Social Networks and Renal Education: Promoting Transplantation

NCT03536858 | Completed DMC

• 1 other identifier: 11648
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

There are significant and persistent disparities in access to kidney transplantation and as a result most patients with end stage renal disease receive hemodialysis (HD). HD is unique as it is a treatment performed in a group setting which lends itself to forming social networks. The goal of this research study is to identify and characterize the social networks of HD patients and measure the influence of HD social networks on knowledge, attitudes, and behaviors towards transplantation using repeated surveys and a network targeted educational intervention.

Conditions

End Stage Renal Disease; Living Donor Kidney Transplantation; Renal Dialysis

Keywords

End Stage Renal Disease; Hemodialysis; Social Network

Outcome Measures

Primary Outcomes (4)

• Primary Knowledge Outcome: Differences in patient knowledge 3 months post-intervention

  The investigators will compare the differences in patient transplant knowledge three months post intervention to baseline knowledge. The investigators will compare survey questionnaire answers collected three months post-intervention to those collected pre-intervention. The investigators will use twelve true/false items on transplant knowledge items, summing the correctly answered items to create a composite knowledge score. The higher the composite score the greater the knowledge.

  Baseline to 3 months post intervention

• Primary Knowledge Outcome: Differences in patient knowledge 1 year post-intervention

  The investigators will compare the differences in patient knowledge regarding transplant one year post intervention to baseline knowledge. The investigators will compare survey questionnaire answers collected one year post-intervention to those collected pre-intervention. They investigators will use twelve true/false items on transplant knowledge items summing the correctly answered items to create a composite knowledge score. The higher the composite score the greater the knowledge.

  Baseline to 1 year post intervention

• Primary Behavioral Outcome: Differences in transplant steps completed 3 months post-intervention

  The investigators will measure the number of transplant steps completed. The investigators will measure the difference in the transplant step at three months and one year post intervention and compare that to the step prior to the intervention. The steps towards transplant include: 1) transplant suitability for referral to transplant center, 2) interest in transplantation, 3) referral call to transplant center, 4) first visit to transplant center, 5) transplant center work-up, 6) work-up complete, 7) active on the list, 8) successfully received a kidney transplant. A larger number indicates more steps completed.

  Baseline to 3 months post intervention

• Primary Behavioral Outcome: Differences in transplant steps completed 1 year post-intervention

  The investigators will measure the number of transplant steps completed. The investigators will measure the difference in the transplant step at three months and one year post intervention and compare that to the step prior to the intervention. The steps towards transplant include: 1) transplant suitability for referral to transplant center, 2) interest in transplantation, 3) referral call to transplant center, 4) first visit to transplant center, 5) transplant center work-up, 6) work-up complete, 7) active on the list, 8) successfully received a kidney transplant. A larger number indicates more steps completed.

  Baseline to 1 year post intervention

Secondary Outcomes (4)

• Completion of transplant work-up 3 months post intervention

  3 months post intervention

• Completion of transplant work-up 1 year post intervention

  1 year post intervention

• Asking for a living donor 3 months post-intervention

  3 months post intervention

• Asking for a living donor 1 year post-intervention

  1 year post intervention

Study Arms (2)

Centrality

ACTIVE COMPARATOR

The patients at clinic one who receive hemodialysis on Tuesday, Thursday, Saturday and the patients on the Monday, Wednesday, Friday schedule at clinic two, will be assigned to the Centrality arm. Two patients per hemodialysis shift with the highest centrality will be selected to participate in the COACH (Communicating about Choices in Transplantation) intervention. The patients selected by centrality will have a centrality greater than 1 standard deviation (SD) from the mean of the other patients on their hemodialysis clinic shift and a clustering less than 1 SD from the mean. The investigators will measure the spread of information, attitudes, and behaviors by comparing the targeted patients to the other patients on their shift.

