Refer to: Greenfield S, Anderson H, Winickoff RN, et al: Nurseprotocol management of low back pain-Outcomes, patient satisfaction and efficiency of primary care. West J Med 123:350-359, Nov 1975
Nurse-Protocol Management of Low Back Pain Outcomes, Patient Satisfaction and Efficiency of Primary Care SHELDON GREENFIELD, MD and HJALMAR ANDERSON, MD, Los Angeles; RICHARD N. WINICKOFF, MD, Boston; ANNABELLE MORGAN, MS, Los Angeles;. and ANTHONY L. KOMAROFF, MD, Boston
To test the validity of a nurse-administered protocol for low back pain, a prospective trial of 419 patients was undertaken in a walk-in clinic. In all, 222 patients were randomly allocated to a "nurse-protocol group" in which they were evaluated by one of five nurses using the protocol; the nurses independently managed 53 percent of the patients and referred to a physician patients with potentially complex conditions. In addition, 197 patients in a randomly allocated control group were managed by one of 32 physicians. Care in the experimental and control groups was compared by follow-up telephone contact and by a four-month chart review. There was no significant difference in symptomatic relief or the development of serious disease in the two groups. Nurseprotocol patients expressed greater satisfaction with the care they had received; patient satisfaction correlated positively with symptom relief. In over 95 percent of the patients, there were noncomplex, nonserious, nonchronic conditions as the cause of back pain. We conclude that nurse-protocol management of this generally benign condition in a primary care setting is both effective and efficient. From the Departments of Medicine and Preventive Medicine, University of California, Los Angeles, School of Medicine; the Ambulatory Care Project of the Department of Medicine, Beth Israel Hospital, Harvard Medical School, Boston, and the Massachusetts Institute of Technology, Lincoln Laboratory, Lexington; and the Southern California Permanente Medical Group. This work was performed pursuant to Contract HSM 110-73-335 with the Bureau of Health Services Research and Evaluation,
350
NOVEMBER 1975 * 123 * 5
Health Resources Administration, Public Health Service, DepartHealth, Education and Welfare. Presented in part at the American Federation of Clinical Research National Meeting, Atlantic City, New Jersey, May 5, 1974. Submitted March 17, 1975. Reprint requests to: Sheldon Greenfield, MD, Room 73-274, UCLA Center for the Health Sciences, Los Angeles, CA 90024.
ment of
NURSE-PROTOCOL MANAGEMENT OF LOW BACK PAIN
PROTOCOLS (also called clinical algorithms) for common problems have been described in several recent reports.1-7 Protocols have been used to train, guide and audit the performance of "new health practitioners"-nurses, nurse-practitioners and physician assistants. Studies of protocolassisted management of such acute minor illnesses as upper respiratory infections2 and urinary tract and vaginal infections' and of return visit management of chronic diseases3 have indicated that practitioners other than physicians can help deliver safe, effective and efficient medical care. We here report on the development and validation of a protocol for the complaint of low back pain. This is a frequent complaint in primary care practice and was the fourth most common complaint among adults with acute symptoms in a recent survey conducted by our group.8 In contrast to common respiratory, urinary and- vaginal infections, the management of low back pain may involve more important psychological aspects as well as more serious, complex disease. Low back pain, therefore, poses a challenge to the protocol approach, and to management by new health
practitioners. The protocol was used by a group of nurses in a prospective randomized controlled trial in which several hypotheses were tested: * The complaint of low back pain in a primary care practice almost always indicates injury to muscles, ligaments or discs of the low back, with or without dorsal root compression; only infrequently is it due to other pathology, and rarely is it due to serious pathology. * A system in which nurses using the low back pain protocol manage many patients without a physician examining those patients, and refer other patients to physicians, can be as medically safe and effective as a system in which only physicians manage patients, and can help physicians make more efficient use of their time. * With a complaint which has as important a psychosocial component and as few objective criteria of improvement as low back pain, patient satisfaction with care correlates with symptomatic relief. Methods Description of the Protocol The Low Back Pain Protocol was designed to provide a logical and medically sound approach to the evaluation of low back pain in adults. The protocol directs the protocol user (in this case, a
