Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease
Phase: NA
Conditions: Congenital Heart Disease
Sponsor: University of Washington

Cover Page 
 
Title: Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease 
NCT number: NCT04738474 
Document date: Sept 5, 2025 
 
Contents: 
Study Protocol 
Statistical Analysis Plan 
 
 

(Research Coordinator’s) Study Protocol <last updated 2023> 
 
 
Specific Aim: Conduct a randomized pilot clinical trial to evaluate the feasibility and 
preliminary efficacy of the PRISM intervention among patients with ACHD. 
Hypothesis: PRISM will be feasible and improve patient-reported resilience compared to 
usual care.  
  
Description of PRISM sessions: 
 
Questionnaire Elements: 
• EuroQOL Scale (EQ5D-3L): 5-item tool used to assess quality of life (QOL) as it relates to health.  
• Linear Analog Scale (LAS): Single item tool used to assess QOL on a continuous 0-100 scale. 
• Hospital Anxiety and Depression Scale (HADS): 14-item tool to assess symptoms related to anxiety 
and depression. It is not intended to diagnose these conditions.  
• Kessler-6 Psychological Distress Scale: 6-item inventory measuring the level of global psychological 
distress.  
• Advance care planning (ACP) comfort: 2- question assessment of experience and comfort with ACP 
• Connor-Davidson Resilience Scale (CD-RISC 10): 10-item measurement of inherent resiliency, 
created based on the original 25-item tool. Questions revolve around personal problem-solving and 
approaches to adversity.  
• Perceived Competence Scale (PCS): 4-item tool that asks about one’s competence in managing 
disease 
 
Domain 
Measurement Tool  
Source & Collection Time 
Patient-Centered Outcomes 
 
 
Quality of Life 
EQ5D-3L & LAS (primary)  
Patient; enrollment & 3 months 
Psychological Distress 
HADS; Kessler-6 
Patient; enrollment & 3 months 
Self-Efficacy (for health) 
PCS 
Patient; enrollment & 3 months 
ACP Comfort 
ACP assessment questions 
Patient; enrollment & 3 months 
Predictor: Resilience 
CD-RISC 10 (primary)  
Patient; enrollment & 3 months 
Effect Modifier: Health 
Status 
Independence in activities of daily living, 
presence of heart-related hospitalization in the 
last year, diagnosis of heart failure 
Electronic health record, patient; 
enrollment 
Topic 
Skills 
Format 
1. Managing Stress 
Mindfulness, Relaxation 
One-on-One, In-
Person or Video 
Chat 
2. Setting Goals 
Setting specific and realistic goals, planning for roadblocks 
3. Positive Reframing 
Recognizing and replacing negative self-talk 
4. Making Meaning  
Identifying benefits, gratitude, purpose, and legacy 
5. Advance Care Planning 
Completion of sections of Voicing My Choices™ advance care 
planning tool for adolescents and young adults 
6. Coming Together 
Discussion of what worked, plans for moving forward 
Family Meeting 
(i) Boosters/Worksheets 
Between-session tools & practice 
Individual 

Potential Confounders: 
Demographics, Social 
Determinants of Health 
Age, sex, race/ethnicity, marital status, 
education, family structure, residential 
information, heart lesion severity  
Electronic health record, patient; 
enrollment 
 
 
General Notes: 
RC will keep complete and secure study records and adhere to protocol fidelity 
RC will meet with PI weekly, Thursdays 10am, to discuss progress and any challenges; RC 
personal development goals will also be reviewed quarterly  
RC will assist in the creation of a secure electronic database and maintain data using REDcap 
 
Study Population:  
Adult (18+ years) outpatients receiving care at the UW ACHD clinic 
Patients with moderate or complex ACHD, stages C or D (stages A and B excluded; if needed, 
can expand back to stage B at a later date)    
Must be able to participate in study activities independently and in English. 
May not have another life-limiting illness or have participated in Aim 2. A life-limiting illness 
includes any illness known to be acutely terminal. Examples are cancer, Alzheimer’s dementia, 
progressive neuromuscular diseases. RC will discuss with PI if uncertain. 
If concern for cognitive impairment, patients will be screened with a six-item screening tool 
(Callahan 2002): 3-item recall [apple, table, penny], 3-item temporal orientation [day of the 
week, month, year]. 
 
Participant Enrollment:  
RC will screen electronic patient lists for ACHD outpatient clinics to identify potential study 
participants. 
RC will contact eligible patients (telephone and email), explain the study, and assess interest in 
participation using study team written and approved recruitment scripts. 
If agreeable, patients will be enrolled into the study. RC will obtain informed consent.  
Participants will be randomized to either the “intervention” (completion of PRISM) or “usual 
care” (non-directive, supportive care without PRISM) groups.  
Randomization will occur following completion of baseline study measures and in a 1:1 
ratio. The unit of randomization is the patient, and the randomization group will be the 
primary predictor of interest (PRISM or “usual care”). Group assignment will be determined 
using computerized random numbers with variable block sizes. Assignment will be provided 
to study staff in sealed, opaque, consecutively numbered envelopes (vs built into REDCap). 
Participants and the RC will not be blinded; other staff will be blinded to the extent possible  
Anticipated sample size of 60 total participants (30 per group). To achieve complete data for 60 
participants, we anticipate enrolling 86 patients, 43 in each arm. Enrollment is anticipated 
within 9 months, may be extended 2-3 months if needed. Goal is to enroll at least 7 patients 
per month to reach the 1-year maximum.  
 
