A Randomized Controlled Trial of Telephone Management of Suspected Urinary Tract Infections in Women

Millions of women with acute dysuria show up at offices, urgent care centers, and emergency departments for suspected urinary tract infections (UTIs), accounting for more than $1 billion in direct costs.¹ Since most UTIs are uncomplicated, numerous strategies have been proposed for managing them in more efficient and less costly ways. Berg² found 82 separate management strategies among 137 family physicians, with costs ranging from negligible to $250.

In a previous study³ we used a cost-utility analysis to demonstrate that among office-based approaches, empiric therapy of suspected UTIs was most cost-effective. This was robust over a wide range of assumptions, including prevalence, test characteristics, costs, complication rates, and outcomes. These findings were recently confirmed by Fenwick and colleagues⁴ in a British analysis. Among the approaches commonly used, telephone management has the potential for reducing cost, increasing convenience for patients, and reducing barriers to care. Saint and coworkers⁵ demonstrated that a clinical practice guideline using telephone-based management of presumed UTIs reduced the use of urine tests and increased the use of guideline-specified antibiotics. Although telephone management is common, we were unable to find any studies directly comparing that approach with office-based care.

We report on the first trial in which women with suspected UTIs were randomly assigned to telephone management or office-based management. The purpose of our study was to identify the prevalence of UTIs in women presenting with suspected UTIs, to determine if telephone management was comparable in outcomes with those of office-based care, and to determine if women whose infections were managed by telephone were satisfied with their care.

Methods

Setting

We enrolled patients at 6 primary care offices (including a walk-in clinic) of the Upper Peninsula Research Network (UPRNet) and the Department of Family Practice at Michigan State University in East Lansing. UPRNet is a primary care research network in the Upper Peninsula of Michigan.

Subjects

Nonpregnant women 18 years or older completed an interview to confirm eligibility when they called their primary care physicians with a suspected uncomplicated UTI. We defined a suspected uncomplicated UTI as a complaint of dysuria, pain on urination, complaint of urinary urgency and frequency, or the patient’s saying, “I think I have a bladder infection.” Patients with symptoms compatible with pyelonephritis (fever, chills, sweats, back or flank pain, or vomiting), vaginitis, or cervicitis (presence of a new or changed vaginal discharge) were excluded from our study. We also excluded women with diabetes, a previous history of pyelonephritis or other complicated UTI, a UTI in the preceding month, symptoms lasting longer than 14 days, and known kidney disease, anatomic abnormalities, or previous renal surgery. In addition, we excluded women receiving chemotherapy and those who had received antibiotics in the preceding month. Informed consent was obtained. Enrollment occurred between October of 1997 and March of 1999. All enrolled patients received $25 for participating in the study. The Michigan State University Committee on Research Involving Human Subjects approved our study.

Procedures and Measures

We stratified each practice, and using a central computer-generated random number, we blindly allocated patients to either treatment by telephone (telephone group) or office-based care (control group) by using an opaque envelope containing the group assignment. The envelope also provided instructions appropriate for the assigned group. We asked the telephone strategy patients to come to the clinic to leave a urine sample and pick up a prescription for an antibiotic; the control (usual care) patients were given a same-day appointment for a regular clinic visit.

We asked patients enrolled in both groups to rate the severity of urinary dysuria, urgency, frequency, function, and how they generally felt about their symptoms. Each was rated on a 10-point scale (10 was most severe). The telephone management patients were given a prescription for sulfamethoxazole/trimethoprim (800 mg/160 mg) twice daily for 7 days. If the patient was allergic to sulfa, she received a prescription for nitrofurantoin 100 mg twice daily for 7 days. Patients were required to have a urinalysis and urine culture before receiving the prescription. We asked the health care providers of the control patients to use their usual management strategies. The control group patients were also required to have a urinalysis and urine culture.

A nurse telephoned all women in both groups for follow-up 3 and 10 days after the time of enrollment. During these telephone calls we assessed patient status (including symptom scores and patient satisfaction) and whether the patient sought care with any practitioner since the initial time of enrollment. If UTI symptoms were still evident at either the 3- or 10-day follow-up, the patient was asked to make an appointment to see her practitioner. We recorded start and stop times for all interviews to assist in estimating and comparing costs of care for the 2 groups.

Primary Outcomes

The primary outcomes for our study were the UTI score and overall evaluation rating (OER)⁶ of the treatment experience. The UTI score is the sum of the ratings of severity of dysuria, urgency, frequency, function, and general symptoms (range=0-50). Since the UTI score has not been previously used, we pilot tested it on 20 women. These same women were reevaluated 2 to 3 days later. Test-retest reliability (measured by the overall correlation between the same items asked on 2 separate occasions with the order of questions changed) was 0.98. Validity (measured by the correlation coefficient between specific questions and a global question for the episode) was 0.52 for burning, 0.89 for frequency, 0.95 for urgency, 0.86 for interference with activities of daily living, and -0.76 for the actual interval between urination (smaller interval associated with greater overall episode severity).

The OER consisted of 2 questions about the overall quality of care and the outcome of care. Each question—answered as poor, fair, good, very good, or excellent—was scored from 1 to 5, respectively. The OER, a validated score,⁶ is a simple sum of the scores for these items (range 2-10, not normally distributed). Also, we asked the women about their overall satisfaction on a 5-point Likert scale.

Secondary Outcomes

We also evaluated urine culture results. We defined a negative culture as one with either no growth or less than 1000 colony-forming units. A positive culture had any growth of a single organism. A contaminated specimen (mixed flora) was rated as a negative culture, since this is how these are usually handled clinically.

