Pilot trials in health-related behavioral intervention research: Problems, solutions, and recommendations.

Freedland, Kenneth E.

doi:10.1037/hea0000946

Cited by 51 publications

(50 citation statements)

References 62 publications

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“…This pilot study aimed to establish the feasibility and acceptability of Khanya, examined using descriptive statistics (means and standard deviations) of implementation outcomes. The study sample size followed recommendations for pilot studies [48,49]. Effectiveness outcomes were examined using multilevel modelling to account for repeated measurements [50].…”

Section: Data Analytic Planmentioning

confidence: 99%

Project Khanya: results from a pilot randomized type 1 hybrid effectiveness‐implementation trial of a peer‐delivered behavioural intervention for ART adherence and substance use in HIV care in South Africa

et al. 2021

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Introduction South Africa (SA) has the highest number of people living with HIV (PLWH) globally, and a significant burden of alcohol and other drug use (AOD). Although integrating AOD treatment into HIV care may improve antiretroviral therapy (ART) adherence, this is not typically routine practice in SA or other low‐resource settings. Identifying interventions that are feasible and acceptable for implementation is critical to improve HIV and AOD outcomes. Methods A pilot randomized hybrid type 1 effectiveness‐implementation trial (N = 61) was conducted to evaluate the feasibility and acceptability of Khanya, a task‐shared, peer‐delivered behavioral intervention to improve ART adherence and reduce AOD in HIV care in SA. Khanya was compared to enhanced treatment as usual (ETAU), a facilitated referral to on‐site AOD treatment. Implementation outcomes, defined by Proctor’s model, included feasibility, acceptability, appropriateness and fidelity. Primary pilot effectiveness outcomes were ART adherence at post‐treatment (three months) measured via real‐time electronic adherence monitoring, and AOD measured using biomarker and self‐report assessments over six months. Data collection was conducted from August 2018 to April 2020. Results and discussion Ninety‐one percent of participants (n = 56) were retained at six months. The intervention was highly feasible, acceptable, appropriate and delivered with fidelity (>90% of components delivered as intended by the peer). There was a significant treatment‐by‐time interaction for ART adherence (estimate = −0.287 [95% CI = −0.507, −0.066]), revealing a 6.4 percentage point increase in ART adherence in Khanya, and a 22.3 percentage point decline in ETAU. Both groups evidenced significant reductions in alcohol use measured using phosphatidylethanol (PEth) (F(2,101) = 4.16, p = 0.01), significantly decreased likelihood of self‐reported moderate or severe AOD (F(2,104) = 7.02, p = 0.001), and significant declines in alcohol use quantity on the timeline follow‐back (F(2,102) = 21.53, p < 0.001). Among individuals using drugs and alcohol, there was a greater reduction in alcohol use quantity in Khanya compared to ETAU over six months (F(2,31) = 3.28, p = 0.05). Conclusions Results of this pilot trial provide initial evidence of the feasibility and acceptability of the Khanya intervention for improving adherence in an underserved group at high risk for ongoing ART non‐adherence and HIV transmission. Implementation results suggest that peers may be a potential strategy to extend task‐sharing models for behavioral health in resource‐limited, global settings.

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Section: Data Analytic Planmentioning

confidence: 99%

Project Khanya: results from a pilot randomized type 1 hybrid effectiveness‐implementation trial of a peer‐delivered behavioural intervention for ART adherence and substance use in HIV care in South Africa

et al. 2021

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“…Bober) reviewed these codes, with consensus achieved through discussion. As per recent recommendations, 35 preliminary outcome data were analyzed descriptively, with 95% confidence intervals calculated to summarize the data at the 2 assessments. A sample size of 30 clinicians completing the study was determined a priori to be adequate to achieve study objectives; this sample size was chosen to maximize the chance of correctly determining feasibility and acceptability (ie, maximize the chance of true-positive results and minimize the chance of false-positive results).…”

Section: Analytic Planmentioning

confidence: 99%

Mobile Technology-Based (mLearning) Intervention to Enhance Breast Cancer Clinicians' Communication About Sexual Health: A Pilot Trial

