Transition to Adult IBD Care: A Pilot Multi-Site, Telehealth Hybrid Intervention

Abstract

Objective 

Transition to adult IBD care continues to be a challenge. Efficacious models of improving transition to adult care in the United States are lacking. We present data from a pilot, prospective, non-randomized, intervention implemented at IBD centers in the Midwest and Southeast United States.

Design and Methods 

Adolescents and young adults (AYAs; 16–20 years) with IBD and their parents completed a 4- to 5-month transition program (1 in-person group session; 4 individual telehealth sessions). Primary outcomes were feasibility (i.e., recruitment, retention, fidelity) and acceptability (i.e., program satisfaction). Secondary outcomes were changes in transition readiness, self-management skill acquisition, perceived readiness to transfer to adult care, and disease knowledge.

Results 

The study exceeded goals for recruitment (target N = 20; actual: 36) and retention (target: 80%; actual: 86.11%). On average, it took participants 20.91 ± 3.15 weeks to complete our 4- to 5-month intervention and there were no deviations from the study protocol. Participant ratings for overall program satisfaction, perceived helpfulness, and program length and format were positive. Increases in transition readiness, t(30) = 8.30, d = 1.49, p < .001, self-management skill acquisition, t(30) = 3.93, d = 0.70, p < .001, and disease knowledge, t(30) = 8.20, d = 1.58, p < .001 were noted. AYA- and parent-perceived transfer readiness also improved (p’s < .05; d’s = 0.76–1.68).

Conclusions 

This article presents feasibility and acceptability data for a 4- to 5-month transition intervention. Improvements in AYA transition readiness, self-management skill acquisition, IBD knowledge, and AYA/parent perceived transfer readiness were also observed.

Introduction

Amongst pediatric populations, transfer to adult care has been associated with poorer adherence to medical treatment (Pai & Ostendorf, 2011), increased disease severity (Annunziato et al., 2007), and undue stress for patients, families, and healthcare providers (Goodhand et al., 2010). Nearly 80% of adult gastroenterologists report inadequacies in the preparation of patients with IBD transferred from pediatrics (Sebastian et al., 2012), suggesting there is ample room for improvement in how we prepare pediatric patients to cross the bridge to adult care.

Numerous commentaries and position statements have discussed this problem (Baldassano et al., 2002; Blum et al., 1993; Hait et al., 2006; Leung et al., 2011) yet few IBD transition programs have published outcome data. In the United States, only four studies have been published, three of which were conference abstracts (Chan et al., 2013; Moulton et al., 2013; Williams et al., 2017). The only published peer-reviewed study, a one-time contact with a clinic-based transition coordinator, saw modest improvements in patients’ transition readiness and self-management skill acquisition across 1 year (Gray et al., 2019). Unfortunately, this study was retrospective and the treatment was not systematized and documented.

Among studies conducted outside of the United States, most interventions are provided toward the end of an adolescents’ time in pediatric care (Erős et al., 2020). This suggests a heavier focus on transfer (i.e., patient handoff between pediatric and adult providers) and is not consistent with recommendations from prominent societies and national organizations (American Academy of Pediatrics, American Academy of Family Physicians, & American College of Physicians-American Society of Internal Medicine, 2002) that transition programming begin early in adolescence. Furthermore, while studies conducted outside of the United States can help identify important targets of intervention, large differences between the United States healthcare system and that of other countries (e.g., privatized health insurance vs. publicly-funded health care) make it difficult to generalize models of transition interventions in Europe to the United States. Thus, because there is no “one-size-fits-all” approach to addressing transition across different health care systems, there is a critical need to develop and evaluate additional programs.

The current study presents the first-known outcome data from a prospective, manualized transition intervention delivered in the United States, the Self-Management Transition Enhancement Program (STEP). This pilot program was developed in a systematic fashion using Intervention Mapping (Bartholomew et al., 2011), a structured protocol that incorporates elements of community-based participatory research to develop theory- and evidence-based health promotion programs. STEP was co-developed through partnerships with adolescent and young adult (AYA) patients and parents, both pre- and post-transfer to adult care, and pediatric and adult health providers across a 2-year period and pilot-tested at two pediatric academic medical centers.

