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

ABSTRACT: INTRODUCTION:Despite the observed and theoretical advantages of shared decision-making in a range of clinical contexts, including contraceptive care, there remains a paucity of evidence on how to facilitate its adoption. This paper describes the protocol for a study to assess the comparative effectiveness of patient-targeted and provider-targeted interventions for facilitating shared decision-making about contraceptive methods. METHODS AND ANALYSIS:We will conduct a 2×2?factorial cluster randomised controlled trial with four arms: (1) video+prompt?card, (2) decision aids+training, (3) video+prompt?card and decision aids+training and (4) usual care. The clusters will be clinics in USA that deliver contraceptive care. The participants will be people who have completed a healthcare visit at a participating clinic, were assigned female sex at birth, are aged 15-49 years, are able to read and write English or Spanish and have not previously participated in the study. The primary outcome will be shared decision-making about contraceptive methods. Secondary outcomes will be the occurrence of a conversation about contraception in the healthcare visit, satisfaction with the conversation about contraception, intended contraceptive method(s), intention to use a highly effective method, values concordance of the intended method(s), decision regret, contraceptive method(s) used, use of a highly effective method, use of the intended method(s), adherence, satisfaction with the method(s) used, unintended pregnancy and unwelcome pregnancy. We will collect study data via longitudinal patient surveys administered immediately after the healthcare visit, four weeks later and six months later. ETHICS AND DISSEMINATION:We will disseminate results via presentations at scientific and professional conferences, papers published in peer-reviewed, open-access journals and scientific and lay reports. We will also make an anonymised copy of the final participant-level dataset available to others for research purposes. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov Identifier: NCT02759939.

SUBMITTER: Thompson R

PROVIDER: S-EPMC5665222 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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

Thompson Rachel R Manski Ruth R Donnelly Kyla Z KZ Stevens Gabrielle G Agusti Daniela D Banach Michelle M Boardman Maureen B MB Brady Pearl P Colón Bradt Christina C Foster Tina T Johnson Deborah J DJ Li Zhongze Z Norsigian Judy J Nothnagle Melissa M Olson Ardis L AL Shepherd Heather L HL Stern Lisa F LF Tosteson Tor D TD Trevena Lyndal L Upadhya Krishna K KK Elwyn Glyn G

BMJ open 20171022 10

<h4>Introduction</h4>Despite the observed and theoretical advantages of shared decision-making in a range of clinical contexts, including contraceptive care, there remains a paucity of evidence on how to facilitate its adoption. This paper describes the protocol for a study to assess the comparative effectiveness of patient-targeted and provider-targeted interventions for facilitating shared decision-making about contraceptive methods.<h4>Methods and analysis</h4>We will conduct a 2×2 factorial ...[more]

PMID: 29061624

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Project description:OBJECTIVES:We explored how negative stories about long-acting reversible contraception (LARC) - defined as a firsthand negative experience with LARC shared directly with the study participant - were involved in participants' decisions about whether to use LARC following abortion, and how counseling affected the influence of negative LARC stories on contraceptive choices. STUDY DESIGN:We performed a multi-methods study, embedded within a trial examining the impact of a theory-based counseling intervention on LARC uptake post-abortion. Participants completed a baseline survey to determine the influence of negative LARC stories. We subsequently invited respondents who reported having heard negative LARC stories to participate in a semi-structured qualitative interview. We analyzed quantitative data with univariate statistics. We analyzed qualitative data using thematic content analysis. RESULTS:Among the 60 participants, 16 (27%) reported having heard negative LARC stories. Two of the 16 (13%) planned to initiate LARC prior to counseling, compared to 18 of 44 women (41%) who had not heard negative LARC stories (p=0.06). Prior to counseling, 69% of participants with negative LARC stories reported that these stories made them less likely to use LARC. In qualitative interviews with 9 women, we identified several key themes: (1) negative LARC stories deterred LARC use; (2) friends and family were valued informants; (3) potential side effects were important to LARC decision-making; and (4) positive and negative features of the counseling encounter influenced the effect of negative LARC stories. CONCLUSIONS:Negative LARC stories are common among women presenting for abortion at our institution and may influence patient uptake of these methods. Implications This study uses a multi-methods approach to examine the influence of negative stories about long-acting reversible contraception (LARC) on decision-making about LARC. These findings can help providers elicit patients' needs in contraception counseling and generate hypotheses for future counseling research.

