Abstract
Objective:
To determine whether postoperative telephone follow-up was non-inferior to in-person clinic visits based on patient satisfaction. Secondary outcomes included safety and clinical outcomes.
Materials and Methods:
Women scheduled for pelvic surgery were recruited from a single, academic institution and randomized to clinic or telephone follow-up. The clinic group returned for visits 2, 6, and 12 weeks post-operatively while the telephone group received a phone call from a nurse at the same time intervals. Women completed the S-CAHPS questionnaire, PFDI-20, and pain scales prior to and 3 months postoperatively. Randomized patients who completed the S-CAHPS questionnaire at 3-month follow-up were included for analysis. Sample size calculations, based on a 15% non-inferiority limit in the S-CAHPS global assessment surgeon rating, required 100 participants, with power=80% and alpha=0.025.
Results:
From October 2016 to November 2017, 100 participants were consented, underwent surgery, were randomized and included in the final analysis (clinic group n=50, telephone group n=50). The mean age was 58.5 ±12.2 years. Demographic data and surgery type, dichotomized into outpatient and inpatient, did not differ between groups. The S-CAHPS global assessment surgeon rating from patients in the telephone group was non-inferior to the clinic group (92% clinic vs 88% telephone participants rated their surgeons 9-10 on S-CAHPS, with a non-inferiority limit of 36.1, p=0.006). Adverse events did not differ between groups (n=26; 57% from clinic vs 43% from telephone group, p=0.36). Patients in the telephone group did not require additional emergency room or primary care visits compared to the clinic group. Clinical outcome measures improved in both groups during the postoperative period, with no differences between groups (all p>0.05).
Conclusion:
Telephone follow-up after pelvic floor surgery results in non-inferior patient satisfaction, without differences in clinical outcomes or adverse events. Telephone follow-up may improve healthcare quality and decrease patient and provider burden for postoperative care.
Clinical Trial Registration:
Précis:
Telephone follow-up for postoperative care has non-inferior patient satisfaction scores with a similar safety profile and clinical outcomes compared to outpatient clinic visits.
Introduction
Healthcare in the United States paradoxically delivers poorer outcomes at higher cost, compared to other developed nations. To realign American healthcare delivery, the focus must shift to quality care. Quality incorporates clinical outcomes, safety, and patient satisfaction [1]. Quality is achieved by improving outcomes and patient satisfaction while decreasing adverse events [2].
The necessity of routine, in-person postoperative visits is unknown as these visits are based on historic norms. Pediatric and adult surgical literature increasingly reports on changes in this traditional practice by performing follow-up care via telephone in place of outpatient postoperative visits [3-9]. In observational studies, telephone-based postoperative care provides safe and effective care at reduced patient costs and improved patient satisfaction on non-validated global scales [3-9].
The utility and acceptability of postoperative telephone visits for patients undergoing surgery for pelvic floor disorders, such as incontinence and prolapse, have not been evaluated. Pelvic floor disorders are very common with one in four women experiencing incontinence or prolapse for which one in five will undergo surgery in their lifetime [10]. In the United States, more than 300,000 surgeries are performed for pelvic organ prolapse each year [11], with an estimated annual surgical cost of more than one billion dollars [12]. Routine postoperative visits contribute to surgical costs, impede access to care for other patients, consume health care resources as well as patients’ time and additional nonmedical costs. Developing an innovative alternative approach to postoperative care that is both safe and convenient has the potential to improve healthcare quality.
To evaluate this approach, we performed a randomized-controlled trial comparing routine postoperative, outpatient clinic visits versus telephone calls for women undergoing surgery for pelvic floor disorders. We hypothesized that telephone calls to patients at regular intervals would result in non-inferior satisfaction scores without differences in safety and clinical outcome measures.
Materials and Methods
This randomized controlled non-inferiority trial was conducted at a single, academic institution. Study procedures were approved by the University of New Mexico Human Research Review Committee #16-103, and all women gave written informed consent. Women planning to undergo surgical management of pelvic floor disorder(s) were invited to participate in the trial. Eligibility requirements included women over 18 years of age undergoing surgery for pelvic floor disorders, ability to give informed consent, having a reliable phone number, and ability to speak and understand either English or Spanish. Patients were excluded if pregnant or incarcerated or if the surgeon decided clinic follow-up was medically necessary. Randomization allocation was determined by a simple, computer-generated scheme. Allocation concealment was achieved using sequentially numbered, sealed, opaque envelopes, and kept by a research assistant not directly involved in patient care.
