Behavioral Contract Adherence Intervention

December 20, 2013 updated by: University of Tennessee

Behavioral Contract Intervention to Improve Adherence Among Renal Transplant Recipients

There is a critical gap in the knowledge on how to implement effective interventions for renal transplant recipients (RTRs) to improve immunosuppressant therapy (IST) adherence and clinical outcomes. The objectives of this project were to address this gap through: (1) designing, implementing, and evaluating a patient-specific behavioral contract intervention to improve RTRs' IST adherence rates (contracts are written, signed agreements between the RTR and healthcare provider in which the RTR agrees to be adherent to IST according to mutually agreed upon criteria); and (2) measuring the effects of IST adherence on RTRs' health-related quality of life (HQoL) and healthcare utilizations and costs. The primary hypothesis was that at one year post trial enrollment, RTRs who establish behavioral contracts with healthcare professionals will be more adherent than those who do not establish behavioral contracts and subsequently will have greater HQoL and lower healthcare utilizations and costs. Once it is better understood how to implement effective IST adherence intervention programs, clinicians will have a valuable tool to promote therapeutic success, improve HQoL, and reduce healthcare utilizations and costs. Therefore, we pursued the following Specific Aims: (1) determine the effectiveness of an IST adherence contract-based intervention on IST adherence; (2) determine the relationship between IST adherence, the intervention, and RTRs' HQoL; and (3) determine the influence of IST adherence and the intervention on RTRs' healthcare utilizations/costs. To achieve the Specific Aims, a randomized controlled trial of the patient-specific behavioral contract-based intervention was conducted, and data regarding adherence, HQoL, and healthcare utilizations/costs were collected over a 12-month period for each RTR study participant and analyzed. This project will promote healthy lives, increase well-being, and reduce burden of illness and disparity among adult RTRs by providing data regarding an adherence intervention and the impact of IST adherence and the behavioral contract intervention on RTRs' health and economic outcomes and HQoL. Collectively, this new knowledge will provide critical steps toward optimizing RTRs' graft maintenance, productivity, and HQoL, while decreasing graft rejection, return to dialysis, morbidity, mortality, and healthcare costs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85721
        • University of Arizona College of Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • renal transplant recipient
  • at least 21 years of age
  • receive an immunosuppressant regimen that contains oral cyclosporine or tacrolimus
  • be at least one year post-transplant
  • obtain immunosuppressant therapy from Avella Specialty Pharmacy for at least one year prior to study enrollment and during the study period

Exclusion Criteria:

  • pregnant
  • prisoner
  • institutionalized
  • unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
No intervention
Experimental: Intervention Group
Behavioral contract intervention
Behavioral: Behavioral Contract
Intervention activities were performed by a study clinical pharmacist. Behavioral contract goal was achieving and maintaining IST adherence. Other components of the contract addressed: (a) motivation(s) or positive reinforcement for achieving IST adherence; (b) problems or barriers that may interfere with achieving IST adherence and possible solutions to overcome problems/barriers; (c) social support available to the RTR such as a significant other who may assist the RTR in following the IST dosing schedule; (d) tools/strategies the RTR may use to remind himself/herself to follow the IST dosing schedule; and (e) possible consequences of IST nonadherence (e.g., graft loss).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Average Immunosuppressant Therapy Adherence for 12-month Study Period
Time Frame: 12 months

Immunosuppressant therapy adherence as measured by pharmacy refill records. Adherence was calculated quarterly for one year by using the number of days between prescription (IST) refills. If the total number of days between refills was less than or equal to the total days' supply of IST, the participant's adherence rate was 1.0, or 100%. If the number of days between refills was greater than the days' supply, the adherence rate was calculated as follows:

1 - [(Days Between Refills - Total Days Supply)/Days Between Refills] = Adherence Rate for Quarterly Time Period

At the end of the 12-month study period, the quarterly adherence rates were averaged to produce an overall adherence rate for the study period.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related Quality of Life (HQoL)
Time Frame: 12 months
The EQ-5D is a multi-attribute, preference-based HQoL instrument. Considered a global HQoL measure, the EQ-5D is a descriptive system that classifies respondents into one of 243 distinct health states based on five dimensions (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has three levels, reflecting "no problems," "some problems," and "extreme problems." A scoring function assigns a value (EQ-5DIndex score) to self-reported health states from a set of preference weights that have been empirically derived. The EQ-5D's total scale (preference value) range is from 0 to 1.0. On this scale, the preference value of 1.0 represents perfect health and 0.0 represents death. Preference values less than 0 are possible, but not reflected on the scale, and reflect health states that the U.S. population consider worse than death.
12 months
Days in Hospital
Time Frame: 12 months

We used a standardized patient reporting approach to collect direct healthcare utilizations data, including days in hospital. A brief healthcare screening questionnaire was administered to both the intervention and control groups on a monthly basis during the one-year study period. Monthly recall periods were chosen to minimize bias and forgetfulness. The questionnaire collected the number of times each month a participant utilized a direct medical service, specifically, days in hospital, emergency department (ED) visit, outpatient visit (clinic, physician office), and home healthcare visit.

Analysis compared proportion of each group who had at least one day in hospital during the 12-month study period.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Marie A Chisholm-Burns, PharmD, University of Tennessee College of Pharmacy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

November 29, 2012

First Submitted That Met QC Criteria

November 29, 2012

First Posted (Estimate)

December 3, 2012

Study Record Updates

Last Update Posted (Estimate)

February 7, 2014

Last Update Submitted That Met QC Criteria

December 20, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 7R01DK081347-04 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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