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

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03656224
• Other study ID #: 2018-0104
• Secondary ID: NCI-2018-0174920
• Status: Completed
• Start date: August 29, 2018
• Est. completion date: August 16, 2021

Study information

• Verified date: August 2021
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: August 16, 2021
• Est. primary completion date: August 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Other:
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   MD Anderson Cancer Center Website