The primary outcome was patient satisfaction based on the Surgical-Consumer Assessment of Healthcare Providers and Systems (S-CAHPS) questionnaire overseen by the U.S. Agency for Healthcare Research and Quality (AHRQ). (https://cahps.ahrq.gov) [13]. This questionnaire was developed by the American College of Surgeons and endorsed by the National Quality Forum in 2012 [14]. It includes seven composites: (1) information to help prepare for surgery, (2) surgeon communication preoperatively, (3) surgeon attentiveness on the day of surgery, (4) information to help during recovery, (5) surgeon communication after surgery, (6) qualities of office staff, and (7) an overall surgeon rating. The overall surgeon rating is the global response score. The sample size for this non-inferiority study was calculated based on the S-CAHPS reported scores for the global response score. This single item question “rate your surgeon from 0 (worst surgeon possible) to 10 (best surgeon possible)”, with “top box” responses of 9-10 out of 10. “Top box” responses in prior studies using this questionnaire ranged from 56-100% with the majority of responses scoring approximately 90% [14]. A non-inferiority calculation was applied using 90% to represent “success” in the control and experimental groups with 80% power, an alpha of 0.025, and 15% non-inferiority limit. The non-inferiority limit was determined acceptable by the surgeons and allowed for a feasible study. Therefore, a total sample size of 100 patients were required, allocating approximately 50 patients to each group. Secondary outcomes included safety and clinical outcomes. Safety was evaluated using adverse outcomes at the time of surgery and throughout the postoperative period based on the Clavien-Dindo scale as well as patient-reported, unscheduled visits to the emergency room, urgent care, and primary care offices [15]. Clinical outcomes were evaluated using Pelvic Floor Distress Inventory-20 (PFDI-20) and pain scales [16].
All study participants gave written consent. This was obtained by the surgeons and research staff at the preoperative visits. Baseline questionnaires included the following: Preoperative S-CAHPS, PFDI-20, and pain scales [16]. Demographic data included age, self-reported race and ethnicity, primary language, marital status, education, estimated annual income, living arrangements, and distance traveled from home to the hospital. Patients signed an authorization form for release of records to obtain detailed information regarding additional emergency room and primary care visits during the postoperative period. A Charlson Comorbidity Index was completed for each patient by chart review [17]. At the time of surgery, surgical procedure(s) and complications were recorded. Adverse events were rated on the Clavien-Dindo scale [15]. Prior to discharge, the Immediate Postoperative S-CAHPs questionnaire was completed and patients were randomized to either clinic visits or telephone calls. Assignment was made by a research assistant not directly involved in patient care. At each follow-up interval (1-2 weeks, 6 weeks, 12 weeks) data were queried regarding adverse events and unscheduled emergency and primary care visits using standardized forms administered during telephone or outpatient visits. These follow-up intervals were the typical timing for follow-up clinic visits prior to the study. At each outpatient visit, a provider obtained the data directly from the patient encounter. Telephone calls were conducted by a registered nurse familiar with urogynecology patients and scripted to review specific assessment criteria. Both the clinic visits and telephone calls included the same script to ensure the same postoperative data were obtained. The postoperative script was developed specifically for this study to include common postoperative visit questions evaluating pain, bowel and bladder function, and return to daily activities. At 3 months, the final S-CAHPS, PFDI-20, and pain scales were administered.
Randomized patients who underwent surgery and completed the entire S-CAHPS questionnaire at the 3-month follow-up were included for final analysis. An intention to treat analysis was performed. Data analysis was performed using (a) Chi-square tests to assess associations between categorical variables, (b) t-tests to compare the means between two groups with respect to a continuous variable, (c) one way analysis of variance (ANOVA) to compare the means between three groups or more with respect to a continuous variable, (d) Multivariate Analysis of Variance (MANOVA) to compare means of outcomes for the intervention and control arms at baseline and 3 months measurements. For top-box measures (M1-M7), a non-inferiority test of two proportions was conducted using a significance level of 0.025. P-values of less than 0.025 from the non-inferiority tests will validate non-inferiority as not P>0.025 but P<0.025 concludes non-inferiority.
