Right For Me: protocol for a cluster randomised trial of two interventions for facilitating shared decision-making about contraceptive methods

Thompson, Rachel; Manski, Ruth; Donnelly, Kyla Z; Stevens, Gabrielle; Agusti, Daniela; Banach, M; Boardman, Maureen B.; Brady, Pearl; Bradt, Christina Colón; Foster, Tina; Johnson, Deborah J.; Li, Zhongze; Norsigian, Judy; Nothnagle, Melissa; Shepherd, Heather L.; Stern, Lisa; Tosteson, Tor D.; Trevena, Lyndal; Upadhya, Krishna K.; Elwyn, Glyn

doi:10.1136/bmjopen-2017-017830

Cited by 9 publications

(7 citation statements)

References 39 publications

(42 reference statements)

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“…In developing our study protocol, we performed detectable difference calculations for the primary outcome based on our anticipated capacity to enrol n=1,040 post-implementation cohort participants per trial arm during the study period and our assumption that 70% of these (i.e., n=728 post-implementation cohort participants per trial arm) would be included in the primary outcome analysis. These calculations are of lesser relevance due to changes in our analytic strategy (see Analysis) but are described in detail, along with relevant underlying assumptions, in our published study protocol (10).…”

Section: Sample Sizementioning

confidence: 99%

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Right For Me: a pragmatic multi-arm cluster randomised controlled trial of two interventions for increasing shared decision-making about contraceptive methods

Thompson

Stevens

Manski

et al. 2021

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Objectives: There is a paucity of evidence on how to facilitate shared decision-making under real-world conditions and, in particular, whether interventions should target patients, health care providers, or both groups. Our objectives were to assess the comparative effectiveness, feasibility, and acceptability of patient- and provider-targeted interventions for improving shared decision-making about contraceptive methods in a pragmatic trial that prioritised applicability to real-world care. Design: The study design was a 2X2 factorial cluster randomized controlled trial with four arms: (1) video + prompt card ("video"), (2) decision aids + training ("decision aids"), (3) dual interventions ("dual"), and (4) usual care. Clusters were 16 primary and/or reproductive health care clinics that deliver contraceptive care in the Northeast United States. Participants: Participants were people who had completed a health care visit at a participating clinic, were assigned female sex at birth, were aged 15-49 years, were able to read and write English or Spanish, and had not previously participated in the study. Participants were enrolled for 13 weeks before interventions were implemented in clinics (pre-implementation cohort) and for 26 weeks after interventions were implemented in clinics (post-implementation cohort). 5,018 participants provided data on at least one study outcome. Interventions: Interventions were a video and prompt card that encourage patients to ask three specific questions in the health care visit and a suite of decision aids on contraceptive methods and training for providers in how to use them to facilitate shared decision-making with patients in the health care visit. Main outcome measures: The primary outcome was shared decision-making about contraceptive methods. Secondary outcomes spanned psychological, behavioural, and health outcomes. All outcomes were patient-reported via surveys administered immediately, four weeks, and six months after the health care visit. Results: We did not observe any between-arm difference in the differences in shared decision-making between the pre- and post-implementation cohorts for the sample as a whole (video vs. usual care: adjusted odds ratio (AOR)=1.23 (95% confidence interval (CI): 0.82 to 1.85), p=0.80; decision aids vs. usual care: AOR=1.47 (95% CI: 0.98 to 2.18), p=0.32; dual vs. video: AOR=0.95 (95% CI: 0.64 to 1.41), p=1.00; dual vs. decision aids: AOR=0.80 (95% CI: 0.54 to 1.17), p=0.72) or for participants with adequate health literacy. Among participants with limited health literacy, the difference in shared decision-making between the pre- and post-implementation cohorts was different in the video arm from the usual care arm (AOR=2.40 (95% CI: 1.01 to 5.71), p=.047) and was also different in the decision aids arm from the usual care arm (AOR=2.65 (95% CI: 1.16 to 6.07), p=.021), however these differences were not robust to adjustment for multiple comparisons. There were no intervention effects on the secondary outcomes among all participants nor among prespecified subgroups. With respect to intervention feasibility, rates of participant-reported exposure to the relevant intervention components were 9.4% for the video arm, 31.5% for the decision aids arm, and 5.0% for the dual arm. All interventions were acceptable to most patients. Conclusions: The interventions studied are unlikely to have a meaningful population-wide impact on shared decision-making or other outcomes in real-world contraceptive care without additional strategies to promote and support implementation. Selective use of the interventions among patients with limited health literacy may be more promising and, if effective, could reduce disparities in shared decision-making. Trial registration: ClinicalTrials.gov NCT02759939.

