SURVEY
OF THE PROVISION OF ELECTRO-CONVULSIVE THERAPY (ECT)
AT NEW YORK STATE PSYCHIATRIC CENTERS
BY THE COMMISSION ON QUALITY OF CARE
AUGUST 7, 2001
I.
Introduction
At the request of Assemblyman Martin Luster, Chair of the
Assembly Committee
on Mental Health, the Commission agreed to conduct a survey
of the provision
of Electro-convulsive Therapy (ECT) at state psychiatric
centers. The
purpose of this survey was to obtain information about the
frequency of
administration of this treatment; facilities management
of such, and the
patients who undergo this treatment, but not to evaluate
its efficacy. As a
result, the Commission obtained information about facility-specific
procedures governing the use of ECT; protocols for privileging
physicians to
administer the procedure; and demographic information regarding
the age,
gender, diagnosis, and capacity to consent for those persons
receiving ECT in
state psychiatric centers between June 1, 1999 and May 31,
2001. In
addition, a review of individual clinical records was conducted
according to
a specific protocol for approximately one in three individuals
identified as
receiving ECT during the survey period, to develop an understanding
of the
patients who receive it.
ECT is currently administered in Manhattan Psychiatric Center,
Creedmoor
Psychiatric Center, Pilgrim Psychiatric Center, The Psychiatric
Institute
(PI), and Rockland Psychiatric Center.
II.
Executive Summary
The Commissions survey revealed that during the two-year
period of the
review, 164 of the more than 10,000 inpatients received
ECT is state operated
facilities. At The Psychiatric Institute, almost all of
the individuals
receiving ECT were diagnosed with mood disorderseither
Bipolar Disorder or
Major Depression. Three out of four individuals at the other
four facilities
were diagnosed as psychotic; either having schizophrenia
or schizoaffective
disorder. Our record review revealed that the clinical presentation
of these
individuals justified the use of ECT as a treatment modality.
Further,
excluding PI, where all ECT patients are voluntary participants
in a
research protocol, approximately two out of five individuals
in state
facilities receiving ECT are doing so pursuant to a court
order.
Our
review of the policies and procedures for administration
of ECT revealed
that protocols varied in detail regarding the procedure
itself, as well as in
issues such as physician privileging and determining capacity
to consent.
III. Overview of ECT
ECT was first introduced in 1938, and consists of the application
of an
electric shock to the brain, which causes a convulsive seizure.
Controversial from the start, ECT was used in the 1940's
and 50's to treat a
variety of mental illnesses. Its popularity diminished in
the 1960's with
the introduction of pharmacological treatments, but again
became a popular
treatment for certain types of symptoms in the 1970's.
A
course of treatment with ECT usually consists of six to
twelve treatments
given up to three times a week. ECT is generally administered
in designated
suites in which there is a specially equipped treatment
room as well as a
recovery room. The patient is given general anesthesia (without
intubation)
and a muscle relaxant. When these have taken full effect,
a course of
electricity is applied to the patients brain through
electrodes, which
produces a seizure lasting approximately one minute. Due
to the use of
muscle relaxants and anesthesia, the patient does not convulse
nor does he or
she feel any pain.
Although
the exact reason why ECT works in not known, it is generally
believed that the biochemical events that accompany or result
from the
electrically induced seizure alter impaired electrochemical
processes in the
brain. One common theory is that ECT stimulates the long-term
production of
neurotransmitters. The accompanying muscle convulsions,
memory loss or other
neurologic effects do not contribute to the therapeutic
effect. Thus, modern
improvements in the technique of ECT such as sedation, anesthesia,
muscle
relaxation, selective electrode placements and current,
have all contributed
to the improved safety of the process while maintaining
the beneficial
aspects of the seizure itself. In essence, if properly administered,
the
patient experiences a brain seizure without sustaining the
classic muscle
convulsions typical of a seizure.
Professional
literature[1] indicates that ECT has been proven effective
in
the treatment of major depressive disorder, bipolar disorder,
schizophrenia,
schizoaffective disorder, and schizophreniform disorder.
