Family Input for Quality and Safety

NCT03202888 | Completed

• 1 other identifier: FIQS
• Study Type: interventional
• Target: 435
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to create and evaluate a tool that gathers patient and family member feedback and makes it rapidly available to providers, enabling nimble and responsive safety and quality improvement efforts. Aim 1. Determine feasibility and acceptability of the patient data collection and provider dashboard tool. The investigators will conduct usability testing prior to study start, measure user (patients and providers) engagement over time, and gather feedback about the tool at study end. This will test the hypothesis that patient and caregiver characteristics will predict tool use. Aim 2. Assess whether reporting patient- and caregiver- observed processes of care to providers leads to changes over time. The investigators hypothesize that performance on structured items of interest will improve over time with rapidly available data presented to providers. Aim 3. Estimate tool implementation effect sizes, using a pre-post design, on medical errors.

Conditions

Patient Safety

Outcome Measures

Primary Outcomes (1)

• Change in rate of preventable medical errors or adverse events per 100 admissions

  This is a hospital unit-level outcome measure, assessing unit-level rate of adverse events and preventable medical errors in a time period before the intervention, and the unit-level rate at the end of the intervention. The investigators will apply standard definitions of medical errors as preventable failures in processes of care and adverse events as preventable and non-preventable unintended consequences of medical care that lead to patient harm. This is a composite measure and will be measured as total count of medical errors plus total count of adverse events per 100 admissions. The investigators will not track this measure across the same group of patients in the before and after periods. Participants will be included for the duration of their admission, which may vary. The rate will be measured cross-sectionally in both time periods.

  Measured cross-sectionally in the hospital unit at baseline for three months, and again for three months at the end of the intervention (months 10,11,12 of the intervention).

Study Arms (1)

Intervention

EXPERIMENTAL

After completing enrollment surveys, including measures of patient activation and medical knowledge, participants will be invited to use the novel IT. The technology is a mobile responsive website for survey data collection made by our technology vendor, QuesGen. Patients and family members will be able to access the website from any personal device with internet access: laptop, tablet, or smart phone. QuesGen will send a text message reminder to participants with a link to specific questionnaires at scheduled time intervals. Frequency of text messaging will likely be daily, but will ultimately reflect family and patient feedback in Aim 1. In addition to text reminders, participants will be able to answer questionnaires at-will by accessing the mobile responsive website.

Behavioral: Intervention

Interventions

Intervention BEHAVIORAL

QuesGen-created mobile responsive website tool, Family Input for Quality and Safety.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient and caregiver participants will be recruited from admitted patients and their family members on the medical-surgical units at UCSF's Benioff Children's Hospital during the study period.
• Eligible providers will be the participating hospitalists during the study period.
• All nurse managers on the units and the patient safety and quality managers for the units will be eligible. All nurses will be eligible on the participating units.

You may not qualify if:

• Patients who are youth in the foster care system will not be eligible.
• Patients or parents/guardians who do not have smart phones will not be eligible.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Benioff Children's Hospital

San Francisco, California, 94158, United States

Location

Related Publications (15)

• James JT. A new, evidence-based estimate of patient harms associated with hospital care. J Patient Saf. 2013 Sep;9(3):122-8. doi: 10.1097/PTS.0b013e3182948a69.

  PMID: 23860193 BACKGROUND

• Classen DC, Resar R, Griffin F, Federico F, Frankel T, Kimmel N, Whittington JC, Frankel A, Seger A, James BC. 'Global trigger tool' shows that adverse events in hospitals may be ten times greater than previously measured. Health Aff (Millwood). 2011 Apr;30(4):581-9. doi: 10.1377/hlthaff.2011.0190.

  PMID: 21471476 BACKGROUND

• Shekelle PG, Pronovost PJ, Wachter RM, Taylor SL, Dy SM, Foy R, Hempel S, McDonald KM, Ovretveit J, Rubenstein LV, Adams AS, Angood PB, Bates DW, Bickman L, Carayon P, Donaldson L, Duan N, Farley DO, Greenhalgh T, Haughom J, Lake ET, Lilford R, Lohr KN, Meyer GS, Miller MR, Neuhauser DV, Ryan G, Saint S, Shojania KG, Shortell SM, Stevens DP, Walshe K. Advancing the science of patient safety. Ann Intern Med. 2011 May 17;154(10):693-6. doi: 10.7326/0003-4819-154-10-201105170-00011.