We present data on program feasibility and acceptability (primary outcomes) and participant transition outcomes (secondary outcomes). Feasibility was evaluated in three ways: recruitment (goal: 20 AYAs and their parents), retention (80% retention rate), and fidelity (delivery of intervention as intended). Acceptability was assessed via AYA- and parent-reported program satisfaction ratings, expecting participants to provide positive ratings (mean scores above 3—neutral) for program satisfaction, convenience, and format. We also expected moderate ratings (i.e., not too short/enough, not too long/many) for questions assessing session length and quantity. Regarding transition outcomes, we hypothesized that AYAs would demonstrate statistically significant increases in overall transition readiness, self-management skill acquisition, and IBD knowledge. We also expected both AYAs and parents to improve in their perceived readiness to transfer to adult care (i.e., transfer readiness).

Methods

Participants and Recruitment

Study procedures were approved by the institutional review boards at each site. Consent and assent were obtained prior to participation. Eligibility criteria for the study included: (a) AYA aged 16–23 years, (b) receiving care for IBD at one of the two recruitment centers (Midwest or Southeast United States), and (c) accompanied by a participating parent/legal guardian. Both sites had large catchment areas comprised of urban, suburban, and rural areas. The Midwest site services Southern Ohio, Northern Kentucky, and east Indiana. The Southeast site is the only children’s hospital in the entire state of Georgia and serves children in neighboring states. We purposefully targeted mid-to-late adolescence because certain aspects of our intervention (i.e., meeting adult providers), would be less salient to younger adolescents who were further away from transferring to adult care. Because this pilot study was focused on examining the impact of the intervention on IBD-specific skill acquisition in typically developing youth with IBD, AYAs with co-morbid chronic medical conditions and/or developmental delay were excluded. Prior to participation in the study, no AYA had previously met with an adult IBD provider.

Because there were no existing guidelines to determine sample size (i.e., no published effect sizes or data-driven cutoff scores for transition readiness), the target recruitment for this pilot trial was 20; however, the opportunity to recruit additional participants arose allowing us to recruit 36 AYAs and their parents. Recruitment occurred in three waves per site from January 2017 to June 2019. Potential participants were screened for eligibility by a research coordinator during clinic pre-visit planning meetings and using clinical registries. A member of the research team attempted to recruit potential participants by telephone or during their upcoming medical appointment. Recruitment for each intervention wave was stopped when a moderately sized group of participants (i.e., 5–8 families) had been recruited. This number was determined to be the ideal group size based on our prior intervention work.

Intervention Development and Content

STEP was developed across 2 years using principles of Intervention Mapping (Bartholomew et al., 2011). Step 1 of Intervention Mapping consists of conducting a “needs assessment” to identify the problem to be addressed by the intervention and the targets of intervention. As part of our needs assessment, we reviewed the existing literature, assessed the transition readiness of AYAs with IBD at our institution (Gray, Holbrook, et al., 2015), surveyed current IBD transition practices in the United States (Gray & Maddux, 2016), conducted focus groups with key stakeholders (Gray, Resmini, et al., 2015), examined differing stakeholder perspectives on transition in a multi-site study (Gray et al., 2018), and systematically reviewed barriers to transition in the research literature (Gray et al., 2018). Information from these studies informed our manualized intervention.

Following the needs assessment, an Advisory Board, comprised of two AYAs (one pre- and one post-transfer), their parents, and health providers from both pediatrics (one IBD nurse, one pediatric gastroenterologist) and our neighboring adult institution (one adult gastroenterologist, one IBD patient care coordinator), was formed. The Board met quarterly for 1 year with the principal investigator at the Midwest site to develop STEP.

The resulting intervention was comprised of one face-to-face group session and four individualized telehealth sessions with a transition coach (see Table I for an overview of session content). A combined group and individualized format were chosen due to information previously acquired from our focus groups (Gray, Resmini, et al., 2015). Families desired the opportunity to connect with others going through the transition process, learn from AYAs and parents who had already transferred to adult care, and meet local adult gastroenterologists. These needs were best met in a group format. At the same time, families recognized the need for individualization of the intervention and desired opportunities to discuss more sensitive information in private (e.g., AYA-specific health concerns and finances). These needs were best met in an individualized format.

Table I.

