Trial no.:	PACTR202506828027846	Date of Registration:	02/06/2025
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

Impact of Patient-Centered Care (PCC) Interventions on Communication, Shared Decision-Making, and Retention among Enrollees in Nigeria’s National Health Insurance Scheme: A Mixed-Methods Randomized Controlled Trial

Official scientific title

Effectiveness of Patient-Centered Care Interventions on Provider Communication, Patient Engagement, and Retention in Nigeria’s National Health Insurance Scheme: A Randomized Controlled Trial with Embedded Qualitative Component

Brief summary describing the background and objectives of the trial

Patient-Centered Care (PCC) is widely recognized for improving healthcare quality, yet its integration within Nigeria’s National Health Insurance Scheme (NHIS) remains limited due to structural inefficiencies, poor communication, and low patient engagement. Enrollee dissatisfaction has contributed to rising dropout rates, particularly among vulnerable populations. This study evaluates the effectiveness of PCC interventions—delivered through structured provider training—on improving communication, shared decision-making, and enrollee retention within NHIS-accredited facilities. Using a mixed-methods randomized controlled trial, the study investigates whether PCC-exposed patients report higher satisfaction and are more likely to remain enrolled in NHIS compared to those receiving standard care. It also explores systemic barriers to PCC implementation through qualitative interviews. The study aims to generate evidence for scalable, equity-enhancing reforms within NHIS and community-based health insurance schemes across low- and middle-income countries.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

PCC-NHIS Trial

Disease(s) or condition(s) being studied

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Education /Training

Anticipated trial start date

01/02/2021

Actual trial start date

06/04/2021

Anticipated date of last follow up

31/07/2021

Actual Last follow-up date

07/12/2021

Anticipated target sample size (number of participants)

376

Actual target sample size (number of participants)

360

Recruitment status

Completed

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification	Sealed opaque envelopes	Masking/blinding used	Outcome Assessors,Participants

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	PCC Training	Two structured training sessions totaling 6 hours, delivered once prior to intervention rollout. PCC-informed care was applied during each outpatient visit over a 12-week period, with enrollees attending an average of 2–3 visits.	12 weeks	Healthcare providers in the intervention arm received two structured PCC training sessions totaling six hours before the study (Table 1a). These sessions combined theoretical instruction with practical skill-building through interactive workshops, clinical case studies, and role-playing exercises to reinforce Patient-Centered Care (PCC) principles. Following training, PCC-informed care was implemented during each patient encounter at the Surgical Outpatient Clinic over a 12-week period. Providers consistently applied PCC strategies, including respectful communication, shared decision-making, and individualized care planning. On average, each NHIS enrollee in the intervention group attended 2–3 outpatient visits during the intervention. The PCC approach aimed to enhance communication quality, patient engagement, and retention in the National Health Insurance Scheme (NHIS).	181
Control Group	Usual Care	Not Applicable	12-weeks	The control group received standard NHIS care at the Medical Outpatient Clinic. The standard care included regular patient consultation, clinical assessment and treatments as provided under the NHIS guidelines without structured PCC-training or additional communication or decision-making enhancements. Providers in this arm did not receive any PCC training and continued delivering routine care following existing NHIS clinical protocols without additional interventions.	179	Active-Treatment of Control Group

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
Inclusion Criteria: Adults aged 18 years and above Enrolled in Nigeria’s National Health Insurance Scheme (NHIS) Received care at the selected outpatient clinic (Medical or Surgical) at least twice in the past 6 months Provided informed consent Capable of participating in interviews or survey assessments in English, Pidgin, or Igbo	Exclusion Criteria: 1. Previously exposed to formal PCC training or interventions 2. Cognitive impairment or severe psychiatric illness that hinders participation 3. Enrollees receiving only inpatient or emergency care during the study period 4. Declined consent or withdrew before data collection 5. Staff or individuals affiliated with the study team	80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s)	18 Year(s)	80 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

15/09/2021

University of Research Ethics Committee of the Ebonyi State University

Ethics Committee Address
Street address	City	Postal code	Country
Room B79/80, Emergency Complex, AEFUTHA, Abakaliki, Ebonyi State, Nigeria	Abakaliki	480231	Nigeria

