Development treatment strategies for symptom management • Pay attention to the burden of symptom assessment and its value • Integrate technology in a meaningful way

UK Health Care Reforms: Patient Centered Care Faden, Chalkidou: NEJM 364:1289, 2011 Roland, Rosen: NEJM 364:1360, 2011

• “No decision about me without me.” • Patient choice is emphasized with a focus on outcomes: outcomes that matter to patients

Patient Centered Care • Patient centered care involves active participation by the patients and their family/caregivers in determining the standards of care which are best suited to maximize the individual’s quality of life. • Patient centered care shifts the focus from care which is dictated (insistence on adherence and compliance to arbitrary measures) to care which is collaborative and cooperative

Patients as “Consumers” Paul Krugman: NY Times 4/22/11 • “Medical care is an area in which crucial decisions – life and death– must be made … And these decisions.. require a vast amount of specialized knowledge…The idea … that doctors are just providers selling services to health care consumers is (not right)… a sign that something has gone very wrong… with our society’s values.”

Do No Harm, Henry Marsh, St. Martin Press 2015

• “Informed consent sounds so easy in principle -- …like going to the supermarket and choosing from the vast array of toothbrushes on offer. The reality is very different. Patients are both terrified and ignorant.” How can they make in informed decision?

Baron and Davis (ABIM, Johns Hopkins), NEJM 1/9/14 Accelerating The Adoption Of High-value Primary Care: Milestones to be Achieved

• Shared decision making, including use of decision aids • Assessments and improvements in patient experience • Meaningful use of health information technology

The Focus on Documentation: images from Yale-New Haven Hospital

Is this meaningful use of technology?

Or What About This: Physician Log-In Screen for a EMR of a LDO

Adequacy: KT/V Bone disease: Ca, Ph, iPTH Anemia: Hct, Hb, iron studies Vascular access: Hospitalization: NOTHING ABOUT HOW THE PATIENT FEELS OR SYMPTOM BURDEN

OR THIS DO NO HARM Henry Marsh, St. Martin Press, 2015 • Hospital charts are filled with irrelevant data on NHS forms • Searching for an operative note, which he cannot find, Marsh finds detailed documentation that his patient passed a “type 4 turd” – taken from a comprehensive chart detailing the seven different types of turds • But what about the operative note??

Or What About This: When Documentation Supersedes Patient Communication Shah et al: JAMA Int Med 175:884, 2015

• “Physicians, nurses, and the institutions in which they work often persist in mundane and long established routines, even when there is no evident benefit to patient care, simply because these routines are assumed to be regulatory requirements.” • “.. Improving patient care requires a proactive approach to questioning established practices and procedures.”

K/DIGO Conference On Supportive Care In CKD: Developing A Roadmap To Improving Quality Care Sara Davison, Gregorio Obrador et al: Kidney Int, In Press, 2015

• 45 participants from all over the world • Domains discussed included symptom assessment and management • An emphasis was placed on focusing on regular symptom assessment using validated tools • Emphasized that patients with advanced CKD have identified symptom assessment as a top priority (Manns B et al CJASN 9:1813, 2014, O’Hare et al CJASN 9:2189, 2014)

Symptom Burden in CKD • • • • • • • • • • •

Pain (proprioceptive or neuropathic, nociceptive) Pruritis • GI symptoms: anorexia, nausea, constipation, Sleep disorders diarrhea Restless legs • Cardiac symptoms: chest Depression pain, edema, DOE, etc Anxiety Impaired physical functioning Loss of energy, vitality Key Question: to what Sexual dysfunction extent are the symptoms Cognitive dysfunction impacting on the patient’s Impact of the dialysis regimen (e.g. post hemodialysis recovery time)

quality of life? Risks of treatment vs the benefits

Challenges in Assessing These Symptoms • Health care providers do not, as a rule, ask about the presence of, and therefore do not appreciate, patients’ symptoms • These symptoms vary over time • Treatment algorithms are difficult to implement • Documenting an impact of treatment on outcomes is difficult • Understanding the impact of the symptom on the patient is critically important