Intervention Overview

Intervention sessions	Session content
Group session (approx. 4.5 h)	Differences between pediatric and adult health care Logistical aspects of transferring to adult care Managing IBD in college and in the workplace: accommodations, legal protections, financial assistance, and other resources Breakout session: Patients: IBD basics Parents: transitioning responsibility and preparing your teen for the adult world Panel discussion with patients and parents who have transferred to adult care Meet and greet with local adult IBD physicians
Coaching session #1: IBD education (approx. 1 h)	Education on concerns raised by adult IBD providers regarding patients transferred from pediatrics Discussion of patient’s current IBD knowledge and review of patient’s correct and incorrect responses on the CCKNOW Education on patient’s specific medication regimen: class of medication, mechanisms of action, side-effects, and other important information Completion of the IBD health passport
Coaching session #2: adherence (approx. 1 h)	Discussion of importance of adherence during the transition to adult care Introduction to 5-step problem solving approach Review of barriers to adherence and identification of a current adherence barrier to target via problem solving Implementation of 5-step problem solving approach to address barrier Creation of an adherence behavioral contract
Coaching session #3: transition of responsibility (approx. 1 h)	Discussion of the importance of transition and potential benefits to the patient and parent Discussion of the impact of health privacy laws on parents’ involvement in patient’s medical care once patient reaches the age of majority Education on the expectations of adult IBD providers Discussion of different approaches to transition and their associated outcomes Evaluation of family’s current approach to transition Review of patient’s current transition readiness, including discrepancies between patient and parent report on the TRAQ Identification of a self-management task to transition responsibility from parent to patient Creation of a transition behavioral contract outlining a plan to facilitate patient independent management of identified self-management task
Coaching session #4: self-advocacy (approx. 1 h)	Discussion of the importance of self-advocacy when transitioning to adult care Practice of self-advocacy skills in a variety of role-play situations (e.g., telling IBD history to a new physician, advocating with a new physician who wants to alter a regimen, requesting academic accommodations at college, disclosing IBD to a new roommate at college). Identification of characteristics important to patient when searching for a new doctor Selection of a potential adult provider from the provider catalogue Creation of a self-advocacy contract Review of all four coaching calls and skills learned

The group intervention included 4.5 h of content and was held on a Saturday at each site. AYAs and their parents were together for most of the group sessions but were separated for a 1-h session to address AYA- and parent-specific needs. The group session ended with an opportunity to meet with local adult gastroenterologists who volunteered to attend the session.

Following the group session, each family was assigned a transition coach and participated together in four 1-h individualized, manualized sessions. All sessions were conducted by phone, scheduled at each family’s convenience, and guided by the AYA’s own data obtained during the pre-intervention assessment. For example, Session 1 focused on providing information about the AYA’s specific medications, reviewing the AYA’s correct and incorrect responses on a previously completed IBD knowledge questionnaire, and increasing the AYA’s knowledge of their own medical history by creating an IBD health passport, a printable wallet-sized medical summary (Benchimol et al., 2011).

To promote retention, families were compensated on a graduated scale: $20 for completing the baseline measures, $75 for attending all individual coaching sessions, and $30 for completing the post-intervention questionnaires.

Interventionists and Treatment Integrity

A psychologist led the group sessions and the parent-only session. Transition coaches led the AYA-only session and the coaching sessions. Transition coaches were three masters-level graduate students in a clinical psychology doctoral program. Coaches were trained by the first author to deliver the manualized intervention. Prior to delivering the intervention, all coaches underwent a structured training that included specialized readings about the medical and psychosocial concerns of pediatric patients with IBD and their families, familiarization with the treatment manual, and role-plays in which the first author modeled the intervention and the transition coaches served as mock families. Roles were then reversed, with the coaches leading mock intervention sessions and the first author observing and providing feedback. All individualized coaching sessions were audio-recorded to evaluate treatment fidelity. These recordings were reviewed by an undergraduate research assistant using a checklist customized to each coaching session to ensure that the intervention was delivered as intended.

Measures

AYAs and their parents completed study measures at home via REDCap, an online data capture platform (Harris et al., 2009), or via pen-and-paper at the study site. All measures were completed at pre- and post-intervention unless otherwise indicated.