nurse) to collect relevant data (history and findings on physical examination) and then guides the user through a sequence of decisions leading to an appropriate action-for example, diagnosis, therapy and disposition. The protocol itself is a single page form which combines a checklist for recording clinical data with a format that displays the logic of medical decisions necessary both in directing data gathering and in making management decisions appropriate to the particular patient (Figure 1). The medical judgments in the protocol were subjected to peer and consultant review. This kind of protocol, and the stages in its development, have been described else-
where.3'9-'1 Figure 2 outlines the major logic pathways through the protocol. The protocol supports the person using it in the independent management of the syndrome of low back strain: an injury to the muscles, ligament or discs of the lumbar spine. How often low back strain is actually due to disc damage is unclear.'2 It is generally agreed that most cases of low back pain are due to disc injuries even when there are no overt root signs.'3'15 The protocol never leads to the explicit diagnosis of disc disease, a diagnosis we feel for medicolegal reasons should be made by a physican. Rather, the protocol states the problem as "low back strain" and adds the phrase "with possible root irritation" when history or physical examination justifies that addition. If in a woman presenting with low back pain there are also symptoms of dysuria or urinary frequency, analysis of urine is ordered and any urinary tract infection found is managed according to the recommendations of a protocol for urinary tract infections.' Under protocol guidance those patients with severe pain from probable disc disease or persistent pain that is not improving with adequate bed rest, such as might be caused by ankylosing spondylitis, metastatic tumor, osteoporosis and the like are referred to a physician. The protocol also is designed to refer to a physician those patients who may have low back pain of any other cause. Patients suspected of having a gastrointestinal, genitourinary, neurologic, traumatic or local infectious cause for the back pain are identified by certain historical and physical examination screening data. For example, to detect gastrointestinal disease, questions about diarrhea, constipation and rectal bleeding are asked. Fever is used as an index of possible osteomyelitis or other infectious THE WESTERN JOURNAL OF MEDICINE
351
NURSE-PROTOCOL MANAGEMENT OF LOW BACK PAIN
LOW BACK PAIN PROTOCOLK (11/74)
Unit #:
Date:
Name: tno
yes
SUBJEC IIVE
Phone:
Birthdate:
.1_
Seern e'4 wks
for
ago
problem
some
Protocol
Iml,pr.ove d Duratio n of pain _
.
r
-i
rft
riht
Any previous episodes r
User:
Age >60
Sciatic notch exam normal i Straight leg raising nornmal I . Big toe elevation normal r- ,- -:. Sensaflun in foot norrial i_. i1 r-1
,
Located in central back Rig3ht side Left ide'
-I
--
I.-
s
;
Groil
Do urittalysis
cuthure
&-
i-
LI
K-li H--t.
jerk
Ankle jerk
--
Knee
abI
eUr
equal
Arnkle e!-'Ks
Tried bed rest (3 1-irs, firm rnattress, on back or side) Some relief during bed rest
eual
abot
PLAN i
Made worse by coughing/sneezing NemIrbn eessf,3pojres ih'=esic:s below waist Blow.; \idrect rauirma0) to low back in post m3 mnths
Knee
4,4
Abdomern Buttock (wih,ico fide Thigh (Whi Ch! siJc Below knee ii"l7ch si!_.de
!.i
consult VD for other
Will.
reasons
Return visit Signs better
R
Ia
Rx
Diurrkeu Urinalysis ordered ec tal
bleeding
recCOi
rar-~
tu r n
'ricuontinenCe ..rin
ltJ e
12
Dx k.r
a.s')
t
D ysuria
Acx
rrnalvy-sis
lo
&
l.> i.,rs i.
Any gaMys Zrlr
t if h
Rix U
Al
,e
t
-is
ur
hcd Nkes
raliure
Ur inary frequiency ] 1^t 2,'IMS EJ
'oere
painI
I
k- _ -.