Results
From October 2016 to November 2017, 430 potential patients had preoperative appointments (Figure 1), and a total of 120 women were enrolled at their preoperative visit. The majority of the 430 preoperative visits were patients who were simply “not asked” to participate in the study. Seventeen were withdrawn prior to randomization due to surgery cancellations or surgeon preference for clinic follow-up. One hundred three women underwent surgery and were randomly assigned to a postoperative followup group; 51 to the outpatient clinic group, 52 to the telephone group. Three patients (one from the clinic group and two from the telephone group) were lost to follow-up. For the final analysis, 50 patients from the clinic group and 50 patients from the telephone group completed the full S-CAHPS questionnaire.
Figure 1:
The Consort Diagram describes the enrollment, randomization, and individuals included for the final analysis
The patients in both follow-up groups were similar in demographic characteristics (Table 1). The mean age was 58.5 ±12.2 years, and 48% were Hispanic. Surgery type was dichotomized into outpatient and inpatient. Outpatient surgeries included the following: midurethral sling, sacral neuromodulation, mesh excision, cystoscopy, colporrhaphy, laparoscopic Burch, and levator ani botulinum toxin injections. Inpatient surgeries included the following: native tissue prolapse repair +/− hysterectomy, sacrocolpopexy +/− hysterectomy, colpocleisis +/− hysterectomy, hysterectomy alone, and fascial sling. No difference in surgery type existed between groups with half of all participants (53%) undergoing inpatient, pelvic organ prolapse repair.
Table 1.
Demographics
| Demographics | Clinic Group | Telephone Group | P Value |
||||
|---|---|---|---|---|---|---|---|
| Total | 50 | 50% | 50 | 50% | 1.000 | ||
| Age Mean (95% CI) | 59.0 | (55.6-62.4) | 57.9 | (54.4-61.4) | 0.65 | ||
| Miles from Surgical Facility Mean (95% C.I.) | 73.2 | (48.1-98.3) | 78.97 | 78.97 (53.9-104.1) | 0.74 | ||
| Charlson Comorbidity Index Mean (95% C.I.) | 1.2 | (0.8-1.5) | 1.5 | (1.1-1.9) | 0.26 | ||
| n | %* | (95% CI) | n | %* | (95% CI) | ||
| Race | 0.17 | ||||||
| American Indian or Alaska | 3 | 6.0 | (0 - 12.7) | 10 | 20.0 | (8.7 - 31.3) | |
| Native | 13 | 26.0 | (13.6 - 38.4) | 8 | 16.0 | (5.7 - 26.3) | |
| Hispanic | 31 | 62.0 | (48.3 - 75.7) | 29 | 58.0 | (44.1 - 71.9) | |
| White | 3 | 6.0 | (0.0 - 12.7) | 3 | 6.0 | (0.0 - 12.7) | |
| Unknown/ Not Reported | |||||||
| Ethnicity | 0.18 | ||||||
| Hispanic or Latino | 27 | 54.0 | (39.9 - 68.1) | 21 | 42.0 | (28.1 - 55.9) | |
| Not Hispanic or Latino | 22 | 44.0 | (30.0 - 58.0) | 24 | 48.0 | (33.9 - 62.1) | |
| Unknown/Not Reported | 1 | 2.0 | (0.0 - 6.0) | 5 | 10.0 | (1.5 - 18.5) | |
| Language | 0.57 | ||||||
| English | 42 | 84.0 | (73.7 - 94.3) | 44 | 88.0 | (78.8 - 97.2) | |