Statistical Analysis

The data were entered into a database, and all entries were double-checked by one of the investigators for transcription errors. We analyzed the data using SAS software (version 7, SAS Institute, Cary, NC). Continuous variables (age, time variables, UTI score) were compared by treatment group using unpaired Student t tests. We used the Shapiro-Wilk test and the Kolmogorov-Smirnov test to confirm that the UTI score and changes in that score between assessments were normally distributed. We compared categorical variables (resolution of symptoms, culture results) by treatment group using a chi-square. We used Wilcoxon rank sum tests to compare ordinal data (OER) between the treatment groups.

For all sample size estimations we wanted to achieve 80% power with two-sided a of 0.05. To detect a 5-point difference in the UTI score, with an estimated a priori standard deviation (SD) of 5, we calculated that 16 subjects in each group are needed (21 for 90% power). With an SD of 7.5, 36 subjects in each group are needed. For patient satisfaction (OER), we estimated a priori that we would need 15 subjects in each group (19 for 90% power) to detect a 1-point difference with an estimated mean of 3.9 and a SD of 0.95.

Results

We identified 201 women with suspected UTIs of whom 99 were not eligible. Of the 102 eligible women, 30 declined to participate. We randomized 36 women to office care (control group) and 36 to telephone management. The subjects were predominantly white (n=62, 86%) and young (mean age=36.6 years, SD=12.3). Five patients had no culture results. Of the 67 remaining cultures, 4 (6%) were contaminated specimens, 20 (29.8%) had negative cultures, and 43 (64.2%) had positive cultures. Of the positive cultures, 34 (79.1%) grew Escherichia coli. Twenty-three of 34 (67.6%) cultures in the control group were positive compared with 20 of 33 (60.6%) in the telephone group (chi-square=0.3611; P=.55).

The groups were similar at baseline Table 1. On day 3 and day 10 there were no significant differences in the change in symptom scores or overall UTI score from baseline. We also found no difference in the change in urinary intervals from baseline. Table 2 shows these data. There was no significant difference in the overall evaluation rating. We also found no difference in satisfaction with care (median response was “very good” in the control group and “excellent” in the telephone group). These are shown in Table 3

On the third day after therapy was inititated, 20 of 33 (60.6%) of the control subjects had persistent urinary symptoms compared with 19 of 34 (55.8%, chi-square=0.1536; P=.70) in the telephone group. By day 10, 6 of 35 control patients (17.1%) had persistent symptoms, compared with 12 of 35 (34.3%) in the telephone group (chi-square=2.6923; P=0.1). Among the patients still symptomatic on the third day, culture results were available for 35, 11 (31%) of which were negative. Among those still symptomatic on the 10th day, 18 had available cultures, 9 (50%) of which were negative.

To evaluate the patients with persistent symptoms at the conclusion of the study we looked at the baseline and final UTI scores and baseline culture results. Six patients in the control group reported persistent symptoms. Three of these patients had final UTI scores less than 10, and 3 had UTI scores greater than 20. Two of these patients also had negative cultures. Twelve patients in the telephone group reported persistent symptoms; all but 1 had final UTI scores less than 10, and only 1 had a final UTI score greater than 20. Seven of the 12 patients had negative cultures at baseline.

We attempted to determine how office care differed from telephone care. Three patients in the control group received no antibiotics. Two of these had negative cultures, and no culture result was available for the third patient. All patients in the telephone group were prescribed antibiotics. Five control group patients who ultimately had positive cultures took antibiotics for less than 7 days, compared with only 3 in the telephone group. Among those receiving antibiotics, 30 of the control group patients received either sulfamethoxazole/trimethoprim or nitrofurantoin, and 3 received second-line agents. Because of allergies, 1 patient in the telephone group did not receive the planned therapy and received cephalexin instead.

We also evaluated the nursing time to administer various elements of the protocol. It took 2.5 minutes (SD=1.3) to determine eligibility to participate in the study and 5.3 minutes (SD=2.1) to enroll the subjects into the study. The nursing time for the day 3 follow-up took on average 5.6 minutes (SD=2.9) and 5.2 minutes (SD=2.0) on day 10.

Discussion

Although managing uncomplicated UTIs by telephone is a common practice in ambulatory primary care settings, we had no previous empiric evidence of its effectiveness compared with seeing patients in the office. In this randomized trial of office management versus management by telephone, two thirds of the women enrolled had culture-confirmed UTIs. The rate was similar in each group and mirrors that reported in the literature.⁷ We found no difference in improvement in symptom scores from baseline and no significant difference in overall satisfaction with the care provided or the outcome.

Gallagher and colleagues⁸ reported that when acute medical problems are triaged by nurses, patients are generally satisfied with care. However, UTIs represented only 5% of the telephone encounters. Delichatsios and coworkers⁹ similarly reported that patients calling to speak with the physician were generally satisfied with the advice given on the telephone, but they did not report outcomes related to specific conditions or therapies. Although 2 independent economic evaluations^3,4 have found empiric therapy to be cost-effective, neither included a strategy that avoids an office visit.

The direct cost of telephone management of uncomplicated UTIs is relatively low. It took only 2.5 minutes of nurse time to identify symptomatic women with risk factors for complicated UTIs who were good candidates for telephone management. This may cause a dilemma. Physicians practicing in predominantly fee-for-service settings will lose income by managing UTIs by telephone. In managed care settings, the financial incentives to reduce utilization make this practice inexpensive while simultaneously maintaining high patient satisfaction. Many physicians, however, complain about the complexity of the patients they now see, and having an occasional uncomplicated UTI might provide some breathing space on hectic days.