Program Feasibility and Acceptability

Program feasibility was qualitatively evaluated by examining our ability to meet the target recruitment of 20, retain at least 80% of participants recruited, and deliver the intervention as intended (e.g., time between sessions approximately 4 weeks, time to complete study approximately 20 weeks). Program acceptability was evaluated via the Feasibility and Acceptability Questionnaire completed by AYAs and their parents at the end of the study. The FAQ has been used in our prior research (Hommel et al., 2012) to obtain participant overall satisfaction (helpfulness of program, convenience), and thoughts about length, format, and content of treatment sessions. For all but the last question, which was open-ended, participants were asked to use a 7-point Likert scale to rate their level of agreement with statements about the treatment. Responses to individual questions were examined across participants to examine acceptability of the STEP intervention.

Demographics

AYAs and parents provided sociodemographic information using a questionnaire developed for this study (pre-assessment only).

Transition Readiness

The Transition Readiness Assessment Questionnaire (TRAQ) (Wood et al., 2014) assesses pediatric patients’ readiness to transition to adult care via 20 questions focused on self-management and self-advocacy behaviors. AYAs rate their skill level using a 5-point Likert scale ranging from 1 (No, I don’t know how) to 5 (Yes, I always do this when I need to). Scores are summed to generate an overall readiness score, with higher scores indicating greater transition readiness. In addition to examining changes in total transition readiness, we also examined the intervention’s impact on the number of self-management skills each AYA had mastered (as indicated by a rating of 5). The TRAQ is among the most commonly used measures by pediatric gastroenterology healthcare providers to examine transition readiness in IBD (Gray & Maddux, 2016). It has been validated in large studies of AYAs with health conditions, including IBD, and is a reliable measure of transition readiness. Internal consistency for the current sample was good (α = .84–.86).

AYA and Parent Perceived Transfer Readiness

In addition to assessing an AYA’s mastery of independent self-management skills and disease knowledge, it is also important to consider each family’s perception of their readiness to transfer to an adult provider. This is an important, yet often overlooked variable despite the fact that parent/AYA reluctance/resistance to transfer is a major barrier encountered by pediatric gastroenterology providers (Gray & Maddux, 2016). Using a 0-to-10 scale created for this study (0 = not at all ready; 10 = completely ready), AYAs rated their own readiness to transfer to adult care and their perception of their parent’s readiness for them to transfer to adult care. Similarly, parents rated their own readiness and their perception of their child’s readiness.

IBD Knowledge

AYA IBD knowledge was assessed using the Crohn’s and Colitis Knowledge Score (CCKNOW) (Eaden et al., 1999). On this 24-item measure, respondents rate various statements about IBD as either “true,” “false,” or “don’t know.” Higher scores are associated with greater knowledge about IBD and its treatment. The CCKNOW demonstrates good internal consistency, readability, and validity. Internal consistencies for the current sample were “good” for both administrations of this measure (α = .83).

Disease Activity

Physician global assessment (PGA), a widely accepted physician-based assessment of disease activity, was obtained from the medical record. PGAs were obtained from the clinic visits within 6 months of, and closest to, the beginning and end of the intervention. Average length of time between the start of the intervention and the pre-intervention PGA was 51.71 ± 38.05 days, with 64.29% of PGAs obtained within the previous 2 months. Average length of time between the end of the intervention and the post-intervention PGA was 62.83 ± 68.38 days, with 58.62% of PGAs obtained within 2 months following study completion.

Data Analytic Plan

Descriptive statistics summarized participant demographic data. Baseline scores on all measures and AYA (i.e., age, diagnosis, age at diagnosis, disease severity, ethnicity) and parent characteristics (i.e., age, marital status, education level, income, ethnicity) were compared across recruitment sites to identify any site-specific differences that may need to be accounted for in future analyses.

Descriptive statistics summarized feasibility and acceptability data, which were compared to previously stated study goals. Paired sample t-tests examined changes in transition readiness, self-management skill acquisition, perceived transfer readiness, and IBD knowledge from pre- to post-intervention. As the first two outcome measures both come from the TRAQ, we implemented a statistical correction (p = .05/2) and the criterion level of significance was set to p < .025. We have chosen to use the TRAQ in this way in our prior research (Gray et al., 2019; Gray, Holbrook, et al., 2015) as well as the current study because each outcome is a different method of examining change. The overall transition readiness score provides a global view of an AYA’s readiness, while the examination of the number of self-management skills mastered is concrete and clinically relevant. Exploratory item-level comparisons on the TRAQ were also conducted to identify which self-management skills improved most from pre- to post-intervention in order to inform future interventions. As this was exploratory, there were no a priori hypotheses. All analyses were conducted using IBM SPSS Statistical Software, Version 24.

