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Development and Initial Feasibility of a Hospital-Based Acceptance and Commitment Therapy Intervention to Improve Retention in Care for Out-of-Care Persons with HIV: Lessons Learned from an Open Pilot Trial.

ABSTRACT: Roughly 40% of persons with HIV (PWH) are not consistently involved in HIV care in the US. Finding out-of-care PWH is difficult, but hospitalization is common and presents an opportunity to re-engage PWH in outpatient care. The aims of this study were to (1) develop an Acceptance and Commitment Therapy (ACT)-based intervention for hospitalized, out-of-care PWH who endorse avoidance-coping to improve HIV treatment engagement; (2) examine the intervention’s initial feasibility and acceptability; and (3) to revise the study protocol (including the intervention), based on stakeholder feedback, in preparation for a randomized controlled trial (RCT) comparing ACT to treatment as usual. Therapists and HIV care experts developed a four-session ACT-based intervention to be delivered during hospitalization. Fifteen hospitalized patients with poorly controlled HIV enrolled in the open trial, eight completed four sessions, two completed three sessions, and seven provided qualitative feedback. Patients universally liked the intervention and the holistic approach to mental health and HIV care. Refinements included repeating key concepts, including representative graphics, and translating to Spanish. Among the patients who attended ≥3 ACT sessions, 5/10 attended a HIV-care follow-up visit and 5/7 who had labs had a viral load <20 2-months post-intervention. Next steps include conducting a randomized clinical trial exploring the impact of the refined intervention to treatment as usual on retention in care and viral load. ClinicalTrials.gov Identifier: NCT04481373.

SUBMITTER: Dindo L

PROVIDER: S-EPMC9147647 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

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Development and Initial Feasibility of a Hospital-Based Acceptance and Commitment Therapy Intervention to Improve Retention in Care for Out-of-Care Persons with HIV: Lessons Learned from an Open Pilot Trial.

Dindo Lilian L Moitra Ethan E Roddy McKenzie K MK Ratcliff Chelsea C Markham Christine C Giordano Thomas T

Journal of clinical medicine 20220517 10

Roughly 40% of persons with HIV (PWH) are not consistently involved in HIV care in the US. Finding out-of-care PWH is difficult, but hospitalization is common and presents an opportunity to re-engage PWH in outpatient care. The aims of this study were to (1) develop an Acceptance and Commitment Therapy (ACT)-based intervention for hospitalized, out-of-care PWH who endorse avoidance-coping to improve HIV treatment engagement; (2) examine the intervention’s initial feasibility and acceptability; a ...[more]

PMID: 35628955

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Project description:BackgroundSustained, routine care is vital to the health of people with HIV (PWH) and decreasing transmission of HIV. We evaluated whether the identification of PWH at-risk of falling out of care and prompts for outreach were effective in retaining PWH in care in the United States.MethodsIn this cluster randomized controlled trial, 20 AIDS Healthcare Foundation Healthcare Centers (HCCs) were randomized to the intervention (n = 10) or control (n = 10) arm; all maintained existing retention efforts. The intervention included daily automated flags in CHORUS™, a mobile app and web-based reporting solution utilizing electronic health record data, that identified PWH at-risk of falling out of care to clinic staff. Among flagged PWH, the association between the intervention and visits after a flag was assessed using logistic regression models fit with generalized estimating equations (independent correlation structure) to account for clustering. To adjust for differences between HCCs, models included geographic region, number of PWH at HCC, and proportions of PWH who self-identified as Hispanic or had the Ryan White Program as a payer.ResultsOf 15,875 PWH in care, 56% were flagged; 76% (intervention) and 75% (control) resulted in a visit, of which 76% were within 2 months of the flag. In adjusted analyses, flags had higher odds of being followed by a visit (odds ratio [OR]: 1.08, 95% confidence interval [CI]: 0.97, 1.21) or a visit within 2 months (OR: 1.07, 95% CI: 0.97, 1.17) at intervention than control HCCs. Among at-risk PWH with viral loads at baseline and study end, the proportion with < 50 copies/mL increased in both study arms, but more so at intervention (65% to 74%) than control (62% to 67%) HCCs.ConclusionDespite challenges of the COVID-19 pandemic, adding an intervention to existing retention efforts, and the reality that behavior change takes time, PWH flagged as at-risk of falling out of care were marginally more likely to return for care at intervention than control HCCs and a greater proportion achieved undetectability. Sustained use of the retention module in CHORUS™ has the potential to streamline retention efforts, retain more PWH in care, and ultimately decrease transmission of HIV.Trial registrationThe study was first registered at Clinical Trials.gov (NCT04147832, https://clinicaltrials.gov/show/NCT04147832 ) on 01/11/2019.

