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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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Patient and Family-Centered I-PASS is a bundle of communication interventions to improve the quality of information exchange between physicians, nurses, and families, and to better integrate families into all aspects of daily decision making in hospitals. This project tests the hypothesis that rates of medical errors and adverse events (primary outcome), hospital experience, communication, and shared understanding will improve following implementation of Patient and Family Centered I-PASS, as compared with current practice.
We conducted an intervention study on pediatric inpatient units in seven North American hospitals. Each site was assigned to one of 3 staggered waves of implementation and data collection. The Patient and Family Centered I-PASS intervention included a health literacy-informed, structured communication framework for family-centered rounds; written rounds summaries for families; a training and learning program; and strategies to support teamwork and implementation. We measured errors and adverse events (AEs) via an established systematic surveillance methodology, family experience via pre-discharge surveys, and communication processes via direct observations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-intervention | No Intervention | Before implementation of Patient and Family Centered I-PASS. | |
| Post-intervention | Experimental | After implementation of Patient and Family Centered I-PASS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient and Family Centered I-PASS | Behavioral | Patient and Family-Centered I-PASS is a bundle of communication interventions to improve the quality of information exchange between physicians, nurses, and families, and to better integrate families into all aspects of daily decision making in hospitals. The intervention included a health literacy-informed, structured communication framework for family-centered rounds; written rounds summaries for families; a training and learning program; and strategies to support teamwork and implementation. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Medical Errors | Our primary outcome was the rate of medical errors, including harmful errors (preventable adverse events) and non-harmful errors. Medical errors and adverse events were measured per 1000 patient-days before and after implementation of Patient and Family Centered I-PASS using an established systematic safety surveillance methodology. Trained research clinicians reviewed patient medical charts, hospital incident reports, family safety interviews, and staff reports for potential errors and adverse events. Trained physician-reviewers blinded to pre- vs. post-intervention status then categorized all suspected incidents as either adverse events, non-harmful errors, or exclusions. Adverse events that were clearly caused by a medical error were subsequently deemed preventable and all other cases were categorized as non-preventable. | 6 months (3 months pre, 3 months post) per site (7 sites total) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Non-Preventable Adverse Events | An additional measure of interest was the rate of non-preventable adverse events. Medical errors and adverse events were measured per 1000 patient-days before and after implementation of Patient and Family Centered I-PASS using an established systematic safety surveillance methodology. Trained research clinicians reviewed patient medical charts, hospital incident reports, family safety interviews, and staff reports for potential errors and adverse events. Trained physician-reviewers blinded to pre- vs. post-intervention status then categorized all suspected incidents as either adverse events, non-harmful errors, or exclusions. Adverse events that were clearly caused by a medical error were subsequently deemed preventable and all other cases were categorized as non-preventable. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher P Landrigan, MD, MPH | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Children's Hospital Stanford | Palo Alto | California | 94304 | United States | ||
| UCSF Benioff Children's Hospital San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25372088 | Background | Starmer AJ, Spector ND, Srivastava R, West DC, Rosenbluth G, Allen AD, Noble EL, Tse LL, Dalal AK, Keohane CA, Lipsitz SR, Rothschild JM, Wien MF, Yoon CS, Zigmont KR, Wilson KM, O'Toole JK, Solan LG, Aylor M, Bismilla Z, Coffey M, Mahant S, Blankenburg RL, Destino LA, Everhart JL, Patel SJ, Bale JF Jr, Spackman JB, Stevenson AT, Calaman S, Cole FS, Balmer DF, Hepps JH, Lopreiato JO, Yu CE, Sectish TC, Landrigan CP; I-PASS Study Group. Changes in medical errors after implementation of a handoff program. N Engl J Med. 2014 Nov 6;371(19):1803-12. doi: 10.1056/NEJMsa1405556. | |
| 28241211 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-intervention | Before implementation of Patient and Family Centered I-PASS. |
| FG001 | Post-intervention | After implementation of Patient and Family Centered I-PASS. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patient (n=1574, n=1532) characteristics derived from hospital administrative data. Parent (n=947, n=890), Physician (n=343, n=252), Nurse (n=191, n=139) characteristics derived from self-reported survey data. Missingness (which ranged 2.0%-9.7%, except for patient race and annual household income) was similar in pre- and post-intervention cohorts.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-intervention | Before implementation of Patient and Family Centered I-PASS. |