Results

Participant Demographics

Thirty-six AYAs, and their parents, enrolled in the study. AYA mean age was 17.36 ± 1.46 years, range 16–20 years. Consistent with the demographics of the IBD population at both recruitment sites, AYAs were primarily Caucasian (83.33%) and diagnosed with Crohn’s Disease (42.22%). As there were no significant differences between sites regarding any of the measures of interest or demographic variables, samples were collapsed prior to data analyses. Demographic data for the entire sample are presented in Table II. An expanded version of Table II, with demographics presented by study site, is available in the Supplementary Materials.

Table II.

Total Sample Demographics

	M ± SD or %
Patients (N = 36)
Age in years	17.36 ± 1.46
Gender
Male	50.00%
Female	50.00%
Ethnicity
White/Caucasian	83.33%
Black/African-American	5.56%
Asian	5.56%
Biracial	5.56%
Age at diagnosis	12.67 ± 3.57
Diagnosis
Crohn’s disease	72.22%
Ulcerative colitis	27.78%
Physician global assessment (baseline)
Quiescent	69.44%
Mild	19.44%
Moderate	5.56%
Severe	–
Missing	5.56%
Parents/caregivers
Age	49.00 ± 5.51
Relationship to patient
Mother	88.89%
Father	2.78%
Other family member	8.34%
Marital status
Single	16.67%
Married	69.44%
Other/not reported	13.89%
Ethnic background
White/Caucasian	86.11%
Black/African-American	5.56%
Hispanic	5.56%
Asian	2.78%
Highest education
High school or below	11.11%
Below 4-year college	22.22%
4-year college/university	38.89
Post-graduate education	16.67%
Unknown/not reported	11.11%
Household income
$50,000 or below	19.44%
$50,001–100,000	13.89%
$100,001–150,000	38.89%
$150,001–200,000	11.11%
Over $200,000	2.78%
Unknown/not reported	13.89%

Feasibility (Primary Outcome)

Recruitment

At the Midwestern site, 448 participants were screened for eligibility. Of these, 196 were ineligible. Of the 252 who were determined eligible, 35 were unreachable and 6 opted-out of contact. Sixty-six participants declined participation. Primary reasons for refusal were: not interested in research (50.00%), family is too busy (27.27%), family unable to comply with study requirements (16.67%), focusing on other issues (4.55%), and AYA not wanting to talk about IBD (1.52%). Once target recruitment was reached, no attempts were made to recruit remaining eligible AYAs. In total, the study team contacted 84 families and 18 participants enrolled at the Midwestern site (18/84 = 21.43% recruitment rate). Average duration of recruitment per wave was 6.72 ± 5.00 weeks (range 1–10.29). At the Southeast site, 225 participants were considered eligible for the study and for each of the three waves of recruitment, approximately 75 families received a one-time-call. Families were asked to call back if interested in the study. Because of this, information about recruitment and decliners is not available. Eighteen participants were enrolled at the Southeast site (18/225 = 8.00% recruitment rate) for a total of 36 participants (Target N = 20; overall recruitment rate: 11.65%).

Retention

Three participants from the Midwest site did not complete the intervention (2—withdrawn due to no-show at group session; 1—time constraints). At the Southeast site, two withdrew after the group session (1—lack of AYA interest, 1—loss to follow-up). In total, 31 out of 36 participants completed all parts of the intervention (86.11% retention rate; goal: 80%).

Fidelity of Implementation

On average, it took participants 20.91 ± 3.15 weeks to complete the 4- to 5-month intervention (4–5 months ≈ 17.38–21.73 weeks). Mean dose was 4.39 ± 1.55 sessions (out of 5 sessions; range 0–5) and mean time between monthly intervention sessions was 5.23 ± 1.71 weeks, slightly over our target of 4 weeks between sessions. Fidelity checks revealed there were no deviations from the treatment protocol or any adverse outcomes. Individual sessions took approximately one hour, as intended. Finally, post-intervention data collection occurred, on average, 3.16 ± 2.91 weeks following completion of the last intervention session.