T
1t. .'!1 0J.
irg
*~~~~~~~~~~'
t
Ss _ Px
Do
"uri
H'lysHv
lenderu ss
arid
r"ul1ttre.
ckOC
Co
Figure 1.-Single page protocol form used 352
NOVEMBER 1975
*
123
*
5
in
study.
Low
Back
Strazi
i rrzlataoi
Return
in
3
2nvedi
NURSE-PROTOCOL MANAGEMENT OF LOW BACK PAIN
cause of back pain. Patients who are over age 60 (older people having a much higher incidence of metastatic disease and other serious causes of low back pain) and patients with pain in the abdomen, fecal or urinary incontinence, urinary retention, inability to walk, urethral discharge or severe pain are all referred to a physician. The protocol is not applicable to patients who have suffered traumatic injury to the back from a direct blow, auto accident or fall. Those patients are at risk for posterior arch vertebral fractures and dislocations which can potentially cause spinal cord damage, and should be seen immediately by a physician. The protocol also does not apply to patients with pain in the neck, arm or shoulders, and patients with symptoms or a viral respiratory infection, because simple low back strain is less likely in these groups. The protocol does not recommend ordering lumbar spine x-ray studies; we believe that they do not help in the management of uncomplicated low back strain, and that most serious causes of low back pain will be identified by the screening, historical and physical examination data. Those few patients with serious but nonacute disease, such as metastatic cancer to the lumbar vertebrae or osteoporosis, are expected to return in a short period after not responding to symptomatic treatment, if they have not been identified at the initial visit. Patients with low back strain are placed at bed rest for a period of up to seven days and are given prescription for analgesics or diazepam or both at the discretion of the practitioner. Patients who also have suspected dorsal root irritation are given similar medications, and told to return for reevaluation in three weeks. All patients who do
not respond to treatment are told to return. The complete protocol and a detailed discussion of its medical content and logic are presented elsewhere.16
Study Design The study design is represented in Figure 3. The study was conducted in the Walk-In Clinic of the Kaiser Permanente facility in Inglewood, California, between July 1973 and May 1974. Patients who presented to the clinic with the complaint of low back pain were randomly allocated into one of two groups. One group of patients was first evaluated by one of five nurses using a protocol. If the protocol recommended that the patient be referred by the nurse to a physician that day, a physician supervisor saw the patient and his management plan was followed. If the protocol recommended that the patient be sent home with specific therapy, the nurse's findings, as recorded on the protocol, were reviewed by the physician supervisor and, if acceptable, the protocol management plan was followed without the physician examining the patient. This group of patients are hereafter referred to as the nurseprotocol group. A second group of patients was randomly assigned to be seen only by one of 32 physicians working in the clinic that day. These patients are hereafter referred to as the MD-control group. The physicians in this group were aware that a study was in progress; however, there was no formal introduction of the protocol or its
Telephone and Medical Record
Follow-up
Figure 2.-Major pathways through the backache protocol.
Telephon Medical F Follow
Percent of respective subgroup
Figure 3.-Illustration of study design. THE WESTERN JOURNAL OF MEDICINE
353
NURSE-PROTOCOL MANAGEMENT OF LOW BACK PAIN TABLE 1.-Age and Sex Distribution of Patients in Nurse-Protocol and MD-Control Groups Nurse-Protocol Group Number Percent
Age
10-19 .......... 15 20-29 .......... 53 30-39 .......... 60 40-49 .......... 48 50-59 .......... 32 60-69 .......... 11 70 + .......... 3
MD-Control Group Number Percent
6.8 23.9 27.1 21.3 14.5 5.0 1.4
7 44 74 54 15 3 0
3.6 22.3 37.6 27.4 7.6 1.5 0.0
197 88 109
100.0
107 115
100.0 48.0 52.0
TOTAL ....... 222
100.0
197
100.0
TOTAL ....... Male .......... Female ........ Sex
222
44.7 55.3