| BG001 | Post-intervention | After implementation of Patient and Family Centered I-PASS. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | A total of 132 subjects (4.3%) were missing data on age in pre-intervention and a total of 153 subjects (5.4%) were missing data on age in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 1.2%-11.6%. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Medical Errors | Our primary outcome was the rate of medical errors, including harmful errors (preventable adverse events) and non-harmful errors. Medical errors and adverse events were measured per 1000 patient-days before and after implementation of Patient and Family Centered I-PASS using an established systematic safety surveillance methodology. Trained research clinicians reviewed patient medical charts, hospital incident reports, family safety interviews, and staff reports for potential errors and adverse events. Trained physician-reviewers blinded to pre- vs. post-intervention status then categorized all suspected incidents as either adverse events, non-harmful errors, or exclusions. Adverse events that were clearly caused by a medical error were subsequently deemed preventable and all other cases were categorized as non-preventable. | Patients admitted to study units. | Posted | Number | 95% Confidence Interval | Medical errors per 1000 patient-days | 6 months (3 months pre, 3 months post) per site (7 sites total) |
|
Time on study unit, from admission to discharge, on average approximately 5 days.
Please see 'Rate of Medical Errors' and 'Rate of Non-Preventable Adverse Events' for detailed results on rates of adverse events pre- and post-intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-intervention | Before implementation of Patient and Family Centered I-PASS. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious Adverse Events | General disorders | Systematic Assessment | These adverse events are not related to the intervention and are adverse events captured system-wide as part of the study's main outcome. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other Adverse Events | General disorders | Systematic Assessment | These adverse events are not related to the intervention and are adverse events captured system-wide as part of the study's main outcomes. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Isabella Liss, Patient and Family Centered I-PASS SCORE Study Coordinator | Boston Children's Hospital | 857-218-3229 | isabella.liss@childrens.harvard.edu |
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| ID | Term |
|---|---|
| D003142 | Communication |
| ID | Term |
|---|---|
| D001519 | Behavior |
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|
| 6 months (3 months pre, 3 months post) per site (7 sites total) |
| Family Experience With Care | Family experience before and after implementation. Experience was measured using a 10-15 minute survey verbally administered prior to discharge. Parents were asked to rate various aspects of their experience with care. This included experience during and after rounds, experience with written communication, experience with physicians and nurses, and overall hospital experience. The survey was developed, cognitively tested, and piloted at a non-intervention site (Boston Children's Hospital) and translated into Arabic, Chinese, Russian, and Spanish. We compared percent top-box experience ratings pre- vs. post-intervention using a GEE chi-squared test for binary outcomes, clustered by site. Top-box score was calculated as the percentage of participants that gave the top-most response for the given survey item (e.g., 5=Extremely; 5=Excellent). Missing data was accounted for through use of multiple imputations appropriate for missing data in clustered studies. | 6 months (3 months pre, 3 months post) per site (7 sites total) |
| Quality of Communication on Rounds | Changes in quality of communication during rounds processes were assessed before and after implementation based on: (a) real-time structured direct observations of rounds (n=653) and (b) post-hoc analyses of audio-recordings of a subset of rounds observations (n=164). Research assistants conducted 1-hour weekly in-person rounds observation sessions per site, simultaneously completing a real-time assessment tool for each patient and audio-recording rounds. Site research clinicians blinded to pre- vs. post-intervention status conducted post-hoc analyses of a subset of rounds audio recordings using a structured assessment tool to measure rounding team adherence. Percent top-box ratings pre- vs. post-intervention were compared using a GEE chi-squared test for binary outcomes, clustered by site. Top-box score was calculated as the percentage of participants that gave the top-most response (e.g., 5=Excellent). Missing data were accounted for through use of multiple imputations. | 6 months (3 months pre, 3 months post) per site (7 sites total) |
| Shared Understanding Between Parent, Resident, and Nurse | Shared understanding between parent, resident, and nurse was measured before and after implementation of the Patient and Family Centered I-PASS intervention. | 6 months (3 months pre, 3 months post) per site (7 sites total) |
| San Francisco |
| California |
| 94158 |
| United States |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | United States |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | United States |
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Background |