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Section: Sample Sizementioning

confidence: 99%

“…Our third objective was to assess the feasibility of the patient-facing intervention components (operationalised as rates of participant exposure to them) and their acceptability to patients. Our specific research questions and hypotheses are provided in Appendix 1 and in our published study protocol (10).…”

Section: Introductionmentioning

confidence: 99%

Right For Me: a pragmatic multi-arm cluster randomised controlled trial of two interventions for increasing shared decision-making about contraceptive methods

Thompson

Stevens

Manski

et al. 2021

Preprint

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“…The aim of this qualitative study was to explore the feasibility and acceptability of two interventions for facilitating SDM about contraceptive methods with a particular focus on factors that influenced their implementation by clinical and administrative staff. The study was embedded within a 2 × 2 factorial cluster randomized controlled trial (RCT), the Right For Me study, and conducted in 16 primary care and reproductive healthcare clinics in the Northeast United States [19].…”

Section: Contributions To the Literaturementioning

confidence: 99%

“…This qualitative study involved semi-structured, one-onone telephone interviews with staff at clinics involved in the Right For Me trial (ClinicalTrials.gov Identifier: NCT02759939). Methods for the trial are published elsewhere [19]. This study was approved by the Dartmouth College Committee for the Protection of Human Subjects (STUDY00029945).…”

Section: Designmentioning

confidence: 99%

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Investigation of factors influencing the implementation of two shared decision-making interventions in contraceptive care: a qualitative interview study among clinical and administrative staff

et al. 2019

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Background: There is limited evidence on how to implement shared decision-making (SDM) interventions in routine practice. We conducted a qualitative study, embedded within a 2 × 2 factorial cluster randomized controlled trial, to assess the acceptability and feasibility of two interventions for facilitating SDM about contraceptive methods in primary care and family planning clinics. The two SDM interventions comprised a patient-targeted intervention (video and prompt card) and a provider-targeted intervention (encounter decision aids and training). Methods: Participants were clinical and administrative staff aged 18 years or older who worked in one of the 12 clinics in the intervention arm, had email access, and consented to being audio-recorded. Semi-structured telephone interviews were conducted upon completion of the trial. Audio recordings were transcribed verbatim. Data collection and thematic analysis were informed by the 14 domains of the Theoretical Domains Framework, which are relevant to the successful implementation of provider behaviour change interventions. Results: Interviews (n = 29) indicated that the interventions were not systematically implemented in the majority of clinics. Participants felt the interventions were aligned with their role and they had confidence in their skills to use the decision aids. However, the novelty of the interventions, especially a need to modify workflows and change behavior to use them with patients, were implementation challenges. The interventions were not deeply embedded in clinic routines and their use was threatened by lack of understanding of their purpose and effect, and staff absence or turnover. Participants from clinics that had an enthusiastic study champion or team-based organizational culture found these social supports had a positive role in implementing the interventions.

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Development and Pilot Testing of a Patient-Centered Web-Based Reproductive Decision Support Tool for Primary Care

et al. 2021

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BACKGROUND: Patient-centered counseling to help women achieve their reproductive goals is an essential yet often absent component of primary care. OBJECTIVE: We developed and piloted MyPath, a novel web-based decision support tool integrating reproductive goals assessment, information about optimizing health before pregnancy, and contraceptive decision support, for use prior to primary care visits in the Veterans Administration (VA). DESIGN: We created MyPath using best practices for decision tool development, including a conceptual framework informed by theory and user-centered design with input from patients, providers, and scientific experts. We conducted a non-randomized pilot in two VA Women's Health primary care clinics. A control group (n = 28) was recruited prior to and intervention group (n = 30) recruited after introduction of MyPath into clinics. PARTICIPANTS: Women Veterans ages 18-44 with an upcoming visit scheduled with one of eight providers. INTERVENTIONS: After recruitment of controls, providers and staff received a brief introduction to MyPath. Patients scheduled to see providers in the intervention phase used MyPath on an iPad in the waiting room prior to their visit. MAIN MEASURES: Acceptability, feasibility, discussions about pregnancy and/or contraceptive needs, and contraceptive decision quality by a survey of participants and providers. KEY RESULTS: Nearly all participants who used MyPath reported they learned new information (97%) and would recommend it to other Veterans (93%). No providers reported that MyPath significantly increased workload. A greater proportion of intervention participants reported having discussions about reproductive needs in their visit compared to controls (93% vs 68%; p = 0.02). Intervention participants also experienced greater increases in pre-/ post-visit knowledge and communication self-efficacy and a trend towards greater reduction in contraceptive decision conflict compared to controls. CONCLUSIONS: MyPath was highly acceptable to women, increased the proportion of primary care visits addressing reproductive needs, and improved decision quality without increasing providers' perceived workload. A larger randomized evaluation of effectiveness is warranted.

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Right For Me: protocol for a cluster randomised trial of two interventions for facilitating shared decision-making about contraceptive methods

Cited by 9 publications

References 39 publications

Right For Me: a pragmatic multi-arm cluster randomised controlled trial of two interventions for increasing shared decision-making about contraceptive methods

Right For Me: a pragmatic multi-arm cluster randomised controlled trial of two interventions for increasing shared decision-making about contraceptive methods

Investigation of factors influencing the implementation of two shared decision-making interventions in contraceptive care: a qualitative interview study among clinical and administrative staff

Development and Pilot Testing of a Patient-Centered Web-Based Reproductive Decision Support Tool for Primary Care

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