logic to these physicians. To our knowledge, none of the physicians inquired about the logic used, and none acquired a copy of the protocol. All patients in both groups were followed-up by a telephone interview within five weeks of the initial clinic visit (mean number of days later was 27 for the nurse-protocol group and 33 for the MD-control group). The interviewer was a research assistant who used a questionnaire designed to assess the patient's satisfaction with the care received, as well as to determine whether the patient had improved symptomatically. In addition to the telephone follow-up, the medical records of all patients in both groups were reviewed four months after the clinic visit to ascertain whether serious sequelae had developed. Roemer showed that only 7.2 percent of admissions to hospital of patients enrolled in the
Kaiser plan occurred in other institutions.17 It therefore seemed that this record review would be adequate to assess the development of serious problems. All records were done by one of us
(S.G.). Results Characteristics of Patients and Providers Of the 592 patients who were admitted to the study, 419 (70.1 percent) completed the study. A similar proportion (no statistically significant difference) of patients in the nurse-protocol group (25.8 percent) and in the MD-control group (32.8 percent) failed to complete the study for two major reasons: some patients who had been assigned to the study on a random basis by the triage clerk were found not to have low back pain; other patients could not be followed-up despite repeated telephone calls. The final study population comprised 419 patients, 222 (52.8 percent) in the nurse-protocol group and 197 (47.2 percent) in the MD-control group. The age and sex distribution of the patients in both groups is shown in Table 1. Most patients in both groups were between the ages of 31 and 59. There were no statistically significant differences between the groups. A more detailed demographic description- of the patient population is found elsewhere.17 The mean age of the 32 physicians was 36 years old. Of the 32 physicians, 17 were internists; the rest were general practitioners. All five of the nurses were registered nurses (RN)none had formal nurse-practitioner training; four
TABLE 2.-Distribution of Initial and Final Diagnoses in Nurse-Protocol and MD-Control Groups Nurse-Protocol Initial Diagnosis Final Diagnosis Number Percent Number Percent
Low back strain* ........ ............. 187 6 Urinary tract infection ...... ........... 0 Pelvic source§ . ....................... 0 Gastrointestinal source§ ................ 5 Viral syndrome. ....................... 0 Viral syndrome and urinary tract infection Other$ .............................. 24
TOTAL ............................. 222
84.2t 2.7* 0.0 0.0 2.2 0.0
10.811 100.0
MD-Control Initial Diagnosis Final Diagnosis Number Percent Number Percent
208 7 0 0 5 0 2
93.7 3.2
175 9
88.8t 4.6t
174 10
0.0 0.0 2.2 0.0 0.9
4 1 5 1 2
2.0 0.5 2.5 0.5 1.0*
4 1 5 1 2
88.3 5.1 2.0 0.5 2.5 0.5 1.0
222
100.0
197
197
100.0
100.0
*With or without dorsal root irritation. tOne patient in each group was initially misdiagnosed as having muscle strain; urinary tract infections discovered on return visit. *These patients had initial presumptive urinary tract infections (UTI) according to urinalysis findings of .10 leukocytes on high power field. One of the protocol patients had a chronic UTI, due to urinary tract anomaly. §Nonspecific, possible pelvic inflammatory disease, gastroenteritis. ¶Possible fracture, contusion, osteoarthritis, suspect serious disease. Illn one patient there was a documented ureteral stone and in cne patient there was continuing pain, possibly due to contusion; all others turned out to have muscle strain on final evaluation. **ln one patient, severe degenerative changes were shown in lumbar spine x-ray studies.
354
NOVEMBER 1975 * 123 * 5
NURSE-PROTOCOL MANAGEMENT OF LOW BACK PAIN TABLE 3.-Patient Satisfaction Assessment Positive Response MD-Control (N = 197 Respondents) Percent
Nurse-Protocol (N=222 Respondents) Percent
Question
Did you seek help elsewhere for your problem after your visit? .......... "I was satisfied with my contact with nurse/MD"........................ "The nurse/MD encouraged me to talk about other health problems"....... "The medical care I received for my backache was better than my usual visits for a health problem"................................... "The nurse/MD showed concern for me"............................... "I feel the nurse/MD understood what was bothering me"................ "On the basis of what the nurse/MD said to me, I feel that I understand my present medical condition"................................. "The nurse/MD did spend enough time with me"........................ "I would prefer to see the same caregiver the next time I come to Kaiser" ..
