Visits Versus Telephone Calls for Postoperative Care

NCT02891187 | Completed Results DMC

• 1 other identifier: 16-103
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Satisfaction; Postoperative Complications; Pelvic Floor Disorder

Keywords

Postoperative Care; Telephone follow-up; Healthcare Value

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction

  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.

  Preoperative until 3 months postoperative

Secondary Outcomes (1)

• Adverse Events

  3 months postoperative

Study Arms (2)

Outpatient Clinic Visits

ACTIVE COMPARATOR

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

Telephone Follow-up

ACTIVE COMPARATOR

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

Interventions

Telephone follow-up BEHAVIORAL

Patients will be called for postoperative care at 1-2 weeks, 6 weeks, and 3 months

Telephone Follow-up

Outpatient Clinic Visits BEHAVIORAL

Patients will return to the clinic at 1-2 weeks, 6 weeks, and 3 months

Outpatient Clinic Visits

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico Health Sciences

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (11)

• Squires D, Anderson C. U.S. health care from a global perspective: spending, use of services, prices, and health in 13 countries. Issue Brief (Commonw Fund). 2015 Oct;15:1-15.

  PMID: 26591905 BACKGROUND

• Cortese DA, Korsmo JO. Putting U.S. health care on the right track. N Engl J Med. 2009 Oct 1;361(14):1326-7. doi: 10.1056/NEJMp0907561. Epub 2009 Sep 23. No abstract available.

  PMID: 19776399 BACKGROUND

• Porter ME. What is value in health care? N Engl J Med. 2010 Dec 23;363(26):2477-81. doi: 10.1056/NEJMp1011024. Epub 2010 Dec 8. No abstract available.

  PMID: 21142528 BACKGROUND

• Fischer K, Hogan V, Jager A, von Allmen D. Efficacy and utility of phone call follow-up after pediatric general surgery versus traditional clinic follow-up. Perm J. 2015 Winter;19(1):11-4. doi: 10.7812/TPP/14-017.

  PMID: 25663201 BACKGROUND

• Rosbe KW, Jones D, Jalisi S, Bray MA. Efficacy of postoperative follow-up telephone calls for patients who underwent adenotonsillectomy. Arch Otolaryngol Head Neck Surg. 2000 Jun;126(6):718-21; discussion 722. doi: 10.1001/archotol.126.6.718.

  PMID: 10864107 BACKGROUND

• Kimman ML, Dirksen CD, Voogd AC, Falger P, Gijsen BC, Thuring M, Lenssen A, van der Ent F, Verkeyn J, Haekens C, Hupperets P, Nuytinck JK, van Riet Y, Brenninkmeijer SJ, Scheijmans LJ, Kessels A, Lambin P, Boersma LJ. Economic evaluation of four follow-up strategies after curative treatment for breast cancer: results of an RCT. Eur J Cancer. 2011 May;47(8):1175-85. doi: 10.1016/j.ejca.2010.12.017. Epub 2011 Jan 21.

  PMID: 21257305 BACKGROUND

• Uppal S, Nadig S, Smith L, Coatesworth AP. A cost-effectiveness analysis of conventional and nurse-led telephone follow-up after nasal septal surgery. Ann R Coll Surg Engl. 2004 Jul;86(4):243-6. doi: 10.1308/147870804515.

  PMID: 15239863 BACKGROUND

• Gray RT, Sut MK, Badger SA, Harvey CF. Post-operative telephone review is cost-effective and acceptable to patients. Ulster Med J. 2010 May;79(2):76-9.

  PMID: 21116423 BACKGROUND

• Hwa K, Wren SM. Telehealth follow-up in lieu of postoperative clinic visit for ambulatory surgery: results of a pilot program. JAMA Surg. 2013 Sep;148(9):823-7. doi: 10.1001/jamasurg.2013.2672.

  PMID: 23842982 BACKGROUND

• Fallaize RC, Tinline-Purvis C, Dixon AR, Pullyblank AM. Telephone follow-up following office anorectal surgery. Ann R Coll Surg Engl. 2008 Sep;90(6):464-6. doi: 10.1308/003588408X300975. Epub 2008 Jul 2.

  PMID: 18598594 BACKGROUND

• Thompson JC, Cichowski SB, Rogers RG, Qeadan F, Zambrano J, Wenzl C, Jeppson PC, Dunivan GC, Komesu YM. Outpatient visits versus telephone interviews for postoperative care: a randomized controlled trial. Int Urogynecol J. 2019 Oct;30(10):1639-1646. doi: 10.1007/s00192-019-03895-z. Epub 2019 Feb 19.

  PMID: 30783704 DERIVED

MeSH Terms

Conditions

Personal Satisfaction; Postoperative Complications; Pelvic Floor Disorders

Interventions

Ambulatory Care

Condition Hierarchy (Ancestors)

Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Jennifer Thompson
• Organization: UNewMexico

jthompson626@gmail.com

16366790301

Study Officials

• Rebecca G Rogers, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: September 7, 2016
• Study Start: September 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: November 1, 2024
• Results First Posted: November 1, 2024

Record last verified: 2024-08

Locations

US (1)