Behavioral: COACH (Communicating about Choices in Transplantation)

Clustering

ACTIVE COMPARATOR

The patients at clinic one who receive hemodialysis on Monday, Wednesday, Friday and the patients on the Tuesday, Thursday, Saturday schedule at clinic two, will be assigned to the Clustering arm.Two patients per hemodialysis shift with the highest clustering coefficient will be selected to participate in the COACH (Communicating about Choices in Transplantation) intervention. The patient selected by clustering coefficient, will have a clustering coefficient greater than 1 SD from the mean of the other patients on their hemodialysis clinic shift and centrality 1 SD less than a mean. The investigators will measure the spread of information, attitudes, and behaviors by comparing the targeted patients to the other patients on their shift.

Behavioral: COACH (Communicating about Choices in Transplantation)

Interventions

COACH (Communicating about Choices in Transplantation) BEHAVIORAL

COACH is a behavioral communication intervention designed specifically for ESRD patients pursuing kidney transplantation. The COACH program consists of four modules: 1) Kidney transplant options, 2) Discussing your transplant options, 3) Requesting living donation, and 4) Maintaining positive relationships. The content and teaching strategies were guided by the concepts of social cognitive theory as well as principles of adult learning and communication skill acquisition. We believe that patients will transfer these skills to other patients at the hemodialysis clinic who are on their shift.

Centrality; Clustering

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients 18 years of age or older, able to consent to participation and respond to the validated survey in English, and who are present in the HD clinics during the initial survey periods, July 2018 to June 2022 are eligible to participate in the baseline network survey.
• Transplant eligible patients will be eligible to participate. All patients who participate will be evaluated via chart review by a study transplant nephrologist for transplant candidacy and, if eligible, the primary nephrologist will be asked whether the patient is an appropriate candidate and reasons they have not been referred. We will defer the transplant referral to the attending nephrologist. Our criteria for transplant ineligibility are nursing home resident, \>79 years of age, active or recent malignancy, inoperable coronary artery disease, or comorbid illness that will make it unlikely that the patient will survive \>3 years after transplant.

You may not qualify if:

• Patients who are unable or unwilling to provide consent or complete the survey in English .

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (3)

• Gillespie A, Fink EL, Traino HM, Uversky A, Bass SB, Greener J, Hunt J, Browne T, Hammer H, Reese PP, Obradovic Z. Hemodialysis Clinic Social Networks, Sex Differences, and Renal Transplantation. Am J Transplant. 2017 Sep;17(9):2400-2409. doi: 10.1111/ajt.14273. Epub 2017 Apr 21.

  PMID: 28316126 BACKGROUND

• Traino HM, West SM, Nonterah CW, Russell J, Yuen E. Communicating About Choices in Transplantation (COACH). Prog Transplant. 2017 Mar;27(1):31-38. doi: 10.1177/1526924816679844. Epub 2016 Nov 25.

  PMID: 27888276 BACKGROUND

• Calvelli H, Gardiner H, Gadegbeku C, Reese P, Obradovic Z, Fink E, Gillespie A. A Social Network Analysis of Hemodialysis Clinics: Attitudes Toward Living Donor Kidney Transplant among Influential Patients. Kidney360. 2024 Apr 1;5(4):577-588. doi: 10.34067/KID.0000000000000383. Epub 2024 Feb 7.

  PMID: 38324254 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Transplantation

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Avrum Gillespie

  Temple University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Hemodialysis staff will be unaware as to whether the patient was targeted based on their network centrality or clustering. Survey administrators will be unaware of which patient received the living donor intervention.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will assign every HD clinic shift to one of the two targeting strategies. They will measure the spread of information, attitudes, and behaviors by comparing the patients targeted to participate in the living donor intervention to the other patients on their shift.

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: May 25, 2018
• Study Start: October 23, 2018
• Primary Completion: July 26, 2022
• Study Completion: July 26, 2022
• Last Updated: January 12, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 7/2023
• Access Criteria: Proposal from researcher

Locations

US (1)