Investigators will determine whether N-of-1 trials, as a pragmatic, participant-centered approach to medication optimization that can overcome key barriers of deprescribing, can lead to increased participant confidence regarding their preference to continue or discontinue beta-blockers in older adults with Heart Failure with Preserved Ejection Fraction (HFpEF).
Ambulatory adults age ≥ 65 years with HFpEF, according to ACC/AHA guidelines (signs and symptoms of heart failure AND ejection fraction ≥ 50%)
Taking beta-blocker
Severe aortic stenosis
Moderate-severe mitral stenosis
Constrictive pericarditis
High output HF
Crossover
Beta blocker
DrugThe intervention is a two-arm crossover withdrawal/reversal design (On \[A\] vs Off \[B\]) with up to 6 periods, each period lasting up to 6 weeks. During the On period (A), participants will be on their home beta-blocker (or highest tolerable) dose. During the Off period (B), their beta blockers will be down-titrated and subsequently discontinued (or the lowest tolerable dose). Participants will be randomized into either ABAB or BABA sequences. Other names: acebutolol, atenolol, betaxolol, bisoprolol, carvedilol, labetalol, metoprolol, metoprolol succinate, metoprolol tartrate, nadolol, nebivolol, propranolol, penbutolol, pindolol, propranolol
Beta blocker
DrugThe intervention is a two-arm crossover withdrawal/reversal design (On \[A\] vs Off \[B\]) with up to 6 periods, each period lasting up to 6 weeks. During the On period (A), participants will be on their home beta-blocker (or highest tolerable) dose. During the Off period (B), their beta blockers will be down-titrated and subsequently discontinued (or the lowest tolerable dose). Participants will be randomized into either ABAB or BABA sequences. Other names: acebutolol, atenolol, betaxolol, bisoprolol, carvedilol, labetalol, metoprolol, metoprolol succinate, metoprolol tartrate, nadolol, nebivolol, propranolol, penbutolol, pindolol, propranolol
Change in participant's confidence regarding their preference to continue or discontinue beta-blocker, as assessed by qualitative interviews
Qualitative interviews will be conducted to assess the change in confidence through their experience participating in N-of-1 trials. Directed content analysis methods will be used to develop relevant categories and themes from interview transcript data. Transcripts will be coded and analyzed by two team members, consulting additional members to establish consensus where needed. Inter-rater reliability between coders will be established using Cohen's Kappa score.
Change in participant decision-confidence, as measured by the Decisional Conflict Scale (DCS)
Measures participant perceptions of uncertainty in decision-making, factors contributing to uncertainty, and effective decision-making. A set of 16 questions with responses ranging from "strongly agree" = (0) to "strongly disagree" = (4). Scores are summed together to produce an overall score between 0 and 100. Lower scores indicate feeling informed and low decisional conflict whereas higher scores indicate feelings of uncertainty and high decisional conflict.
Features of a feasible and pragmatic protocol for deprescribing N-of-1 trials in participants with Heart Failure with Preserved Ejection Fraction, as measured by qualitative interviews.
Qualitative interviews will be conducted to assess the feasibility and acceptability of participant-facing materials and themes related to N-of-1 trials, and their experience participating in them, at each of the following time points. Directed content analysis methods will be used to develop relevant categories and themes from interview transcript data. Transcripts will be coded and analyzed by two team members, consulting additional members to establish consensus where needed. Inter-rater reliability between coders will be established using Cohen's Kappa score.
Change in participants feeling informed through an N-of-1 protocol, as measured by the Decisional Conflict sub-scale
A set of 3 items within the Decisional Conflict Scale assessing participant's sense of knowing the options available to them and their benefits. Answers range from "strongly agree" = (0) to "strongly disagree" = (4). Scores are summed together to produce an overall score between 0 (feels extremely informed) and 100 (feels extremely uninformed).
Change in participants feeling uncertainty through an N-of-1 protocol, as measured by the Decisional Conflict sub-scale
A set of 3 items within the Decisional Conflict Scale assessing how sure participants feel about making a given decision. Answers range from "strongly agree" = (0) to "strongly disagree" = (4). Scores are summed together to produce an overall score between 0 (feels extremely certain about best choice) and 100 (feels extremely uncertain about best choice).
Change in participants feeling supported through an N-of-1 protocol, as measured by the Decisional Conflict sub-scale
A set of 3 items within the Decisional Conflict Scale assessing if participant's feel supported or pressured by others when making a given decision. Answers range from "strongly agree" = (0) to "strongly disagree" = (4). Scores are summed together to produce an overall score between 0 (feels extremely supported in decision making) and 100 (feels extremely unsupported in decision making).
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Weill Medical College of Cornell University
Lead sponsor
National Institute on Aging (NIA)
Collaborator
