Brief Intervention to Prevent Poor Psychosocial Outcomes in Living Donors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Brief Nursing Intervention to Prevent Poor Psychosocial Outcomes in Living Donors

Conditions
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Living Donation

Intervention / Treatment
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* Behavioral: Motivational Interviewing
* Behavioral: Healthy Lifestyles Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational Interviewing<br>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<br>* 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.<br>|
| Active Comparator: Enhanced Standard Care<br>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<br>* Educational information will be presented to subjects in didactic form on lifestyles issues of relevance to living donors.<br>|
| No Intervention: Standard Care<br>Subjects will receive the standard care and education provided by the Living Donor Program at their medical center. | |

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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living donation, organ donation, psychological adaptation, mental health, physical well-being, interpersonal relations, quality of life, psychosocial factors