A Web-Based Tool to Help People With Health Conditions Make Contraceptive Decisions

Official title

A Web-based Contraceptive Decision Support Tool for Individuals With Health Conditions: A Cluster Randomized Controlled Trial With Mixed Methods

Overview

Among people who do not want to get pregnant, some do not use any birth control. This is also called contraceptive nonuse. Common reasons for contraceptive nonuse include concerns about birth control safety or side effects. People with health conditions, such as diabetes or high blood pressure, also report worries about how different birth control methods might affect their health condition or medicines. The goal of this clinical trial is to learn if a web tool called My Health, My Choice helps people with health conditions understand their birth control options and choose birth control that is right for them. The study will also look at the medical safety of birth control methods that participants decide to use. The main questions it aims to answer are: • Does the My Health My Choice tool lower the number of participants who do not use any birth control method? (contraceptive nonuse) In other words, does the My Health My Choice tool increase the number of participants who use any birth control method? (contraceptive use) Participants who use the My Health, My Choice tool before a clinic visit with their clinician (Intervention Group) will be compared to participants who only go to a clinic visit with their clinician (Usual Care Group). For this study, a "clinician" is any licensed health care provider who counsels about birth control, prescribes birth control, and/or inserts birth control devices. All participants will: * Complete 4-5 online surveys that take 5-10 minutes each, over a 3 month time period * Be asked to go to a scheduled clinic visit with their health care provider * A small group of participants (about 30) will be invited to a 1 hour exit interview Participants in the intervention arm will be asked to: • Use the My Health My Choice tool before their clinic visit

Detailed description

Fourteen outpatient clinics in the United States that provide birth control services, including primary care and obstetrics and gynecology clinics, will be enrolled. Each clinic will be randomly assigned to the My Health My Choice Group (intervention group) or the Usual Care group. Only patients who receive health care at enrolled clinics are eligible for study participation.

Participants must be aged 18-49 years, read English, fertile (able to get pregnant), have at least one index health condition, characteristic or medication usage (full list of 60+ eligible conditions, characteristics, and 50+ medications available upon request); and want to talk about birth control at an upcoming clinic visit with their clinician.

Eligible participants will be enrolled over the phone. Enrolled participants will complete a baseline electronic survey about their demographics, health history, contraceptive use, and contraceptive knowledge before learning which study group they are in.

Study Activities for Participants in the Intervention Arm Only:

* Before their scheduled clinic visit, open and use the My Health My Choice tool via a password-protected weblink on a mobile device, computer * Complete a brief electronic survey about their experience using the My Health My Choice web tool.

Study Activities for All Participants:

* Go to their scheduled clinic visit with their clinician * Complete a survey shortly after the clinic visit * Complete a survey 1 month after the clinic visit * Complete a survey 3 months after the clinic visit

All surveys take about 5-10 minutes to complete. About 30 participants across all clinic sites will be asked to do an optional 1 hour exit interview by phone or teleconference.

Clinicians who provide contraceptive care, including residents who have finished their intern year, are eligible to participate. Eligible clinicians include doctors, nurse practitioners, physician assistants, and certified nurse midwives. Enrolled clinicians will complete a brief baseline and exit survey about their contraceptive counseling, the type of contraceptive methods they provide, and their contraceptive knowledge.

Activities for All Clinicians

* Complete a baseline survey * Complete an exit survey * Provide care to enrolled patients at their scheduled visits * Complete a brief survey after each visit with an enrolled patient

Activities for Clinicians in the Intervention Arm Only

• Before or during the scheduled clinic visit, open and use Clinician Version of the My Health My Choice tool via a password-protected weblink on a mobile device, computer

The Clinician Version of the My Health My Choice has information to help clinicians counsel patients with health conditions about the safety of different birth control methods. Clinicians can also review the "Birth Control Summary" of enrolled patients before or during the clinic visit.

All clinician surveys take 3-10 minutes to complete. About 30 clinician participants across all clinic sites will be asked to participate in an optional 1 hour exit interview by phone or teleconference.

After patients exit the study, an electronic health record (EHR) review will be done to find out if participants got birth control prescriptions or birth control devices during the study. The EHR review also includes checking if participants report plans to get permanent birth control (tubal sterilization for themselves or vasectomy for their partners).

The primary and secondary outcomes are patient-reported or patient-related outcomes. There are no primary or secondary outcomes for clinicians.

The study aims to enroll 725 patients and 70 clinicians (795 in total).

Interventions

• Behavioral My Health, My Choice Web-Based Contraceptive Decision Tool
  The My Health My Choice decision tool is a web-based interactive tool designed to educate patients with health conditions about their contraceptive options, elicit their personal preferences and contraceptive concerns, and help them prepare for a contraceptive discussion with their clinician. Patients can compare features of different contraceptive methods side-by-side and grouped by medical risk according to the Center for Disease Control and Prevention U.S. Medical Eligibility Criteria (US MEC
• Behavioral Usual Contraceptive Care
  Participants will attend clinic visits per routine. Clinicians proceed with usual contraceptive care. All study activities and incentives for participants in the usual contraceptive care arm are the same as for participants in the intervention arm except for those related to the intervention itself.