The major side
effect, short-term memory loss, is of great concern to many
individuals.
Bilateral ECT (i.e. electric current introduced at both
sides of the head) is
associated with greater memory loss than unilateral ECT,
but with greater
efficacy.
ECT
is an effective treatment where the illness is characterized
by behavior
which is a threat to the safety and well-being of the patient
or others, and
which cannot be controlled by drugs or other means, or,
for which drugs
cannot be employed because of adverse reactions or because
of the risks which
their use entails.
IV.
The Patients Who Received ECT
In the two year period reviewed, our survey identified 164
patients who
received ETC. According to the New York State Office of
Mental Health (OMH),
during calender year 2000, approximately 1.3% of the 10,000
adult inpatients
in OMH operated psychiatric centers, received ETC. Of the
approximately 60
cases reviewed in depth during our survey, the Commission
found that all met
criteria for use of ETC. Additionally, it was found that
when ECT did not
result in desired outcomes, it was promptly terminated.
A.
Gender/Age: As can be seen below, at New York State facilities,
ECT is
administered to women more often than men.
Table 1.
|
Gender
|
Manhattan
|
Creedmoor
|
Pilgrim
|
PI
|
Rockland
|
Total
|
| Total
|
23
|
19 |
45 |
66 |
11 |
164
|
|
Males
|
12
(52%)
|
4
(21%)
|
17
(38%)
|
21
(32%)
|
8
(73%)
|
62
(38%)
|
|
Females
|
11
(48%)
|
15
(79%)
|
28 (62%)
|
45
(68%)
|
3
(27%)
|
102
(62%)
|
ECT was most commonly given to those individuals between
18 and 64, and is
not administered to children.
Table
2.
|
Age
|
Manhattan
|
Creedmoor
|
Pilgrim
|
PI
|
Rockland
|
Total
|
| <18
|
0
|
0 |
0 |
0 |
0 |
0
|
|
18-64
|
22
(96%)
|
17
(89%)
|
34
(76%)
|
58
(88%)
|
11
(100%)
|
142
(86%)
|
|
>64
|
1
(04%)
|
2
(11%)
|
11
(24%)
|
8
(12%)
|
0
|
22
(14%)
|
B. Diagnosis: The diagnosis of individuals receiving ECT
at PI reflects
what one would expect at a typical voluntary hospital. Most
people (88%) are
diagnosed with either major depression or bipolar disorder.
The record
reviews reveal that these individuals are all being treated
with ECT after
traditional pharmacological therapy has failed to lift their
depressions.
However,
at the other state facilities, the vast majority of individuals
are
diagnosed with schizophrenia or schizoaffective disorder.
Most often, their
ECT is designed to treat severe psychoses with much different
symptomatologysevere self injury such as biting off
pieces of ones tongue
or drinking household chemicals; significant assaultive
behavior toward staff
and peers; or severe psychosis. Typically, these individuals
are either not
able to tolerate pharmacological interventions, or such
interventions have
proven ineffective.
Table
3.
|
Diagnosis
|
Manhattan
|
Creedmoor
|
Pilgrim
|
PI
|
Rockland
|
Total
|
Major Depression |
1
(04%)
|
4
(21%)
|
0
|
45
(68%)
|
1
(09%)
|
51
(31%)
|
|
Bipolar
Disorder
|
2
(09%)
|
1
(05%)
|
10
(22%)
|
13
(20%)
|
1
(09%)
|
27
(16%)
|
|
Schizophrenia
|
8
(35%)
|
2
(11%)
|
10
(22%)
|
1
(01%)
|
5
(46%)
|
26
(16%)
|
| Schizo-affective
Disorder |
10
(43%)
|
12
(63%)
|
24
(53%)
|
0
|
3
(27%)
|
49
(30%)
|
| Other |
2
(09%)
|
0
|
1
(03%)
|
7
(11%)
|
1
(09%)
|
11
(07%)
|
The
record review at Manhattan revealed that the typical person
receiving ECT
is similar to Mr. MJ, a 51 year old man diagnosed with schizoaffective
disorder. He has a history of more than ten hospitalizations
with paranoid
delusions and homicidal threats. His psychiatrist justified
the use of ECT,
stating that his symptoms of mental illness have persisted,
despite receiving
both traditional and new antipsychotic medications. He received
a total of
56 treatments over a seven month period. They were eventually
stopped due to
a lack of response.