  PMID: 21576538 BACKGROUND

• Landrigan CP, Parry GJ, Bones CB, Hackbarth AD, Goldmann DA, Sharek PJ. Temporal trends in rates of patient harm resulting from medical care. N Engl J Med. 2010 Nov 25;363(22):2124-34. doi: 10.1056/NEJMsa1004404.

  PMID: 21105794 BACKGROUND

• Chassin MR. Improving the quality of health care: what's taking so long? Health Aff (Millwood). 2013 Oct;32(10):1761-5. doi: 10.1377/hlthaff.2013.0809.

  PMID: 24101066 BACKGROUND

• Erasmus V, Daha TJ, Brug H, Richardus JH, Behrendt MD, Vos MC, van Beeck EF. Systematic review of studies on compliance with hand hygiene guidelines in hospital care. Infect Control Hosp Epidemiol. 2010 Mar;31(3):283-94. doi: 10.1086/650451.

  PMID: 20088678 BACKGROUND

• Conway PH, Mostashari F, Clancy C. The future of quality measurement for improvement and accountability. JAMA. 2013 Jun 5;309(21):2215-6. doi: 10.1001/jama.2013.4929. No abstract available.

  PMID: 23736730 BACKGROUND

• Blumenthal D, McGinnis JM. Measuring Vital Signs: an IOM report on core metrics for health and health care progress. JAMA. 2015 May 19;313(19):1901-2. doi: 10.1001/jama.2015.4862. No abstract available.

  PMID: 25919301 BACKGROUND

• Rossi P, Lipsey M, Freeman H. Evaluation: A Systematic Approach. 7th Edition ed: SAGE Publications, Inc; 2003.

  BACKGROUND

• Bardach NS, Asteria-Penaloza R, Boscardin WJ, Dudley RA. The relationship between commercial website ratings and traditional hospital performance measures in the USA. BMJ Qual Saf. 2013 Mar;22(3):194-202. doi: 10.1136/bmjqs-2012-001360. Epub 2012 Nov 23.

  PMID: 23178860 BACKGROUND

• Greaves F, Pape UJ, King D, Darzi A, Majeed A, Wachter RM, Millett C. Associations between Web-based patient ratings and objective measures of hospital quality. Arch Intern Med. 2012 Mar 12;172(5):435-6. doi: 10.1001/archinternmed.2011.1675. Epub 2012 Feb 13. No abstract available.

  PMID: 22331980 BACKGROUND

• Greaves F, Pape UJ, King D, Darzi A, Majeed A, Wachter RM, Millett C. Associations between Internet-based patient ratings and conventional surveys of patient experience in the English NHS: an observational study. BMJ Qual Saf. 2012 Jul;21(7):600-5. doi: 10.1136/bmjqs-2012-000906. Epub 2012 Apr 20.

  PMID: 22523318 BACKGROUND

• Han E, Hudson Scholle S, Morton S, Bechtel C, Kessler R. Survey shows that fewer than a third of patient-centered medical home practices engage patients in quality improvement. Health Aff (Millwood). 2013 Feb;32(2):368-75. doi: 10.1377/hlthaff.2012.1183.

  PMID: 23381530 BACKGROUND

• Clancy CM. Where we are a decade after To err is human. J Patient Saf. 2009 Dec;5(4):199-200. doi: 10.1097/PTS.0b013e3181c2114a. No abstract available.

  PMID: 22130210 BACKGROUND

• Guide to Patient and Family Engagement: Environmental Scan Report. October 2014; http://www.ahrq.gov/research/findings/final-reports/ptfamilyscan/ptfamilysum.html. Accessed June 10, 2015.

  BACKGROUND

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Naomi Bardach, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 29, 2017
• Study Start: June 26, 2017
• Primary Completion: April 27, 2018
• Study Completion: April 27, 2018
• Last Updated: October 26, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)