Project description:BackgroundLow back pain is a common and disabling condition leading to large health service and societal costs. Although there are several treatment options for back pain little is known about how to improve patient choice in treatment selection. The purpose of this study was to pilot a decision support package to help people choose between low back pain treatments.MethodsThis was a single-centred pilot cluster randomised controlled trial conducted in a community physiotherapy service. We included adults with non-specific low back pain referred for physiotherapy. Intervention participants were sent an information booklet prior to their first consultation. Intervention physiotherapists were trained to enhance their skills in shared informed decision making. Those in the control arm received care as usual. The primary outcome was satisfaction with the treatment received at four months using a five-point Likert Scale dichotomised into "satisfaction" (very satisfied or somewhat satisfied) and "non-satisfaction" (neither satisfied nor dissatisfied, somewhat dissatisfied or very dissatisfied).ResultsWe recruited 148 participants. In the control arm 67% of participants were satisfied with their treatment and in the intervention arm 53%. The adjusted relative risk of being satisfied was 1.28 (95% confidence interval 0.79 to 2.09). For most secondary outcomes the trend was towards worse outcomes in the intervention group. For one measure; the Roland Morris Disability Questionnaire, this difference was clinically important (2.27, 95% confidence interval 0.08 to 4.47). Mean healthcare costs were slightly lower (£38 saving per patient) within the intervention arm but health outcomes were also less favourable (0.02 fewer QALYs); the estimated probability that the intervention would be cost-effective at an incremental threshold of £20,000 per QALY was 16%.ConclusionWe did not find that this decision support package improved satisfaction with treatment; it may have had a substantial negative effect on clinical outcome, and is very unlikely to prove cost-effective. That a decision support package might have a clinically important detrimental effect is of concern. To our knowledge this has not been observed previously. Decision support packages should be formally tested for clinical and cost-effectiveness, and safety before implementation.Trial registrationCurrent Controlled Trials ISRCTN46035546 registered on 11/02/10.

Project description:BackgroundPoor patient-provider communication, among other reasons, is a notable barrier to contraceptive decision-making among Latinas. Patient-centered approaches to contraceptive counseling that optimize communication align with shared decision-making (SDM) -which is associated with satisfaction and continued contraceptive use among various populations.ObjectiveTo examine associations of patient-provider communication and importance of SDM tenets with consistent contraceptive use among a population of Latinas.Patient involvementFormative work for this study included prior qualitative and quantitative research with Latinas who expressed the importance of patient-provider communication during contraceptive counseling and therefore were instrumental in problem definition.MethodsCross-sectional surveys were administered to Latinas ages 15-29 years. Patient-provider communication, patient-reported importance of specific SDM tenets, and consistent contraception use were measured and analyzed for associations.Results103 Latinas (mean age = 21.4) participated. 33% of participants<21 years were using contraception consistently vs. 67% for those ≥ 21 (p = 0.003). Among participants ≥ 21, consistent users reported higher communication scores compared to inconsistent users and non-users (p = 0.042). For participants< 21, consistent users were more likely than inconsistent users and non-users to report that 2 SDM tenets (discussion of contraceptive preferences and avoidance of race/ethnic-based judgement) are important (p = 0.052, 0.028, respectively).DiscussionPatient-provider communication was especially important for Latinas ≥ 21 while using an SDM approach during counseling was highly valued by those<21. Patient-centered approaches to contraceptive counseling provide opportunities to optimize healthcare delivery for this vulnerable population.Practical valueResults from this research demonstrate that patient-centered communication is highly valued by Latina study participants and is an important consideration in their contraceptive counseling. Clinicians should consider employing techniques such as SDM as they seek to provide patient-centered care during contraceptive counseling for this patient population.