Limitations

We did not ask the practitioners who provided office-based care to alter their usual approach. By patient report, only 3 control patients received no antibiotics. This may reflect a knee-jerk response in which antibiotics are prescribed for all women with a suspected UTI. It may also reflect a very appropriate therapeutic threshold where physicians have a gestalt about the probability of a UTI that exceeds any diagnostic uncertainty. Although this has been described explicitly,¹⁰ we believe that seasoned clinicians do this implicitly. We did not attempt to open the “black box” to further understand this process.

Approximately half the women calling for appointments were not eligible to participate in our study because of the presence of 1 or more complicating factor. The most common reason was the presence of back pain, a complaint that commonly accompanies uncomplicated as well as complicated UTIs. Although the prevalence of acute pyelonephritis is very low, our protocol conservatively put women with this isolated complaint in a potentially high-risk group that required an office visit. It is quite likely that using a constellation of symptoms (such as back or flank pain plus fever or chills or nausea and vomiting, and so forth) would have allowed more women to be eligible. The participation rate was high among eligible women, improving the generalizability of the data. Although we enrolled predominantly white women (reflecting the ethnic mix of the participating practices), we believe the biologic responses in our study are not race dependent. We are not confident, however, that patient satisfaction data will extrapolate to other groups, since women in groups that have traditionally been underserved by the health care system may see telephone management as a way to shortchange them.

Our study was planned to have 80% power to detect important differences in the primary outcome variables but lacks sufficient sample size to determine if patients in either group were more likely to experience pyelonephritis or other complications. Since the specific therapy was similar in each group, one would suspect a similar rate of complications.

Twice as many patients in the telephone group were still symptomatic after 10 days, compared with those seen in the office. The small numbers in our study raise the possibility that clinically meaningful differences did not reach statistical significance. However, a closer look at the UTI scores suggests that only 1 of the 12 patients in the telephone group who reported persistent symptoms had a high score compared with 3 of the 6 control patients. This suggests that the severity of the persistent symptoms was quite low. Also, it raises the possibility that symptoms such as low back pain that were not captured by the UTI score or possibly not related to UTI were unimproved. We also believe that many of these women may have had other conditions causing their persistent symptoms. Finally, it is possible that these findings reflect a significant degree of statistical “noise” due to the wide confidence intervals associated with small studies. This is an area for further study.

This study used 7 days of antibiotic therapy. Currently, 3 days of therapy are increasingly used. Interestingly, more than half the women were still symptomatic on day 3. At the conclusion of the study, though, 75% of all women reported resolution of their symptoms. Although this discussion places this observation in a different context, it may raise potential concerns about whether 3-day therapy (while effective in delivering laboratory “cures”) may not provide enough relief to patients to be worth the tradeoffs.

Conclusions

This study demonstrates that managing uncomplicated UTIs in otherwise healthy women over the telephone has comparable outcomes and patient satisfaction with managing these women with an office visit. Whether symptom resolution is the same is not adequately answered by our study. More research on the optimal use of triage protocols for common acute conditions is needed in the primary care setting.

Acknowledgments

Our research was funded by the Blue Cross Blue Shield of Michigan Foundation grant # 231-II: a randomized clinical trial comparing telephone and usual care strategies for the management of suspected UTI in otherwise healthy adult women. We thank the following practices that participated in our study: Michigan State University Department of Family Practice, East Lansing; Order of St. Francis Medical Group, Escanaba; and Doctors Park Family Physicians, Escanaba. We are especially appreciative of the efforts of the office nurses and physician’s assistants who recruited and provided the telephone follow-up of the patients: Barb Bedient, LPN; Lisa Sweet, LPN; Debi Besson, RN; Grace Borkadi, PAC; Gloria Johnson, LPN; and Mary Baron, RN. Conflict of interest statement: Dr Ebell is editor of The Journal of Family Practice, Dr Hickner is an associate editor, and Dr Barry is an assistant editor. Therefore, the peer review process, including selection of reviewers, editorial review, editing, and the decision to accept or reject the manuscript was performed by Dr Bernard Ewigman, MD, MSPH, Associate Editor of JFP.

Millions of women with acute dysuria show up at offices, urgent care centers, and emergency departments for suspected urinary tract infections (UTIs), accounting for more than $1 billion in direct costs.¹ Since most UTIs are uncomplicated, numerous strategies have been proposed for managing them in more efficient and less costly ways. Berg² found 82 separate management strategies among 137 family physicians, with costs ranging from negligible to $250.

In a previous study³ we used a cost-utility analysis to demonstrate that among office-based approaches, empiric therapy of suspected UTIs was most cost-effective. This was robust over a wide range of assumptions, including prevalence, test characteristics, costs, complication rates, and outcomes. These findings were recently confirmed by Fenwick and colleagues⁴ in a British analysis. Among the approaches commonly used, telephone management has the potential for reducing cost, increasing convenience for patients, and reducing barriers to care. Saint and coworkers⁵ demonstrated that a clinical practice guideline using telephone-based management of presumed UTIs reduced the use of urine tests and increased the use of guideline-specified antibiotics. Although telephone management is common, we were unable to find any studies directly comparing that approach with office-based care.

We report on the first trial in which women with suspected UTIs were randomly assigned to telephone management or office-based management. The purpose of our study was to identify the prevalence of UTIs in women presenting with suspected UTIs, to determine if telephone management was comparable in outcomes with those of office-based care, and to determine if women whose infections were managed by telephone were satisfied with their care.

Methods

Setting

We enrolled patients at 6 primary care offices (including a walk-in clinic) of the Upper Peninsula Research Network (UPRNet) and the Department of Family Practice at Michigan State University in East Lansing. UPRNet is a primary care research network in the Upper Peninsula of Michigan.