P
19.4 89.2 78.4
23.9 78.2 55.8
Nurse-Protocol Management of Low Back Pain Outcomes, Patient Satisfaction and Efficiency of Primary Care SHELDON GREENFIELD, MD and HJALMAR ANDERSON, MD, Los Angeles; RICHARD N. WINICKOFF, MD, Boston; ANNABELLE MORGAN, MS, Los Angeles;. and ANTHONY L. KOMAROFF, MD, Boston
To test the validity of a nurse-administered protocol for low back pain, a prospective trial of 419 patients was undertaken in a walk-in clinic. In all, 222 patients were randomly allocated to a "nurse-protocol group" in which they were evaluated by one of five nurses using the protocol; the nurses independently managed 53 percent of the patients and referred to a physician patients with potentially complex conditions. In addition, 197 patients in a randomly allocated control group were managed by one of 32 physicians. Care in the experimental and control groups was compared by follow-up telephone contact and by a four-month chart review. There was no significant difference in symptomatic relief or the development of serious disease in the two groups. Nurseprotocol patients expressed greater satisfaction with the care they had received; patient satisfaction correlated positively with symptom relief. In over 95 percent of the patients, there were noncomplex, nonserious, nonchronic conditions as the cause of back pain. We conclude that nurse-protocol management of this generally benign condition in a primary care setting is both effective and efficient. From the Departments of Medicine and Preventive Medicine, University of California, Los Angeles, School of Medicine; the Ambulatory Care Project of the Department of Medicine, Beth Israel Hospital, Harvard Medical School, Boston, and the Massachusetts Institute of Technology, Lincoln Laboratory, Lexington; and the Southern California Permanente Medical Group. This work was performed pursuant to Contract HSM 110-73-335 with the Bureau of Health Services Research and Evaluation,
350
NOVEMBER 1975 * 123 * 5
Health Resources Administration, Public Health Service, DepartHealth, Education and Welfare. Presented in part at the American Federation of Clinical Research National Meeting, Atlantic City, New Jersey, May 5, 1974. Submitted March 17, 1975. Reprint requests to: Sheldon Greenfield, MD, Room 73-274, UCLA Center for the Health Sciences, Los Angeles, CA 90024.
ment of
NURSE-PROTOCOL MANAGEMENT OF LOW BACK PAIN
PROTOCOLS (also called clinical algorithms) for common problems have been described in several recent reports.1-7 Protocols have been used to train, guide and audit the performance of "new health practitioners"-nurses, nurse-practitioners and physician assistants. Studies of protocolassisted management of such acute minor illnesses as upper respiratory infections2 and urinary tract and vaginal infections' and of return visit management of chronic diseases3 have indicated that practitioners other than physicians can help deliver safe, effective and efficient medical care. We here report on the development and validation of a protocol for the complaint of low back pain. This is a frequent complaint in primary care practice and was the fourth most common complaint among adults with acute symptoms in a recent survey conducted by our group.8 In contrast to common respiratory, urinary and- vaginal infections, the management of low back pain may involve more important psychological aspects as well as more serious, complex disease. Low back pain, therefore, poses a challenge to the protocol approach, and to management by new health
practitioners. The protocol was used by a group of nurses in a prospective randomized controlled trial in which several hypotheses were tested: * The complaint of low back pain in a primary care practice almost always indicates injury to muscles, ligaments or discs of the low back, with or without dorsal root compression; only infrequently is it due to other pathology, and rarely is it due to serious pathology. * A system in which nurses using the low back pain protocol manage many patients without a physician examining those patients, and refer other patients to physicians, can be as medically safe and effective as a system in which only physicians manage patients, and can help physicians make more efficient use of their time. * With a complaint which has as important a psychosocial component and as few objective criteria of improvement as low back pain, patient satisfaction with care correlates with symptomatic relief. Methods Description of the Protocol The Low Back Pain Protocol was designed to provide a logical and medically sound approach to the evaluation of low back pain in adults. The protocol directs the protocol user (in this case, a