| Spanish | 8 | 16.0 | (5.7 - 26.3) | 6 | 12.0 | (2.8 - 21.2) | |
| Marital Status | 0.05 | ||||||
| Single | 13 | 26.0 | (13.6 - 38.4) | 3 | 6.0 | (0.0 - 12.7) | |
| Married/Partner | 23 | 46.0 | (31.9 - 60.1) | 30 | 60.0 | (46.2 - 73.8) | |
| Divorced/Separated | 6 | 12.0 | (2.8 - 21.2) | 9 | 18.0 | (7.2 - 28.8) | |
| Widowed | 8 | 16.0 | (5.7 - 26.3) | 8 | 16.0 | (5.7 - 26.3) | |
| Education | 0.79 | ||||||
| Less than High School | 7 | 14.0 | (4.2 - 23.8) | 8 | 16.0 | (5.7 - 26.3) | |
| High School/GED | 14 | 28.0 | (15.3 - 40.7) | 20 | 40.0 | (26.2 - 53.8) | |
| Associate College Degree | 17 | 34.0 | (20.6 - 47.4) | 12 | 24.0 | (12.0 - 36.0) | |
| 4-year College Degree | 6 | 12.0 | (2.8 - 21.2) | 4 | 8.0 | (0.4 - 15.7) | |
| Graduate Degree | 5 | 10.0 | (1.5 - 18.5) | 5 | 10.0 | (1.5 - 18.5) | |
| Unknown/Not Reported | 1 | 2.0 | (0.0 - 6.0) | 1 | 2.0 | (0.0 - 6.0) | |
| Annual Income | 0.47 | ||||||
| <$25,000 | 22 | 44.0 | (30.0 - 58.0) | 23 | 46.0 | (31.9 - 60.1) | |
| $25,000–49,000 | 10 | 20.0 | (8.7 - 31.3) | 13 | 26.0 | (13.6 - 38.4) | |
| $50,000 – 74,999 | 5 | 10.0 | (1.5 - 18.5) | 7 | 14.0 | (4.2 - 23.8) | |
| $75,000 – 99,999 | 5 | 10.0 | (1.5 - 18.5) | 1 | 2.0 | (0.0–6.0) | |
| >$100,000 | 7 | 14.0 | (4.2 - 23.8) | 4 | 8.0 | (0.4 - 15.7) | |
| Unknown | 1 | 2.0 | (0.0–6.0) | 2 | 4.0 | (0.0 - 9.5) | |
| Living Arrangements | 0.34 | ||||||
| Alone | 12 | 24.0 | (12.0 - 36.0) | 8 | 16.0 | (5.7 - 26.3) | |
| Spouse or Other | 25 | 50.0 | (35.9 - 64.1) | 33 | 66.0 | (52.6 - 79.4) | |
| Children | 8 | 16.0 | (5.7 - 26.3) | 4 | 8.0 | (0.4 - 15.7) | |
| Other Family Member | 5 | 10.0 | (1.5 - 18.5) | 4 | 8.0 | (0.4 - 15.7) | |
| Other | 0 | 0.0 | (0.0 - 0.0) | 1 | 2.0 | (0.0 - 6.0) | |
| Outpatient Surgery (n=39)† | 21 | 53.9 | (37.4-69.6) | 18 | 46.2 | (30.4-62.6) | 0.63 |
| Outpatient Surgery | 0.25 | ||||||
| Midurethral Sling | 8 | 38.1 | (18.9-61.3) | 8 | 44.4 | (22.4-68.7) | |
| Sacral Neuromodulation | 2 | 9.5 | (1.7-31.8) | 4 | 22.2 | (7.4-48.1) | |
| Mesh Excision | 4 | 19.1 | (6.3-42.6) | 6 | 33.3 | (14.4-58.9) | |
| Cystoscopy | 2 | 9.5 | (1.7-31.8) | 0 | 0.0 | (0.0-21.9) | |
| Colporrhaphy | 1 | 4.8 | (0.3-25.9) | 0 | 0.0 | (0.0-21.9) | |
| Laparoscopic Burch | 2 | 9.5 | (1.7-31.8) | 0 | 0.0 | (0.0-21.9) | |
| Levator Ani Botox | 2 | 9.5 | (1.7-31.8) | 0 | 0.0 | (0.0-21.9) | |
| Injections | |||||||
| Inpatient Surgery (n=61)† | 29 | 47.5 | (34.8-60.6) | 32 | 52.5 | (39.4-65.2) | 0.70 |
| Inpatient Surgery | 0.63 | ||||||
| Native Tissue +/− Hyst. | 15 | 51.7 | (32.9-70.1) | 15 | 46.9 | (29.5-65.0) | |
| Sacrocolpopexy +/− Hyst | 3 | 10.3 | (2.7-28.5) | 5 | 15.6 | (5.9-33.6) | |
| Colpocleisis +/− Hyst | 8 | 27.6 | (13.5-47.5) | 7 | 21.9 | (9.9-40.4) | |
| Hysterectomy | 2 | 6.9 | (1.2-24.2) | 1 | 3.1 | (0.2-18.0) | |
| Fascial Sling | 1 | 3.5 | (0.2-19.6) | 4 | 12.5 | (4.1-29.9) | |
%=column percent
%=row percent
S-CAHPS