Project description:BackgroundOpportunistic recruitment in primary care is challenging due to the inherent unpredictability of incident conditions, and workload and time pressures. Many clinical trials do not recruit to target, leading to equivocal answers to research questions. Learning from the experiences of patients and recruiters to trials of incident conditions has the potential to improve recruitment and retention to future trials, thereby enhancing the quality and impact of research findings. The aim of this research was to learn from the trial experiences of UTI patients and recruiters to the Cranberry for UTI (CUTI) trial, to help plan an adequately powered trial of similar design.MethodsOne-to-one semi-structured interviews were embedded within the CUTI feasibility trial, an open-label, randomised feasibility trial of cranberry extract for symptoms of acute, uncomplicated Urinary Tract Infection (UTI) in primary care. Interviews were conducted with a sample of: CUTI trial participants; non-CUTI trial UTI patients; and, recruiters to the CUTI trial. Verbatim transcripts were analysed thematically.ResultsTwenty-six patients with UTI and eight recruiters (nurses and GPs) to the CUTI trial were interviewed. Three themes were developed around: reasons for participating in research; barriers to opportunistic recruitment; and, UTI patients' experiences of trial procedures. Recruiters found that targeted electronic prompts directed at healthcare practitioners based in clinics where patients with incident conditions were likely to present (e.g. minor illness clinic) were more effective than generic prompts (e.g. desk prompts) at filtering patients from their usual clinical pathway to research clinics. Using a script to explain the delayed antibiotic trial group to patients was found to be helpful, and may have served to boost recruitment. For UTI patients, using an electronic diary to rate their symptoms was considered an acceptable medium, and often preferable to using a paper diary or mobile phone application.ConclusionsThe use of targeted prompts directed at clinicians, a script to explain trial groups that may be deemed less desirable, and an appropriate diary format for patient-reported outcomes, may help to improve trial recruitment and retention.

Project description:IntroductionExcessive alcohol consumption is a leading global risk factor for ill-health and premature death. Digital alcohol interventions can be effective at reducing alcohol consumption, but their widespread adoption is lagging behind. This study aimed to identify factors promoting or inhibiting the implementation of a digital alcohol intervention in Norwegian primary care, by using Normalization Process Theory (NPT).MethodsA mixed methods feasibility study combining quantitative and qualitative methods. A digital alcohol intervention called "Endre" was implemented across four GP practices in Stavanger and Oslo. Usage of the intervention was logged on the digital platform. General practitioners (GPs) reported their perceived uptake of the intervention via a web-based survey. The Normalization MeAsure Development (NoMAD) survey was used to measure support staff's perceived normalization of the intervention. Qualitative data were analyzed using the NPT framework, with quantitative data analyzed descriptively and using χ 2 and Wilcoxon signed-rank test for differences in current and future normalization.ResultsThirty-seven GPs worked in the clinics and could recruit patients for the digital intervention. Thirty-six patients registered for the intervention. Nine patients dropped out early and 25 completed the intervention as intended. Low normalization scores at follow-up (n = 27) indicated that Endre did not become fully embedded in and across practices. Nonetheless, staff felt somewhat confident about their use of Endre and thought it may become a more integral part of their work in the future. Findings from six semi-structured group interviews suggested that limited implementation success may have been due to a lack of tailored implementation support, staff's lack of involvement, their diminished trust in Endre, and a lack of feedback on intervention usage. The outbreak of the Covid-19 pandemic further limited opportunities for GPs to use Endre.ConclusionThis study investigated the real-world challenges of implementing a digital alcohol intervention in routine clinical practice. Future research should involve support staff in both the development and implementation of digital solutions to maximize compatibility with professional workflows and needs. Integration of digital solutions may further be improved by including features such as dashboards that enable clinicians to access and monitor patient progress and self-reported outcomes.

