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Use of Financial Incentives to Increase Live Kidney Donor Follow-up Compliance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03090646
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : May 1, 2019
Sponsor:
Collaborators:
The Living Legacy Foundation
University of Maryland, College Park
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This study evaluates whether using small financial incentives increases patient compliance with nationally-mandated living kidney donor follow-up at 6-months, 1-year, and 2-years after donation. Half of participants will receive a financial incentive (mailed gift card) after completing required follow-up activities (brief questionnaire and lab draw), while the other half will be asked to complete the required follow-up activities but will not receive a financial incentive (current standard of care).

Condition or disease Intervention/treatment Phase
Living Donors Nephrectomy Kidney Other: Financial Incentive Not Applicable

Detailed Description:

Living kidney donors account for nearly a third of kidney transplants performed in the United States each year. While donor nephrectomy poses minimal post-surgical risk, donors face a small but measurable increase in the risk of developing kidney failure and other chronic diseases (including hypertension, chronic kidney disease, and diabetes) in the long-term. Routine screening presents an opportunity for the early detection and management of chronic conditions.

Transplant hospital reporting requirements mandate the submission of laboratory and clinical data at 6-months, 1-year, and 2-years after kidney donation, but less than 50% of hospitals are able to comply. Transplant hospitals commonly cite barriers such as donor inconvenience, direct and indirect costs to donors, donors not wanting to return to the program, and the burden of data collection. Tools to improve donor engagement and strategies that mitigate patient and administrative burden are needed.

Financial incentives have been employed in many realms of healthcare to change health-related behaviors. Financial incentives include a variety of rewards that have an economic value for the recipient, including cash payments, coupons, goods, and services, and have been shown to positively influence both simple (i.e. accomplished through a single action) and complex (i.e. accomplished repeatedly over a period of time, often involving sustained lifestyle modifications) health-related behaviors. However, prior work suggests that the effectiveness of financial incentives in achieving health behavior often varies based on the characteristics of the population and health behavior of interest and may decrease over time.

Given that patient-level factors are commonly cited by transplant hospitals as barriers to compliance with federally-mandated donor follow-up thresholds, financial incentives might be a valuable tool to promote patient engagement in postdonation monitoring efforts. However, given the uncertainty in the literature, a randomized controlled trial is necessary to evaluate the effectiveness of using financial incentivization to promote patient compliance with follow-up care in this setting.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized, controlled, nonblinded, two-arm, superiority trial with a 1:1 allocation ratio. Participants allocated to the intervention arm will receive up to three gift cards to a major online retailer in the mail after completion of the required 6-month, 1-year, and 2-year follow-up activities. Participants will be followed for the federally-mandated 2-year follow-up period.
Masking: Single (Outcomes Assessor)
Masking Description:

An analyst on the JHU study team (blind to group allocations) will use Stata 15/MP for Linux (College Station, TX, USA) to generate a list of sequential group assignments. This list will be used to create sequentially numbered, sealed, opaque envelopes that will be used to allocate participants to the control or intervention arms. Study personnel who create the sealed envelopes will not be involved in patient recruitment. Study personnel who conduct recruitment will not be permitted to view the list of sequential group assignment, and the envelopes will not be opened until after patients consent to participate. Therefore, group allocation will be concealed to both participants and recruiters until after study enrollment.

The study is not blinded to providers, patients, or study personnel conducting data collection, but will be blinded to outcome assessors.

Primary Purpose: Supportive Care
Official Title: Use of Financial Incentives to Increase Live Kidney Donor Follow-up Compliance
Actual Study Start Date : March 22, 2017
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 1, 2023

Arm Intervention/treatment
No Intervention: Standard of Care
Participants in the control arm will be instructed to attend required follow-up as is standard of care, but will not receive a financial incentive.
Experimental: Financial Incentive
Up to three gift cards to a major online retailer will be mailed to participants assigned to the intervention arm after complete (i.e. all components addressed) and timely (i.e. within the policy-defined follow-up period) submission of follow-up data at each 6-month, 1-year, and 2-year follow-up visit.
Other: Financial Incentive
Up to three gift cards to a major online retailer.
Other Name: Behavioral




Primary Outcome Measures :
  1. Patient Compliance with Follow-Up [ Time Frame: 2 years ]
    Rate of policy-defined complete (all components addressed) and timely (within 60 days before or after the 6-month, 1-year, or 2-year postdonation date; i.e. 120-day period) submission of data at 6-month, 1-year, and 2-year follow-up visits (assessed separately for each follow-up time point and as a composite outcome over the study period).


Secondary Outcome Measures :
  1. Hospital compliance with Reporting Requirements [ Time Frame: 2 years ]
    Transplant hospital-level compliance with OPTN reporting requirements (submission of clinical data for 80% and laboratory data for 75% of donors) at each visit (assessed separately for each follow-up time point and as a composite outcome over the study period).


Other Outcome Measures:
  1. Logistical Challenges of Intervention Implementation [ Time Frame: 2 years ]
    Data related to potential logistical challenges of implementing the intervention (e.g., number of mailing attempts necessary, failed delivery attempts, incorrect or out-of-date contact information, etc.).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (≥18 years)
  • Have undergone live donor nephrectomy at the Johns Hopkins Hospital Comprehensive Transplant Center (MDJH) or the University of Maryland Medical Center Transplant Center (MDUM).

Exclusion Criteria:

  • International live kidney donors
  • Non-English speaking live kidney donors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090646


Contacts
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Contact: Macey L. Henderson, PhD, JD 443-287-6649 macey@jhmi.edu
Contact: Dorry L. Segev, MD, PhD 410-502-6115 dorry@jhmi.edu

Locations
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United States, Maryland
University of Maryland Medical Center Transplant Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Joseph Scalea, MD         
Principal Investigator: Joseph Scalea, MD         
The Johns Hopkins Hospital Comprehensive Transplant Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Madeleine Waldram, BA         
Principal Investigator: Macey L Henderson, JD, PhD         
Sponsors and Collaborators
Johns Hopkins University
The Living Legacy Foundation
University of Maryland, College Park
Investigators
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Principal Investigator: Macey L. Henderson, PhD, JD Johns Hopkins University

Publications:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03090646    
Other Study ID Numbers: IRB00126158
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
social behavioral
living donor kidney transplant
follow-up
health utilization
incentives