nurse) to collect relevant data (history and findings on physical examination) and then guides the user through a sequence of decisions leading to an appropriate action-for example, diagnosis, therapy and disposition. The protocol itself is a single page form which combines a checklist for recording clinical data with a format that displays the logic of medical decisions necessary both in directing data gathering and in making management decisions appropriate to the particular patient (Figure 1). The medical judgments in the protocol were subjected to peer and consultant review. This kind of protocol, and the stages in its development, have been described else-
where.3'9-'1 Figure 2 outlines the major logic pathways through the protocol. The protocol supports the person using it in the independent management of the syndrome of low back strain: an injury to the muscles, ligament or discs of the lumbar spine. How often low back strain is actually due to disc damage is unclear.'2 It is generally agreed that most cases of low back pain are due to disc injuries even when there are no overt root signs.'3'15 The protocol never leads to the explicit diagnosis of disc disease, a diagnosis we feel for medicolegal reasons should be made by a physican. Rather, the protocol states the problem as "low back strain" and adds the phrase "with possible root irritation" when history or physical examination justifies that addition. If in a woman presenting with low back pain there are also symptoms of dysuria or urinary frequency, analysis of urine is ordered and any urinary tract infection found is managed according to the recommendations of a protocol for urinary tract infections.' Under protocol guidance those patients with severe pain from probable disc disease or persistent pain that is not improving with adequate bed rest, such as might be caused by ankylosing spondylitis, metastatic tumor, osteoporosis and the like are referred to a physician. The protocol also is designed to refer to a physician those patients who may have low back pain of any other cause. Patients suspected of having a gastrointestinal, genitourinary, neurologic, traumatic or local infectious cause for the back pain are identified by certain historical and physical examination screening data. For example, to detect gastrointestinal disease, questions about diarrhea, constipation and rectal bleeding are asked. Fever is used as an index of possible osteomyelitis or other infectious THE WESTERN JOURNAL OF MEDICINE
351
NURSE-PROTOCOL MANAGEMENT OF LOW BACK PAIN
LOW BACK PAIN PROTOCOLK (11/74)
Unit #:
Date:
Name: tno
yes
SUBJEC IIVE
Phone:
Birthdate:
.1_
Seern e'4 wks
for
ago
problem
some
Protocol
Iml,pr.ove d Duratio n of pain _
.
r
-i
rft
riht
Any previous episodes r
User:
Age >60
Sciatic notch exam normal i Straight leg raising nornmal I . Big toe elevation normal r- ,- -:. Sensaflun in foot norrial i_. i1 r-1
,
Located in central back Rig3ht side Left ide'
-I
--
I.-
s
;
Groil
Do urittalysis
cuthure
&-
i-
LI
K-li H--t.
jerk
Ankle jerk
--
Knee
abI
eUr
equal
Arnkle e!-'Ks
Tried bed rest (3 1-irs, firm rnattress, on back or side) Some relief during bed rest
eual
abot
PLAN i
Made worse by coughing/sneezing NemIrbn eessf,3pojres ih'=esic:s below waist Blow.; \idrect rauirma0) to low back in post m3 mnths
Knee
4,4
Abdomern Buttock (wih,ico fide Thigh (Whi Ch! siJc Below knee ii"l7ch si!_.de
!.i
consult VD for other
Will.
reasons
Return visit Signs better
R
Ia
Rx
Diurrkeu Urinalysis ordered ec tal
bleeding
recCOi
rar-~
tu r n
'ricuontinenCe ..rin
ltJ e
12
Dx k.r
a.s')
t
D ysuria
Acx
rrnalvy-sis
lo
&
l.> i.,rs i.
Any gaMys Zrlr
t if h
Rix U
Al
,e
t
-is
ur
hcd Nkes
raliure
Ur inary frequiency ] 1^t 2,'IMS EJ
'oere
painI
I
k- _ -.
T
1t. .'!1 0J.
irg
*~~~~~~~~~~'
t
Ss _ Px
Do
"uri
H'lysHv
lenderu ss
arid
r"ul1ttre.
ckOC
Co
Figure 1.-Single page protocol form used 352
NOVEMBER 1975
*
123
*
5
in
study.
