Survey of Post-Acute Inpatient Rehabilitation Safety Concerns in Participants With Cancer

Survey of Post-Acute Inpatient Rehabilitation Safety Concerns in the Cancer Population

This trial studies a survey of post-acute inpatient rehabilitation safety concerns in participants with cancer. Collecting patients' feedback via surveys may help doctors to learn more about the safety concerns that patients have when they are discharged from the acute inpatient cancer rehabilitation unit.

Study Overview

• Status: Completed
• Conditions: Malignant Neoplasm
• Intervention / Treatment: Other: Survey Administration

Detailed Description

PRIMARY OBJECTIVES:

I. Assess patients' perceptions regarding safety after acute inpatient rehabilitation at discharge and after approximately one month from discharge date.

SECONDARY OBJECTIVES:

I. Assess patient's perception of factors impacting continuity of care at discharge and after approximately one month from discharge date.

II. Determine the frequency of reported falls and the circumstance surrounding reported falls during hospitalization and within approximately one month from discharge date.

III. Determine the frequency of reported near falls and the circumstance surrounding reported near falls within approximately one month from discharge date.

IV. Identify demographic and clinical characteristics associated with feeling safe and unsafe.

OUTLINE:

Participants complete surveys over 15 minutes at 1-2 days before discharge and at 1 month after discharge.

• Study Type: Observational
• Enrollment (Actual): 261

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants who are discharged from the acute cancer inpatient rehabilitation unit to personal residence

Description

Inclusion Criteria:

• All patients who are discharged from the acute cancer inpatient rehabilitation unit to personal residence (house, apartment, condominium, hotel, assisted living, etc.)
• Patients who provide informed consent
• English-speaking participants

Exclusion Criteria:

• Patients discharged to another hospital or health facility (Skilled Nursing Facility [SNF], Long Term Acute Care Hospital [LTACH], inpatient hospice, etc.)
• Patients with moderate to severe cognitive deficits as determined by speech language pathologist and/or rehabilitation physician
• Patients who were re-hospitalized at any time during study period (since completion of first survey in the hospital and discharged from the hospital until approximately one month after discharge
• Patients who were readmitted to acute inpatient rehabilitation service and previously completed both surveys

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (survey); Participants complete surveys over 15 minutes at 1-2 days before discharge and at 1 month after discharge.	Other: Survey Administration; Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' perceptions regarding safety after acute inpatient rehabilitation	Will be assessed by Patient Continuity of Care Checklist and Perceptions Regarding Safety after Rehabilitation. At the end of study, patients' demographics and clinical characteristics will be summarized for all the patients who participated in the study by standard descriptive statistics such as mean, standard deviation, median, and range for continuous variables and frequency and proportion for categorical variables. The association between these characteristics and feeling safe will be evaluated by Wilcoxon rank sum test and chi-square (or Fisher's exact) test for continuous and categorical variables, respectively. The proportion of patients who claim they feel safe at each time will be estimated and reported along with the 95% Clopper-Pearson exact confidence interval. McNemar's test will be applied to evaluate whether the status of feeling safe has changed from the time of discharge to one month afterwards.	1 month after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of experiencing falls and/or near falls	Will be calculated and reported along with a 95% confidence interval. Furthermore, circumstances surrounding reported falls collected by question 19 and 20 in the survey will be summarized by descriptive statistics. Answers about other aspects of safety concerns collected by the questionnaire will be reported by descriptive statistics. To further investigate the association of sociodemographic and disease characteristics of patients with their perception of safety logistic regression models may be applied. Answers to "Patient Continuity of Care Checklist" questionnaire will be summarized and subscale scores will be calculated. Subscale scores will be compared between patients with different safety perception by applying Wilcoxon rank sum test. All tests will be performed two-sided and at 5% nominal significance level unless otherwise stated. Other statistical approaches may be utilized when appropriate.	1 month after discharge

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jegy Tennison, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2018
• Primary Completion (Actual): August 16, 2021
• Study Completion (Actual): August 16, 2021

Study Registration Dates

• First Submitted: August 27, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): September 4, 2018

Study Record Updates

• Last Update Posted (Actual): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2018-0104 (Other Identifier: M D Anderson Cancer Center); NCI-2018-01749 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No