The S-CAHPS questionnaire evaluated patient satisfaction. The global assessment question that rates the surgeon 0 to 10 showed non-inferiority among the telephone group compared to the clinic group. Most patients selected a “top box” rating of their surgeon that equates to 9-10/10: 92% of the clinic vs 88% of the telephone participants, with a non-inferiority limit of 36.1, p=0.006 (Table 2). One composite (M5) asks, “How well the surgeon communicates with patients after surgery”. This one composite did not show non-inferiority, most likely because the patients in the telephone group were communicating with the nurse instead of their physician during the postoperative period. All other composites of the S-CAHPS questionnaire showed non-inferiority between the telephone and clinic groups.
Table 2.
The Primary Outcome is patient satisfaction defined by the S-CAHPS questionnaire. Secondary Outcomes include adverse events, PFD-20 scores, and Pain scales.
| Outcomes | Clinic | Telephone | Non- inferiority limit |
P Value |
|||||
|---|---|---|---|---|---|---|---|---|---|
| Primary Outcomes S-CAHPS* |
n | %Ŧ | (95% CI) | n | %Ŧ | (95% CI) | |||
| M1: Information to help you prepare for surgery (2 items) | 43 | 50.6 | (39.8-61.4) | 42 | 49.4 | (38.6-60.2) | 35.6 | 0.0039 | |
| M2: How well surgeon communicates with patients before surgery (4 items) | 43 48.9 | 48.9 | (38.2-59.5) | 45 | 51.1 | (40.5-61.8) | 33.9 | 0.0003 | |
| M3: Surgeon’s attentiveness on day of surgery (2 items) | 40 | 47.6 | (36.8-58.5) | 44 | 52.4 | (41.5-63.3) | 32.6 | <0.001 | |
| M4: Information to help you recover from surgery (4 items) | 37 | 48.7 | (37.3-60.1) | 39 | 51.3 | (39.9-62.8) | 33.7 | 0.0006 | |
| M5: How well surgeon communicates with patients after surgery (4 items) | 38 | 71.7 | (59.2-84.2) | 15 | 28.3 | (15.8-40.8) | 56.7 | 1.000 | |
| M6: Helpful, courteous, and respectful staff at surgeon’s office (2 items) | 46 | 50.0 | (39.6-60.4) | 46 | 50.0 | (39.6-60.4) | 35.0 | 0.0013 | |
| M7: Rating of surgeon (1 item) | 46 | 51.1 | (40.6-61.6) | 44 | 48.9 | (38.4-59.4) | 36.1 | 0.0058 | |
| Secondary Outcomes | n | % | (95% CI) | n | % | (95% CI) | |||
| Adverse Events (n=26)† | 15 | 30.0 | (18.3-44.8) | 11 | 22.0 | (12.0-36.3) | 0. 36 | ||
| Adverse Events† | 0.36 | ||||||||
| UTI | 8 | 53.3 | (27.4-77.7) | 7 | 63.6 | (31.6-87.6) | |||
| Readmission | 2 | 13.3 | (2.3-41.6) | 2 | 18.2 | (3.2-52.3) | |||
| Reoperation within 3 m | 1 | 6.7 | (0.4-34.0) | 1 | 9.1 | (0.5-42.9) | |||
| Intraop complications | 0 | 0.0 | (0.0-25.4) | 0 | 0.0 | (0.0-32.2) | |||
| Other Adverse Events | 4 | 26.7 | (8.9-55.2) | 1 | 9.1 | (0.5-42.9) | |||
| mean | (95% CI) | mean | (95% CI) | ||||||
| PFDI-20 Total Score | T0§ | 110.7 | (94.5-126.9) | 112.3 | (96.1-128.5) | 0.45 | |||
| T3∥ | 39.2 | (26.3-52.2) | 49.4 | (36.5-62.4) | |||||
| POPDI (1-6) | TO | 36.5 | (29.5-43.5) | 38.4 | (31.4-45.4) | 0.89 | |||