Low
Back
Strazi
i rrzlataoi
Return
in
3
2nvedi
NURSE-PROTOCOL MANAGEMENT OF LOW BACK PAIN
cause of back pain. Patients who are over age 60 (older people having a much higher incidence of metastatic disease and other serious causes of low back pain) and patients with pain in the abdomen, fecal or urinary incontinence, urinary retention, inability to walk, urethral discharge or severe pain are all referred to a physician. The protocol is not applicable to patients who have suffered traumatic injury to the back from a direct blow, auto accident or fall. Those patients are at risk for posterior arch vertebral fractures and dislocations which can potentially cause spinal cord damage, and should be seen immediately by a physician. The protocol also does not apply to patients with pain in the neck, arm or shoulders, and patients with symptoms or a viral respiratory infection, because simple low back strain is less likely in these groups. The protocol does not recommend ordering lumbar spine x-ray studies; we believe that they do not help in the management of uncomplicated low back strain, and that most serious causes of low back pain will be identified by the screening, historical and physical examination data. Those few patients with serious but nonacute disease, such as metastatic cancer to the lumbar vertebrae or osteoporosis, are expected to return in a short period after not responding to symptomatic treatment, if they have not been identified at the initial visit. Patients with low back strain are placed at bed rest for a period of up to seven days and are given prescription for analgesics or diazepam or both at the discretion of the practitioner. Patients who also have suspected dorsal root irritation are given similar medications, and told to return for reevaluation in three weeks. All patients who do
not respond to treatment are told to return. The complete protocol and a detailed discussion of its medical content and logic are presented elsewhere.16
Study Design The study design is represented in Figure 3. The study was conducted in the Walk-In Clinic of the Kaiser Permanente facility in Inglewood, California, between July 1973 and May 1974. Patients who presented to the clinic with the complaint of low back pain were randomly allocated into one of two groups. One group of patients was first evaluated by one of five nurses using a protocol. If the protocol recommended that the patient be referred by the nurse to a physician that day, a physician supervisor saw the patient and his management plan was followed. If the protocol recommended that the patient be sent home with specific therapy, the nurse's findings, as recorded on the protocol, were reviewed by the physician supervisor and, if acceptable, the protocol management plan was followed without the physician examining the patient. This group of patients are hereafter referred to as the nurseprotocol group. A second group of patients was randomly assigned to be seen only by one of 32 physicians working in the clinic that day. These patients are hereafter referred to as the MD-control group. The physicians in this group were aware that a study was in progress; however, there was no formal introduction of the protocol or its
Telephone and Medical Record
Follow-up
Figure 2.-Major pathways through the backache protocol.
Telephon Medical F Follow
Percent of respective subgroup
Figure 3.-Illustration of study design. THE WESTERN JOURNAL OF MEDICINE
353
NURSE-PROTOCOL MANAGEMENT OF LOW BACK PAIN TABLE 1.-Age and Sex Distribution of Patients in Nurse-Protocol and MD-Control Groups Nurse-Protocol Group Number Percent
Age
10-19 .......... 15 20-29 .......... 53 30-39 .......... 60 40-49 .......... 48 50-59 .......... 32 60-69 .......... 11 70 + .......... 3
MD-Control Group Number Percent
6.8 23.9 27.1 21.3 14.5 5.0 1.4
7 44 74 54 15 3 0
3.6 22.3 37.6 27.4 7.6 1.5 0.0
197 88 109
100.0
107 115
100.0 48.0 52.0
TOTAL ....... 222
100.0
197
100.0
TOTAL ....... Male .......... Female ........ Sex
222
44.7 55.3
logic to these physicians. To our knowledge, none of the physicians inquired about the logic used, and none acquired a copy of the protocol. All patients in both groups were followed-up by a telephone interview within five weeks of the initial clinic visit (mean number of days later was 27 for the nurse-protocol group and 33 for the MD-control group). The interviewer was a research assistant who used a questionnaire designed to assess the patient's satisfaction with the care received, as well as to determine whether the patient had improved symptomatically. In addition to the telephone follow-up, the medical records of all patients in both groups were reviewed four months after the clinic visit to ascertain whether serious sequelae had developed. Roemer showed that only 7.2 percent of admissions to hospital of patients enrolled in the