Mr.
SS is a man diagnosed with chronic undifferentiated schizophrenia,
polysubstance abuse, and antisocial personality disorder,
who was noted to be
paranoid and suicidal. A course of 26 ECT treatments along
with high doses
of Effexor, Seroquel, and Gabapentin brought his clinical
picture under
control.
A
third individual, Mr. EC, is noted to be sensitive to certain
types of
medication, which caused severe extrapyramidal symptoms.
Diagnosed with
schizoaffective disorder and obsessive compulsive disorder,
ECT was justified
due to his non-response to the medication he was taking.
Similarly,
Ms. BN, with a history of several past suicide attempts,
was given
ECT after sustaining several serious complications to medications
she was
taking and not responding to medications she did tolerate.
ECT was justified
based upon her continued significant psychosis and assaultive
behavior.
At
Creedmoor, 63% of individuals receiving ECT had a diagnosis
of
schizoaffective disorder. Ms. RP hears voices telling her
she is going to
die and has been in Creedmoor since 1991. She is sensitive
to all
neuroleptics which cause severe EPS, mimicking catatonia.
The record states
that she is responsive only to ETC.
Ms.
YN lives in a state operated community residence and comes
into Creedmoor
for maintenance ECT every two weeks. Diagnosed with schizoaffective
disorder, she has a long history of suicide attempts and
assaultive behavior.
A combination of maintenance ECT and medication have been
successful in the
past two years.
Ms.
XL is described as withdrawn, depressed, and hallucinating.
ECT was
administered to treat her suicidal ideation and hopelessness.
After 15
sessions, the treatment was stopped due to a lack of response.
She has been
placed on a different anti-depressant and anti-psychotic
medication.
Nearly
one-quarter of the people receiving ECT at Creedmoor have
schizophrenia diagnoses. Ms. EP has had multiple hospitalizations,
is
noncompliant with medications, and rapidly decompensates.
She is paranoid,
religiously preoccupied, and delusional. She is so aggressive
and assaultive
that she requires secure care. She has been receiving ECT
for a number of
years, and the treatment decreases her preoccupation, delusions
about devils,
and aggressive and assaultive episodes. However, she remains
floridly
delusional and psychotic.
Patients
receiving ECT at Pilgrim are particularly ill. For example,
Ms. PS
has been treatment refractory since 1986, in spite of various
trials of
psychotropics. She is assaultive, delusional, and has a
history of past
suicide attempts.
Ms.
GL is paranoid, believes her food is poisoned, and will
not eat. She has
received naso-gastric tube feeding in the past after losing
20% of her body
weight. The record indicates that ECT is the only option
for this woman, as
neuroleptics have not helped.
Mr.
JS has a psychiatric history going back to 1948. He has
received insulin
shock, pre-frontal lobotomy and ETC. The record noted that
Mr. JS was
showing severe refractory mania, not responsive to conventional
mood
stabilizers. The mania is debilitating with fatigue. ECT
was prescribed to
prevent dangerous levels of exhaustion.
Mr.
WP also has an extensive history of ECT going back to 1953.
He gets
severe extrapyramidal symptoms with standard neuroleptics
and has had four
episodes of Neuroleptic Malignant Syndrome (NMS)[2] in the
past five years.
Most recently, ECT was justified to try to control his abusive,
agitated,
paranoid behavior. Due to patients inability
to tolerate antipsychotic
mediations, history of NMS, positive and favorable responses
to ECT, ECT is
considered the safest and the only mode of treatment to
prevent further
deterioration...
Mr.
JM, twenty years old, has a history of multiple psychiatric
admissions,
and multiple suicide attempts including: cutting his wrist,
jumping off a
bridge, and overdosing on insulin. At moderate risk for
suicide, the record
noted he was almost mute, refusing to eat or take insulin.
