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Visits Versus Telephone Calls for Postoperative Care (OPTIONs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02891187
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
University of New Mexico

Brief Summary:
The OPTIONs study is a randomized controlled, non-inferiority study to evaluate postoperative care using outpatient clinic visits versus telephone calls for women undergoing surgery for pelvic floor disorders. The primary outcome is patient satisfaction using the Surgical-Consumer Assessment of Healthcare Providers and Systems (S-CAHPS) questionnaire provided by the Agency for Healthcare Research and Quality (AHRQ). Secondary outcomes include safety and cost analysis for patients' direct and indirect medical costs. Women who speak and understand either English or Spanish and planning to undergo an elective surgery for a pelvic disorder will be recruited. Baseline demographics, satisfaction, and cost analysis questionnaires will be acquired pre-operatively. Randomization will be assigned at the time of discharge from the hospital. Patients will either have scheduled clinic visits at 1-2 weeks, 6 weeks, and 3 months or telephone calls by a registered nurse at these same intervals. Questionnaires will be completed at 3 months for satisfaction and cost analysis.

Condition or disease Intervention/treatment Phase
Satisfaction Postoperative Complications Pelvic Floor Disorder Behavioral: Telephone follow-up Behavioral: Outpatient Clinic Visits Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Outpatient Visits Versus Telephone Interviews for Postoperative Care: A Randomized Controlled Trial
Actual Study Start Date : September 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Behavioral: Outpatient Clinic Visits
Patients will return to the clinic at 1-2 weeks, 6 weeks, and 3 months

Active Comparator: Telephone Follow-up
Patients will be called instead of returning to clinic for postoperative care at 1-2 weeks, 6 weeks, and 3 months.
Behavioral: Telephone follow-up
Patients will be called for postoperative care at 1-2 weeks, 6 weeks, and 3 months




Primary Outcome Measures :
  1. Patient Satisfaction [ Time Frame: Preoperative until 3 months postoperative ]
    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.


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 3 months postoperative ]
    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.


Other Outcome Measures:
  1. Cost-effectiveness [ Time Frame: Preoperative to 3 months postoperative ]
    The objective is to determine the difference in cost-effectiveness between postoperative telephone follow-up versus outpatient visits from the patient and societal perspectives. The investigators hypothesize that telephone calls will be more cost-effective for both patients and society. This will be accomplished using detailed questionnaires and the European Quality of Life-5 Dimensions (EQ-5D)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects ≥ 18 years of age
  2. Women undergoing surgery for a pelvic floor disorder
  3. Able to give informed consent
  4. Has a reliable phone number for contact postoperatively
  5. Able to speak and understand English or Spanish. Spanish forms will be submitted after initial review of English materials.

Exclusion Criteria:

  1. Any patient whose physician decides medical necessity for the patient to have postoperative follow-up in the clinic
  2. Unable to give written informed consent
  3. Does not have a reliable phone number
  4. Inability to speak and understand either English or Spanish. As noted above, Spanish forms will be submitted after initial review of English materials.
  5. Those who specifically request postoperative clinic visits
  6. Pregnant patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891187


Locations
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United States, New Mexico
University of New Mexico Health Sciences
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
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Principal Investigator: Rebecca G Rogers, MD University of New Mexico
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT02891187    
Other Study ID Numbers: 16-103
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Keywords provided by University of New Mexico:
Postoperative Care
Telephone follow-up
Healthcare Value
Additional relevant MeSH terms:
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Pelvic Floor Disorders
Postoperative Complications
Pathologic Processes
Pregnancy Complications