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Retention likelihood	Pre-intervention at week 0 and post intervention at week 12
Secondary Outcome	Provider-Patient Communication Quality, Patient Involvement in Decision-Making, Overall Satisfaction with NHIS Services and Qualitative Outcomes (Exploratory) ,	The first two secondary outcomes were measured at both baseline, which is week 0 and endline/post intervention which is week 12. The last two secondary outcome were measured at endline which, week 12

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Alex Ekwueme Federal University Teaching Hospital	12 Nna	Abakaliki	480101	Nigeria

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Ibeneme Georgian Chiaka	33 Favour Street, Jedidiah Gardens	Centenary City Enugu	400108	Nigeria

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Ibeneme Georgian Chiaka	33 Favour Street, Jedidiah Gardens	Centenary City Enugu	400108	Nigeria	Individual

COLLABORATORS
Name	Street address	City	Postal code	Country
Gerhard Fortwengel	Expo Plaza 12, Messe Ost 30539	Hannover	30539	Germany

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Georgian Ibeneme	ibenemegeorgian@gmail.com	+2347035394761	33 Favour Street, Jedidiah Gardens
City	Postal code	Country	Position/Affiliation
Centenary City Enugu	400108	Nigeria	Lecturer I Ebonyi State University
Role	Name	Email	Phone	Street address
Public Enquiries	Chika Ugochukwu	chikaugo@yahoo.com	+2348068407836	1 College Road, University of Nigeria, Enugu Campua
City	Postal code	Country	Position/Affiliation
Enugu	410002	Nigeria	Senior Lecturer University of Nigeria
Role	Name	Email	Phone	Street address
Scientific Enquiries	Sam Ibeneme	sam.ibeneme@unn.edu.ng	+2347038138435	33 Favour Jedidiah Gardens
City	Postal code	Country	Position/Affiliation
Centenary City Enugu	400108	Nigeria	Professor University of Nigeria