Subjects

Nonpregnant women 18 years or older completed an interview to confirm eligibility when they called their primary care physicians with a suspected uncomplicated UTI. We defined a suspected uncomplicated UTI as a complaint of dysuria, pain on urination, complaint of urinary urgency and frequency, or the patient’s saying, “I think I have a bladder infection.” Patients with symptoms compatible with pyelonephritis (fever, chills, sweats, back or flank pain, or vomiting), vaginitis, or cervicitis (presence of a new or changed vaginal discharge) were excluded from our study. We also excluded women with diabetes, a previous history of pyelonephritis or other complicated UTI, a UTI in the preceding month, symptoms lasting longer than 14 days, and known kidney disease, anatomic abnormalities, or previous renal surgery. In addition, we excluded women receiving chemotherapy and those who had received antibiotics in the preceding month. Informed consent was obtained. Enrollment occurred between October of 1997 and March of 1999. All enrolled patients received $25 for participating in the study. The Michigan State University Committee on Research Involving Human Subjects approved our study.

Procedures and Measures

We stratified each practice, and using a central computer-generated random number, we blindly allocated patients to either treatment by telephone (telephone group) or office-based care (control group) by using an opaque envelope containing the group assignment. The envelope also provided instructions appropriate for the assigned group. We asked the telephone strategy patients to come to the clinic to leave a urine sample and pick up a prescription for an antibiotic; the control (usual care) patients were given a same-day appointment for a regular clinic visit.

We asked patients enrolled in both groups to rate the severity of urinary dysuria, urgency, frequency, function, and how they generally felt about their symptoms. Each was rated on a 10-point scale (10 was most severe). The telephone management patients were given a prescription for sulfamethoxazole/trimethoprim (800 mg/160 mg) twice daily for 7 days. If the patient was allergic to sulfa, she received a prescription for nitrofurantoin 100 mg twice daily for 7 days. Patients were required to have a urinalysis and urine culture before receiving the prescription. We asked the health care providers of the control patients to use their usual management strategies. The control group patients were also required to have a urinalysis and urine culture.

A nurse telephoned all women in both groups for follow-up 3 and 10 days after the time of enrollment. During these telephone calls we assessed patient status (including symptom scores and patient satisfaction) and whether the patient sought care with any practitioner since the initial time of enrollment. If UTI symptoms were still evident at either the 3- or 10-day follow-up, the patient was asked to make an appointment to see her practitioner. We recorded start and stop times for all interviews to assist in estimating and comparing costs of care for the 2 groups.

Primary Outcomes

The primary outcomes for our study were the UTI score and overall evaluation rating (OER)⁶ of the treatment experience. The UTI score is the sum of the ratings of severity of dysuria, urgency, frequency, function, and general symptoms (range=0-50). Since the UTI score has not been previously used, we pilot tested it on 20 women. These same women were reevaluated 2 to 3 days later. Test-retest reliability (measured by the overall correlation between the same items asked on 2 separate occasions with the order of questions changed) was 0.98. Validity (measured by the correlation coefficient between specific questions and a global question for the episode) was 0.52 for burning, 0.89 for frequency, 0.95 for urgency, 0.86 for interference with activities of daily living, and -0.76 for the actual interval between urination (smaller interval associated with greater overall episode severity).

The OER consisted of 2 questions about the overall quality of care and the outcome of care. Each question—answered as poor, fair, good, very good, or excellent—was scored from 1 to 5, respectively. The OER, a validated score,⁶ is a simple sum of the scores for these items (range 2-10, not normally distributed). Also, we asked the women about their overall satisfaction on a 5-point Likert scale.

Secondary Outcomes

We also evaluated urine culture results. We defined a negative culture as one with either no growth or less than 1000 colony-forming units. A positive culture had any growth of a single organism. A contaminated specimen (mixed flora) was rated as a negative culture, since this is how these are usually handled clinically.

Statistical Analysis

The data were entered into a database, and all entries were double-checked by one of the investigators for transcription errors. We analyzed the data using SAS software (version 7, SAS Institute, Cary, NC). Continuous variables (age, time variables, UTI score) were compared by treatment group using unpaired Student t tests. We used the Shapiro-Wilk test and the Kolmogorov-Smirnov test to confirm that the UTI score and changes in that score between assessments were normally distributed. We compared categorical variables (resolution of symptoms, culture results) by treatment group using a chi-square. We used Wilcoxon rank sum tests to compare ordinal data (OER) between the treatment groups.

For all sample size estimations we wanted to achieve 80% power with two-sided a of 0.05. To detect a 5-point difference in the UTI score, with an estimated a priori standard deviation (SD) of 5, we calculated that 16 subjects in each group are needed (21 for 90% power). With an SD of 7.5, 36 subjects in each group are needed. For patient satisfaction (OER), we estimated a priori that we would need 15 subjects in each group (19 for 90% power) to detect a 1-point difference with an estimated mean of 3.9 and a SD of 0.95.

Results

We identified 201 women with suspected UTIs of whom 99 were not eligible. Of the 102 eligible women, 30 declined to participate. We randomized 36 women to office care (control group) and 36 to telephone management. The subjects were predominantly white (n=62, 86%) and young (mean age=36.6 years, SD=12.3). Five patients had no culture results. Of the 67 remaining cultures, 4 (6%) were contaminated specimens, 20 (29.8%) had negative cultures, and 43 (64.2%) had positive cultures. Of the positive cultures, 34 (79.1%) grew Escherichia coli. Twenty-three of 34 (67.6%) cultures in the control group were positive compared with 20 of 33 (60.6%) in the telephone group (chi-square=0.3611; P=.55).