Acceptability (Primary Outcome)

As seen in Table III, average parent and AYA ratings for the program’s helpfulness and convenience were above our target (mean > 3). On average, participants reported liking the group + individual format and found this format helpful (target mean > 3). Participants gave moderate ratings for length of time and number of sessions, suggesting that they did not consider the time commitment to be too short or too long.

Table III.

Acceptability Ratings

	Parent (M ± SD, range)	AYA (M ± SD, range)
Program satisfaction
1. STEP was helpful in preparing my child/me to successfully transition to adult care (0—Not at all, 6—A lot)	5.20 ± 1.00, 3–6	4.67 ± 1.12, 2–6
2. Attending the STEP program was convenient (0—Strongly Disagree, 6—Strongly Agree)	4.63 ± 1.52, 0–6	4.37 ± 1.07, 3–6
Format and length
1. I liked the group + individual session format of the STEP program (0—Strongly Disagree, 6—Strongly Agree)	5.17± 1.26, 1–6	4.27 ± 1.60, 0–6
2. I think the group + individual session format was helpful (0–Strongly Disagree, 6—Strongly Agree)	5.13 ± 1.20, 2–6	4.57 ± 1.55, 0–6
3. The length of time (half day for group session; 60 min coaching sessions) (0—Too Short, 6—Too Long)	3.43 ± 1.10, 1–6	3.83 ± 1.15, 1–6
4. The number of sessions (i.e., 5 sessions: 1 group and 4 individual) (0—Not Enough, 6—Too Many)	2.77 ± 0.82, 0–4	3.13 ± 0.82, 2–5

Regarding suggestions for topics that should be removed or added, most parents provided praise for the program and/or had no recommendations (N = 21). Other recommendations were grouped into three major categories: (a) Finances and insurance (i.e., resources at state-level or private insurance, how to obtain insurance and maintain it as an adult; N = 3), (b) Lifestyle and psychosocial issues (e.g., mental health/emotional issues, emphasizing daily exercise, talking with peers who have IBD, how to transition from high school to college), and (c) Other (expanding directory of adult GI providers to cover a larger area, managing medical records and advance directives, and letting topics be driven by parent/AYA perceptions of need).

Most adolescents made positive comments about the program and had no recommendations (N = 13). Their recommendations were grouped into four categories: (a) Finances and insurance (i.e., how insurance works, what it covers, N = 5), (b) Medical information (i.e., the prognosis of IBD in adulthood, education on medical terminology, more information about medications and side-effects, what to do in a medical emergency, N = 4), (c) Lifestyle and psychosocial issues (i.e., adding topics for homeschooling families, mental health, obtaining disability accommodations in college; exploring worries about the transition to adult care), and (d) Communicating with physicians (i.e., how to follow up on lab tests/results, requiring participants to call their physician on their own, additional training on assertiveness with physicians).

Transition Outcomes (Secondary Outcomes)

Correlations between outcome measures are presented in Table IV (Supplementary Materials). AYA age and transition readiness (pre r = .61, post r = .37, p’s < .05) and age and parent perception of their AYA’s readiness to transfer to adult care (pre r = .38, post r = .43, p’s < .05) were significantly associated. No other demographics were associated with outcomes.

Transition Readiness and Skill Acquisition

Participants significantly increased in their overall transition readiness, t(30) = 8.30, d = 1.49, p <.001, and number of self-management skills mastered, t(30) = 3.93, d = 0.70, p < .001, from pre- to -post-intervention. See Table V for a summary of the data. Significant improvements were seen across every item on the TRAQ, except for four items, which had high baseline scores: taking medicine on own, telling doctor/nurse what they are feeling, answering questions by doctors, preparing meals/food.

Table V.

Summary of Pre-to-Post Changes in Transition Outcomes

	Pre-intervention (M ± SD, range)	Post-intervention (M ± SD, range)
Outcome
Transition readiness	68.95 ± 11.32, 41–88	81.58 ± 8.97, 60–95
Number of skills mastered	6.13 ± 3.82, 0–14	9.32 ± 3.56, 3–18
Parent report of readiness to transfer
Own readiness	3.29 ± 2.78, 0–8	7.55 ± 1.67, 2–10
AYA readiness	3.87 ± 3.05, 0–9	6.90 ± 2.15, 0–10
AYA report of readiness to transfer
Own readiness	4.94 ± 2.63, 0–10	7.50 ± 1.46, 3–10
Parent readiness	5.23 ± 2.84, 0–10	7.57 ± 1.59, 3–10
IBD knowledge	8.35 ± 3.80, 1–17	13.94 ± 4.83, 4–22

Note: All pre-post changes above significant at the p < .001 level.

