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CompletedNCT04968145Updated Jul 20, 2021

Home To Stay: a Randomized Trial Evaluating a Post-discharge Mobile App for Elective Colorectal Surgery

An interventional study of Home To Stay Mobile Health Application in Colorectal Cancer, Inflammatory Bowel Diseases and Utilization, Health Care, sponsored by Division of General Surgery , Mt. Sinai Hospital. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-20.

Sponsored by Division of General Surgery , Mt. Sinai Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 11 months after the study started (first participant enrolled Jul 2017, registered Jul 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
282
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

A single center randomized controlled trial to evaluate the effect of a post-discharge mobile health application on 30-day re-admission and patient reported outcomes following elective colorectal surgery

Read the detailed description

Background: Following elective colorectal surgery, rates of re-admission are high and result in significant healthcare resource use. However, up to 20% of these re-admissions may be preventable. This represents an opportunity to improve patient outcomes, reduce health care utilization and costs through targeted interventions.

Home To Stay is an integrated discharge monitoring program using a mobile app platform that was developed to support the needs of patients following discharge after colorectal surgery. In the initial pilot testing, the 30-day re-admission rate for patients using Home to Stay was reduced from 18% to 6% and patient anxiety was reduced in over 75% of the participants.

Methods: This study is a two arm, single center, randomized control trial that will be conducted in the colorectal unit of an academic tertiary care center. Patients will be randomized1:1 using a single randomized consent design to either usual follow up in the control group or post discharge monitoring with Home to Stay in the intervention group.

Objective: The objective of this study is to evaluate the Home to Stay app and its effect on healthcare utilization and patient reported outcomes.

02

Conditions studied

  • Colorectal Cancer
  • Inflammatory Bowel Diseases
  • Utilization, Health Care
  • Surgery
  • Post Discharge Monitoring
03

In context

Inflammatory Bowel Diseases

1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 438 are open to participants now.

This study's enrollment of 282 is above the median of 70 across 770 interventional studies indexed under Inflammatory Bowel Diseases.

Browse Inflammatory Bowel Diseases studies →

Lead sponsor

This is the only study on the registry with Division of General Surgery , Mt. Sinai Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients undergoing elective, inpatient colorectal surgery
  • Able to speak and read in English
  • Able to provide informed consent
  • Have access to a smartphone/tablet or desktop computer with internet access

Exclusion criteria

Exclusion Criteria:

  • Patients undergoing semi-elective/emergent procedure
  • Patients undergoing elective day surgery
  • Expected post operative admission of less than 3 days
  • Discharge to another institution (rehabilitation facility/nursing home/long term care).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
282 participants (actual)

Study arms

  • No intervention
    Control Group

    Participants in the control group receive routine follow up care which consists of (i) written instructions regarding potential complications and the contact information of their treating surgeon, (ii) a follow up telephone call 4 weeks following discharge by a member of the health care team and (iii) an in-person follow up visit in clinic with the treating surgeon 4-6 weeks following discharge.

  • Experimental
    Intervention Group

    The participants in the intrevention group receive the same routine care as the control group in addition to post discharge monitoring with the Home to Stay app

    Other: Home To Stay Mobile Health Application

Interventions

  • OtherHome To Stay Mobile Health Application

    Home to stay is an integrated discharge monitoring system with a mobile application. Features of the application include a "Daily Health Check" to report on post-operative recovery, picture taking capability to photograph incisions/wounds and educational information on post-operative care at home. Patients will complete a "Daily Health Check" on post-discharge Day #1-14, #21 and #30. The Daily Health Check consists of a series of questions specific to colorectal surgery as well as the Quality of Recovery (QoR-15) questionnaire. After completion, the participant will receive a list of recommendations tailored to their responses including relevant education modules, to contact the surgical team or in urgent cases to go to the nearest emergency room. The participants' responses will be monitored daily via a secure web site. Any participants' responses in the extreme ranges are automatically "red flagged" and notify the health care team that a follow up telephone call is required.

06

What researchers measure

Primary outcomes

  1. 30-day re-admission

    Patient reported re-admission to any hospital within 30 days of discharge following surgery

    Time frame: 30 Days

Secondary outcomes

  1. 30-day ER visits

    Patient reported presentation to any hospital emergency room within 30 days of discharge following surgery

    Time frame: 30 Days

  2. 30-day primary care visits

    Patient reported presentation to their primary care physician within 30 days of discharge following surgery

    Time frame: 30 Days

  3. 30-day unplanned health care visits

    A composite of any re-admission, ER presentation or primary care visit within 30 days following the date of discharge.