He has a past
history of successful ECT treatment.
Ms.
PJ has a twenty-year history of psychiatric hospitalization,
and exhibits
very difficult behaviors including head banging, throwing
self to the floor,
and drinking household chemicals. The record notes that
despite intensive
pharmacological interventions, there has been no sustained
improvement in her
psychiatric symptomatology, and ECT is the only treatment
modality left that
may produce a desired outcome.
Ms.
CD also has a twenty-year history of psychiatric hospitalization.
She
has a history of NMS and violent self injury that shows
dramatic improvement
after treatment with ETC.
Mr.
RB, who has a twenty-plus-year history of mental illness,
was most
recently admitted to Pilgrim after assaulting seven staff
members at
Southside Hospital. On continuous one-to-one supervision
since his
admission, he has been restrained numerous times to prevent
self injury. He
bites off pieces of his tongue in response to command hallucinations,
and is
now missing two-thirds of his tongue. ECT was ordered after
he lost 35
pounds in a month and developed stage II ulcers on his buttocks.
At
Rockland, Ms. SK is being treated for a history of self-injurious
behavior, severe psychosis, homicidal and suicidal ideation.
She currently
receives once weekly maintenance ETC. Mr. AA, with a history
of 17 previous
suicide attempts, was prescribed ECT after a poor response
to treatment with
medication.
V.
Governance of ECT in State Psychiatric Centers
While all facilities have policies and procedures in place
governing the use
of ECT,[3] policies regarding the credentialing of physicians
and addressing
informed consent varied widely.
A.
Policies and Procedures: Each facility visited during the
survey has a
readily available written procedure for administering ETC.
The procedures
varied from the very basic to the exceptionally detailed.
All, however, were
current, and contained sections detailing clinical indications
for ECT,
referral process, capacity to consent determinations, pre-ECT
medical
clearance, pre-treatment considerations, anesthesia, the
actual
administration of ECT, post-ECT care, and documentation
requirements.
Rockland
Psychiatric Centers protocol was last revised on January
20, 2000.
It is a very basic, nine-page protocol. Manhattan Psychiatric
Centers
protocol was last revised on March 17, 1999. It runs ten
pages, with over
two of the ten pages devoted to special considerations and
precautions.
Creedmoors protocol was issued in December, 1998 and
runs fourteen pages.
Although the protocol describes at some length the indications
for usage, it
does not define contraindications for use as do some other
facilities
policies.
The
Pilgrim policy is a very detailed 58 pages, last revised
on February 20,
2001. While the protocol states that there are no absolute
contraindications to ECT, it recognizes that there are situations
in which
ECT is associated with an appreciable likelihood of serious
morbidity or
mortality. Those situations associated with substantial
risk are not
treated at PPC and would require transfer to a general medical
facility for
treatment. PIs policy was revised on January
22, 2001 and is a very
detailed thirty pages, plus a number of appendices.
B.
Physician Privileging: Each facility devotes a portion of
its protocol
to defining the manner in which physicians are privileged
to conduct ETC. At
Rockland, to be credentialed to perform ECT, a psychiatrist
must
successfully complete a five-day ECT fellowship program
or a preceptorship;
perform a minimum of five supervised ECT treatments; be
Intermediate Response
EMS trained every six months; and be approved by the Privileging
Committee
and the Clinical Director.
At
Manhattan Psychiatric Center, to be ECT certified, a psychiatrist
must
pass a written examination on ECT, observe five administrations
of ECT, and
perform five supervised ECT treatments.
At
Pilgrim, a psychiatrist must have completed an accredited
ECT training
course and/or performed at least 20 supervised ECT treatments.
Additionally,
re-privileging requires relevant CME credits related
to ECT.
At
Creedmoor, a psychiatrist must have completed 50 hours of
theoretical and
practical training in ECT, which meets with the approval
of the head of the
ECT program.
At
PI, the medical director of ECT recommends psychiatrists
for privileging.
