Colorectal CancerNCT04968145

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

A study testing Home To Stay Mobile Health Application in people with Colorectal Cancer and Inflammatory Bowel Diseases, run by Division of General Surgery , Mt. Sinai Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer, Inflammatory Bowel Diseases, Utilization, Health Care
What is being tested?: Home To Stay Mobile Health Application
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 282 participants
Where: 1 siteCanada
Study dates: 19 Jul 2017to 21 Jan 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

Canada1 site

Mt Sinai Hospital
Toronto, Ontario, M5G 1X5

Other trials in Canada

About this study

Official title: Home To Stay: a Randomized Controlled Trial Evaluating the Effect of a Post-discharge Mobile App on 30-day Re-admission 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.

Conditions: Colorectal Cancer, Inflammatory Bowel Diseases, Utilization, Health Care, Surgery, Post Discharge Monitoring
Being tested: Home To Stay Mobile Health Application
Medical subject headings: Colorectal Neoplasms, Inflammatory Bowel Diseases, Patient Acceptance of Health Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT04968145
Study group	Role	What they receive
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 Receives: Other: Home To Stay Mobile Health Application

What is being measured

The primary outcome is the main question the study is designed to answer.

30-day re-admission
Patient reported re-admission to any hospital within 30 days of discharge following surgery
Measured: 30 Days

Secondary outcomes (4)

30-day ER visits
Patient reported presentation to any hospital emergency room within 30 days of discharge following surgery
Measured: 30 Days
30-day primary care visits
Patient reported presentation to their primary care physician within 30 days of discharge following surgery
Measured: 30 Days
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.
Measured: 30 Days
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
Measured: 30 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jul 201721 Jan 2020

First posted20 Jul 2021
Study start19 Jul 2017
Primary completion21 Jan 2020
Study completion21 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 282 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04968145
Sponsor's protocol ID: HomeToStay
Status last verified: Jul 2021
First submitted: 13 Jul 2021
Last updated: 20 Jul 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Home To Stay: a Randomized Controlled Trial Evaluating the Effect of a Post-discharge Mobile App on 30-day Re-admission Following Elective Colorectal Surgery
ClinicalTrials.gov ID: NCT04968145
Acronym / sponsor ID: HomeToStay
Conditions: Colorectal Cancer, Inflammatory Bowel Diseases, Utilization, Health Care, Surgery, Post Discharge Monitoring
Study type: Interventional
Recruitment status: Completed
Enrolment: 282 participants (actual)
Lead sponsor: Division of General Surgery , Mt. Sinai HospitalUniversity, hospital or other
Study start: 19 Jul 2017 (actual)
Primary completion: 21 Jan 2020 (actual)
Study completion: 21 Jan 2020 (actual)
First posted: 20 Jul 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
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	Other: Home To Stay Mobile Health ApplicationThe 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Home To Stay Mobile Health ApplicationHome 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.	Other	Intervention Group

Primary outcome

30-day re-admission
Time frame: 30 Days
Patient reported re-admission to any hospital within 30 days of discharge following surgery

4 secondary outcomes

30-day ER visits
Time frame: 30 Days
30-day primary care visits
Time frame: 30 Days
30-day unplanned health care visits
Time frame: 30 Days
Patient reported outcomes
Time frame: 30 Days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
Background: PubMed 17665252Guinier 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.
Background: PubMed 23730901Li 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.
Background: PubMed 22067174Wick 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.
Background: PubMed 23529659Burke 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.
Background: PubMed 26228016Ceppa 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.
Background: PubMed 19189907Jack 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.
Background: PubMed 27353404Jones 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.
Background: PubMed 33457571Keng 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.
Background: PubMed 25063074Sedgwick P, Hooper C. What are randomised consent designs? BMJ. 2014 Jul 25;349:g4727. doi: 10.1136/bmj.g4727. No abstract available.
Background: PubMed 23411725Stark 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.
Background: PubMed 30602332De 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.
Background: PubMed 33393925Patel 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Home To Stay Mobile Health Application in people with Colorectal Cancer and Inflammatory Bowel Diseases, run by Division of General Surgery , Mt. Sinai Hospital at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30-day re-admission (time frame: 30 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04968145, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.