| T3 | 11.2 | (7.3-15.1) | 12.5 | (8.6-16.4) | |||||
| CRADI (7-14) | TO | 23.4 | (17.6-29.1) | 21.2 | (15.4-27.0) | 0.08 | |||
| T3 | 10.4 | (6.0-14.9) | 14.3 | (9.8-18.7) | |||||
| UDI (15-20) | TO | 50.8 | (43.2-58.5) | 52.7 | (45.0-60.3) | 0.60 | |||
| T3 | 17.6 | (11.0-24.2) | 22.7 | (16.1-29.2) | |||||
| Pain: At Rest | TO | 1.7 | (1.0-2.5) | 2.4 | (1.6-3.1) | 0.30 | |||
| T3 | 1.4 | (0.7-2.1) | 1.5 | (0.8-2.2) | |||||
| Pain: Normal | TO | 2.8 | (1.9-3.8) | 3.5 | (2.6-4.5) | 0.47 | |||
| Activity | T3 | 1.6 | (0.8-2.3) | 1.8 | (1.0-2.5) | ||||
| Pain: Exercise, | TO | 2.6 | (1.4-3.8) | 3.7 | (2.4-5.0) | 0.30 | |||
| Strenuous Work | T3 | 1.6 | (0.8-2.5) | 1.8 | (0.9-2.8) | ||||
| Pain: Worst Pain | TO | 3.1 | (2.08-4.16) | 3.8 | (2.8-4.8) | 0.47 | |||
| Today | T3 | 1.9 | (1.02-2.86) | 2.0 | (1.1-2.9) | ||||
%=row percent;
%=column percent;
percentage of respondents giving a “top box” answer to the S-CAHPS questionnaires;
T0= preoperative scores;
T3= postoperative scores at 3 months
SAFETY
The total number of adverse events was 26 (Table 2). There was no difference in adverse events between the clinic and telephone groups, p=0.36. The clinic group had 15 events (95% Cl 18.29-44.78) and the telephone group had 11 events (95% Cl 11.99-36.33). The majority of adverse events were urinary tract infections (58%) and did not differ between groups (Clinic=8, Telephone=7). There were 4 total readmissions postoperatively—2 in the telephone group (for pneumonia/sepsis and hematoma evacuation) and 2 in the clinic group (pelvic abscess treated with intravenous antibiotics and sacrospinous ligament suture removal for pain). There were no intraoperative complications among patients. Other adverse events within the clinic group included an emergency room visit for a hypertensive emergency, pelvic pain treatment with pudendal injections, and nausea postoperatively. Other adverse events within the telephone group included an allergic reaction to surgical glue.
The clinic group returned for 147 total clinic visits (range=0-7, mean= 2.9 visits). Patients randomized to the telephone group were invited to return to clinic at any point during their postoperative care if they desired a follow-up visit with their surgeon. There were 35 total clinic visits by patients in the telephone group (range= 0-5, mean 0.7 visits).
Information regarding patients receiving care elsewhere (outside the urogynecology outpatient clinic or via telephone calls) was captured at each postoperative visit and telephone call. These included additional emergency room, urgent care, and primary care visits. In the clinic group, 8 emergency room/urgent care visits and 5 primary care visits were reported. In the telephone group, 3 emergency room/urgent care visits and 4 primary care visits were reported. Telephone postoperative care did not increase the frequency of emergency or primary care visits (p>0.05.
