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OpenTrials
Completed

NCT Number: NCT04666844

Predicting Transfers to Hemodialysis in Peritoneal Dialysis Patients Using the Surprise Question

The investigators will assess the prediction performance of the modified Surprise Question (Will the participant be surprised if this patient transfers to hemodialysis in the next 6 months?) for identification of peritoneal dialysis at high risk of transfer to hemodialysis. The investigators will also assess the prediction performance of a modified mortality surprise question (Will the participant be surprised if this patient dies in the next 6 months?).

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Key information

Conditions

Peritoneal Dialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Satellite Healthcare Inc

San Jose, California, 95128, United States

About this study

Physicians and nurses will be asked two questions regarding each of their peritoneal dialysis patients:

  • Will the participant be surprised if this patient transfers to hemodialysis in the next 6 months?
  • Will the participant be surprised if this patient dies in the next 6 months?

Patients will be followed for 6 months for outcomes (with two extra months for ascertainment of outcomes).

Who can participate

Healthy volunteers accepted: No

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

Patients:

Inclusion criteria

  • Incident and prevalent PD population at Satellite Healthcare

Exclusion criteria

  • Age < 18 years
  • Patients already enrolled in hospice
  • Patients on PD training
  • Patients on backup hemodialysis

Treatment and study plan

No intervention

Other

Observational Study

Primary outcomes

  1. Performance measures of the modified surprise question answered by the physicians as a prediction instrument for transfer to hemodialysis of peritoneal dialysis patients in 6 months.

    Time frame: at 6 months

Secondary outcomes

  1. Performance measures of the modified SQ Responses of the nurses to predict Transfers to hemodialysis

    Time frame: at 6 months

  2. Performance measures of the mortality SQ Responses of the physician and nurses to predict death

    Time frame: at 6 months

  3. Performance of prediction model for transfer to HD developed from variables obtained at baseline.

    Time frame: at 0 months

  4. Comparison of performance of baseline variables model to performance of the SQ model, and to a model that combines baseline variables and the SQ.

    Time frame: at 6 month

  5. Rate of hospitalizations in patients identified as high risk by the surprise question.

    Time frame: at 6 months

  6. Rate of peritonitis in patients identified as high risk by the surprise question.

    Time frame: at 6 months

  7. Proportion of patients identified as high risk who transition to HD.

    Time frame: At time of transfer to hemodialysis, for those who transfer to hemodialysis within the observation period, which is 6 months from response to the surprise question

  8. Proportion of patients who transition to HD who (i) start Home HD and those who (ii) start HD with AVF/AVG - in the whole group and among those identified high or low risk by the surprise question.

    Time frame: At time of transfer to hemodialysis, for those who transfer to hemodialysis within the observation period, which is 6 months from response to the surprise question

  9. Evaluating the agreement of assessments made by the primary nephrologist and the primary nurse of the patient

    Time frame: at baseline

  10. Factors associated with predictions made by the MD and nurse.

    Time frame: at baseline

Sponsors and collaborators

Lead sponsor

Satellite Healthcare

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Dec 14, 2020
Registry last updated
Jul 26, 2022

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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