Perceived Transfer Readiness

Parent perceptions of their own readiness for their child to transfer to adult care significantly improved, t(30) = 9.37, d = 1.68, p < .001, as did their perception of their child’s own readiness, t(30) = 6.06, d = 1.09, p < .001. Similarly, AYAs reported that both they and their parents were more ready for transfer after the intervention, t(29) = 5.68, d = 0.76, p < .001 and t(29) = 4.19, d = 1.05, p < .001.

IBD Knowledge

AYA IBD knowledge significantly increased from pre- to post-intervention, t(30) = 8.20, d = 1.58, p < .001.

Discussion

The current study presents data from an IBD-specific transition intervention developed in the United States. This intervention was systematically crafted across several years using empirically-based methods and was heavily informed by pre- and post-transfer AYAs and parents, and pediatric and adult IBD providers. What resulted from this iterative process was an intervention consisting of one group session and four individualized coaching sessions, each 1 month apart.

Overall, the study demonstrated adequate feasibility and acceptability. We were able to meet our target recruitment, retention, and fidelity goals. However, it is important to note that the program was offered to many families who did not participate for various reasons. Overall, participant retention was high and there was no common theme regarding reasons for study withdrawal. The intervention was implemented as intended regarding session content, the spacing of sessions, and overall session length. Participants generally felt that the program was helpful, convenient, and about the right length and duration. Acceptability ratings may be due to the involvement of parents and AYAs with IBD in the development of the program. Indeed, these individuals provided valuable insight that shaped the resulting program content and format.

Participants in the study provided additional recommendations worth considering. A common theme across parents and AYAs was the desire for more information about insurance and finances related to IBD. These are topics that need to be expanded in future iterations of STEP. Both parents and AYAs also recommended incorporating more psychosocial issues into the program, such as mental health issues and other important life transitions, such as how to prepare for the transition from high school to college. This program was heavily focused on education and skill building and mental health was not directly addressed in the program. However, we feel it is an important topic to address in future iterations of STEP.

AYAs uniquely expressed the desire for more medical information and additional guidance and practice with communicating with their physician. Although an IBD education was provided in both the group session (general information) and coaching session #1 (personalized information), AYAs identified additional education topics worth addressing. Our intervention focused on IBD education in the here-and-now, not in the future. It is understandable that AYAs with IBD might worry about the prognosis of their illness and careful attention should be given to sharing what information is known about this topic with the caveat that much remains unknown and is the subject of ongoing population-based studies. Communicating with physicians, through applied exercises, is an excellent recommendation that we plan to incorporate into our future work. AYAs want to improve their ability to communicate with their physicians. Sharing resources, such as those found at TeensHealth from Nemours (https://kidshealth.org/en/teens/talk-doctor.html), and incorporating applied exercises through phone calls with providers and time spent alone with providers during clinic visits may help to strengthen AYA skills and comfort communicating with providers. Although meeting alone with providers was recommended to participants by AYAs and parents who had already transferred to adult care, this was not a standard practice at either medical center during this study.

Regarding transition outcomes, significant improvements were seen in transition readiness, self-management skill acquisition, parent and AYA perceived transfer readiness, and IBD knowledge. Several aspects of this intervention were designed to target the uncertainty/lack of information AYAs and parents cited as a major concern of transferring to adult care (Gray, Resmini, et al., 2015). Families received education on the differences between pediatric and adult care, with an emphasis on the benefits of the adult care system. They also had the opportunity to learn from AYAs and parents who had already transferred to adult care. Finally, they were given the opportunity to meet with local adult gastroenterologists. These features of the program were aimed at minimizing the “unknowns” of the adult care system and all these components in sum likely contributed to improved perceptions of transfer readiness. At the beginning of our study, a validated measure of IBD knowledge in AYAs with IBD had not been published. Since this time, a number of pediatric-specific measures have been presented in the literature, including the IBD-KID (Haaland et al., 2014) and the IBD KNOW-IT (Maddux et al., 2020). Future studies should make use of knowledge measures specifically developed for pediatric populations.

