Telehealth Postop Follow up RCT

Study Overview
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Brief Summary
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A randomized controlled trial that will evaluate whether telephone two-week postoperative follow up visits are an acceptable and safe alternative to traditional face-to-face-clinic two-week postoperative visits.

Detailed Description
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This is a two group, parallel randomized non-inferiority clinical trial at one institution evaluating telephone postoperative visits as non-inferior in patient satisfaction, patient preference, and patient safety, when compared with clinic postoperative visits. This protocol was written in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines 2011.

Official Title
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Preferred Method of Postoperative Follow Up After Pelvic Reconstructive Surgery. (Phone Call Versus Clinic Visit): A Non-Inferiority Randomized Clinical Trial

Conditions
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Patient Satisfaction

Intervention / Treatment
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* Other: Telehealth 2 week postoperative visit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women >18 desiring surgical management of prolapse or incontinence English speaking Willing and able to provide written and informed consent without assistance from medical surrogate or interpreter Immediate access to telephone services (landline, mobile phone, office phone) Exclusion Criteria: Women <18 Non-English speaking Unwilling and unable to provide written and informed consent without assistance from surrogate or interpreter Hearing impairment No access to telephone services (landline, mobile phone, office phone) Grade 3 complication- a complication requiring surgical, endoscopic, or radiological intervention. [3] Patient who did not attend any postoperative follow up visit

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible patients will be randomized to Arm1 or Arm2 (Telephone follow up or clinic follow up). Permuted block randomization with randomly varying block sizes will be used. Generation of allocation sequences will be performed using a random-number table. The allocation sequence will be generated by our statistician who is neither responsible for patient recruitment or outcome assessment. Sequentially numbered opaque sealed envelopes will be used for concealment of treatment allocation. It is not possible to mask clinical staff or participants, as they will be aware of the follow-up care that is being delivered over the telephone or in clinic. As such this is not a blinded study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Telephone Group<br>The patient randomized into the telephone follow up group, will be contacted, at the pre-scheduled date and time, by the urogynecology clinic nurse. The nurse will utilize a scripted series of postoperative questions, which are consistent with questions asked during our standard postoperative clinic visits. Vital signs and physical examination will be deferred for the patients in the telephone follow up group. Any patient responses that are not consistent with a usual postoperative course will be escalated to an in person visit. However, these patients will remain in the group, to which they were originally randomized, for research analysis purposes. | Other: Telehealth 2 week postoperative visit<br>* The patient randomized into the telephone follow up group, will be contacted, at the pre-scheduled date and time, by the urogynecology clinic nurse. The nurse will utilize a scripted series of postoperative questions, which are consistent with questions asked during our standard postoperative clinic visits. Vital signs and physical examination will be deferred for the patients in the telephone follow up group. Any patient responses that are not consistent with a usual postoperative course will be escalated to an in person visit. However, these patients will remain in the group, to which they were originally randomized, for research analysis purposes. (Intent to treat)<br>|
| No Intervention: In Person Clinic Visit Group<br>For the patient randomized into the clinic group, the clinic visit will entail questions about common postoperative complications (including fever, nausea/vomiting, pain, urinary symptoms, constipation, etc.). As per usual, vital signs and a focused physical examination will be completed at the clinic visit. All clinic visits will be performed by an FPRMS fellow and/or attending physician | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction (questionnaire) | Comparison of patient satisfaction as determined by completion of a non-validated, treatment non-specific satisfaction questionnaire between the two groups. | Survey will be provided at the six-week follow up visit. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient safety (adverse events) | • Comparison of adverse events and Emergency Department (ED) visits between the two groups. Will be determined by reviewing the patient's record to identify adverse events as defined below | Postoperative period up to 6 weeks | 
| Time Spent (post op telephone follow up compared to clinic follow up [minutes]) | • Actual time spent on phone call during postoperative telephone follow up compared to time spent in clinic follow up measured in minutes. | Calculated from time spent at the two week follow up visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative patient satisfaction