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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04968145
• Other study ID #: HomeToStay
• Status: Completed
• Phase: N/A
• Start date: July 19, 2017
• Est. completion date: January 21, 2020

Study information

• Verified date: July 2021
• Source: Division of General Surgery , Mt. Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: January 21, 2020
• Est. primary completion date: January 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• 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).

Related Conditions & MeSH terms

• Colorectal Cancer
• Inflammatory Bowel Diseases
• Surgery
• Utilization, Health Care

Intervention

Other:
• Home 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.

Locations

Country	Name	City	State
Canada	Mt Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Division of General Surgery , Mt. Sinai Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

Dahlberg K, Philipsson A, Hagberg L, Jaensson M, Hälleberg-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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Sedgwick P, Hooper C. What are randomised consent designs? BMJ. 2014 Jul 25;349:g4727. doi: 10.1136/bmj.g4727. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day re-admission	Patient reported re-admission to any hospital within 30 days of discharge following surgery	30 Days
Secondary	30-day ER visits	Patient reported presentation to any hospital emergency room within 30 days of discharge following surgery	30 Days
Secondary	30-day primary care visits	Patient reported presentation to their primary care physician within 30 days of discharge following surgery	30 Days
Secondary	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.	30 Days
Secondary	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	30 Days