Trial Outcomes & Findings for Visits Versus Telephone Calls for Postoperative Care (NCT NCT02891187)
NCT ID: NCT02891187
Last Updated: 2024-11-01
Results Overview
The objective is to compare patient satisfaction between women who present for clinic postoperative visits versus telephone follow-up. The investigators hypothesize that telephone calls will show non-inferior patient satisfaction when compared to clinic postoperative visits. The investigators will test the working hypothesis by using the approach of randomizing patients undergoing surgery for PFDs to either telephone follow-up or routine outpatient visits for their postoperative care and utilizing the S-CAHPS questionnaire preoperatively and 3 months postoperatively.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
Preoperative until 3 months postoperative
Results posted on
2024-11-01
Participant Flow
17 patients withdrew from the study prior to randomization- surgery cancellations or surgeon preference for clinic follow-up.
Participant milestones
| Measure |
Outpatient Clinic Visits
Outpatient clinic visits for postoperative care is currently the standard of care. Patients who undergo surgery for a pelvic floor disorder will be scheduled appointments in the outpatient clinic at 1-2 weeks, 6 weeks, and 3 months where they will be evaluated by a physician.
Outpatient Clinic Visits: Patients will return to the clinic at 1-2 weeks, 6 weeks, and 3 months
|
Telephone Follow-up
Patients will be called instead of returning to clinic for postoperative care at 1-2 weeks, 6 weeks, and 3 months.
Telephone follow-up: Patients will be called for postoperative care at 1-2 weeks, 6 weeks, and 3 months
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
52
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Outpatient Clinic Visits
Outpatient clinic visits for postoperative care is currently the standard of care. Patients who undergo surgery for a pelvic floor disorder will be scheduled appointments in the outpatient clinic at 1-2 weeks, 6 weeks, and 3 months where they will be evaluated by a physician.
Outpatient Clinic Visits: Patients will return to the clinic at 1-2 weeks, 6 weeks, and 3 months
|
Telephone Follow-up
Patients will be called instead of returning to clinic for postoperative care at 1-2 weeks, 6 weeks, and 3 months.
Telephone follow-up: Patients will be called for postoperative care at 1-2 weeks, 6 weeks, and 3 months
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Visits Versus Telephone Calls for Postoperative Care
Baseline characteristics by cohort
| Measure |
Outpatient Clinic Visits
n=50 Participants
Outpatient clinic visits for postoperative care is currently the standard of care. Patients who undergo surgery for a pelvic floor disorder will be scheduled appointments in the outpatient clinic at 1-2 weeks, 6 weeks, and 3 months where they will be evaluated by a physician.
Outpatient Clinic Visits: Patients will return to the clinic at 1-2 weeks, 6 weeks, and 3 months
|
Telephone Follow-up
n=50 Participants
Patients will be called instead of returning to clinic for postoperative care at 1-2 weeks, 6 weeks, and 3 months.
Telephone follow-up: Patients will be called for postoperative care at 1-2 weeks, 6 weeks, and 3 months
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
50 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 12.0 • n=99 Participants
|
57.9 years
STANDARD_DEVIATION 12.9 • n=107 Participants
|
58.5 years
STANDARD_DEVIATION 12.4 • n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=99 Participants
|
50 participants
n=107 Participants
|
50 participants
n=206 Participants
|
|
Language
English
|
42 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Language
Spanish
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Marital Status
Single
|
13 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Marital Status
Married/Partner
|
23 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Marital Status
Divorced/Separated
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Marital Status
Widowed
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Education
Less than high school
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Education
High school/GED
|
14 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Education
Associate College Degree
|
17 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Education
4 year College Degree
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Education
Graduate Degree
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Education
Unknown/Not reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Annual Income
<$25,000
|
22 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Annual Income
%25,000-49,999
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Annual Income
$50,000-74,999
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Annual Income
$75,000-99,999
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Annual Income
>$100,000
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Annual Income
Unknown
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Living Arrangements
Alone
|
12 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Living Arrangements
With spouse or other
|
25 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Living Arrangements
Unknown or Not reported
|
13 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Miles from surgical facility
|
73.2 miles
STANDARD_DEVIATION 88 • n=99 Participants
|
78.97 miles
STANDARD_DEVIATION 87.1 • n=107 Participants
|
76.1 miles
STANDARD_DEVIATION 87.2 • n=206 Participants
|
|
type of surgery
outpatient surgery
|
21 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
type of surgery
inpatient surgery
|
29 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Preoperative until 3 months postoperativePopulation: "top box" rating on teh S-CAHPS questionnaire
The objective is to compare patient satisfaction between women who present for clinic postoperative visits versus telephone follow-up. The investigators hypothesize that telephone calls will show non-inferior patient satisfaction when compared to clinic postoperative visits. The investigators will test the working hypothesis by using the approach of randomizing patients undergoing surgery for PFDs to either telephone follow-up or routine outpatient visits for their postoperative care and utilizing the S-CAHPS questionnaire preoperatively and 3 months postoperatively.
