Brief Intervention to Prevent Poor Psychosocial Outcomes in Living Donors

Brief Nursing Intervention to Prevent Poor Psychosocial Outcomes in Living Donors

The purpose of this study is to evaluate the potential effectiveness of a psychosocial intervention based on the principles of motivational interviewing. The novel intervention will assist living donor candidates to think through any remaining concerns or questions that they may have about living donation. If the intervention is effective, it may help to prevent post-donation problems related to psychological and health outcomes.

Study Overview

• Status: Completed
• Conditions: Living Donation
• Intervention / Treatment: Behavioral: Motivational Interviewing; Behavioral: Healthy Lifestyles Education

Detailed Description

The protection of living donors' well-being and the prevention of any negative consequences of donation are among the foremost priorities in transplantation. Some donors experience poor psychosocial outcomes after donation, including psychological distress, poor perceived physical well-being, and strained family relationships. No preventive interventions have been mounted or tested for their ability to avert poor psychosocial outcomes in living donors. The present study will provide an initial test of a new intervention for this purpose. The new intervention utilizes motivational interviewing (MI) to address remaining concerns that individuals may have about proceeding with living donation. Study participants will be randomly assigned to either (a) participate in the MI intervention (during which they will be asked to answer a series of questions to help them better delineate their reasons for and against proceeding with living organ donation), (b) participate in a comparison intervention designed to inform them about healthy lifestyle habits, or (c) not receive any intervention. We plan to recruit a maximum of 150 adults who are considering whether to serve as living kidney or liver donors. We hypothesize that participants receiving the MI intervention will have superior outcomes (less psychological distress, fewer physical health complaints, better interpersonal relationships within their family, better overall quality of life)after donation.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Score of 1 or greater on the Simmons Ambivalence Scale;
• Must be able to speak English;
• Have been evaluated as a potential living kidney or liver donor candidate;
• Aged 18 or older

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motivational Interviewing; Subjects will receive two, individual telephone sessions with an interventionist, each lasting approximately 30-45 minutes. The sessions will focus on assisting subjects to delineate their reasons for or against proceeding with living organ donation and assisting subjects to resolve any lingering concerns about their decisions regarding donation.	Behavioral: Motivational Interviewing; Standard motivational interviewing techniques will be applied to assist subjects to consider and work to resolve any remaining concerns, doubts, or ambivalence about their decision about donating an organ to someone else.
Active Comparator: Enhanced Standard Care; Subjects will receive two individual telephone sessions with an interventionist, each lasting approximately 30-45 minutes. The sessions will focus on providing educational information to subjects regarding healthy lifestyle issues (healthy eating, diet, exercise, quitting smoking).	Behavioral: Healthy Lifestyles Education; Educational information will be presented to subjects in didactic form on lifestyles issues of relevance to living donors.
No Intervention: Standard Care; Subjects will receive the standard care and education provided by the Living Donor Program at their medical center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
psychological distress	PRIME-MD depression and anxiety modules, Brief Symptom Inventory (BSI) anxiety items, Simmons Feelings About Donation items; Simmons Psychosocial Concerns About Donation items	6 weeks post-donation
somatic/physical health perceptions	Concerns About Donation Effects items, Simmons Post-donation Medical Concerns, Brief Pain Inventory short form, FACIT-fatigue scale, Post-surgery Body Image Questionnaire, Post-donation Symptom Checklist, Simmons Concerns About Future Health items, Simmons Perceived Stressfulness of Donation items	6 weeks post-donation
interpersonal relationship quality and distress	Simmons Family Relationship items, Short Dyadic Adjustment Scale, Family ICPS conflict and intimacy subscales	6 weeks post-donation
quality of life	RAND-12	6 weeks post-donation
psychological distress	PRIME-MD depression and anxiety modules, BSI anxiety items, Simmons Feelings About Donation items; Simmons Psychosocial Concerns About Donation items	3 months post-donation
somatic/physical health perceptions	Concerns About Donation Effects items, Simmons Post-donation Medical Concerns, Brief Pain Inventory short form, FACIT-fatigue scale, Post-surgery Body Image Questionnaire, Post-donation Symptom Checklist, Simmons Concerns About Future Health items, Simmons Perceived Stressfulness of Donation items	3 months post-donation
interpersonal relationship quality and distress	Simmons Family Relationship items, Short Dyadic Adjustment Scale, Family ICPS conflict and intimacy subscales	3 months post-donation
quality of life	RAND-12	3 months post-donation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with intervention	adapted Client Satisfaction Scale	pre-donation (on average, 1 week post-intervention but before donation has occurred)
Quality of decision to donate	Simmons Ambivalence Scale items; Decision Conflict Scale, Decision Satisfaction Scale items	pre-donation (on average, 1 week post-intervention but before donation has occurred)

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Mary Amanda Dew, Ph.D., University of Pittsburgh

Publications and helpful links

General Publications

• Dew MA, DiMartini AF, DeVito Dabbs AJ, Zuckoff A, Tan HP, McNulty ML, Switzer GE, Fox KR, Greenhouse JB, Humar A. Preventive intervention for living donor psychosocial outcomes: feasibility and efficacy in a randomized controlled trial. Am J Transplant. 2013 Oct;13(10):2672-84. doi: 10.1111/ajt.12393. Epub 2013 Aug 7.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: October 26, 2010
• First Submitted That Met QC Criteria: November 2, 2010
• First Posted (Estimate): November 3, 2010

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 10, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: quality of life; mental health; organ donation; living donation; psychosocial factors; psychological adaptation; interpersonal relations; physical well-being
• Other Study ID Numbers: R21NR011149 (U.S. NIH Grant/Contract)