NCT04968145

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
282

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 19, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

2.5 years

First QC Date

July 13, 2021

Last Update Submit

July 13, 2021

Conditions

Colorectal CancerInflammatory Bowel DiseasesUtilization, Health CareSurgeryPost Discharge Monitoring

Outcome Measures

Primary Outcomes (1)

  • 30-day re-admission

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

    30 Days

Secondary Outcomes (4)

  • 30-day ER visits

    30 Days

  • 30-day primary care visits

    30 Days

  • 30-day unplanned health care visits

    30 Days

  • Patient reported outcomes

    30 Days

Study Arms (2)

Control Group

NO INTERVENTION

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.

Intervention Group

EXPERIMENTAL

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

Home To Stay Mobile Health ApplicationOTHER

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.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mt Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Publications (15)

  • 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.

    PMID: 17665252BACKGROUND

  • 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.

    PMID: 23730901BACKGROUND

  • 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.

    PMID: 22067174BACKGROUND

  • 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.

    PMID: 23529659BACKGROUND

  • 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.

    PMID: 26228016BACKGROUND

  • 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.

    PMID: 19189907BACKGROUND

  • 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.

    PMID: 27353404BACKGROUND

  • 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.

    PMID: 33457571BACKGROUND

  • Sedgwick P, Hooper C. What are randomised consent designs? BMJ. 2014 Jul 25;349:g4727. doi: 10.1136/bmj.g4727. No abstract available.

    PMID: 25063074BACKGROUND

  • 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.

    PMID: 23411725BACKGROUND

  • 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.

    PMID: 30602332BACKGROUND

  • 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.

    PMID: 33393925BACKGROUND

  • 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.

    PMID: 29077818BACKGROUND

  • 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.

    PMID: 29077819BACKGROUND

  • 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.

    PMID: 28329223BACKGROUND

MeSH Terms

Conditions

Colorectal NeoplasmsInflammatory Bowel DiseasesPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesGastroenteritisTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

July 13, 2021

First Posted

July 20, 2021

Study Start

July 19, 2017

Primary Completion

January 21, 2020

Study Completion

January 21, 2020

Last Updated

July 20, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)