Reese

Zimmaro

Bober

et al. 2021

Journal of the National Comprehensive Cancer Network

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Background: Most breast cancer clinicians lack training to counsel patients about sexual concerns. The purpose of this study was to assess the feasibility, acceptability, and preliminary effects of a mobile learning (mLearning) intervention (improving Sexual Health and Augmenting Relationships through Education [iSHARE]) aimed at enhancing breast cancer clinicians’ knowledge of, beliefs about, and comfort with discussing patients’ sexual health concerns. Methods: Clinicians listened to a 2-part educational podcast series offering information on breast cancer–related sexual health concerns and effective communication on the topic, which consisted of interviews with expert guests. Intervention feasibility was assessed through rates of enrollment, retention, and intervention completion, with benchmarks of 40%, 70%, and 60%, respectively. Acceptability was assessed through program evaluations, with 75% of clinicians rating the intervention favorably (eg, relevance, satisfaction) signifying acceptability. Clinicians self-reported their knowledge about breast cancer–related sexual health concerns, beliefs (ie, self-efficacy for discussing sexual health concerns), and comfort with discussing sexual concerns measured at preintervention and postintervention. Qualitative analysis examined clinicians’ perceptions of lessons learned from the intervention. Results: A total of 32 breast cancer clinicians enrolled (46% of those invited; 97% of those who responded and screened eligible), 30 (94%) completed both the intervention and study surveys, and 80% rated the intervention favorably, demonstrating feasibility and acceptability. Results showed positive trends for improvement in clinician knowledge, beliefs, and comfort with discussing sexual health concerns. Clinicians reported key lessons learned, including taking a proactive approach to discussing sexual health concerns, normalizing the topic, addressing vaginal health, sending the message that help is available, and assessing sexual health concerns with patients from different backgrounds. Conclusions: Breast cancer clinicians were amenable to participating in the iSHARE intervention and found it useful. iSHARE showed promise for improving clinician’s knowledge and comfort discussing patients’ sexual health concerns. A larger trial is required to demonstrate efficacy. Future studies should also examine whether iSHARE can improve patient–clinician communication and address patients’ sexual concerns.

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“…Participants' feedback and comments from the post-program survey informed acceptability and opportunities for program refinement. Per recent recommendations for the reporting of preliminary data [33], means and 95% confidence intervals (CI) were used to characterize participants' levels of psychological distress, mindfulness, and self-compassion at baseline and post-program. Inter-individual differences were calculated between baseline and follow-up, and confidence intervals were obtained around these inter-individual differences.…”

Section: Analytic Planmentioning

confidence: 99%

A Telephone-Adapted Mindfulness-Based Stress Reduction Program: Preliminary Effects among Healthcare Employees

Zimmaro

Moss

Reibel

et al. 2021

Behavioral Sciences

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Healthcare employees often experience high stress and may benefit from accessible psychosocial interventions. In this pilot study, we explored preliminary feasibility, acceptability, and psychological effects of a telephone-based adaption of mindfulness-based stress reduction (MBSR) for healthcare employees. Eleven participants (M age = 49.9; 27.3% ethnic/racial minority) were enrolled in an eight-session group-based MBSR program adapted for telephone delivery. Feasibility was assessed using rates of program attrition and session completion; acceptability was explored qualitatively via participants’ responses to an open-ended item about their program experience. Participants also completed pre-and post-program assessments on psychosocial outcomes (distress (overall distress, depression, anxiety, somatization), mindfulness, and self-compassion). We characterized mean change scores, 95% confidence intervals, and effect sizes to explore preliminary program effects. With regard to preliminary feasibility, one participant dropped out prior to the intervention; of the remaining 10 participants, 90% completed at least half (≥4) of the sessions; 70% completed at least three-quarters (≥6 sessions). Feedback reflected positive experiences and included suggestions for program delivery. Participants reported reductions in distress post-program (M difference range = −5.0 to −9.4), showing medium to large effect sizes (d range = 0.68 to 1.11). Mindfulness scores increased from pre- to post-intervention (M difference range = 1.0 to 10.4), with small-to-medium effects (d range = 0.18 to 0.55). Almost all aspects of self-compassion remained stable over time, with the exception of common humanity, which increased post-program (M difference = 2.9, CI 95% 0.5 to 5.4, d = 0.91). Preliminary findings from our small pilot trial suggest that telephone-based adaptations of MBSR may be a useful mode of delivery for healthcare employees; however, larger studies are needed to provide further evidence of feasibility, acceptability, and program effects.

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Pilot trials in health-related behavioral intervention research: Problems, solutions, and recommendations.

Cited by 51 publications

References 62 publications

Project Khanya: results from a pilot randomized type 1 hybrid effectiveness‐implementation trial of a peer‐delivered behavioural intervention for ART adherence and substance use in HIV care in South Africa

Project Khanya: results from a pilot randomized type 1 hybrid effectiveness‐implementation trial of a peer‐delivered behavioural intervention for ART adherence and substance use in HIV care in South Africa

Mobile Technology-Based (mLearning) Intervention to Enhance Breast Cancer Clinicians' Communication About Sexual Health: A Pilot Trial

A Telephone-Adapted Mindfulness-Based Stress Reduction Program: Preliminary Effects among Healthcare Employees

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