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NCT Number: NCT03656224

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

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.

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Key information

Conditions

Malignant Neoplasm Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Patients' perceptions regarding safety after acute inpatient rehabilitation

    Time frame: 1 month after discharge

    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.

Secondary outcomes

  1. Frequency of experiencing falls and/or near falls

    Time frame: 1 month after discharge

    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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 4, 2018
Registry last updated
Aug 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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