Provider Recognition of Symptoms of HD Pts

75 pts, 18

providers – MDs, PAs, NPs (Weisbord: CJASN: 2:960, 2007)

symptom SOB Nausea Headache Vomiting Muscle cramps Feeling sad Dry skin Feeling anxious interest in sex

sensitivity 52% 50% 25% 25% 17% 17% 10% 6% 6%

Questions were asked on the same day of patient and provider concerning sx present in the preceding 7 days

Sensitivity: proportion of pts with sx correctly identified by provider as having the sx

Patient vs Caregiver Perceptions The Psychosocial Impact of Physical Changes Reported that physical changes caused patients to feel: Unattractive Anxious/Nervous Frustrated/Upset Angry/Irritable Depressed Embarrassed Feel Uncomfortable in… Unable to Be Intimate… Lonely Unable to Perform… Unable to Enjoy… Unable to Attend Work 0%

P  0.01 for all comparisons

20% Patient Reported

Peters TG, et al. Transplantation. 2004;78:1-7.

40%

60%

Clinician Reported

80%

Challenges in Assessing These Symptoms • Health care providers do not, as a rule, ask about the presence of, and therefore do not appreciate, patients’ symptoms • These symptoms vary over time • Treatment algorithms are difficult to implement • Documenting an impact of treatment on outcomes is difficult • Understanding the impact of the symptom on the patient is critically important

Comparison of symptom management strategies for pain, erectile dysfunction, and depression in patients receiving chronic HD: a cluster randomized effectiveness trial Weisbord et al CJASN 2013 8:90-9. • Pain, ED, and depression were assessed monthly during an observation usual care phase of treatment. • 81% of patients reported pain, 30% reported depressive symptoms, and 89% of men reported ED • Patients were then randomized to 12-month participation in either a feedback arm in which these symptoms were assessed monthly and two treatment arms developed: a) standard arm: renal providers were informed of patients' symptoms and treatment was left to their discretion b) a nurse management arm: trained nurses were used to evaluate patients and generate and facilitate the implementation of treatment recommendations.

Key findings: 1. Variability over time 2. No difference in feedback or nurse management group 3. Slight improvement in both groups over time

pain

Erectile dysfunction

Depressive sx

The Importance of a Time Varying Analysis: Mortality and Peritonitis 6 Months After Each BDI Risk Of Peritonitis In CPD Patients (based on 281 BDI scores) peritonitis episodes in 6 months after each BDI (Troidle et al AJKD 42:350, 2003)

Variable

Relative risk

95% confidence intervals

BDI >11

2.7*

1.23-6.03

Age >65

0.8

0.29-1.88

Diabetes

1.0

0.46-2.13

CAD

0.6

0.39- 1.23

Depression And Mortality In HD Patients Kimmel Kidney Int 57:2093, 2000

90 85 80 75 70 65 60 55 50

12 mon th

15

Challenges in Assessing These Symptoms • Health care providers do not, as a rule, ask about the presence of, and therefore do not appreciate, patients’ symptoms • These symptoms vary over time • Treatment algorithms are difficult to implement • Documenting an impact of treatment on outcomes is difficult • Understanding the impact of the symptom on the patient is critically important

Depression and CKD: The Facts • High incidence of depression in patients with chronic kidney disease • Strong association of depressive symptoms (and clinical depression) with mortality and hospitalization rates, as well as other outcomes (such as peritonitis in PD patients) • Association of depressive symptoms with low HRQOL assessments • Small trials have shown that depression can be treated (pharmacologically and non-pharmacologically) • No studies have shown that treating depression improves “hard” outcomes (mortality, hospitalizations)

Relative Risk of Death and Hospitalization per 5 point Increase in CES-D score (adjusted for country, years on dialysis, age, sex, co-morbidities, albumin, hemoglobin, KT/V)

Lopes: KI. 66:2047, 2004: 9382 randomly selected patients from 12 countries

death

hospitalization

2 1.8 1.6 1.4 1.2 1 0.8 0.6 0.4 0.2 0

1.4 1.2 1 0.8 0.6 0.4 0.2 0

0 to 4

5 to 9

10 to 14

15-30

CES-D Score

0 to 4

5 to 9

10 to 14

15 to 30

DIAGNOSIS AND TREATMENT OF DEPRESSION IN ESRD PATIENTS (Wuerth, Semin Dial 18:142, 2005) • A review our 7 yr. experience of 380 pts maintained on PD • Patients. were screened for depression using the Beck Depression Inventory and those with those with BDI scores > 11 were referred for structured interviews and assessed with the Hamilton Depression scale • Those with Hamilton scores > 18, in conjunction with the presence of DSM-IV criteria, were considered to be clinically depressed • If no contraindication, antidepressants recommended • Successful treatment was defined as completion of a course of antidepressant medication for at least a 12-week period.