Project description:BackgroundMyDiabetesPlan is a web-based, interactive patient decision aid that facilitates patient-centred, diabetes-specific, goal-setting and shared decision-making (SDM) with interprofessional health care teams.ObjectiveAssess the feasibility of (1) conducting a cluster randomized controlled trial (RCT) and (2) integrating MyDiabetesPlan into interprofessional primary care clinics.MethodsWe conducted a cluster RCT in 10 interprofessional primary care clinics with patients living with diabetes and at least two other comorbidities; half of the clinics were assigned to MyDiabetesPlan and half were assigned to usual care. To assess recruitment, retention, and resource use, we used RCT conduct logs and financial account summaries. To assess intervention fidelity, we used RCT conduct logs and website usage logs. To identify barriers and facilitators to integration of MyDiabetesPlan into clinical care across the IP team, we used audiotapes of clinical encounters in the intervention groups.ResultsOne thousand five hundred and ninety-seven potentially eligible patients were identified through searches of electronic medical records, of which 1113 patients met the eligibility criteria upon detailed chart review. A total of 425 patients were randomly selected; of these, 213 were able to participate and were allocated (intervention: n = 102; control: n = 111), for a recruitment rate of 50.1%. One hundred and fifty-one patients completed the study, for a retention rate of 70.9%. A total of 5745 personnel-hours and $6104 CAD were attributed to recruitment and retention activities. A total of 179 appointments occurred (out of 204 expected appointments-two per participant over the 12-month study period; 87.7%). Forty (36%), 25 (23%), and 32 (29%) patients completed MyDiabetesPlan at least twice, once, and zero times, respectively. Mean time for completion of MyDiabetesPlan by the clinician and the patient during initial appointments was 37 min. From the clinical encounter transcripts, we identified diverse strategies used by clinicians and patients to integrate MyDiabetesPlan into the appointment, characterized by rapport building and individualization. Barriers to use included clinician-related, patient-related, and technical factors.ConclusionAn interprofessional approach to SDM using a decision aid was feasible. Lower than expected numbers of diabetes-specific appointments and use of MyDiabetesPlan were observed. Addressing facilitators and barriers identified in this study will promote more seamless integration into clinical care. Trial registration Clinicaltrials.gov Identifier: NCT02379078. Date of Registration: February 11, 2015. Protocol version: Version 1; February 26, 2015.

Project description:BackgroundMotor neuron disease (MND) is a fatal, progressive neurodegenerative disease that causes progressive weakening and wasting of limb, bulbar, thoracic and abdominal muscles. Clear evidence-based guidance on how psychological distress should be managed in people living with MND (plwMND) is lacking. Acceptance and Commitment Therapy (ACT) is a form of psychological therapy that may be particularly suitable for this population. However, to the authors' knowledge, no study to date has evaluated ACT for plwMND. Consequently, the primary aim of this uncontrolled feasibility study was to examine the feasibility and acceptability of ACT for improving the psychological health of plwMND.MethodsPlwMND aged ≥ 18 years were recruited from 10 UK MND Care Centres/Clinics. Participants received up to 8 one-to-one ACT sessions, developed specifically for plwMND, plus usual care. Co-primary feasibility and acceptability outcomes were uptake (≥ 80% of the target sample [N = 28] recruited) and initial engagement with the intervention (≥ 70% completing ≥ 2 sessions). Secondary outcomes included measures of quality of life, anxiety, depression, disease-related functioning, health status and psychological flexibility in plwMND and quality of life and burden in caregivers. Outcomes were assessed at baseline and 6 months.ResultsBoth a priori indicators of success were met: 29 plwMND (104%) were recruited and 76% (22/29) attended ≥ 2 sessions. Attrition at 6-months was higher than anticipated (8/29, 28%), but only two dropouts were due to lack of acceptability of the intervention. Acceptability was further supported by good satisfaction with therapy and session attendance. Data were possibly suggestive of small improvements in anxiety and psychological quality of life from baseline to 6 months in plwMND, despite a small but expected deterioration in disease-related functioning and health status.ConclusionsThere was good evidence of acceptability and feasibility. Limitations included the lack of a control group and small sample size, which complicate interpretation of findings. A fully powered RCT to evaluate the clinical and cost-effectiveness of ACT for plwMND is underway.Trial registrationThe study was pre-registered with the ISRCTN Registry (ISRCTN12655391).

Dataset Information

Development and Initial Feasibility of a Hospital-Based Acceptance and Commitment Therapy Intervention to Improve Retention in Care for Out-of-Care Persons with HIV: Lessons Learned from an Open Pilot Trial.

Publications

Development and Initial Feasibility of a Hospital-Based Acceptance and Commitment Therapy Intervention to Improve Retention in Care for Out-of-Care Persons with HIV: Lessons Learned from an Open Pilot Trial.

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