Outcome measures
| Measure |
Outpatient Clinic Visits
n=50 Participants
Outpatient clinic visits for postoperative care is currently the standard of care. Patients who undergo surgery for a pelvic floor disorder will be scheduled appointments in the outpatient clinic at 1-2 weeks, 6 weeks, and 3 months where they will be evaluated by a physician.
Outpatient Clinic Visits: Patients will return to the clinic at 1-2 weeks, 6 weeks, and 3 months
|
Telephone Follow-up
n=50 Participants
Patients will be called instead of returning to clinic for postoperative care at 1-2 weeks, 6 weeks, and 3 months.
Telephone follow-up: Patients will be called for postoperative care at 1-2 weeks, 6 weeks, and 3 months
|
|---|---|---|
|
Patient Satisfaction
Information to help you prepare for surgery
|
43 participants
|
42 participants
|
|
Patient Satisfaction
How well surgeon communicates with patients before surgery
|
43 participants
|
45 participants
|
|
Patient Satisfaction
Surgeon's attentiveness on day of surgery
|
40 participants
|
44 participants
|
|
Patient Satisfaction
Information to help you recover from surgery
|
37 participants
|
39 participants
|
|
Patient Satisfaction
How well surgeon communicates with patients after surgery
|
38 participants
|
15 participants
|
|
Patient Satisfaction
Helpful, courteous, and respectful staff at surgeon's office
|
46 participants
|
46 participants
|
|
Patient Satisfaction
Rating of surgeon
|
46 participants
|
44 participants
|
SECONDARY outcome
Timeframe: 3 months postoperativePopulation: Adverse events included urinary tract infection, readmission, re-operation within 3 months, intraoperative complications, and other
The objective is to demonstrate telephone follow-up as both an effective and safe modality for postoperative care. The investigators hypothesize telephone calls and outpatient visits will not show a significant difference in adverse outcomes or patient outcomes for their pelvic floor dysfunction. Adverse events will be captured during the 3 months postoperative period for both groups in this study.
Outcome measures
| Measure |
Outpatient Clinic Visits
n=50 Participants
Outpatient clinic visits for postoperative care is currently the standard of care. Patients who undergo surgery for a pelvic floor disorder will be scheduled appointments in the outpatient clinic at 1-2 weeks, 6 weeks, and 3 months where they will be evaluated by a physician.
Outpatient Clinic Visits: Patients will return to the clinic at 1-2 weeks, 6 weeks, and 3 months
|
Telephone Follow-up
n=50 Participants
Patients will be called instead of returning to clinic for postoperative care at 1-2 weeks, 6 weeks, and 3 months.
Telephone follow-up: Patients will be called for postoperative care at 1-2 weeks, 6 weeks, and 3 months
|
|---|---|---|
|
Adverse Events
|
15 Participants
|
11 Participants
|
Adverse Events
Outpatient Clinic Visits
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Telephone Follow-up
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Outpatient Clinic Visits
n=50 participants at risk
Outpatient clinic visits for postoperative care is currently the standard of care. Patients who undergo surgery for a pelvic floor disorder will be scheduled appointments in the outpatient clinic at 1-2 weeks, 6 weeks, and 3 months where they will be evaluated by a physician.
Outpatient Clinic Visits: Patients will return to the clinic at 1-2 weeks, 6 weeks, and 3 months
|
Telephone Follow-up
n=50 participants at risk
Patients will be called instead of returning to clinic for postoperative care at 1-2 weeks, 6 weeks, and 3 months.
Telephone follow-up: Patients will be called for postoperative care at 1-2 weeks, 6 weeks, and 3 months
|
|---|---|---|
|
Surgical and medical procedures
Readmission
|
6.0%
3/50 • Number of events 3 • Adverse events were recorded 3 months postoperatively
We used the definition provided by clinical trails
|
6.0%
3/50 • Number of events 3 • Adverse events were recorded 3 months postoperatively
We used the definition provided by clinical trails
|
Other adverse events
| Measure |
Outpatient Clinic Visits
n=50 participants at risk
Outpatient clinic visits for postoperative care is currently the standard of care. Patients who undergo surgery for a pelvic floor disorder will be scheduled appointments in the outpatient clinic at 1-2 weeks, 6 weeks, and 3 months where they will be evaluated by a physician.
Outpatient Clinic Visits: Patients will return to the clinic at 1-2 weeks, 6 weeks, and 3 months
|
Telephone Follow-up
n=50 participants at risk
Patients will be called instead of returning to clinic for postoperative care at 1-2 weeks, 6 weeks, and 3 months.
Telephone follow-up: Patients will be called for postoperative care at 1-2 weeks, 6 weeks, and 3 months
|
|---|---|---|
|
Surgical and medical procedures
Infection, other
|
24.0%
12/50 • Number of events 12 • Adverse events were recorded 3 months postoperatively
We used the definition provided by clinical trails
|
16.0%
8/50 • Number of events 8 • Adverse events were recorded 3 months postoperatively
We used the definition provided by clinical trails
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place