Project description:OBJECTIVE:To translate an informed shared decision-making programme (ISDM-P) for patients with type 2 diabetes from a specialised diabetes centre to the primary care setting. DESIGN:Patient-blinded, two-arm multicentre, cluster randomised controlled trial of 6 months follow-up; concealed randomisation of practices after patient recruitment and acquisition of baseline data. SETTING:22 general practices providing care according to the German Disease Management Programme (DMP) for type 2 diabetes. PARTICIPANTS:279 of 363 eligible patients without myocardial infarction or stroke. INTERVENTIONS:The ISDM-P comprises a patient decision aid, a corresponding group teaching session provided by medical assistants and a structured patient-physician encounter.Control group received standard DMP care. PRIMARY AND SECONDARY OUTCOME MEASURES:Primary endpoint was patient adherence to antihypertensive or statin drug therapy by comparing prescriptions and patient-reported uptake after 6 months. Secondary endpoints included informed choice, risk knowledge (score 0-11 from 11 questions) and prioritised treatment goals of patients and doctors. RESULTS:ISDM-P: 11 practices with 151 patients; standard care: 11 practices with 128 patients; attrition rate: 3.9%. There was no difference between groups regarding the primary endpoint. Mean drug adherence rates were high for both groups (80% for antihypertensive and 91% for statin treatment). More ISDM-P patients made informed choices regarding statin intake, 34% vs 3%, OR 16.6 (95% CI 4.4 to 63.0), blood pressure control, 39% vs 3%, OR 22.2 (95% CI 5.3 to 93.3) and glycated?haemoglobin, 43% vs 3%, OR 26.0 (95% CI 6.5 to 104.8). ISDM-P patients achieved higher levels of risk knowledge, with a mean score of 6.96 vs 2.86, difference 4.06 (95% CI 2.96 to 5.17). In the ISDM-P group, agreement on prioritised treatment goals between patients and doctors was higher, with 88.5% vs 57%. CONCLUSIONS:The ISDM-P was successfully implemented in general practices. Adherence to medication was very high making improvements hardly detectable. TRIAL REGISTRATION NUMBER:ISRCTN77300204; Results.

Project description:IMPORTANCE:For antidepressants, the translation of evidence of comparative effectiveness into practice is suboptimal. This deficit directly affects outcomes and quality of care for patients with depression. To overcome this problem, we developed the Depression Medication Choice (DMC) encounter decision aid, designed to help patients and clinicians consider the available antidepressants and the extent to which they improved depression and other issues important to patients. OBJECTIVE:Estimate the effect of DMC on quality of the decision-making process and depression outcomes. DESIGN, SETTING, AND PARTICIPANTS:We conducted a cluster randomized trial of adults with moderate to severe depression considering treatment with an antidepressant. Primary care practices in 10 rural, suburban, and urban primary care practices across Minnesota and Wisconsin were randomly allocated to treatment of depression with or without use of the DMC decision aid. INTERVENTION:Depression Medication Choice, a series of cards, each highlighting the effect of the available options on an issue of importance to patients for use during face-to-face consultations. MAIN OUTCOMES AND MEASURES:Decision-making quality as judged by patient knowledge and involvement in decision making, patient and clinician decisional comfort (Decisional Conflict Scale) and satisfaction, encounter duration, medication adherence, depression symptoms, and the Patient Health Questionnaire for depression (PHQ-9). RESULTS:We enrolled 117 clinicians and 301 patients (67% women; mean [SD] age, 44 [15] years; mean [SD] PHQ-9 score, 15 [4]) into the trial. Compared with usual care (UC), use of DMC significantly improved patients' decisional comfort (DMC, 80% vs UC, 75%; P = .02), knowledge (DMC, 65% vs UC, 56%; P =?.03), satisfaction (risk ratio [RR], from 1.25 [P =?.81] to RR, 2.4 [P =?.002] depending on satisfaction domain), and involvement (DMC, 47% vs UC, 33%; P<.001). It also improved clinicians' decisional comfort (DMC, 80% vs UC, 68%; P <?.001) and satisfaction (RR, 1.64; P =?.02). There were no differences in encounter duration, medication adherence, or improvement of depression control between arms. CONCLUSIONS AND RELEVANCE:The DMC decision aid helped primary care clinicians and patients with moderate to severe depression select antidepressants together, improving the decision-making process without extending the visit. On the other hand, DMC had no discernible effect on medication adherence or depression outcomes. By translating comparative effectiveness into patient-centered care, use of DMC improved the quality of primary care for patients with depression. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT01502891.

Project description: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. CONCLUSIONS:Variation in capabilities and motivation among clinical and administrative staff, coupled with inconsistent use of the interventions in routine workflow contributed to suboptimal implementation of the interventions. Future trials may benefit by using implementation strategies that embed SDM in the organizational culture of clinical settings.

Dataset Information

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

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

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