| Khan A, Coffey M, Litterer KP, Baird JD, Furtak SL, Garcia BM, Ashland MA, Calaman S, Kuzma NC, O'Toole JK, Patel A, Rosenbluth G, Destino LA, Everhart JL, Good BP, Hepps JH, Dalal AK, Lipsitz SR, Yoon CS, Zigmont KR, Srivastava R, Starmer AJ, Sectish TC, Spector ND, West DC, Landrigan CP; the Patient and Family Centered I-PASS Study Group; Allair BK, Alminde C, Alvarado-Little W, Atsatt M, Aylor ME, Bale JF Jr, Balmer D, Barton KT, Beck C, Bismilla Z, Blankenburg RL, Chandler D, Choudhary A, Christensen E, Coghlan-McDonald S, Cole FS, Corless E, Cray S, Da Silva R, Dahale D, Dreyer B, Growdon AS, Gubler L, Guiot A, Harris R, Haskell H, Kocolas I, Kruvand E, Lane MM, Langrish K, Ledford CJW, Lewis K, Lopreiato JO, Maloney CG, Mangan A, Markle P, Mendoza F, Micalizzi DA, Mittal V, Obermeyer M, O'Donnell KA, Ottolini M, Patel SJ, Pickler R, Rogers JE, Sanders LM, Sauder K, Shah SS, Sharma M, Simpkin A, Subramony A, Thompson ED Jr, Trueman L, Trujillo T, Turmelle MP, Warnick C, Welch C, White AJ, Wien MF, Winn AS, Wintch S, Wolf M, Yin HS, Yu CE. Families as Partners in Hospital Error and Adverse Event Surveillance. JAMA Pediatr. 2017 Apr 1;171(4):372-381. doi: 10.1001/jamapediatrics.2016.4812. |
| 30518517 | Derived | Khan A, Spector ND, Baird JD, Ashland M, Starmer AJ, Rosenbluth G, Garcia BM, Litterer KP, Rogers JE, Dalal AK, Lipsitz S, Yoon CS, Zigmont KR, Guiot A, O'Toole JK, Patel A, Bismilla Z, Coffey M, Langrish K, Blankenburg RL, Destino LA, Everhart JL, Good BP, Kocolas I, Srivastava R, Calaman S, Cray S, Kuzma N, Lewis K, Thompson ED, Hepps JH, Lopreiato JO, Yu CE, Haskell H, Kruvand E, Micalizzi DA, Alvarado-Little W, Dreyer BP, Yin HS, Subramony A, Patel SJ, Sectish TC, West DC, Landrigan CP. Patient safety after implementation of a coproduced family centered communication programme: multicenter before and after intervention study. BMJ. 2018 Dec 5;363:k4764. doi: 10.1136/bmj.k4764. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall). | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Pre-intervention |
Before implementation of Patient and Family Centered I-PASS. |
| OG001 | Post-intervention | After implementation of Patient and Family Centered I-PASS. |
|
|
| Secondary | Rate of Non-Preventable Adverse Events | An additional measure of interest was the rate of non-preventable adverse events. Medical errors and adverse events were measured per 1000 patient-days before and after implementation of Patient and Family Centered I-PASS using an established systematic safety surveillance methodology. Trained research clinicians reviewed patient medical charts, hospital incident reports, family safety interviews, and staff reports for potential errors and adverse events. Trained physician-reviewers blinded to pre- vs. post-intervention status then categorized all suspected incidents as either adverse events, non-harmful errors, or exclusions. Adverse events that were clearly caused by a medical error were subsequently deemed preventable and all other cases were categorized as non-preventable. | Patients admitted to study units. | Posted | Number | 95% Confidence Interval | Non-preventable AE per 1000 patient-days | 6 months (3 months pre, 3 months post) per site (7 sites total) |
|
|
|
| Secondary | Family Experience With Care | Family experience before and after implementation. Experience was measured using a 10-15 minute survey verbally administered prior to discharge. Parents were asked to rate various aspects of their experience with care. This included experience during and after rounds, experience with written communication, experience with physicians and nurses, and overall hospital experience. The survey was developed, cognitively tested, and piloted at a non-intervention site (Boston Children's Hospital) and translated into Arabic, Chinese, Russian, and Spanish. We compared percent top-box experience ratings pre- vs. post-intervention using a GEE chi-squared test for binary outcomes, clustered by site. Top-box score was calculated as the percentage of participants that gave the top-most response for the given survey item (e.g., 5=Extremely; 5=Excellent). Missing data was accounted for through use of multiple imputations appropriate for missing data in clustered studies. | English-, Arabic-, Chinese-, Russian-, and Spanish-speaking parents/caregivers of <18-year-old patients on the study units were eligible to participate. Of these, 6-8 per week per site were randomly selected and surveyed 24 hours prior to discharge about their experiences with various aspects of communication. | Posted | Number | 95% Confidence Interval | Top-box percentage | 6 months (3 months pre, 3 months post) per site (7 sites total) |
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|
|
| Secondary | Quality of Communication on Rounds | Changes in quality of communication during rounds processes were assessed before and after implementation based on: (a) real-time structured direct observations of rounds (n=653) and (b) post-hoc analyses of audio-recordings of a subset of rounds observations (n=164). Research assistants conducted 1-hour weekly in-person rounds observation sessions per site, simultaneously completing a real-time assessment tool for each patient and audio-recording rounds. Site research clinicians blinded to pre- vs. post-intervention status conducted post-hoc analyses of a subset of rounds audio recordings using a structured assessment tool to measure rounding team adherence. Percent top-box ratings pre- vs. post-intervention were compared using a GEE chi-squared test for binary outcomes, clustered by site. Top-box score was calculated as the percentage of participants that gave the top-most response (e.g., 5=Excellent). Missing data were accounted for through use of multiple imputations. | Observations and audio-recordings of rounds were conducted at each site for one hour at a time on a randomly selected day each week. A median of 3 (IQR 2,5) patients were observed and recorded per session. Of these, 2 patients per week per site were randomly selected for post-hoc analysis. | Posted | Number | 95% Confidence Interval | Top-box percentage | 6 months (3 months pre, 3 months post) per site (7 sites total) |