380 CPD Patients Were Screened with the BDI Mean BDI Score 12 +7 194 patients had BDI 11 Mean BDI= 17+7

84 pts agree to evaluation Mean BDI 19 + 6

71(85%) clinically depressed

13 were not depressed

71 Patients were Diagnosed with Major Depression

4 pts. were not candidates for Medication Treatment

67 were Recommended For Treatment

34 Did Not Complete Treatment

34 Completed Course of Medication Treatment 13: Acute Med. Problems, Substance Abuse BDI Score Decreased from 17.4 to 6.6

9: Medication Side Effects

15: Axis 2 Personality Disorders

Hedayati, Finkelstein Kidney Int 81:247, 2012

Sadness or anhedonia present

Screen pos

Use self-report scale to screen

Screen neg

Sadness and anhedonia absent

Confirm Dx by structured interview No suicidal ideation Uncomplicated MDE Pharmacologic Treatment

Antidepressant medications

Suicidal ideation Psychosis

Nonpharmacologic Treatment

Cognitive behavioral therapy* Modify dialysis regimen

Treat anxiety, pain, sexual dysfunction, etc.

Exercise*

Alternative therapies

Rescreen in 6-12 months

Consider other causes

Bipolar Disorder

Uremia Dialysis inadequacy Refer to Mental Health

Poor nutrition Cognitive dysfunction Comorbid illness Inflammatory conditions

Challenges in Assessing These Symptoms • Health care providers do not, as a rule, ask about the presence of, and therefore do not appreciate, patients’ symptoms • These symptoms vary over time • Treatment algorithms are difficult to implement • Documenting an impact of treatment on outcomes is difficult • Understanding the impact of the symptom on the patient is critically important: sex, pain, and dialysis treatment regimen

Sexual Dysfunction in Men and Women on Hemodialysis: 85% of patients Strippoli G et al Clin J Am Soc Nephrol 7: 974–981, 2012-women Navaneethan SD et al: AJKD 560:670, 2010 – men and women Vecchio M et al: NDT 27: 2479. 2012-men

Men Overall (n = 946)

Mild to No erectile moderate dysfunction (n erectile = 165) 17% dysfunction (n = 336) 36%

Woman Overall (n=659)

No Sexual Dysfunction (n=104 [15.8%])

Severe erectile dysfunction (n = 445) 47%

Sexual Dysfunction (n=555 [84.2%])

DESIRED VS ACTUAL FREQUENCY OF INTERCOURSE (Steele et al, JASN 7:1165, 1996) N=68

No desire

Group 1 N=24 (n=43) never Group 2

< 2x/month >2x/month

N=5

N=14

N=6

N=7

N=1

N=11

(n=13)2x/mth

Sexual Dysfunction in Female HD Patients (Mor et al: Clin J Am Soc Nephrol. 2014 9:128-34)

• 81% of women reported that they were not sexually active • Reasons for sexual inactivity a) lack of a partner (39%) b) lack of interest (43%) • Actual sexual difficulties were cited by only 2% of women • 64% were moderately to very satisfied with their sexual life • 5% indicated an interest in learning about the causes of and treatment for sexual dysfunction Key Question: to what extent are the symptoms impacting on the patient’s quality of life?

