Clinical trial NCT06173323: A Stakeholder-enhanced Intervention to Improve the Decisional Partnership of Chronic Kidney Disease Dyads (IMPART)
Official title: An Optimization Trial of a Stakeholder-enhanced Intervention to Improve the Decisional Partnership of Chronic Kidney Disease Dyads (IMPART)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Decision Making, Shared
Family Caregiving
Chronic Kidney Disease
Keywords: chronic kidney disease
shared decision making
family caregiving
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-12-15
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this study is to pilot test, an optimization trial approach to develop and refine the decision partnering skills of persons with stage 4 chronic kidney disease and their caregivers. Using a 2x2x2 full factorial design, 64 dyads (patients and one identified caregiver) will be randomized to receive one or more lay coach-delivered decision partnering training components, based on Pearlin's Stress-Health Model of Family Caregiving and Rini's Social Support Effectiveness theory. The components include: 1) caregiver coaching on effective decision support (1 vs. 3 sessions); 2) caregiver decision support communication training (1 session vs. none); and 3) patient social support effectiveness psychoeducation (yes vs. no).

Detailed description: Of the estimated 37 million U.S. adults with chronic kidney disease (CKD), many who are newly diagnosed with advancing CKD rely on the support of family caregivers to help cope with serious illness and make health-related decisions, such as dialysis and end of life choices. Underprepared family and patient decision-makers may lack CKD knowledge, have poor disease understanding, and unclear expectations about treatments, especially at the end of life. Underprepared CKD dyads (patient and caregiver) may experience greater decisional conflict, ineffective coping, and heightened distress compared to adequately prepared ones. Black CKD patients and their families who face discrimination experience additional obstacles when navigating health-related decisions.

There is a critical need to train CKD dyads to effectively partner with each other and their clinicians when contemplating treatment related decisions, early in disease trajectory to increase trust and enhance communication. However, few interventions exist to enhance dyad skills in effectively requesting the specific support and resources they need to successfully navigate decision-making and to manage their illness experience. To date, systematic reviews and national reports have highlighted how interventions to optimize health-related decision-making in CKD have focused mainly on the patient and have not included the family caregiver, particularly in historically excluded populations. Furthermore, nearly all work has focused on interventions for specific CKD medical decisions and not the broader landscape of health-related decision-making along the CKD illness trajectory (i.e., biopsy, medication regiment, diet and nutrition). To develop an intervention to enhance the decision-making partnership between CKD dyads, the investigators have identified intervention components from other caregiving interventions that focus on optimizing the dyad's ability to partner in decision-making earlier in the course of illness. However, it is unknown which of these components and component combinations might best comprise a packaged intervention that optimizes patient and caregiver health-related decision-making as related to advancing CKD. Traditional intervention development approaches typically treat interventions as "bundled" treatment packages, making it difficult to determine which components of an intervention are effective. Hence, the investigators propose an intervention development and testing approach using the Multiphase Optimization Strategy (MOST), aiming to develop and test intervention components more efficiently.

Study Objective: The overall purpose of this study is to pilot test components of ImPart (Improving Chronic Kidney Disease Decisional Partnerships), a telehealth, decision support training intervention for stage 4 CKD dyads (2 estimated glomerular filtration rate \[eGFR\] values between 15ml/min - 29ml/min in the last 90 days based on the new 2021 CKD-EPI creatinine race-free equation), using pilot data from current works and the MOST framework for intervention development and testing. A pilot 2X2X2 factorial trial to assess the stakeholder-informed individual components to evaluate feasibility, acceptability, and preliminary component efficacy with 64 stage 4 CKD dyads (128 individuals) randomized to 1 of 8 experimental conditions. Tentative intervention components include 1) caregiver coaching on effective decision support (1 vs. 3 sessions); 2) caregiver decision support communication training (1 session vs. none); and 3) patient social support effectiveness psychoeducation (yes vs. no).

The research specific aims (SA) are to:

SA 1. Determine acceptability \& feasibility of the refined intervention components in a sample of 64 dyads over 24 weeks using a pilot factorial design. Feasibility: Completion of ≥75% of intervention session \&; data collection completion and the results of the feasibility of intervention measure. Acceptability: Post-intervention acceptability interviews, acceptability of intervention measure, and intervention appropriateness measure.

SA 2. Explore the preliminary efficacy of individual intervention components on patient and caregiver outcomes over 24 weeks, including patient-reported decisional conflict using the Decision Conflict Scale (primary). Secondary outcomes: Patients: a) social support effectiveness (Social Support Effectiveness Scale), b) distress (Hospital Anxiety and Depression Scale), c) quality of life (Kidney Disease Quality of Life 36-item short-form \[KDQOL-36\]) Caregivers: a) distress (Hospital Anxiety and Depression Scale), b) quality of life (PROMIS Global 10) Both: dyadic interaction (Dyadic Coping Inventory).

Eligibility criteria: Inclusion Criteria:

* Patients

  1. Age ≥18;
  2. EMR documented diagnosis of stage 4 CKD (2 eGFR 29-15 within 90 days);
  3. Ability to speak and read English and complete baseline questionnaires;
  4. Patients must have an enrolled caregiver

Exclusion Criteria:

* Patients

  1. Receiving hospice;
  2. Receiving dialysis;
  3. Medical record documentation of active unmedicated severe mental illness, moderate-severe dementia, suicidal ideation, uncorrected hearing loss, and active substance abuse.

Inclusion Criteria:

* Caregivers

  1. Age ≥18;
  2. Self-endorsing or identified by the patient as a relative, friend, or partner that has a close relationship with you and who assists you with your medical decisions and who may or may not live in the same residence as you and who is not paid for their help
  3. Caring for a patient with CKD;
  4. Ability to speak and read English and complete baseline questionnaires;
  5. Caregivers must have an enrolled patient.

Exclusion Criteria:

* Caregivers 1) Self-reported unmedicated mental illness, Moderate-severe dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse ascertained by scripted study introduction questioning.

Primary outcomes:
measure: Acceptability of Intervention Measure
timeFrame: 12 weeks
measure: Intervention Appropriateness Measure
timeFrame: 12 weeks
measure: Feasibility of Intervention
timeFrame: 12 weeks after baseline
measure: Feasibility of Data Collection
timeFrame: baseline, 12 weeks, 24 weeks after baseline
measure: Feasibility of Intervention Process
timeFrame: 12 weeks
measure: Acceptability of Intervention and Study Procedures
timeFrame: 24 weeks
Secondary outcomes:
measure: Health-related decision process for patient as measured by the Decision Conflict Scale
timeFrame: baseline, 12 weeks, and 24 weeks after baseline
measure: Health-related decision process for patient as measured by the Social Support Effectiveness- Questionnaire
timeFrame: baseline, 12 weeks, and 24 weeks after baseline
measure: Patient and Caregiver well-being/distress as measured by the Hospital Anxiety and Depression Scale
timeFrame: baseline, 12 weeks, and 24 weeks after baseline
measure: Patient wellbeing/quality of life as measured by the Kidney Disease Quality of Life Scale (KDQOL 36)
timeFrame: baseline, 12 weeks, and 24 weeks after baseline
measure: Patient and caregiver interaction as measured by the Dyadic Coping Inventory
timeFrame: baseline, 12 weeks, and 24 weeks after baseline
measure: Caregiver wellbeing/quality of life as measured by the PROMIS Global Health 10
timeFrame: baseline, 12 weeks, and 24 weeks after baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Shena Gazaway
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Shena Gazaway, PhD
role: PRINCIPAL_INVESTIGATOR
References: