Project Overview
The goal of this 12-month, 3-phase formative evaluation intervention pilot study was to create a patient component to a decision support training intervention in development for family caregivers, called ImPart (Improving Decisional Partnership of CKD Dyads). ImPart consists of two caregiver components: 1) coaching on effective decision support and 2) decision support communication training. As a part of the original intervention, patients were only to receive Ottawa Decision Guide training. After understanding through interviews with patients and caregivers that this was not enough, we undertook this study to develop a more comprehensive patient-focused component to the intervention. The purposes of the study were:
- In Phase I, to use collaborative research principles to partner with patient and caregiver stakeholder group to use previously collected interview data to adapt the caregiver decision support training for patients.
- In Phase II, to test the refined patient component in a single-arm pilot study consisting of two consecutive waves of 5 patient/caregiver dyads/waves. While only patients participated in the decisional support training, caregivers were also interviewed to explore their perceptions of the patient’s ability to be a better decisional-support partner. To ensure that diverse experiences were captured, we purposively ensured that 50% of participants identify as Black.
- In Phase III, to share the preliminary data regarding acceptability and useability and complete final refinement of the patient component.
This deposit provides the interview data from the Phase 2 acceptability interviews with CKD patients-caregivers dyads to describe their health-related decision-making experiences, needs, and challenges. These data have led to discussions about how patient training in communication could enhance the decision support partnership between the patient and caregiver. Additionally, this study was guided by an engaged, established patient and caregiver stakeholder group. Consisting of 8 members (4 patients, 4 caregivers/ 4 Black) this group has partnered with the study team since development and are committed to continue serving as their health allows in ongoing research endeavors.
By using data and engaging those who have experience in CKD we have created a more robust dyadic version of ImPart that is better designed to empower the CKD dyad, with the decisional partnership and communication skills required to navigate advanced CKD before illness decisions are necessary (stage 3B and 4) so they can: 1. contemplate the decision needed; 2. positively deal with emotions; 3. request the resources/support needed; and 4. make decisions that reflect one’s expectations, values, and preferences.
Data and Data Collection Overview Phase I (July 2022 – October 2022)
Dr. Gazaway coordinated the 8-member (4 patients, 4 caregivers/50% identifying as Black) stakeholder group. The group met via Zoom to collaborate on the adaption of the patient decisional support communication program. Meetings occurred bi-weekly for this timeframe to achieve the goals of this phase – content adaptation, treatment manual, and participant guidebook development. Phase II (November 2022 – May 2023)
Following eligibility screening, signed informed consent, and baseline data collection, a lay coach scheduled a phone-based introductory session with each patient participant. Their caregiver also was contacted to be part of the study for data collection purposes. The remaining sessions were scheduled for subsequent consecutive weeks (3 sessions over 3 weeks). After completing the structured sessions, the decisional coach contacted the patient participant for two follow-up monthly calls. The primary goal of the intervention was to enhance the caregiver-patient decision making partnership through communication skills training.
Post-completion of each wave, acceptability and useability interviews were conducted with both the patient and caregivers. There was no provision of direct medical care. The stakeholder group also met monthly during these months to receive study updates. Phase III (June 2023 – November 2023)
No new data were collected during this phase. Participant Selection
Stakeholders participating as collaborators in the study included four individuals (two CKD patients and two CKD caregivers, 50% identifying as Black). These individuals were invited from an already established patient and caregiver stakeholder group.
A convenience sample of 5 patient/caregiver dyads was recruited during Wave 1 and Wave 2 of Phase II from the UAB Nephrology Outpatient Offices (total 10 dyads). Participants were all adults (age ≥18) with at least stage 3 of higher CKD. UAB nephrologists see more than 200 CKD patients/week and the research team has working relationships with three practicing nephrologists who assisted with recruitment. As the primary purpose of this pilot was to assess the acceptability of component delivery, the sample size was not increased when participants dropped out.
The primary study outcome concerns acceptability. During Waves 1 and 2, within 4 weeks of the patient’s follow-up session, PI Gazaway and a study coordinator conducted telephone semi-structured acceptability interviews with the patient and caregiver (individually) using an interview guide developed in collaboration with the stakeholder group and based on the team’s prior work. These digitally recorded (with consent) interviews solicited feedback about all aspects of the intervention to identify areas of needed modification.
The collected recordings were transcribed by a professional company (Landmark Associates Inc.), and thematic coding was conducted by the PI and coordinator. The participant’s language was maintained in code themes and categories whenever possible. Data trustworthiness is supported through the process of member checking, whereby summarized data were presented to the stakeholder group and the PI meet regularly with her mentorship team to ensure proper reflexivity of her positionality as PI, nurse, and experienced CKD caregiver.
Project Team
- Shena Gazaway, PhD – PI and author
- Rachel Wells, PhD, RN – author
- John Haley, DNP, MDiv, APRN, FNP-BC – author
- Orlando M. Gutierrez, MD – author
- Tamara Nix-Parker, BA – study coordinator
- Isaac Martinez, BA – study coordinator
- Clare Lyas, MD – author and community advisory board member
- Katina Lang-Lindsey, PhD, LMSW – author and community advisory board member
- Richard Knight, MBA – author and community advisory board member
- Nicholas J. Odom, PhD, RN – author
Shared Data Organization
The data files consist of 25 of the 28 de-identified individual interview transcripts conducted (most of which represent patient-caregiver dyads). Each file is numbered in order, with a file name suffix designating whether the interview was with a caregiver (“CG”) or patient (“patient”). Three transcripts do not appear: Dyads 05 and 09 were administratively withdrawn after consenting because the patient participants did not start the intervention. Caregiver 11 never did the interview.
The documentation files consist of separate patient and caregiver acceptability interview questionnaires, the separate patient and caregiver consent form, this Data Narrative, and an administrative README file. The codebook developed for thematic analysis is still being finalized and will be added at a later point. |