CLINICAL OUTCOMES
The PFDI-20 scores for each domain improved postoperatively in both groups (all p<0.05). PFDI-20 change scores did not differ between groups (Table 2). The pain scales assessed patients’ pain scores from 0 to 10 at rest, with normal activity, with strenuous activity, and worst pain that day. There was no difference in postoperative pain scores between patients in the clinic or telephone groups (Table 2).
Discussion
Telephone calls for postoperative follow-up after surgical management of pelvic floor disorders results in non-inferior patient satisfaction without sacrificing safety or clinical outcomes. These findings, assessing an innovative approach to postoperative care, shifts the focus to quality of care. While others have reported outcomes from observational studies, no randomized trials compare in-person visits to telephone visits for postoperative care. Quality is an essential component in the healthcare value equation [1]. Healthcare quality relies on patient satisfaction, safety, and clinical outcomes. Our results highlight the patient-perceived quality of telephone follow-up for postoperative care. Improving postoperative care is one small piece to improving the American healthcare system quality.
The demographics of participants in this study, including age, race, and ethnicity, reflect the urogynecology patient population common to rural Southwestern United States communities [18]. In our practice, patients travel a significant distance to receive subspecialty care. We have previously reported that patients travel 42.4 miles on average (SD +/− 91.5 miles) one-way for their appointments to address pelvic floor disorders in our clinic [18]. The patients in our study traveled on average 76.1 miles one-way for their appointments. This difference may reflect that patients who live farther from clinical care were more interested in receiving telephone follow-up and participating in this trial since this would be more convenient for them and their families. In addition, the majority of patients enrolled in this study reported an annual household income of less than $25,000. This suggests that patients with more limited incomes may accrue the greatest benefit from this type of innovative postoperative care. This study highlights the need to consider implementation of innovative care to reduce financial burdens and provide more convenient care for our patients.
Telephone follow-up for postoperative care has been effective for various medical specialties since the 1990s. Pediatric studies evaluating patient satisfaction used a non-validated global assessment to determine if patients or their parents were satisfied with their care and/or desired a clinic visit [3, 4, 7, 19]. These satisfaction scores were high, and only about 10% of patients required a clinic visit [3, 4, 7, 19]. In the urogynecology literature, one study from the United Kingdom evaluated a telephone follow-up protocol for midurethral slings. Again, patients reported high satisfaction with a low rate of required clinic follow-up [19]. Overall, the existing literature regarding telephone follow-up used very specific surgeries including adenotonsillectomies, uncomplicated and minimally invasive general surgery procedures, with a single outpatient urogynecology procedure. However, these studies a prospective comparison study design as well as validated measures of satisfaction. Our study adds to this body of literature because of the randomized controlled study design and inclusion of a variety of outpatient and more complicated inpatient surgeries and evaluated adult patients utilizing validated satisfaction scores with the S-CAHPS questionnaire.
Safety and clinical outcomes are two other important components that should be considered when evaluating healthcare quality. The safety profile of our study is similar to other pelvic floor disorder studies. The incidence of serious adverse events from other trials range from 11.6-16.7% [20, 21]. The rate of serious adverse events from our trial was 6%. The most common adverse event in our study were urinary tract infections, occurring at the relatively low rate of 15% of participants. The rate of urinary tract infection after midurethral sling procedures and prolapse repairs in other studies ranges from 31-33.6% [20, 22]. In the current study, urinary tract infections contributed to 58% of the total rate of adverse events (n=26). There was no difference in adverse events between telephone and clinic follow-up groups. Currently, there are no guidelines to direct scheduling of postoperative appointments following urogynecologic surgeries. While most serious complications occur before a two week postoperative appointment, other foreign body complications, such as mesh erosion, may take longer [23]. Addressing common symptoms over the telephone was just as effective as clinic visits to identify complications in our study.
Patient-centered clinical outcomes are especially important for elective surgery. The PFDI-20 is a validated questionnaire evaluating pelvic floor symptom severity [16]. The improvement of severity scores preoperatively to three months postoperatively was significant better in both groups. However, this change in improvement did not differ between patients who received their postoperative care in the outpatient clinic or over the phone. Contrary to pre-study assumptions, provider evaluation of a patient postoperatively does not influence symptom improvement after surgical management of pelvic floor disorders.