Primary outcome measures

• Proportion of participants who report contraceptive nonuse at 3 months [Time frame: Baseline, 1 month, and 3 months after the clinic visit]

Secondary outcome measures (1)

• Medical Eligibility Risk (MER) Category among participants who report contraceptive method use [Time frame: Baseline, 1 month, and 3 months]

Eligibility criteria

Patient Inclusion Criteria:

• Between the ages of 18 and 49
• Assigned female sex at birth, regardless of gender identity
• Presumed to be fertile (have an intact uterus/tube/ovary; premenopausal)
• Have at least one index health condition, characteristic or medication usage (full list of 60+ eligible conditions, characteristics, and 50+ medications available upon request); and want to talk about birth control at an upcoming clinic visit with their clinician
• Able to read in English
• Access to mobile phone, computer, or tablet with internet capabilities
• Not currently pregnant
• Desire to talk to their clinician about starting, switching, or adding a contraceptive method for the purpose of preventing pregnancy

Patient Exclusion Criteria:

• Trying to get pregnant in the next 12 months
• Presumed infertile for any surgical or medical reason (e.g., postmenopausal, hysterectomy, chemotherapy)

There are additional clarifications regarding patient eligibility, such as a full list of eligible medical diagnoses and medicines, that can be found in the protocol.

Clinician Inclusion Criteria:

• Any licensed clinician who provides contraceptive care at a participating clinic, including physicians, physician assistants, certified nurse midwives, nurse practitioners. (For clinicians, there are no restrictions based upon age, gender identify or sex).

Clinician Exclusion Criteria:

• Physician interns (PGY-1) are not eligible

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 18 centers

• University of Arizona College of Medicine - Phoenix Department of Family, Community and Pr — Phoenix
• Pomona Valley Hospital Medical Center — Pomona
• Full Circle Health Family Medicine Residency of Idaho - Nampa Program — Nampa
• University of Kansas Medical Center Department of Family Medicine & Community Health — Kansas City
• MaineHealth Primary Care - Family Medicine - Sanford — Sanford
• Boston Medical Center's Department of Family Medicine — Boston
• Department of Family Medicine Research Office — Ann Arbor
• Von Voigtlander Women's Hospital Obstetrics and Gynecology Clinic University of Michigan H — Ann Arbor
• … and 10 more centers

Puerto Rico · 1 center

• University of Puerto Rico Department of Obstetrics and Gynecology — San Juan

Publications

• Campbell MK, Elbourne DR, Altman DG; CONSORT group. CONSORT statement: extension to cluster randomised trials. BMJ. 2004 Mar 20;328(7441):702-8. doi: 10.1136/bmj.328.7441.702. No abstract available. PMID 15031246
• Dehlendorf C, Henderson JT, Vittinghoff E, Grumbach K, Levy K, Schmittdiel J, Lee J, Schillinger D, Steinauer J. Association of the quality of interpersonal care during family planning counseling with contraceptive use. Am J Obstet Gynecol. 2016 Jul;215(1):78.e1-9. doi: 10.1016/j.ajog.2016.01.173. Epub 2016 Jan 28. PMID 26827879
• Thompson R, Manski R, Donnelly KZ, Stevens G, Agusti D, Banach M, Boardman MB, Brady P, Colon Bradt C, Foster T, Johnson DJ, Li Z, Norsigian J, Nothnagle M, Olson AL, Shepherd HL, Stern LF, Tosteson TD, Trevena L, Upadhya KK, Elwyn G. Right For Me: protocol for a cluster randomised trial of two interventions for facilitating shared decision-making about contraceptive methods. BMJ Open. 2017 Oct 22 PMID 29061624
• Murray DM, Blistein JL. Methods to reduce the impact of intraclass correlation in group-randomized trials. Eval Rev. 2003 Feb;27(1):79-103. doi: 10.1177/0193841X02239019. PMID 12568061
• Murphy DM. Planning the Trial. Design and Analysis of Group-Randomized Trials. Oxford University Press; 1998:19-65
• Weijer C, Grimshaw JM, Eccles MP, McRae AD, White A, Brehaut JC, Taljaard M; Ottawa Ethics of Cluster Randomized Trials Consensus Group. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials. PLoS Med. 2012;9(11):e1001346. doi: 10.1371/journal.pmed.1001346. Epub 2012 Nov 20. PMID 23185138
• Stacey D, Legare F, Boland L, Lewis KB, Loiselle MC, Hoefel L, Garvelink M, O'Connor A. 20th Anniversary Ottawa Decision Support Framework: Part 3 Overview of Systematic Reviews and Updated Framework. Med Decis Making. 2020 Apr;40(3):379-398. doi: 10.1177/0272989X20911870. PMID 32428429
• Kang MM, Guetterman TC, Prussack JK, Ursu A, Wu JP. Contraceptive Care for Women With Medical Conditions: A Qualitative Study to Identify Potential Best Practices for Primary Care Physicians. Fam Med. 2019 Jul;51(7):559-566. doi: 10.22454/FamMed.2019.499467. PMID 31287901

Identifiers

NCT: NCT07075536 · HUM00234187 · 5R01HD110570-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