|
|
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| Secondary | Shared Understanding Between Parent, Resident, and Nurse | Shared understanding between parent, resident, and nurse was measured before and after implementation of the Patient and Family Centered I-PASS intervention. | These data were collected but final analyses are still pending. The shared understanding measure was a novel secondary measure in this study, and the analysis was more complex than initially anticipated. Therefore, the number of participants analyzed is currently 0. | Posted | 6 months (3 months pre, 3 months post) per site (7 sites total) |
|
|
| 0 |
| 1,574 |
| 165 |
| 1,574 |
| 0 |
| 1,574 |
| EG001 | Post-intervention | After implementation of Patient and Family Centered I-PASS. | 0 | 1,532 | 95 | 1,532 | 0 | 1,532 |
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| Male |
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| Male |
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| Male |
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| Black |
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| White |
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| Other |
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| Asian |
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| Black |
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| White |
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| Other |
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| Asian |
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| Black |
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| White |
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| Other |
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| Asian |
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| Black |
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| White |
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| Other |
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| Explanation of changes to look out for |
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| Satisfied with opportunity to ask questions on FCR |
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| Medical team listened to family concerns |
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| Family was included in decision making |
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| Family felt important in their role on rounds |
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| Family respectfully spoken to on rounds |
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| Quality of communication during morning rounds |
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| Satisfaction with frequency of updates on child |
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| Quality of update explanations |
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| Inclusion in decision making later in day |
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| Frequency of written updates |
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| Understood written updates provided |
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| Usefulness of written updates |
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| Shared understanding with doctors of medical plan |
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| Doctors addressed family concerns |
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| MDs made family feel important part of care team |
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| Shared understanding with nurses of medical plan |
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| Nurses addressed family concerns |
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| RNs made family feel important part of care team |
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| Teamwork among nurses and doctors |
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| Understood reason for child's hospital stay |
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| Understood requirements for child's discharge |
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| Overall quality of child's care |
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| Quality of communication during hospital stay |
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| Nurse engagement |
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| Family engagement |
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| Written summary provided to family |
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| Family expressed concerns at start of rounds |
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| Family reporting of illness severity |
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| Family synthesis (i.e., reading back) of key items |
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| Effective use of plain language by providers |
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