The groups were similar at baseline Table 1. On day 3 and day 10 there were no significant differences in the change in symptom scores or overall UTI score from baseline. We also found no difference in the change in urinary intervals from baseline. Table 2 shows these data. There was no significant difference in the overall evaluation rating. We also found no difference in satisfaction with care (median response was “very good” in the control group and “excellent” in the telephone group). These are shown in Table 3

On the third day after therapy was inititated, 20 of 33 (60.6%) of the control subjects had persistent urinary symptoms compared with 19 of 34 (55.8%, chi-square=0.1536; P=.70) in the telephone group. By day 10, 6 of 35 control patients (17.1%) had persistent symptoms, compared with 12 of 35 (34.3%) in the telephone group (chi-square=2.6923; P=0.1). Among the patients still symptomatic on the third day, culture results were available for 35, 11 (31%) of which were negative. Among those still symptomatic on the 10th day, 18 had available cultures, 9 (50%) of which were negative.

To evaluate the patients with persistent symptoms at the conclusion of the study we looked at the baseline and final UTI scores and baseline culture results. Six patients in the control group reported persistent symptoms. Three of these patients had final UTI scores less than 10, and 3 had UTI scores greater than 20. Two of these patients also had negative cultures. Twelve patients in the telephone group reported persistent symptoms; all but 1 had final UTI scores less than 10, and only 1 had a final UTI score greater than 20. Seven of the 12 patients had negative cultures at baseline.

We attempted to determine how office care differed from telephone care. Three patients in the control group received no antibiotics. Two of these had negative cultures, and no culture result was available for the third patient. All patients in the telephone group were prescribed antibiotics. Five control group patients who ultimately had positive cultures took antibiotics for less than 7 days, compared with only 3 in the telephone group. Among those receiving antibiotics, 30 of the control group patients received either sulfamethoxazole/trimethoprim or nitrofurantoin, and 3 received second-line agents. Because of allergies, 1 patient in the telephone group did not receive the planned therapy and received cephalexin instead.

We also evaluated the nursing time to administer various elements of the protocol. It took 2.5 minutes (SD=1.3) to determine eligibility to participate in the study and 5.3 minutes (SD=2.1) to enroll the subjects into the study. The nursing time for the day 3 follow-up took on average 5.6 minutes (SD=2.9) and 5.2 minutes (SD=2.0) on day 10.

Discussion

Although managing uncomplicated UTIs by telephone is a common practice in ambulatory primary care settings, we had no previous empiric evidence of its effectiveness compared with seeing patients in the office. In this randomized trial of office management versus management by telephone, two thirds of the women enrolled had culture-confirmed UTIs. The rate was similar in each group and mirrors that reported in the literature.⁷ We found no difference in improvement in symptom scores from baseline and no significant difference in overall satisfaction with the care provided or the outcome.

Gallagher and colleagues⁸ reported that when acute medical problems are triaged by nurses, patients are generally satisfied with care. However, UTIs represented only 5% of the telephone encounters. Delichatsios and coworkers⁹ similarly reported that patients calling to speak with the physician were generally satisfied with the advice given on the telephone, but they did not report outcomes related to specific conditions or therapies. Although 2 independent economic evaluations^3,4 have found empiric therapy to be cost-effective, neither included a strategy that avoids an office visit.

The direct cost of telephone management of uncomplicated UTIs is relatively low. It took only 2.5 minutes of nurse time to identify symptomatic women with risk factors for complicated UTIs who were good candidates for telephone management. This may cause a dilemma. Physicians practicing in predominantly fee-for-service settings will lose income by managing UTIs by telephone. In managed care settings, the financial incentives to reduce utilization make this practice inexpensive while simultaneously maintaining high patient satisfaction. Many physicians, however, complain about the complexity of the patients they now see, and having an occasional uncomplicated UTI might provide some breathing space on hectic days.

Limitations

We did not ask the practitioners who provided office-based care to alter their usual approach. By patient report, only 3 control patients received no antibiotics. This may reflect a knee-jerk response in which antibiotics are prescribed for all women with a suspected UTI. It may also reflect a very appropriate therapeutic threshold where physicians have a gestalt about the probability of a UTI that exceeds any diagnostic uncertainty. Although this has been described explicitly,¹⁰ we believe that seasoned clinicians do this implicitly. We did not attempt to open the “black box” to further understand this process.

Approximately half the women calling for appointments were not eligible to participate in our study because of the presence of 1 or more complicating factor. The most common reason was the presence of back pain, a complaint that commonly accompanies uncomplicated as well as complicated UTIs. Although the prevalence of acute pyelonephritis is very low, our protocol conservatively put women with this isolated complaint in a potentially high-risk group that required an office visit. It is quite likely that using a constellation of symptoms (such as back or flank pain plus fever or chills or nausea and vomiting, and so forth) would have allowed more women to be eligible. The participation rate was high among eligible women, improving the generalizability of the data. Although we enrolled predominantly white women (reflecting the ethnic mix of the participating practices), we believe the biologic responses in our study are not race dependent. We are not confident, however, that patient satisfaction data will extrapolate to other groups, since women in groups that have traditionally been underserved by the health care system may see telephone management as a way to shortchange them.

Our study was planned to have 80% power to detect important differences in the primary outcome variables but lacks sufficient sample size to determine if patients in either group were more likely to experience pyelonephritis or other complications. Since the specific therapy was similar in each group, one would suspect a similar rate of complications.

Twice as many patients in the telephone group were still symptomatic after 10 days, compared with those seen in the office. The small numbers in our study raise the possibility that clinically meaningful differences did not reach statistical significance. However, a closer look at the UTI scores suggests that only 1 of the 12 patients in the telephone group who reported persistent symptoms had a high score compared with 3 of the 6 control patients. This suggests that the severity of the persistent symptoms was quite low. Also, it raises the possibility that symptoms such as low back pain that were not captured by the UTI score or possibly not related to UTI were unimproved. We also believe that many of these women may have had other conditions causing their persistent symptoms. Finally, it is possible that these findings reflect a significant degree of statistical “noise” due to the wide confidence intervals associated with small studies. This is an area for further study.