Some of the limitations of this study are inherent to the S-CAHPS questionnaire and its ceiling effect. Eighty-eight percent and 92% of patients in the telephone and clinic groups respectively rated their surgeon 9 to 10 out of 10. There was a high proportion of respondents marking the “top box”. Therefore, we cannot stratify any meaningful range of data utilizing this instrument. This same rightward skew was observed among other surgical satisfaction evaluations using the S-CAHPS questionnaire [14]. We chose the S-CAHPS because of it’s a patient-centered, validated measure of surgical satisfaction, but we were not powered, nor would it be possible to power to evaluate other important parts of post-operative experience such as delayed ureteral injury. Thus we cannot determine if telephone visits would delay or hinder care for uncommon post-operative events. Another study limitation may have been due to selection bias. In order for patients to enroll in this study, they needed to be willing to accept both forms of postoperative follow-up. If patients were not willing to have all of their postoperative follow-up over the phone, they presumably declined study enrollment and proceeded with traditional, outpatient clinic visits after their surgery. Similarly, physicians needed to agree that both forms of care were appropriate for the patient. Therefore, the outcomes in satisfaction scores may not be generalizable to all patients undergoing surgery for pelvic floor disorders but rather those willing and able to have telephone follow-up. Patients enrolled in the current study may have had demographic factors that differ from the general population—a large Hispanic population of the Southwest, patients living further distances from the hospital, and patients who find the economic consequences of clinic visits to be untenable. A strength of this study is its novel approach to postoperative care and its thorough assessment of healthcare quality in the postoperative setting. Telephone calls address patients’ postoperative needs and provide attention to patients’ questions and concerns. From a clinical standpoint, this study provides strategies to improve patient flow through a subspecialty clinic. The significant reduction in outpatient visits allows for clinical time to be dedicated to other follow-up visits and new patient visits. This format has the potential to provide adequate service and high satisfaction for postoperative patients who live far away, are unable to take time off work, who cannot rely on family members or friends for transportation, or any other circumstances that are barriers to returning to clinic for postoperative followup. Meanwhile, new patient and follow-up visits can be scheduled more easily, earlier, allowing for improved clinical productivity. Furthermore, this form of postoperative follow-up may be generalizable to other surgical specialties as well as routine gynecologic surgery.
Healthcare delivery in the United States is undergoing significant changes because of mounting expenses, inefficiencies, and poor outcomes that seem insurmountable. Evaluating bureaucratic mandates is necessary to direct healthcare that actually meet patients’ needs. The system is in desperate need for new, innovative ways to deliver high quality care. Since this study, the urogynecology department at the University of New Mexico is working towards system changes to allow for more accessible, quality care. Efforts toward evaluating the efficacy and quality of routine postoperative patient care can help move our system towards these ends. Telephone follow-up for postoperative care provides high patient satisfaction without sacrificing safety and clinical outcomes. This patient-centered delivery of postoperative care provides an efficient and effective model for our healthcare system that shifts the focus to improving quality of care.
Acknowledgments
Disclosures:
This project was supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences of the National Institutes of Health through Grant Number UL1TR001449. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
This project was funded by the University of New Mexico’s ObGyn department Seligman Fund and the Clinical & Translational Science Center (CTSC) Pilot Grant JC Thompson, SB Cichowski, F Qeadan, J Zambrano, C Wenzl, PC Jeppson report no conflict of interest.
GC Dunivan receives research support from Pelvalon, Inc. unrelated to the submitted work.
RG Rogers is DSMB chair for the TRANSFORM trial sponsored by American Medical Systems and receives royalties for scientific writings from UptoDate. She receives travel and stipend from IUGA for editor in chief services for IUJ and from ABOG for work for the board.
YM Komesu reports grants from NIH funded grant (grant #PA11-260), non-financial support from National Center for Research Resources and the National Center for Advancing Translational Sciences of the National Institutes of Health through Grant Number 8UL1TR000041, The University of New Mexico Clinical and Translational Science Center, grants from NIH: U grant funding the Pelvic Floor Support Disorders Network via the Eunice Kennedy Shriver NICHD (institute).
Footnotes
Study conducted in Albuquerque, New Mexico, United States of America
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