Study Strengths and Limitations

This study had several strengths and limitations. Regarding strengths, the intervention was systematically developed using Intervention Mapping. The mix of group and individual format allowed for features of the intervention not typically seen in clinic-only based programs while still providing personalized care. The intervention was conducted at two academic medical centers, thereby increasing generalizability. The study also had high participant retention.

Regarding limitations, this pilot study did not have a comparison control. The study sample may be a self-selected sample as families who chose to participate may have been more motivated and concerned about transition than those who did not. Additionally, compensation was given, which may have contributed to high retention as well as high completion of intervention sessions. This has important implications for both feasibility and acceptability as it is not typical to offer incentives for participation in non-research-based interventions. Although there was no formal transition program in place at either institution at the time of this study, some participants may have received informal instruction in their prior clinical care. Because of our small sample size, we were underpowered to control for correlations between AYA age and transition readiness and parent perceptions of AYA transfer readiness. Another limitation is the reach of the intervention. Although common in pediatric research, the uptake of the intervention among the eligible population was low across both sites. The most common reason for refusal was lack of interest in research. Because reasons for refusal were not further probed, we do not know what, if any, changes to the study may have improved families’ willingness to participate in research. Applying quality improvement methods in traditional controlled trials has been shown to improve recruitment and retention rates (Sauers-Ford et al., 2017). For example, refining recruitment methods in a pretrial improvement phase, monitoring recruitment failures, and actively targeting them via rapid-cycle testing of interventions may help to improve uptake in larger efficacy trials of our intervention. Finally, our study assessed self-report of transition readiness, which may be an overreport of an AYA’s actual skill acquisition. Clinician-facilitated assessments requiring AYAs to demonstrate their skills may be more accurate.

Future Directions and Clinical Implications

We have provided preliminary evidence that STEP was feasible to implement at two academic medical centers. Furthermore, families found STEP acceptable. Participants in our intervention improved on key transition outcomes in a 4- to 5-month period. National organizations (American Academy of Pediatrics, American Academy of Family Physicians, & American College of Physicians-American Society of Internal Medicine, 2002; Baldassano et al., 2002; Cooley et al., 2011; White et al., 2018), recommend introducing the concept of transition as early as age 12. We echo these recommendations and believe that elements of this program, particularly those focused on disease education and self-management, would be well-suited to implementing in early adolescence. For those AYAs diagnosed in mid-to-late adolescence (mean age of IBD diagnosis = 15 years) (Kappelman et al., 2007), a more intensive intervention, such as the one presented here, may be helpful in guiding them along an accelerated transition timeline.

In our study, interventionists were a licensed psychologist (group session) and masters-level graduate students in clinical psychology (coaching sessions). However, this does not mean that STEP cannot be implemented by other health professionals, such as physicians, nurses, or social workers. In fact, these individuals played a critical role in the development of STEP. Involving multiple professionals in the delivery of the intervention would capitalize on the unique strengths of each discipline, which may result in a richer experience for families.

To assist clinicians with implementing their transition program at other institutions, providers are encouraged to access freely available resources such as the ImproveCareNow Transfer Toolkit (available at: https://www.improvecarenow.org), the MyHealth Passport from Sick Kid’s Good to Go Transition Program (https://www.sickkids.ca/myhealthpassport/), and the Doc4Me app, which helps connect AYA patients with adult IBD providers (available on iTunes and Google Play). Finally, clinicians are encouraged to join the transition and transfer workgroups that exist within the ImproveCareNow community.

Looking toward the future of IBD transition research, we plan to leverage existing technology to automate as much of STEP as possible, thereby reducing the time and personnel needed to run the intervention. Lack of time and personnel are commonly-reported barriers to implementing transition programs (Gray & Maddux, 2016). Future research needs to demonstrate the impact of transition interventions in improving AYA health outcomes following transfer. The current intervention, due to time and funding limitations, was designed to improve AYA transition readiness in anticipation of their future transfer to adult care. Long-term follow-up of AYAs who’ve transferred to adult care is needed to evaluate the effectiveness of transition preparation.

Supplementary Data

Supplementary data can be found at: https://academic.oup.com/jpepsy.