This study used 7 days of antibiotic therapy. Currently, 3 days of therapy are increasingly used. Interestingly, more than half the women were still symptomatic on day 3. At the conclusion of the study, though, 75% of all women reported resolution of their symptoms. Although this discussion places this observation in a different context, it may raise potential concerns about whether 3-day therapy (while effective in delivering laboratory “cures”) may not provide enough relief to patients to be worth the tradeoffs.

Conclusions

This study demonstrates that managing uncomplicated UTIs in otherwise healthy women over the telephone has comparable outcomes and patient satisfaction with managing these women with an office visit. Whether symptom resolution is the same is not adequately answered by our study. More research on the optimal use of triage protocols for common acute conditions is needed in the primary care setting.

Acknowledgments

Our research was funded by the Blue Cross Blue Shield of Michigan Foundation grant # 231-II: a randomized clinical trial comparing telephone and usual care strategies for the management of suspected UTI in otherwise healthy adult women. We thank the following practices that participated in our study: Michigan State University Department of Family Practice, East Lansing; Order of St. Francis Medical Group, Escanaba; and Doctors Park Family Physicians, Escanaba. We are especially appreciative of the efforts of the office nurses and physician’s assistants who recruited and provided the telephone follow-up of the patients: Barb Bedient, LPN; Lisa Sweet, LPN; Debi Besson, RN; Grace Borkadi, PAC; Gloria Johnson, LPN; and Mary Baron, RN. Conflict of interest statement: Dr Ebell is editor of The Journal of Family Practice, Dr Hickner is an associate editor, and Dr Barry is an assistant editor. Therefore, the peer review process, including selection of reviewers, editorial review, editing, and the decision to accept or reject the manuscript was performed by Dr Bernard Ewigman, MD, MSPH, Associate Editor of JFP.

Millions of women with acute dysuria show up at offices, urgent care centers, and emergency departments for suspected urinary tract infections (UTIs), accounting for more than $1 billion in direct costs.¹ Since most UTIs are uncomplicated, numerous strategies have been proposed for managing them in more efficient and less costly ways. Berg² found 82 separate management strategies among 137 family physicians, with costs ranging from negligible to $250.

In a previous study³ we used a cost-utility analysis to demonstrate that among office-based approaches, empiric therapy of suspected UTIs was most cost-effective. This was robust over a wide range of assumptions, including prevalence, test characteristics, costs, complication rates, and outcomes. These findings were recently confirmed by Fenwick and colleagues⁴ in a British analysis. Among the approaches commonly used, telephone management has the potential for reducing cost, increasing convenience for patients, and reducing barriers to care. Saint and coworkers⁵ demonstrated that a clinical practice guideline using telephone-based management of presumed UTIs reduced the use of urine tests and increased the use of guideline-specified antibiotics. Although telephone management is common, we were unable to find any studies directly comparing that approach with office-based care.

We report on the first trial in which women with suspected UTIs were randomly assigned to telephone management or office-based management. The purpose of our study was to identify the prevalence of UTIs in women presenting with suspected UTIs, to determine if telephone management was comparable in outcomes with those of office-based care, and to determine if women whose infections were managed by telephone were satisfied with their care.

Methods

Setting

We enrolled patients at 6 primary care offices (including a walk-in clinic) of the Upper Peninsula Research Network (UPRNet) and the Department of Family Practice at Michigan State University in East Lansing. UPRNet is a primary care research network in the Upper Peninsula of Michigan.

Subjects

Nonpregnant women 18 years or older completed an interview to confirm eligibility when they called their primary care physicians with a suspected uncomplicated UTI. We defined a suspected uncomplicated UTI as a complaint of dysuria, pain on urination, complaint of urinary urgency and frequency, or the patient’s saying, “I think I have a bladder infection.” Patients with symptoms compatible with pyelonephritis (fever, chills, sweats, back or flank pain, or vomiting), vaginitis, or cervicitis (presence of a new or changed vaginal discharge) were excluded from our study. We also excluded women with diabetes, a previous history of pyelonephritis or other complicated UTI, a UTI in the preceding month, symptoms lasting longer than 14 days, and known kidney disease, anatomic abnormalities, or previous renal surgery. In addition, we excluded women receiving chemotherapy and those who had received antibiotics in the preceding month. Informed consent was obtained. Enrollment occurred between October of 1997 and March of 1999. All enrolled patients received $25 for participating in the study. The Michigan State University Committee on Research Involving Human Subjects approved our study.

Procedures and Measures

We stratified each practice, and using a central computer-generated random number, we blindly allocated patients to either treatment by telephone (telephone group) or office-based care (control group) by using an opaque envelope containing the group assignment. The envelope also provided instructions appropriate for the assigned group. We asked the telephone strategy patients to come to the clinic to leave a urine sample and pick up a prescription for an antibiotic; the control (usual care) patients were given a same-day appointment for a regular clinic visit.

We asked patients enrolled in both groups to rate the severity of urinary dysuria, urgency, frequency, function, and how they generally felt about their symptoms. Each was rated on a 10-point scale (10 was most severe). The telephone management patients were given a prescription for sulfamethoxazole/trimethoprim (800 mg/160 mg) twice daily for 7 days. If the patient was allergic to sulfa, she received a prescription for nitrofurantoin 100 mg twice daily for 7 days. Patients were required to have a urinalysis and urine culture before receiving the prescription. We asked the health care providers of the control patients to use their usual management strategies. The control group patients were also required to have a urinalysis and urine culture.