    Time frame: 30 Days

  4. Patient reported outcomes

    satisfaction with the discharge process, overall well-being and level of anxiety during 30-day post-discharge period were rated on a 10- point Likert scale

    Time frame: 30 Days

07

Study locations

1 site
  • Mt Sinai Hospital
    Toronto, Ontario M5G 1X5, Canada
08

References and documents

Publications

  • Guinier D, Mantion GA, Alves A, Kwiatkowski F, Slim K, Panis Y; Association Francaise de Chirurgie. Risk factors of unplanned readmission after colorectal surgery: a prospective, multicenter study. Dis Colon Rectum. 2007 Sep;50(9):1316-23. doi: 10.1007/s10350-007-0310-x. PubMed 17665252 ↗
  • Li LT, Mills WL, White DL, Li A, Gutierrez AM, Berger DH, Naik AD. Causes and prevalence of unplanned readmissions after colorectal surgery: a systematic review and meta-analysis. J Am Geriatr Soc. 2013 Jul;61(7):1175-81. doi: 10.1111/jgs.12307. Epub 2013 Jun 3. PubMed 23730901 ↗
  • Wick EC, Shore AD, Hirose K, Ibrahim AM, Gearhart SL, Efron J, Weiner JP, Makary MA. Readmission rates and cost following colorectal surgery. Dis Colon Rectum. 2011 Dec;54(12):1475-9. doi: 10.1097/DCR.0b013e31822ff8f0. PubMed 22067174 ↗
  • Burke RE, Coleman EA. Interventions to decrease hospital readmissions: keys for cost-effectiveness. JAMA Intern Med. 2013 Apr 22;173(8):695-8. doi: 10.1001/jamainternmed.2013.171. PubMed 23529659 ↗
  • Ceppa EP, Pitt HA, Nakeeb A, Schmidt CM, Zyromski NJ, House MG, Kilbane EM, George-Minkner AN, Brand B, Lillemoe KD. Reducing Readmissions after Pancreatectomy: Limiting Complications and Coordinating the Care Continuum. J Am Coll Surg. 2015 Sep;221(3):708-16. doi: 10.1016/j.jamcollsurg.2015.05.012. Epub 2015 May 27. PubMed 26228016 ↗
  • Jack BW, Chetty VK, Anthony D, Greenwald JL, Sanchez GM, Johnson AE, Forsythe SR, O'Donnell JK, Paasche-Orlow MK, Manasseh C, Martin S, Culpepper L. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009 Feb 3;150(3):178-87. doi: 10.7326/0003-4819-150-3-200902030-00007. PubMed 19189907 ↗
  • Jones CE, Hollis RH, Wahl TS, Oriel BS, Itani KM, Morris MS, Hawn MT. Transitional care interventions and hospital readmissions in surgical populations: a systematic review. Am J Surg. 2016 Aug;212(2):327-35. doi: 10.1016/j.amjsurg.2016.04.004. Epub 2016 Jun 1. PubMed 27353404 ↗
  • Keng CJS, Goriawala A, Rashid S, Goldstein R, Schmocker S, Easson A, Kennedy E. Home to Stay: An Integrated Monitoring System Using a Mobile App to Support Patients at Home Following Colorectal Surgery. J Patient Exp. 2020 Dec;7(6):1241-1246. doi: 10.1177/2374373520904194. Epub 2020 Feb 12. PubMed 33457571 ↗
  • Sedgwick P, Hooper C. What are randomised consent designs? BMJ. 2014 Jul 25;349:g4727. doi: 10.1136/bmj.g4727. No abstract available. PubMed 25063074 ↗
  • Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b. PubMed 23411725 ↗
  • De La Cruz Monroy MFI, Mosahebi A. The Use of Smartphone Applications (Apps) for Enhancing Communication With Surgical Patients: A Systematic Review of the Literature. Surg Innov. 2019 Apr;26(2):244-259. doi: 10.1177/1553350618819517. Epub 2019 Jan 2. PubMed 30602332 ↗
  • Patel B, Thind A. Usability of Mobile Health Apps for Postoperative Care: Systematic Review. JMIR Perioper Med. 2020 Jul 20;3(2):e19099. doi: 10.2196/19099. PubMed 33393925 ↗
  • Jaensson M, Dahlberg K, Eriksson M, Nilsson U. Evaluation of postoperative recovery in day surgery patients using a mobile phone application: a multicentre randomized trial. Br J Anaesth. 2017 Nov 1;119(5):1030-1038. doi: 10.1093/bja/aex331. PubMed 29077818 ↗
  • Dahlberg K, Philipsson A, Hagberg L, Jaensson M, Halleberg-Nyman M, Nilsson U. Cost-effectiveness of a systematic e-assessed follow-up of postoperative recovery after day surgery: a multicentre randomized trial. Br J Anaesth. 2017 Nov 1;119(5):1039-1046. doi: 10.1093/bja/aex332. PubMed 29077819 ↗
  • Armstrong KA, Coyte PC, Brown M, Beber B, Semple JL. Effect of Home Monitoring via Mobile App on the Number of In-Person Visits Following Ambulatory Surgery: A Randomized Clinical Trial. JAMA Surg. 2017 Jul 1;152(7):622-627. doi: 10.1001/jamasurg.2017.0111. PubMed 28329223 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04968145
Lead sponsor
Division of General Surgery , Mt. Sinai Hospital
Responsible party
Amandeep Pooni (Research Fellow, Division of General Surgery , Mt. Sinai Hospital) — Principal investigator
First posted
Jul 20, 2021
Start date
Jul 19, 2017
Primary completion
Jan 21, 2020
Completion
Jan 21, 2020
Last update
Jul 20, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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