Kaiser plan occurred in other institutions.17 It therefore seemed that this record review would be adequate to assess the development of serious problems. All records were done by one of us
(S.G.). Results Characteristics of Patients and Providers Of the 592 patients who were admitted to the study, 419 (70.1 percent) completed the study. A similar proportion (no statistically significant difference) of patients in the nurse-protocol group (25.8 percent) and in the MD-control group (32.8 percent) failed to complete the study for two major reasons: some patients who had been assigned to the study on a random basis by the triage clerk were found not to have low back pain; other patients could not be followed-up despite repeated telephone calls. The final study population comprised 419 patients, 222 (52.8 percent) in the nurse-protocol group and 197 (47.2 percent) in the MD-control group. The age and sex distribution of the patients in both groups is shown in Table 1. Most patients in both groups were between the ages of 31 and 59. There were no statistically significant differences between the groups. A more detailed demographic description- of the patient population is found elsewhere.17 The mean age of the 32 physicians was 36 years old. Of the 32 physicians, 17 were internists; the rest were general practitioners. All five of the nurses were registered nurses (RN)none had formal nurse-practitioner training; four
TABLE 2.-Distribution of Initial and Final Diagnoses in Nurse-Protocol and MD-Control Groups Nurse-Protocol Initial Diagnosis Final Diagnosis Number Percent Number Percent
Low back strain* ........ ............. 187 6 Urinary tract infection ...... ........... 0 Pelvic source§ . ....................... 0 Gastrointestinal source§ ................ 5 Viral syndrome. ....................... 0 Viral syndrome and urinary tract infection Other$ .............................. 24
TOTAL ............................. 222
84.2t 2.7* 0.0 0.0 2.2 0.0
10.811 100.0
MD-Control Initial Diagnosis Final Diagnosis Number Percent Number Percent
208 7 0 0 5 0 2
93.7 3.2
175 9
88.8t 4.6t
174 10
0.0 0.0 2.2 0.0 0.9
4 1 5 1 2
2.0 0.5 2.5 0.5 1.0*
4 1 5 1 2
88.3 5.1 2.0 0.5 2.5 0.5 1.0
222
100.0
197
197
100.0
100.0
*With or without dorsal root irritation. tOne patient in each group was initially misdiagnosed as having muscle strain; urinary tract infections discovered on return visit. *These patients had initial presumptive urinary tract infections (UTI) according to urinalysis findings of .10 leukocytes on high power field. One of the protocol patients had a chronic UTI, due to urinary tract anomaly. §Nonspecific, possible pelvic inflammatory disease, gastroenteritis. ¶Possible fracture, contusion, osteoarthritis, suspect serious disease. Illn one patient there was a documented ureteral stone and in cne patient there was continuing pain, possibly due to contusion; all others turned out to have muscle strain on final evaluation. **ln one patient, severe degenerative changes were shown in lumbar spine x-ray studies.
354
NOVEMBER 1975 * 123 * 5
NURSE-PROTOCOL MANAGEMENT OF LOW BACK PAIN TABLE 3.-Patient Satisfaction Assessment Positive Response MD-Control (N = 197 Respondents) Percent
Nurse-Protocol (N=222 Respondents) Percent
Question
Did you seek help elsewhere for your problem after your visit? .......... "I was satisfied with my contact with nurse/MD"........................ "The nurse/MD encouraged me to talk about other health problems"....... "The medical care I received for my backache was better than my usual visits for a health problem"................................... "The nurse/MD showed concern for me"............................... "I feel the nurse/MD understood what was bothering me"................ "On the basis of what the nurse/MD said to me, I feel that I understand my present medical condition"................................. "The nurse/MD did spend enough time with me"........................ "I would prefer to see the same caregiver the next time I come to Kaiser" ..
P
19.4 89.2 78.4
23.9 78.2 55.8