A nurse telephoned all women in both groups for follow-up 3 and 10 days after the time of enrollment. During these telephone calls we assessed patient status (including symptom scores and patient satisfaction) and whether the patient sought care with any practitioner since the initial time of enrollment. If UTI symptoms were still evident at either the 3- or 10-day follow-up, the patient was asked to make an appointment to see her practitioner. We recorded start and stop times for all interviews to assist in estimating and comparing costs of care for the 2 groups.

Primary Outcomes

The primary outcomes for our study were the UTI score and overall evaluation rating (OER)⁶ of the treatment experience. The UTI score is the sum of the ratings of severity of dysuria, urgency, frequency, function, and general symptoms (range=0-50). Since the UTI score has not been previously used, we pilot tested it on 20 women. These same women were reevaluated 2 to 3 days later. Test-retest reliability (measured by the overall correlation between the same items asked on 2 separate occasions with the order of questions changed) was 0.98. Validity (measured by the correlation coefficient between specific questions and a global question for the episode) was 0.52 for burning, 0.89 for frequency, 0.95 for urgency, 0.86 for interference with activities of daily living, and -0.76 for the actual interval between urination (smaller interval associated with greater overall episode severity).

The OER consisted of 2 questions about the overall quality of care and the outcome of care. Each question—answered as poor, fair, good, very good, or excellent—was scored from 1 to 5, respectively. The OER, a validated score,⁶ is a simple sum of the scores for these items (range 2-10, not normally distributed). Also, we asked the women about their overall satisfaction on a 5-point Likert scale.

Secondary Outcomes

We also evaluated urine culture results. We defined a negative culture as one with either no growth or less than 1000 colony-forming units. A positive culture had any growth of a single organism. A contaminated specimen (mixed flora) was rated as a negative culture, since this is how these are usually handled clinically.

Statistical Analysis

The data were entered into a database, and all entries were double-checked by one of the investigators for transcription errors. We analyzed the data using SAS software (version 7, SAS Institute, Cary, NC). Continuous variables (age, time variables, UTI score) were compared by treatment group using unpaired Student t tests. We used the Shapiro-Wilk test and the Kolmogorov-Smirnov test to confirm that the UTI score and changes in that score between assessments were normally distributed. We compared categorical variables (resolution of symptoms, culture results) by treatment group using a chi-square. We used Wilcoxon rank sum tests to compare ordinal data (OER) between the treatment groups.

For all sample size estimations we wanted to achieve 80% power with two-sided a of 0.05. To detect a 5-point difference in the UTI score, with an estimated a priori standard deviation (SD) of 5, we calculated that 16 subjects in each group are needed (21 for 90% power). With an SD of 7.5, 36 subjects in each group are needed. For patient satisfaction (OER), we estimated a priori that we would need 15 subjects in each group (19 for 90% power) to detect a 1-point difference with an estimated mean of 3.9 and a SD of 0.95.

Results

We identified 201 women with suspected UTIs of whom 99 were not eligible. Of the 102 eligible women, 30 declined to participate. We randomized 36 women to office care (control group) and 36 to telephone management. The subjects were predominantly white (n=62, 86%) and young (mean age=36.6 years, SD=12.3). Five patients had no culture results. Of the 67 remaining cultures, 4 (6%) were contaminated specimens, 20 (29.8%) had negative cultures, and 43 (64.2%) had positive cultures. Of the positive cultures, 34 (79.1%) grew Escherichia coli. Twenty-three of 34 (67.6%) cultures in the control group were positive compared with 20 of 33 (60.6%) in the telephone group (chi-square=0.3611; P=.55).

The groups were similar at baseline Table 1. On day 3 and day 10 there were no significant differences in the change in symptom scores or overall UTI score from baseline. We also found no difference in the change in urinary intervals from baseline. Table 2 shows these data. There was no significant difference in the overall evaluation rating. We also found no difference in satisfaction with care (median response was “very good” in the control group and “excellent” in the telephone group). These are shown in Table 3

On the third day after therapy was inititated, 20 of 33 (60.6%) of the control subjects had persistent urinary symptoms compared with 19 of 34 (55.8%, chi-square=0.1536; P=.70) in the telephone group. By day 10, 6 of 35 control patients (17.1%) had persistent symptoms, compared with 12 of 35 (34.3%) in the telephone group (chi-square=2.6923; P=0.1). Among the patients still symptomatic on the third day, culture results were available for 35, 11 (31%) of which were negative. Among those still symptomatic on the 10th day, 18 had available cultures, 9 (50%) of which were negative.

To evaluate the patients with persistent symptoms at the conclusion of the study we looked at the baseline and final UTI scores and baseline culture results. Six patients in the control group reported persistent symptoms. Three of these patients had final UTI scores less than 10, and 3 had UTI scores greater than 20. Two of these patients also had negative cultures. Twelve patients in the telephone group reported persistent symptoms; all but 1 had final UTI scores less than 10, and only 1 had a final UTI score greater than 20. Seven of the 12 patients had negative cultures at baseline.

We attempted to determine how office care differed from telephone care. Three patients in the control group received no antibiotics. Two of these had negative cultures, and no culture result was available for the third patient. All patients in the telephone group were prescribed antibiotics. Five control group patients who ultimately had positive cultures took antibiotics for less than 7 days, compared with only 3 in the telephone group. Among those receiving antibiotics, 30 of the control group patients received either sulfamethoxazole/trimethoprim or nitrofurantoin, and 3 received second-line agents. Because of allergies, 1 patient in the telephone group did not receive the planned therapy and received cephalexin instead.

We also evaluated the nursing time to administer various elements of the protocol. It took 2.5 minutes (SD=1.3) to determine eligibility to participate in the study and 5.3 minutes (SD=2.1) to enroll the subjects into the study. The nursing time for the day 3 follow-up took on average 5.6 minutes (SD=2.9) and 5.2 minutes (SD=2.0) on day 10.

