Trial Outcomes & Findings for Visits Versus Telephone Calls for Postoperative Care (NCT 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

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

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

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

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
Age, Continuous	59 years STANDARD_DEVIATION 12.0 • n=5 Participants	57.9 years STANDARD_DEVIATION 12.9 • n=7 Participants	58.5 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=5 Participants	21 Participants n=7 Participants	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	24 Participants n=7 Participants	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants	29 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants	11 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	50 participants n=7 Participants	50 participants n=5 Participants
Language English	42 Participants n=5 Participants	44 Participants n=7 Participants	86 Participants n=5 Participants
Language Spanish	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Marital Status Single	13 Participants n=5 Participants	3 Participants n=7 Participants	16 Participants n=5 Participants
Marital Status Married/Partner	23 Participants n=5 Participants	30 Participants n=7 Participants	53 Participants n=5 Participants
Marital Status Divorced/Separated	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Marital Status Widowed	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Education Less than high school	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Education High school/GED	14 Participants n=5 Participants	20 Participants n=7 Participants	34 Participants n=5 Participants
Education Associate College Degree	17 Participants n=5 Participants	12 Participants n=7 Participants	29 Participants n=5 Participants
Education 4 year College Degree	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Education Graduate Degree	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Education Unknown/Not reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Annual Income <$25,000	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Annual Income %25,000-49,999	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Annual Income $50,000-74,999	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Annual Income $75,000-99,999	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Annual Income >$100,000	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Annual Income Unknown	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Living Arrangements Alone	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Living Arrangements With spouse or other	25 Participants n=5 Participants	33 Participants n=7 Participants	58 Participants n=5 Participants
Living Arrangements Unknown or Not reported	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Miles from surgical facility	73.2 miles STANDARD_DEVIATION 88 • n=5 Participants	78.97 miles STANDARD_DEVIATION 87.1 • n=7 Participants	76.1 miles STANDARD_DEVIATION 87.2 • n=5 Participants
type of surgery outpatient surgery	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
type of surgery inpatient surgery	29 Participants n=5 Participants	32 Participants n=7 Participants	61 Participants n=5 Participants

PRIMARY outcome

Timeframe: Preoperative until 3 months postoperative

Population: "top box" rating on teh S-CAHPS questionnaire

Outcome measures

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 postoperative

Population: 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

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

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

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

Dr. Jennifer Thompson

UNewMexico

Phone: 16366790301

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place