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	The individual participant data (IPD) that will be shared include de-identified data underlying the reported results in the manuscript, covering primary and secondary outcomes (e.g., NHIS retention likelihood, communication quality, decision-making involvement, patient satisfaction), baseline characteristics, and relevant sociodemographic variables.	Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol	IPD and associated documents will be available six months after the manuscript's publication and will remain available for three years after publication.	Access to the IPD will be granted to qualified researchers with a methodologically sound proposal, for purposes related to replicating or extending the analyses or conducting systematic reviews or meta-analyses. Proposals should be directed to the corresponding author at sam.ibeneme@unn.edu.ng. Data requestors will need to sign a data access agreement.
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	Yes		03/05/2025
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:
Result - 08/05/2025	Result - 08/05/2025	Result - 08/05/2025	Result - 08/05/2025	Result - 08/05/2025
Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Eligibility	Age group	08/05/2025	The minimum age which is 18years is included in the range for adolescent.	Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year	Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	08/05/2025	7 participants dropped from the intervention group hence the number reduced from 188 to 181		Experimental Group, PCC Training, Two structured training sessions totaling 6 hours, delivered once prior to intervention rollout. PCC-informed care was applied during each outpatient visit over a 12-week period, with enrollees attending an average of 2–3 visits., 12 weeks, Healthcare providers in the intervention arm received two structured PCC training sessions totaling six hours before the study (Table 1a). These sessions combined theoretical instruction with practical skill-building through interactive workshops, clinical case studies, and role-playing exercises to reinforce Patient-Centered Care (PCC) principles. Following training, PCC-informed care was implemented during each patient encounter at the Surgical Outpatient Clinic over a 12-week period. Providers consistently applied PCC strategies, including respectful communication, shared decision-making, and individualized care planning. On average, each NHIS enrollee in the intervention group attended 2–3 outpatient visits during the intervention. The PCC approach aimed to enhance communication quality, patient engagement, and retention in the National Health Insurance Scheme (NHIS)., 181,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	08/05/2025	9 participants dropped from the control arm hence the reduction in number from 188 to 179	Control Group, Usual Care, Not Applicable, 12-weeks, The control group received standard NHIS care at the Medical Outpatient Clinic. The standard care included regular patient consultation, clinical assessment and treatments as provided under the NHIS guidelines without structured PCC-training or additional communication or decision-making enhancements. Providers in this arm did not receive any PCC training and continued delivering routine care following existing NHIS clinical protocols without additional interventions., 188, Active-Treatment of Control Group	Control Group, Usual Care, Not Applicable, 12-weeks, The control group received standard NHIS care at the Medical Outpatient Clinic. The standard care included regular patient consultation, clinical assessment and treatments as provided under the NHIS guidelines without structured PCC-training or additional communication or decision-making enhancements. Providers in this arm did not receive any PCC training and continued delivering routine care following existing NHIS clinical protocols without additional interventions., 179, Active-Treatment of Control Group
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	08/05/2025	Specified the week as pre-intervention and post-intervention	Primary Outcome, Retention likelihood , Week 0 and 12	Primary Outcome, Retention likelihood , Pre-intervention at week 0 and post intervention at week 12
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	08/05/2025	Clarity for the time points	Secondary Outcome, Provider-Patient Communication Quality, Patient Involvement in Decision-Making, Overall Satisfaction with NHIS Services and Qualitative Outcomes (Exploratory) , , Week 0 - 12	Secondary Outcome, Provider-Patient Communication Quality, Patient Involvement in Decision-Making, Overall Satisfaction with NHIS Services and Qualitative Outcomes (Exploratory) , , The first two secondary outcomes were measured at both baseline, which is week 0 and endline/post intervention which is week 12. The last two secondary outcome were measured at endline which, week 12
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Ethics	Ethics List	16/05/2025	Typographical Error	TRUE, University of Research Ethics Committee of the Ebonyi State University , Room B79/80, Emergency Complex, AEFUTHA, Abakaliki, Ebonyi State, Nigeria, Abakaliki, 480231, Nigeria, , 06 Apr 2021, +2349032419744, info@fethabakaliki.org, 34674_31815_4737.pdf	TRUE, University of Research Ethics Committee of the Ebonyi State University , Room B79/80, Emergency Complex, AEFUTHA, Abakaliki, Ebonyi State, Nigeria, Abakaliki, 480231, Nigeria, , 23 Jul 2019, +2349032419744, info@fethabakaliki.org, 34674_31815_4737.pdf
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Ethics	Ethics List	27/05/2025	Typographical Error	TRUE, University of Research Ethics Committee of the Ebonyi State University , Room B79/80, Emergency Complex, AEFUTHA, Abakaliki, Ebonyi State, Nigeria, Abakaliki, 480231, Nigeria, , 23 Jul 2019, +2349032419744, info@fethabakaliki.org, 34674_31815_4737.pdf	TRUE, University of Research Ethics Committee of the Ebonyi State University , Room B79/80, Emergency Complex, AEFUTHA, Abakaliki, Ebonyi State, Nigeria, Abakaliki, 480231, Nigeria, , 23 Jul 2019, +2349032419744, info@fethabakaliki.org, 34674_31815_4737.pdf
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Ethics	Ethics List	02/06/2025	PACTR Admin	TRUE, University of Research Ethics Committee of the Ebonyi State University , Room B79/80, Emergency Complex, AEFUTHA, Abakaliki, Ebonyi State, Nigeria, Abakaliki, 480231, Nigeria, , 23 Jul 2019, +2349032419744, info@fethabakaliki.org, 34674_31815_4737.pdf	TRUE, University of Research Ethics Committee of the Ebonyi State University , Room B79/80, Emergency Complex, AEFUTHA, Abakaliki, Ebonyi State, Nigeria, Abakaliki, 480231, Nigeria, , 15 Sep 2021, +2349032419744, info@fethabakaliki.org, 34674_31815_4737.pdf
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	Result Summary Pdf file1	08/05/2025	for clarity	34674_25110_1045.pdf	34674_25110_1045.pdf
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	Result Summary Pdf file 2	08/05/2025	for clarity	34674_25110_1046.pdf	34674_25110_1046.pdf
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	Result Summary Pdf file 3	08/05/2025	for clarity	34674_25110_1047.pdf	34674_25110_1047.pdf
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	Result Summary Pdf file 4	08/05/2025	for clarity	34674_25110_1048.pdf	34674_25110_1048.pdf
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	Result Summary Pdf file 5	08/05/2025	for clarity	34674_25110_1049.pdf	34674_25110_1049.pdf

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