Planned Enrollment Report 
Racial Categories 
Ethnic Categories 
Total 
Not Hispanic or Latino 
Hispanic or Latino 
Female 
Male 
Female 
Male 

American 
Indian/Alaska Native 
0 
1 
0 
0 
1 
Asian 
8 
8 
0 
0 
16 
Native Hawaiian or 
Other Pacific Islander 
1 
0 
0 
0 
1 
Black or African 
American 
2 
2 
1 
1 
6 
White 
24 
24 
3 
3 
54 
More than One Race 
3 
4 
0 
1 
8 
Total 
38 
38 
5 
5 
86 
 
Study Measures and Data Collection:  
RC will confirm and document contact information for study follow-up at enrollment.  
RC will deliver the baseline questionnaire to all participants. 
- Questionnaire will be completed either directly in REDCap via an emailed link, or on paper 
which will then be transcribed by study personnel into REDCap (if transcribed, will be 
double checked by another team member).  
- At least 5 telephone and email attempts will be made to obtain responses, unless patients 
opt out  
- RC will review responses within one week. If any responses suggest severe participant 
distress (HADS >16 (?) or K6 >12), RC will discuss with PI immediately. 
RC will extract additional pertinent demographic information from medical records  
- MRN 
- Age 
- Sex (Gender*) 
- Race 
- Ethnicity 
- Insurance type 
- ACHD diagnosis 
- ACHD complexity (A&P classifications) 
- Diagnosis of heart failure (or Fontan failure) 
- Cardiac hospitalization in last year 
- Diagnosis of mood or anxiety disorder (anxiety, depression, bipolar, post-traumatic stress 
disorder) 
 
Usual Care group: 
- No interim interventions apart from routine clinical care 
- Direct any study questions to the PI 
- At 3 months, RC will deliver the 3-mo questionnaire. At least 5 telephone and email 
attempts will be made to obtain responses, unless patients opt out. 
- RC will provide gift cards ($50) to participants ahead of final questionnaire completion. 
Intervention group: 
- Within 2 weeks of baseline data collection, RC will schedule an initial research visit to 
introduce PRISM and create a completion plan.  
- Patients will subsequently schedule and participate in five 30-50-minute sessions (four 
core PRISM skills sessions and one ACP session), followed by one 30-50-minute “Coming 
Together” session with patients and their caregivers. Ideally, the first session is conducted 

in person [changed Jan 2023] Sessions will occur using telephone or video chat. Each 
subsequent session will occur within 1-2 weeks of the previous session (=intervention 
completion by 3 months). At least 5 telephone and email attempts will be made to schedule 
sessions, unless patients opt out.  
- After completing PRISM, RC will deliver the 3-mo questionnaire. At least 5 telephone and 
email attempts will be made to obtain responses, unless patients opt out.  
- RC will provide gift cards ($50) to participants ahead of final questionnaire completion. 
Study-related activities (such as parking; case-by-case basis, discuss with PI) will also be 
reimbursed.  
- RC will conduct “exit interviews” with a subset of PRISM participants (discuss with PI) to 
gather feedback about the experience/intervention. A modest gift card will be provided to 
interview participants. 
- RC will keep notes on patient interactions and any feedback or comments provided during or 
related to sessions. This will occur in a separate “PRISM Memos/Feedback” document. 
 
 

Statistical Analysis Plan 
 
(As Published in Contemporary Clinical Trials, October 2024; 
https://doi.org/10.1016/j.cct.2024.107638) 
 
Our primary aim is to describe feasibility, defined by the proportion of patients who a) 
enroll in the study among those who are eligible during the recruitment period, and b) complete 
the PRISM intervention among those randomized to that arm. We anticipate 70% enrollment 
and retention rates. We will also gain insight into feasibility from a qualitative content analysis 
of transcribed exit interview data. We anticipate that transcriptions will be reviewed by two 
study team members, using an inductively developed coding matrix to identify and organize 
topics discussed. Finally, the research coordinator and PRISM coach will provide an 
assessment of feasibility from the interventionist standpoint, summarizing study conduct 
adaptations and barriers that must be addressed in future studies, or if PRISM were to be 
implemented at scale in the ACHD population.  
Additionally, we will evaluate the efficacy of the PRISM intervention to increase 
resilience in this population. We will evaluate the difference in mean resilience at 3 months 
after randomization between participants randomized to PRISM and participants randomized 
to usual care, following the intent-to-treat principle. We will adjust for resilience score at 
randomization, via a linear regression model, as resilience at randomization and 3 months later 
(after the intervention period) will likely be highly correlated and thus the adjustment will 
improve our precision. In exploratory analyses, we will evaluate the effect of the PRISM 
intervention on QOL, psychological distress, perceived competence for health care 
management, and comfort with advance care planning using analogous analyses.