Pain • Over 50 publications looking at 7500 CKD patients have noted that about 58% of patients experience pain and that the majority rate their pain as moderate to severe in intensity • In some studies, over 75% of dialysis patients report pain Key Question: to what extent are the symptoms impacting on the patient’s quality of life? Risks of treatment vs the benefits

Pain Assessment • Distinguish between nociceptive pain (denoting pain arising from the stimulation of nerve cells) and neuropathic (proprioceptive) pain (resulting from injury to pain receptors and characterized by burning, tingling, or stabbing)

• Assess the severity of the pain • Assess the impact of the pain on the patient’s life

Pain Treatment nociceptive Pain • Mild: acetaminophen • Moderate: hydrocodone (start at 5 mg q 4h), oxycodone (start at 5 mg q. 4h), tramadol (start at 25 mg qd) • Severe: hydromorphone (start at 1mg po q 4h); fentanyl patch (if pain is continuous, not controlled, or dose exceeds 25 mg/day, use a 25 mcg/hr)

• DO NOT USE: morphine, meperidine, codeine, prepoxyphene Always Balance the Risk of Side Effects vs the Benefits of Pain Control

Pain Treatment proprioceptive (neuropathic)pain • Gabapentin: (start at 100 mg qhs and increase as needed to a maximum dose of 300 mg q hs – can sometimes be used up to 600 mg q hs) eliminated by renal excretion

• Pre-gabalin: (start at 25 mg q hs and increase as needed to 100 mg qd) – eliminated by renal excretion

• Desipramine(start at 10 mg q hs and increase up to 150 mg q h – metabolites eliminated by renal excretion

Always Balance the Risk of Side Effects vs the Benefits of Pain Control

The Impact of the Dialysis Treatment Regimen • Satisfaction with care • Negative impact of the treatment on quality of life • Caregiver burden

Renal Replacement Therapy 3x/week In-center HD

Palliative Care

Transplantation

Short, 4-6x/week In-center

CAPD Short, 5-6x/week Home HD CCPD, APD Home HD 3-4x/week

Nocturnal home HD 3-6x/week

Nocturnal In-center HD

Hybrid dialysis: combined PD and HD

PATIENTS’ GLOBAL PERCEPTION OF THEIR CARE: The CHOICE STUDY (Rubin et al: JAMA 291:697, 2004) Quality of How much dialysis care could be better*

Would you recommend your center

% exc ratings: PD

85%

60%

91%

% exc ratings: HD

56%

39%

75%

Adj prob PD/HD

1.46

1.70

1.20

% of best possible response

NEW HAVEN STUDIES: Satisfaction With Care and Impact Of Therapy On Patients’ Lives (Juergensen CJASN, 2006) • Questionnaires administered to a large cohort of PD and HD patients, maintained on dialysis for a mean duration of 36 months for both groups Global Satisfaction with & impact of therapy on patient lives

On multivariate analysis, the only significant difference was attributable to modality

Impact of specific domains

Time to recovery: London (Ontario) Experience (Lindsay et al: CJASN 1:952,2006)

Time to Recovery, minutes

700 600 500 400

short daily nocturnal controls

300 200 100 0 baseline

6 mths

12 mths

1000 800

Time to Recovery:

600

FREEDOM STUDY

400

Jaber et al Am J Kidney Dis. 2010 56:531-9

200 0

Baseline

Month-4

Month-12

Post-dialysis time to recovery distribution (%)

Post-dialysis time to recovery (minutes)

1200

100% => 60 minutes 36%

80% 60%

< 60 minutes 84%

40% 64% 20% 16% 0% Baseline

Month-12

Caregiver Burden • In FREEDOM Study, 20% of patients drop out and transfer to center HD • Caregiver burden is cited by patients as the biggest negative about home HD

Suggested PROS: (Caveats: need to be individualized and meaningful; burden on pts and staff)

• Physical symptom check list • Global Health or quality of life assessment • Depression: PHQ 2 or 9, BDI , CES-D • Sleep problems: MOS, Epworth Sleep, PSQI • Restless legs: IRLS • Pain: direct question about presence, nature, severity, impact

• Time to recovery • Physical functioning, energy, vitality: SF-36,

PROMIS, Fact-Fatigue, etc

• Sexual functioning, marital and famly discord: direct discussion • Satisfaction with care: CHOICE questionnaire

• Burden of Illness and therapy: Juergensen instrument or other

• Caregiver burden: Zarit Burden Interview questionnaire

Our Challenge • Incorporate PRO measures into routine patient care and recognize these measures as important ingredients in standard care assessment • Development treatment strategies for symptom management • Integrate technology in a meaningful way • Pay attention to the burden of symptom assessment and its value