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How Do Structural Social Determinants of Health Affect AKT-MP and Outcomes

Primary Purpose

Kidney Diseases, Social Determinants of Health

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Kidney Transplant Fast Track (KTFT)
Peer Navigation (PN)
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Kidney Diseases focused on measuring Transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Undergoing kidney transplant evaluation at the University of New Mexico
  2. Greater than or equal to 18 years of age
  3. Mentally competent

Exclusion Criteria:

  1. Inclusion across the lifespan - children less than 18 years of age are excluded because all research-related measurements are designed for patients over the age of 18. Children less than 18 years of age have dissimilar decision-making authority as a result of their developmental stage and dependency on adult guardians who must make all their transplant-related decisions, as required by all pediatric transplant centers. The proposed study focuses only on adult transplant patients.
  2. Waitlisted or undergoing evaluation at another transplant center
  3. Prior kidney transplant
  4. Incarcerated patients
  5. Pregnant women
  6. Active systemic infection
  7. Non-skin malignancy or melanoma in the past 2 years
  8. Known cognitive impairment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    KTFT

    PN

    Arm Description

    Outcomes

    Primary Outcome Measures

    Time to Transplant
    Time from evaluation initiation to receipt of transplant

    Secondary Outcome Measures

    Type of transplant received
    Living or deceased donor kidney transplant received

    Full Information

    First Posted
    October 20, 2022
    Last Updated
    July 31, 2023
    Sponsor
    University of New Mexico
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05597982
    Brief Title
    How Do Structural Social Determinants of Health Affect AKT-MP and Outcomes
    Official Title
    How Do Structural Social Determinants of Health Affect AKT-MP and Outcomes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI confirmed this study was withdrawn and did not begin locally.
    Study Start Date
    July 31, 2023 (Actual)
    Primary Completion Date
    July 31, 2023 (Actual)
    Study Completion Date
    July 31, 2023 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of New Mexico

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Our parent award compares two patient-centered methods to facilitate KT evaluation: kidney transplant fast track (FT), a streamlined KT evaluation process; and peer navigators (PN), a peer assisted evaluation program that incorporates motivational interviewing. This pragmatic randomized trial uses a comparative effectiveness approach to assess whether FT or PN can help patients overcome barriers to transplant listing. The aims of the parent study are to: (1) compare FT and PN to assess improvements in kidney transplant (KT) related outcomes and cost effectiveness; (2) examine how each approach effects changes in cultural/contextual factors, concerns about, and ambivalence to KT; and (3) develop a framework for widespread implementation of either approach. Recent guidelines encourage using PhenX toolkit measures for kidney-disease research and clinical data reporting, but research to date has been limited by cross sectional or retrospective analyses, and incomplete or missing data on key variables, and show limited clinical application or interventions. In addition to the several PhenX individual social determinants of health (SDOH) already collected for the parent award, we propose to add PhenX structural SDOH, including concentrated poverty, food swamp, race/ethnic segregation, and social vulnerability, to our baseline data collection for all 398 patient participants under the proposed administrative supplement. Also, we will add a third assessment to determine how and whether the intervention affected post-transplant outcomes. We will follow patients via their medical records through receipt of KT to determine time to receive transplant (from time evaluation started), and type of transplant received (living or deceased donor KT). At ~6 months post-KT, participants will complete a third interview to assess KT patient reported outcomes, including health-related quality of life (QOL) and satisfaction with service.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Diseases, Social Determinants of Health
    Keywords
    Transplant

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    KTFT
    Arm Type
    Experimental
    Arm Title
    PN
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Kidney Transplant Fast Track (KTFT)
    Intervention Description
    Streamlined KT evaluation involving completion of most or all testing on the same day a patient arrives for their first pre-transplant clinic appointment. Or, a transplant clinic scheduler secures testing within a 4 week period.
    Intervention Type
    Other
    Intervention Name(s)
    Peer Navigation (PN)
    Intervention Description
    Uses trained, previous KT recipients who meet weekly to monthly with patient participants to provide tailored information and assistance in completing the necessary steps to proceed to transplant.
    Primary Outcome Measure Information:
    Title
    Time to Transplant
    Description
    Time from evaluation initiation to receipt of transplant
    Time Frame
    Through study completion, an average of 2-3 years
    Secondary Outcome Measure Information:
    Title
    Type of transplant received
    Description
    Living or deceased donor kidney transplant received
    Time Frame
    Through study completion, an average of 2-3 years
    Other Pre-specified Outcome Measures:
    Title
    Patient Reported Quality of Life using the PROMIS Scale v1.2 Global Health
    Description
    We will use Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 Global Health measure to assess quality of life (QOL). It includes items relevant to patients with kidney disease, including overall health, physical limitations, work, pain, energy, and emotional problems. The measure is brief, based on extensive item banks, has been validated in general and CKD populations, and is favored by the International Consortium for Health Outcomes Measurement (ICHOM) CKD Working Group.
    Time Frame
    Through study completion, an average of 2-3 years
    Title
    Satisfaction with service using the Client Satisfaction Questionnaire
    Description
    Assesses patient reported satisfaction with services received by the transplant clinic team using the Client Satisfaction Questionnaire by Attkisson and colleagues. The measure is brief, and has been used in many clinical populations, along with our previous research CKD and kidney transplant studies.
    Time Frame
    Through study completion, an average of 2-3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Undergoing kidney transplant evaluation at the University of New Mexico Greater than or equal to 18 years of age Mentally competent Exclusion Criteria: Inclusion across the lifespan - children less than 18 years of age are excluded because all research-related measurements are designed for patients over the age of 18. Children less than 18 years of age have dissimilar decision-making authority as a result of their developmental stage and dependency on adult guardians who must make all their transplant-related decisions, as required by all pediatric transplant centers. The proposed study focuses only on adult transplant patients. Waitlisted or undergoing evaluation at another transplant center Prior kidney transplant Incarcerated patients Pregnant women Active systemic infection Non-skin malignancy or melanoma in the past 2 years Known cognitive impairment

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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