The recommendation is reviewed in turn by the Medical Staff
Credentialing and
Privileging Committee, the Medical Staff Executive Committee
and the
Governing Body. Privileging is based upon an assessment
of the general
competency of the psychiatrist and specific experience with
and knowledge of
ETC. Supervised administration at PI of at least 20 ECT
treatments is
required before a physician will be considered for privileging.
C.
Informed Consent: Obtaining a patients informed consent
for ECT, among
other specified treatments which require informed consent,
is the subject
matter of 14 NYCRR §27.9. This provision is part of
the body of regulations
promulgated before the Department of Mental Hygiene was
reorganized in 1978
into three autonomous offices: OMH, OMRDD, and OASAS. Since
that
reorganization, these offices, including OMH, have promulgated
regulations
specific to their own functions which have superceded in
part the earlier
provisions. Section 27.9 is one of those earlier regulations
which has been
superceded, though only in part.
Section
27.9 provides as follows (in non-emergency situations):
If
an adult patient has the requisite capacity to consent to
ECT treatment
and does so, the treatment may proceed;
If
the patient has the requisite capacity to consent to ECT
treatment but
objects, the treatment may not proceed;
If
it is not clear whether the patient has the requisite capacity
to consent
to ECT treatment, an independent opinion about the patients
capacity must be
obtained from a qualified consultant who is not an employee
of the facility;
and,
If
the patient does not have the requisite capacity to consent
to ECT
treatment but does not object, the treatment may only proceed
if substituted
consent is obtained from a surrogate decision-maker such
as the spouse, a
parent, an adult child, or a court of competent jurisdiction.
Section
27.9 also provides that if the patient does not have the
requisite
capacity to consent to ECT treatment but does object, the
objection may be
overridden administratively by the hospital. However, this
provision of
Section 27.9 has been superceded as a result of the Court
of Appeals 1986
decision in Rivers v. Katz. OMH promulgated Section 527.8
to supercede this
provision in order to clarify that an incapacitated patient
may be treated
over objection only by court order.
Only
Pilgrims policy operationally defines capacity to
consent. It is
defined as being able to comprehend the nature and seriousness
of the illness
for which treatment is offered, to understand the information
provided
concerning the treatment modality, and to form a rational
response based upon
this information. PI indicates that, in their view, patients
are considered
to have the capacity to consent for ECT unless the evidence
to the contrary
is compelling.
For
a patient who has sufficient mental capacity to give informed
consent to
ECT, according to policy at PI, Pilgrim and Creedmoor, only
the patient can
give consent, and if the patient refuses to give consent,
ECT will not be
administered and the hospital will not go to court. If ECT
treatment is
deemed necessary for a competent patient who refuses ECT,
Rockland and
Manhattan policy allows them to go to court to obtain an
order for treatment
over objection.
Policies
generally define the length of time a consent is valid.
At PI,
informed consent is good for up to 25 treatments of a single
course of ETC.
For maintenance ECT, consent is good for 25 treatments or
six months,
whichever comes first. At Pilgrim, consent is good for 25
treatments or
three months, whichever comes first. For maintenance ECT,
new consent must
be obtained every six months. Except for patients receiving
maintenance ECT,
a gap of more than 14 days requires that a new consent be
obtained at both PI
and Pilgrim. Creedmoor requires a new consent every three
months. Rockland
requires that consent be updated every six months. Manhattan
has no written
requirement for the renewing informed consent, but does
require that MHLS be
notified before anyone, consenting or not, receives ETC.
Policies
at PI, Pilgrim, Creedmoor indicate that legally designated
surrogates or a court of competent jurisdiction can give
consent to ECT if
the patient lacks capacity to give informed consent, but
does not object.
Creedmoor mandates that two psychiatrists, neither associated
with the ECT
unit, must certify that a patient lacks the capacity to
give informed consent
because of impaired mental ability to comprehend the nature
of the need for
ECT, and they must further certify that the patient does
not object. At
Manhattan and Rockland, court orders are required before
ECT can be given to
anyone who is determined to lack the capacity to give consent.
In
cases where a patient lacks capacity to give informed consent,
and does
object to ECT, all five facilities require that ECT be administered
pursuant
to court order.