Discussion

Although managing uncomplicated UTIs by telephone is a common practice in ambulatory primary care settings, we had no previous empiric evidence of its effectiveness compared with seeing patients in the office. In this randomized trial of office management versus management by telephone, two thirds of the women enrolled had culture-confirmed UTIs. The rate was similar in each group and mirrors that reported in the literature.⁷ We found no difference in improvement in symptom scores from baseline and no significant difference in overall satisfaction with the care provided or the outcome.

Gallagher and colleagues⁸ reported that when acute medical problems are triaged by nurses, patients are generally satisfied with care. However, UTIs represented only 5% of the telephone encounters. Delichatsios and coworkers⁹ similarly reported that patients calling to speak with the physician were generally satisfied with the advice given on the telephone, but they did not report outcomes related to specific conditions or therapies. Although 2 independent economic evaluations^3,4 have found empiric therapy to be cost-effective, neither included a strategy that avoids an office visit.

The direct cost of telephone management of uncomplicated UTIs is relatively low. It took only 2.5 minutes of nurse time to identify symptomatic women with risk factors for complicated UTIs who were good candidates for telephone management. This may cause a dilemma. Physicians practicing in predominantly fee-for-service settings will lose income by managing UTIs by telephone. In managed care settings, the financial incentives to reduce utilization make this practice inexpensive while simultaneously maintaining high patient satisfaction. Many physicians, however, complain about the complexity of the patients they now see, and having an occasional uncomplicated UTI might provide some breathing space on hectic days.

Limitations

We did not ask the practitioners who provided office-based care to alter their usual approach. By patient report, only 3 control patients received no antibiotics. This may reflect a knee-jerk response in which antibiotics are prescribed for all women with a suspected UTI. It may also reflect a very appropriate therapeutic threshold where physicians have a gestalt about the probability of a UTI that exceeds any diagnostic uncertainty. Although this has been described explicitly,¹⁰ we believe that seasoned clinicians do this implicitly. We did not attempt to open the “black box” to further understand this process.

Approximately half the women calling for appointments were not eligible to participate in our study because of the presence of 1 or more complicating factor. The most common reason was the presence of back pain, a complaint that commonly accompanies uncomplicated as well as complicated UTIs. Although the prevalence of acute pyelonephritis is very low, our protocol conservatively put women with this isolated complaint in a potentially high-risk group that required an office visit. It is quite likely that using a constellation of symptoms (such as back or flank pain plus fever or chills or nausea and vomiting, and so forth) would have allowed more women to be eligible. The participation rate was high among eligible women, improving the generalizability of the data. Although we enrolled predominantly white women (reflecting the ethnic mix of the participating practices), we believe the biologic responses in our study are not race dependent. We are not confident, however, that patient satisfaction data will extrapolate to other groups, since women in groups that have traditionally been underserved by the health care system may see telephone management as a way to shortchange them.

Our study was planned to have 80% power to detect important differences in the primary outcome variables but lacks sufficient sample size to determine if patients in either group were more likely to experience pyelonephritis or other complications. Since the specific therapy was similar in each group, one would suspect a similar rate of complications.

Twice as many patients in the telephone group were still symptomatic after 10 days, compared with those seen in the office. The small numbers in our study raise the possibility that clinically meaningful differences did not reach statistical significance. However, a closer look at the UTI scores suggests that only 1 of the 12 patients in the telephone group who reported persistent symptoms had a high score compared with 3 of the 6 control patients. This suggests that the severity of the persistent symptoms was quite low. Also, it raises the possibility that symptoms such as low back pain that were not captured by the UTI score or possibly not related to UTI were unimproved. We also believe that many of these women may have had other conditions causing their persistent symptoms. Finally, it is possible that these findings reflect a significant degree of statistical “noise” due to the wide confidence intervals associated with small studies. This is an area for further study.

This study used 7 days of antibiotic therapy. Currently, 3 days of therapy are increasingly used. Interestingly, more than half the women were still symptomatic on day 3. At the conclusion of the study, though, 75% of all women reported resolution of their symptoms. Although this discussion places this observation in a different context, it may raise potential concerns about whether 3-day therapy (while effective in delivering laboratory “cures”) may not provide enough relief to patients to be worth the tradeoffs.

Conclusions

This study demonstrates that managing uncomplicated UTIs in otherwise healthy women over the telephone has comparable outcomes and patient satisfaction with managing these women with an office visit. Whether symptom resolution is the same is not adequately answered by our study. More research on the optimal use of triage protocols for common acute conditions is needed in the primary care setting.

Acknowledgments

Our research was funded by the Blue Cross Blue Shield of Michigan Foundation grant # 231-II: a randomized clinical trial comparing telephone and usual care strategies for the management of suspected UTI in otherwise healthy adult women. We thank the following practices that participated in our study: Michigan State University Department of Family Practice, East Lansing; Order of St. Francis Medical Group, Escanaba; and Doctors Park Family Physicians, Escanaba. We are especially appreciative of the efforts of the office nurses and physician’s assistants who recruited and provided the telephone follow-up of the patients: Barb Bedient, LPN; Lisa Sweet, LPN; Debi Besson, RN; Grace Borkadi, PAC; Gloria Johnson, LPN; and Mary Baron, RN. Conflict of interest statement: Dr Ebell is editor of The Journal of Family Practice, Dr Hickner is an associate editor, and Dr Barry is an assistant editor. Therefore, the peer review process, including selection of reviewers, editorial review, editing, and the decision to accept or reject the manuscript was performed by Dr Bernard Ewigman, MD, MSPH, Associate Editor of JFP.