Table
4. Consent Status
Manhattan Creedmoor Pilgrim PI
Rockland Total
Has Capacity 6 (26%) 13 (68%) 31 (68%) 66 (100%) 10
(91%) 126 (77%)
Lacks Capacity 1 (4%) 0 1 (02%) 0
0 1 (1%)
Court Ordered 16 (70%) 6 (32%) 14 (30%) 0
1 (09%) 37 (22%)
Because
in most cases the provision of ECT at PI is part of a research
protocol, all patients receiving ECT there are considered
to have the
capacity to consent. If PI is thus excluded from this discussion,
approximately two in five patients at the remaining four
facilities are
receiving ECT as a result of a court order.
Table
5. Consent Status (Excluding PI Patients)
Manhattan Creedmoor Pilgrim Rockland
Total
Has Capacity 6 13 31 10
60 (61%)
Surrogate Consent 1 0 0 0
1 (01%)
Court Order 16 6 14
1 37 (38%)
At
Rockland Psychiatric Center, Ms. SK did not object to treatment,
but
because she was determined to lack capacity, the hospital
successfully sought
a court order. At Pilgrim, doctors wrote that Ms. LB had
no factual
understanding of the treatment. The ECT procedure
was explained to Ms. PS,
, but she did not seem to understand. The
proposed treatment benefits
and risks have been explained, to Ms. GL, but, she
does not have the
capacity to give or withhold consent. Mr. JS was declared
to not have
capacity because, he is unable to concentrate due
to acute mania, racing
thoughts and is unable to process information given to him.
For Manhattan
patient PC, ...the patients ability to make
a reasoned decision relative
to the proposed treatment, its risks, benefits and alternatives,
is
considered to be poor.
Family
gave consent for ECT for Mr. RB. I have tried several
times to
explain to the patient about ECT and its benefits and complications...(he)
does not have capacity to sign permits...
Notes
justifying an individuals ability to give consent
were similar to
this: ECT was discussed with (Pilgrim patient CD)
and she is aware of ECT
need, side effects. Is capable of signing consent. Feels
ECT will help
her. At Creedmoor, Ms. YN signed consent as she has
capacity and
understands risks/benefits.
VIII.
Summary and Recommendation
The Commissions survey revealed that during the two-year
period of the
review, 164 individuals received ECT in state-operated facilities.
Our
record review revealed that the clinical presentation of
these individuals
justified the use of ECT as a treatment modality.
With
respect to consent, excluding patients at PI, approximately
two out of
five individuals in state facilities are receiving ECT pursuant
to court
order.
Our
review of the policies and procedures revealed differing
protocols. Not
only were they varied in detail regarding the procedure
itself, they varied
regarding physician privileging and discerning consent issues.
Accordingly,
the Commission recommends that the Office of Mental Health
establish a blue ribbon task force charged with the responsibility
of
developing ECT protocols that can be applied consistently
in state facilities
administering ECT and which promote the application of best
practices while
ensuring strict adherence to statutory and regulatory standards
for
safeguarding patient rights. The Commission would welcome
the opportunity to
assist OMH in this regard.
VIII.
Addendum
In his response to this survey, OMH Commissioner James Stone
indicated that
his agency has been at work since last January developing
a set of guidelines
based upon the recently revised American Psychiatric Associations
ECT
standards. These guidelines will soon be forwarded to groups
such as the APA
and HANYS for comment.
[1]
See for example, Hermann et al, Diagnoses of Patients
With ECT: A
Comparison of Evidence-Based Standards With Reported Use.
Psychiatric
Services: 1059-1065, August 1999; or National Institute
of Mental Health:
Consensus conference on electroconvulsive therapy. JAMA:
254:103-108, 1985.
[2]
Hyperthermia with extrapyramidal and autonomic disturbances
which may
result in death, following the use of neuroleptic medication.
[3]
Manhattan Psychiatric Center routinely performs ECT on patients
from
Kirby Forensic Psychiatric Center and Bronx Psychiatric
Center. For purposes
of this survey, we did not include protocols from these
two facilities.
Source:
http://www.cqc.state.ny.us/ectsurvey.htm